The Anti-Aging and Rejuvenating Properties of Stem Cells

 

In recent years, biomedical research on topics surrounding longevity and aging has gained a tremendous amount of traction. The biotech industry as well as major pharmaceutical companies, have also jumped onto the bandwagon of discovering ways to alter and reverse the aging process. Currently, the business of anti-aging is valued at about $110 billion and is expected to expand to more than $600 billion within the next four years¹. This new obsession with anti-aging is not without good reason; global aging is a concerning phenomenon. The United Nations estimates that by 2050, there will be more than 1.5 billion people aged 65 and over². As a result, the global incidence and burden of disease of age-related diseases will follow a similar trend. Therefore, the goal of anti-aging research is not solely to extend the human lifespan but to treat or prevent age-related diseases ranging from Alzheimer’s to Parkinson’s to diabetes and cardiovascular diseases, etc.

In order to achieve these goals, many of these biotech companies are leveraging on the regenerative prowess of stem cells
³.  This comes as no surprise since human pluripotent stem cells (hPSCs) are unlimited sources of self-renewing cells that can be differentiated into any cell type. This essentially means that large quantities of healthy and young hPSC-derived cells can easily be generated for cell replacement therapy. Also, stem cell-derived exosomes have recently come under the spotlight for their anti-aging properties. In addition, the induced pluripotent stem cells (iPSCs) technology can be leveraged to reverse aging phenotypes in cells. These will be further elaborated on in this article.

 

Aging and Stem Cells Share an Intimate Relationship

Aging is a complex biological process, but research has pointed to an intimate relationship between aging and stem cells⁴. Adult stem cells are found in many different organs and tissues, but they are low in numbers. They function to regenerate damaged cells and tissues. However, their regenerative capacity declines with age. This explains why injuries in older individuals take a longer time to heal as compared to a younger person. There are several mechanisms underlying the depreciation of adult stem cell functions⁵; targeting these mechanisms head-on may be a strategy to enhance the functions of adult stem cells as we age. However, there are other alternative solutions.

Firstly, therapeutics may be designed to enhance the function or proliferation of endogenous (existing) adult stem cells. Secondly, these adult stem cells can be isolated from tissues and expanded in vitro. Although difficult, researchers have been successful in isolating and expanding certain adult stem cells^6–8. These expanded cells can subsequently be used for transplantation to enhance cellular repair and tissue regeneration. In Herrera et al.’s (2006) study ⁶, they were able to isolate adult stem cells from adult human liver and after transplanting these cells into immune-deficient mice, the stem cells were able to regenerate portions of the liver. Thirdly, hPSCs can be differentiated into different types of progenitor cells using well-defined protocols. These hPSC-derived progenitors can then be used for transplantation⁹. Post-transplantation, these cells contribute to cell repair and regeneration, similar to that of adult stem cells. Recently, a group of researchers from the University of Tehran carefully differentiated hPSCs to cardiovascular progenitors before transplanting them into a rat model of myocardial infarction (heart attack). These progenitor cells significantly improved functionalities of the heart and reduced scar tissue formation in these rats¹⁰.

Although more work has to be done on improving the methods of isolating and expanding adult stems in vitro, and differentiating hPSCs to progenitor cells to ensure that the cells are safe and effective for use in transplantation therapies, there is great promise in utilizing these strategies to delay or prevent aging and age-associated diseases.

 

Exosomes Produced from Stem Cells

Another exciting frontier lies in the anti-aging properties of stem cell-derived exosomes. Studies have shown that exosomes derived from human embryonic stem cells, mesenchymal and stromal stem cells have regenerative capabilities^11–13. Exosomes are nano-sized, membrane-bound, extra-cellular particles secreted by cells. They contain various biological materials such as nucleic acids, proteins, metabolites, and function to facilitate cell-cell communication. While the underlying mechanisms as to how exosomes promote regeneration remains to be fully elucidated, it is likely that the amalgamation of inflammatory signals, growth factors, microRNAs, long non-coding RNAs, enzymes, and proteins found in exosomes promotes and reversal of cellular senescence, thus contributing to its anti-aging properties¹¹. Stem cell-derived exosomes are currently being explored as a therapeutic option for age-related musculoskeletal disorders¹⁴. Although research on exosomes is still in the early phases, exploitation of its anti-aging effects might potentially be a safe and effective anti-aging therapeutic strategy.

 

 

Stem Cell Technology Can Rejuvenate Old Cells

Yamanaka and colleagues’ Nobel prize-winning discovery of iPSCs revolutionized stem cell research^15,16. By simply introducing key transcription factors into adult cells, they can be reprogrammed back into a pluripotent state (‘infancy’). This process is known as cellular reprogramming, and the transcription factors are collectively referred to as ‘Yamanaka factors’. Recently, researchers from Stanford University were able to exploit this cellular reprogramming technology to rejuvenate old human cells¹⁷. By introducing several factors (including Yamanaka factors) transiently into old human cells, they were able to rewind these cells to a ‘youthful’ state, while preserving the cellular identities of cells. After further analysis, these rejuvenated cells were found to be more similar to younger cells than elderly cells.

As a proof of concept, the researchers then went on to introduce the same set of factors into aged mouse-derived skeletal muscle stem cells (MuSC) and transplanted them into the muscles of aged mice. Post-transplantation, these rejuvenated MuSCs were able to restore muscle functionality of old mice to a younger state. This remarkable study has illustrated that stem cell technology has great potential in reversing aging in cells to obtain ‘youthful’ cells and these cells could be used in cell transplantation therapies to treat age-related conditions. 

 

In the Coming Years

Experts agree that stem cell science holds answers to human longevity and has great potential in treating and preventing age-related diseases¹⁸. Numerous stakeholders in the biomedical industry have invested interests in tapping on stem cells to realize these goals. In the coming years, we will be expecting more research efforts dedicated towards a deeper level of understanding, as well as further optimization of stem cell-based interventions for aging. Companies involved in utilizing this science are worth researching and learning about while this segment of biotech is yet to approach potential.

 

About the Author:  Nicole Pek is a stem cell biologist and enthusiastic science communicator.
She has worked on using human pluripotent stem cells to study cellular
development in multiple organ systems, to model complex human diseases, and
screen for therapeutics that could treat the diseases. Outside of the lab,
Nicole plays a pro-active role in communicating to the public through her
science blog ‘Two Cells’ and her education podcast ‘The Diploid Duo’.

 

Suggested Content:

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References

 

1.         Grover, N. Healthier, longer lifespans will be a reality sooner than you think, Juvenescence promises as it closes $100M round. Endpoints News https://endpts.com/healthier-longer-lifespans-will-be-a-reality-sooner-than-you-think-juvenescence-promises-as-it-closes-100m-round/.

2.         World Population Ageing 2019 Highlights.

3.         Jefferson, R. S. ‘Extraordinary’ Breakthroughs In Anti-Aging Research ‘Will Happen Faster Than People Think’. Forbes https://www.forbes.com/sites/robinseatonjefferson/2019/08/26/how-extraordinary-breakthroughs-in-anti-aging-research-will-happen-faster-than-people-think/.

4.         Ullah, M. & Sun, Z. Stem cells and anti-aging genes: double-edged sword—do the same job of life extension. Stem Cell Res Ther 9, (2018).

5.         Ahmed, A. S. I., Sheng, M. H., Wasnik, S., Baylink, D. J. & Lau, K.-H. W. Effect of aging on stem cells. World J Exp Med 7, 1–10 (2017).

6.         Herrera, M. B. et al. Isolation and characterization of a stem cell population from adult human liver. Stem Cells 24, 2840–2850 (2006).

7.         Messina, E. et al. Isolation and Expansion of Adult Cardiac Stem Cells From Human and Murine Heart. Circulation Research 95, 911–921 (2004).

8.         Mantovani, C., Terenghi, G. & Shawcross, S. G. Isolation of adult stem cells and their differentiation to Schwann cells. Methods Mol Biol 916, 47–57 (2012).

9.         Thies, R. S. & Murry, C. E. The advancement of human pluripotent stem cell-derived therapies into the clinic. Development 142, 3077–3084 (2015).

10.       Vahdat, S. et al. Expansion of Human Pluripotent Stem Cell-derived Early Cardiovascular Progenitor Cells by a Cocktail of Signaling Factors. Sci Rep
9, 16006 (2019).

11.       Ha, D. H. et al. Mesenchymal Stem/Stromal Cell-Derived Exosomes for Immunomodulatory Therapeutics and Skin Regeneration. Cells 9, (2020).

12.       Chen, B. et al. Human embryonic stem cell-derived exosomes promote pressure ulcer healing in aged mice by rejuvenating senescent endothelial cells. Stem
Cell Research & Therapy 10, 142 (2019).

13.       Newton, W. C., Kim, J. W., Luo, J. Z. Q. & Luo, L. Stem cell-derived exosomes: a novel vector for tissue repair and diabetic therapy. Journal of Molecular
Endocrinology 59, R155–R165 (2017).

14.       Yao, X.
et al. Stem cell derived exosomes: microRNA therapy for age-related musculoskeletal disorders. Biomaterials 224, 119492 (2019).

15.       Takahashi, K. & Yamanaka, S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 126, 663–676 (2006).

16.       Takahashi, K. et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell 131, 861–872 (2007).

17.       Sarkar, T. J. et al. Transient non-integrative expression of nuclear reprogramming factors promotes multifaceted amelioration of aging in human cells. Nat Commun 11, (2020).

18.       Stem Cells and Aging: What’s Next? Cell Stem Cell 16, 578–581 (2015).

 

 

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Image Credit: EU Protection & Humanitarian Aid (Flickr)

How Virus Detectives Trace the Origins of an Outbreak – and Why it’s So Tricky

 

Every time there is a major disease outbreak, one of the first questions scientists and the public ask is: “Where did this come from?”

In order to predict and prevent future pandemics like COVID-19, researchers need to find the origin of the viruses that cause them. This is not a trivial task. The origin of HIV was not clear until 20 years after it spread around the world. Scientists still don’t know the origin of Ebola, even though it has caused periodic epidemics since the 1970s.

As an expert in viral ecology, I am often asked how scientists trace the origins of a virus. In my work, I have found many new viruses and some well-known pathogens that infect wild plants without causing any disease. Plant, animal or human, the methods are largely the same. Tracking down the origins of a virus involves a combination of extensive fieldwork, thorough lab testing and quite a bit of luck.

 

Viruses Jump from Wild Animal Hosts to Humans

Many viruses and other disease agents that infect people originate in animals. These diseases are zoonotic, meaning they are caused by animal viruses that jumped to people and adapted to spread through the human population.

It might be tempting to start the viral origin search by testing sick animals at the site of the first known human infection, but wild hosts often don’t show any symptoms. Viruses and their hosts adapt to each other over time, so viruses often don’t cause obvious disease symptoms until they’ve jumped to a new host species. Researchers can’t just look for sick animals.

Another problem is that people, and their food animals aren’t stationary. The place where researchers find the first infected person is not necessarily close to the place where the virus first emerged.

In the case of COVID-19, bats were an obvious first place to look. They’re known hosts for many coronaviruses and are the probable source of other zoonotic diseases like SARS and MERS.

For SARS-CoV-2, the virus that causes COVID-19, the nearest relative scientists have found so far is BatCoV RaTG13. This virus is part of a collection of bat coronaviruses discovered in 2011 and 2012 by virologists from the Wuhan Virology Institute. The virologists were looking for SARS-related coronaviruses in bats after the SARS-CoV-1 pandemic in 2003. They collected fecal samples and throat swabs from bats at a site in Yunnan Province about 932 miles (1,500 kilometers) from the institute’s lab in Wuhan, where they brought samples back for further study.

To test whether the bat coronaviruses could spread into people, researchers infected monkey kidney cells and human tumor-derived cells with the Yunnan samples. They found that a number of the viruses from this collection could replicate in the human cells, meaning they could potentially be transmitted directly from bats to humans without an intermediate host. Bats and people don’t come into direct contact very often, however, so an intermediate host is still quite likely.

 

Finding the Nearest Relatives

The next step is to determine how closely related a suspected wildlife virus is to the one infecting humans. Scientists do this by figuring out the genetic sequence of the virus, which involves determining the order of the basic building blocks, or nucleotides, that make up the genome. The more nucleotides two genetic sequences share, the more closely related they are.

Genetic sequencing of bat coronavirus RaTG13 showed it to be over 96% identical to SARS-CoV-2. This level of similarity means that RaTG13 is a pretty close relative to SARS-CoV-2, confirming that SARS-CoV-2 probably originated in bats, but is still too distant to be a direct ancestor. There likely was another host that caught the virus from bats and passed it on to humans.

Because some of the earliest cases of COVID-19 were found in people associated with the wildlife market in Wuhan, there was speculation that a wild animal from this market was the intermediate host between bats and humans. However, researchers never found the coronavirus in animals from the market.

Likewise, when a related coronavirus was identified in pangolins confiscated in an anti-smuggling operation in southern China, many leaped to the conclusion that SARS-CoV-2 had jumped from bats to pangolins to humans. The pangolin virus was found to be only 91% identical to SARS-CoV-2, though, making it unlikely to be a direct ancestor of the human virus.

To pinpoint the origin of SARS-CoV-2, a lot more wild samples need to be collected. This is a difficult task – sampling bats is time-consuming and requires strict precautions against accidental infection. Since SARS-related coronaviruses are found in bats across Asia, including Thailand and Japan, it’s a very big haystack to search for a very small needle.

 

 

Creating a family tree for SARS-CoV-2

In order to sort out the puzzle of viral origins and movement, scientists not only have to find the missing pieces, but also figure out how they all fit together. This requires collecting viral samples from human infections and comparing those genetic sequences both to each other and to other animal-derived viruses.

To determine how these viral samples are related to each other, researchers use computer tools to construct the virus’s family tree, or phylogeny. Researchers compare the genetic sequences of each viral sample and construct relationships by aligning and ranking genetic similarities and differences.

The direct ancestor to the virus, sharing the greatest genetic similarity, could be thought of as its parent. Variants sharing that same parent sequence but with enough changes to make them distinct from each other are like siblings. In the case of SARS-CoV-2, the South African variant, B.1.351, and the U.K. variant, B.1.1.7, are siblings.

Building a family tree is complicated by the fact that different analysis parameters can give different results: The same set of genetic sequences can produce two very different family trees.

 

 

The nucleotide sequences of six fictional viruses are shown on the top. Below are two family trees of these viruses created using two different programs. The tree on the left uses only percent identity, while the tree on the right also considers whether the two sequences share similar characters. – Marilyn Roossinck, CC BY-ND

For SARS-CoV-2, phylogenetic analysis proves particularly difficult. Though tens of thousands of SARS-CoV-2 sequences are now available, they don’t differ from one another enough to form a clear picture of how they’re related to each other.

 

The Current Debate: Wild Host or Lab Spillover?

Could SARS-CoV-2 have been released from a research lab? Although current evidence implies that this is not the case, 18 prominent virologists recently suggested that this question should be further investigated.

Although there has been speculation about SARS-CoV-2 being engineered in a lab, this possibility seems highly unlikely. When comparing the genetic sequence of wild RaTG13 with SARS-CoV-2, differences are randomly spread across the genome. In an engineered virus, there would be clear blocks of changes that represent introduced sequences from a different viral source.

[Get our best science, health and technology stories. Sign up for The Conversation’s science newsletter.]

There is one unique sequence in the SARS-CoV-2 genome that codes for a part of the spike protein that seems to play an important role in infecting people. Interestingly, a similar sequence is found in the MERS coronavirus that causes a disease similar to COVID-19.

Though it is not clear how SARS-CoV-2 acquired these sequences, viral evolution suggests they arose from natural processes. Viruses accumulate changes either by genetic exchange with other viruses and their hosts, or by random mistakes during replication. Viruses that gain a genetic change that gives them a reproductive advantage would typically continue to pass it on through replication. That MERS and SARS-CoV-2 share a similar sequence in this part of the genome suggests that it naturally evolved in both and spread because it helps them infect human cells.

 

Where to Go from Here?

Figuring out the origin of SARS-CoV-2 could give us clues to understand and predict future pandemics, but we may never know exactly where it came from. Regardless of how the SARS-CoV-2 jumped into humans, it’s here now, and it’s probably here to stay. Going forward, researchers need to continue monitoring its spread, and get as many people vaccinated as possible.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts.  Written by Marilyn J. Roossinck

Professor of Plant Pathology and Environmental Microbiology, Penn State

 

Suggested Reading:

Scientists Now Better Understand Viral Mutations	Preventing the Immune System from Rejecting Gene Therapy

Small Caps in the Covid-19 Treatment Space	Therapeutic Discovery Made Possible by Stem Cell Science

 

Helius Medical Technologies (HSDT) Virtual Road Show – Thursday June 10 @ 1:00pm EDT Join Helius Medical Technologies Interim CEO Dane Andreeff, CFO Joyce LaViscount, and Medical Advisor Jonathan Sackier for this exclusive corporate presentation, followed by a Q & A session moderated by Joe Gomes, Noble’s senior research analyst, featuring questions taken from the audience. Registration is free and open to all investors, at any level. Register Now  |  View All Upcoming Road Shows

 

 

 

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PDS Biotechnology Set to Join Russell Microcap® Index

 

FLORHAM PARK, N.J., June 07, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the Company is set to join the Russell Microcap^® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the US market opens on June 28, according to a preliminary list of additions posted June 4.

Membership in the Russell Microcap^® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

“Inclusion in the Russell Microcap Index underscores the progress we are making to increase shareholder value by driving our three (3) Phase 2 clinical programs forward for our lead HPV-cancer immunotherapy PDS0101, including an oral presentation of interim data for our National Cancer Institute-led trial at the American Society of Clinical Oncology annual meeting later today,” said Dr. Frank Bedu-Addo, President and CEO of PDS Biotech. “Inclusion in the Index significantly benefits our Company and shareholders by elevating our visibility within the global investment community. We look forward to continuing to progress the clinical development of PDS0101 while also moving additional oncology pipeline products into human testing within the next year.”

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell Microcap^® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About FTSE Russell

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Friday, June 04, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Reports 2Q21 Results, Momentum Continues to Build

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

2Q21 Results. For the fiscal second quarter ended April 30th, Avivagen reported revenue of $159,614 and a net loss of $2.2 million, or a loss of $0.04 per share. This compares to revenue of $29,625 and a net loss of $1.4 million, or $0.03 per share, in the same period last year. We had forecast revenue of $550,000 and a net loss of $1.3 million, or a loss of $0.02 per share.


Timing is Everything.  As with most early stage revenue companies, the timing of orders can have an outsized impact on quarterly results, and we believe this is what happened in the quarter when comparing actual results to our projections. In the broader picture, the miss is not material, as long as we continue to see building momentum going forward. The bottom line miss is related to $665,203 …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Neovasc Inc. Reports Results of Annual General Meeting of Shareholders

 

Vancouver, BC, Canada – (NewMediaWire) – June 3, 2021 – Neovasc Inc.(Neovasc or the Company) (NASDAQ, TSX: NVCN) is pleased to announce the results of the votes on matters considered at its Annual General Meeting of Shareholders held on June 3, 2021 in Vancouver, B.C. (the Meeting).

At the Meeting, the shareholders of the Company (the Shareholders) re-elected board members Steven Rubin, Paul Geyer, Doug Janzen, Norman Radow, Alexei Marko and Fred Colen to serve in office until the next annual meeting or until their successors are duly elected or appointed. Detailed results of the voting in respect of the election of directors are as follows:

Nominee	Votes For	% Votes For	Votes Withheld	% Votes Withheld
Steven Rubin	6,318,465	94.48%	369,431	5.52%
Paul Geyer	6,410,453	95.85%	277,431	4.15%
Doug Janzen	6,332,243	94.68%	355,653	5.32%
Norman Radow	6,410,462	95.85%	277,434	4.15%
Alexei Marko	6,320,514	94.51%	367,382	5.49%
Fred Colen	6,174,668	92.33%	513,228	7.67%

At the Meeting, the Shareholders also approved the unallocated options under the Company’s stock option plan (90.49% of votes cast in favor) and re-appointed Grant Thornton LLP, Chartered Accountants as auditors of the Company.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and TiaraTM for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com

Investors

Mike Cavanaugh
Westwicke/ICR

Phone: +1.646.877.9641
[email protected]

Media

Sean Leous
Westwicke/ICR

Phone: +1.646.866.4012
[email protected]

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking
statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995 and applicable Canadian securities laws that may not be based on
historical fact. When used herein, the words “expect”,
“anticipate”, “estimate”, “may”,
“will”, “should”, “intend,” “believe”,
and similar expressions, are intended to identify forward-looking statements.
Forward-looking statements may involve but are not limited to, expectations as
to the growing cardiovascular marketplace. Forward-looking statements are based
on estimates and assumptions made by the Company in light of its experience and
its perception of historical trends, current conditions and expected future
developments, as well as other factors that the Company believes are
appropriate in the circumstances. Many factors could cause the Company’s actual
results, performance or achievements to differ materially from those expressed
or implied by the forward looking statements, including those described in the
“Risk Factors” section of the Company’s Annual Information Form and
in the Management’s Discussion and Analysis for the three months ended March
31, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered
carefully, and readers should not place undue reliance on the Company’s
forward-looking statements. The Company has no intention and undertakes no
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.

Neovasc Inc. Reports Results of Annual General Meeting of Shareholders

 

Vancouver, BC, Canada – (NewMediaWire) – June 3, 2021 – Neovasc Inc.(Neovasc or the Company) (NASDAQ, TSX: NVCN) is pleased to announce the results of the votes on matters considered at its Annual General Meeting of Shareholders held on June 3, 2021 in Vancouver, B.C. (the Meeting).

At the Meeting, the shareholders of the Company (the Shareholders) re-elected board members Steven Rubin, Paul Geyer, Doug Janzen, Norman Radow, Alexei Marko and Fred Colen to serve in office until the next annual meeting or until their successors are duly elected or appointed. Detailed results of the voting in respect of the election of directors are as follows:

Nominee	Votes For	% Votes For	Votes Withheld	% Votes Withheld
Steven Rubin	6,318,465	94.48%	369,431	5.52%
Paul Geyer	6,410,453	95.85%	277,431	4.15%
Doug Janzen	6,332,243	94.68%	355,653	5.32%
Norman Radow	6,410,462	95.85%	277,434	4.15%
Alexei Marko	6,320,514	94.51%	367,382	5.49%
Fred Colen	6,174,668	92.33%	513,228	7.67%

At the Meeting, the Shareholders also approved the unallocated options under the Company’s stock option plan (90.49% of votes cast in favor) and re-appointed Grant Thornton LLP, Chartered Accountants as auditors of the Company.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and TiaraTM for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com

Investors

Mike Cavanaugh
Westwicke/ICR

Phone: +1.646.877.9641
[email protected]

Media

Sean Leous
Westwicke/ICR

Phone: +1.646.866.4012
[email protected]

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking
statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995 and applicable Canadian securities laws that may not be based on
historical fact. When used herein, the words “expect”,
“anticipate”, “estimate”, “may”,
“will”, “should”, “intend,” “believe”,
and similar expressions, are intended to identify forward-looking statements.
Forward-looking statements may involve but are not limited to, expectations as
to the growing cardiovascular marketplace. Forward-looking statements are based
on estimates and assumptions made by the Company in light of its experience and
its perception of historical trends, current conditions and expected future
developments, as well as other factors that the Company believes are
appropriate in the circumstances. Many factors could cause the Company’s actual
results, performance or achievements to differ materially from those expressed
or implied by the forward looking statements, including those described in the
“Risk Factors” section of the Company’s Annual Information Form and
in the Management’s Discussion and Analysis for the three months ended March
31, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered
carefully, and readers should not place undue reliance on the Company’s
forward-looking statements. The Company has no intention and undertakes no
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.

Friday, June 04, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Reports 2Q21 Results, Momentum Continues to Build

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

2Q21 Results. For the fiscal second quarter ended April 30th, Avivagen reported revenue of $159,614 and a net loss of $2.2 million, or a loss of $0.04 per share. This compares to revenue of $29,625 and a net loss of $1.4 million, or $0.03 per share, in the same period last year. We had forecast revenue of $550,000 and a net loss of $1.3 million, or a loss of $0.02 per share.


Timing is Everything.  As with most early stage revenue companies, the timing of orders can have an outsized impact on quarterly results, and we believe this is what happened in the quarter when comparing actual results to our projections. In the broader picture, the miss is not material, as long as we continue to see building momentum going forward. The bottom line miss is related to $665,203 …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Avivagen Inc. Announces Results for the Second Quarter Ending April 30, 2021

 

• Record 64.5 tonne order for OxC-betaTM Livestock over 18 months
• New expansion efforts and customer wins in Central and South America
• Launch of first product for human health.

Ottawa, ON /Business Wire/ June 2, 2021/ Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced its unaudited financial results for the second quarter of 2021.

Milestones achieved in Q2 2021 include:
• Secured its largest recurring order to date for OxC-betaTM Livestock, an 18-month contract at four tonnes per month for use in Mexico. The 64.5 tonne total order is the largest to date in both size and length of contract, and a direct result of the Meyenberg International Group agreement finalized in Q2.
• Selected Meyenberg International Group to spearhead expansion efforts in Central and South America.
• In conjunction with Mimi’s Rock Corp., announced the launch of Dr. Tobias Beta Blend on Amazon.com – Avivagen’s first product designed for human consumption.
• Announced the closing of its oversubscribed $7.5 million bought deal unit offering.
• Announced the publication of its New Zealand OxC-betaTM Livestock dairy trial for use against sub-clinical mastitis in the New Zealand Veterinary Journal, and its upcoming publication of research highlighting the benefits of OxC-betaTM Livestock for Broiler Poultry in Poultry Science.

Since the end of the quarter Avivagen also announced it had:
• Secured a new customer win in Western Mexico.
• Terminated its previous exclusive U.S. sales and distribution agreement and initiated discussions with potential partners to ramp up sales efforts in the lucrative region.
• Recorded its first order from Brazil, received on May 28, 2021.
• Secured first order with major swine and poultry producer in Thailand following numerous trials.

Second Quarter April 30, 2021, Financial Results
The Company’s unaudited Financial Statements for the second quarter ended April 30, 2021 and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the second quarter ended April 30, 2021, should be read in conjunction with the Company’s unaudited Financial Statements as well as its Management’s Discussion and Analysis for the second quarter ended April 30, 2021.

The Company reported revenues of $159,614 ($29,625 in the quarter ending April 30, 2020) and a comprehensive loss of $(2,197,649) for the quarter ending April 30, 2021. This compares to a comprehensive loss in the quarter ending April 30, 2020 of $(1,393,497).

As reported in the statements of cash flows, the April 30, 2021 quarter comprehensive loss of $(2,197,649) consists of $1,181,373 in non-cashflow items such as share-based payment expense, depreciation, and adjustments to the Company’s ACOA loans. The Company reported $724,505 in interest accretion and adjustments related to the ACOA loans as a result of an increase in management’s estimate of future revenues. As noted, this ACOA adjustment is a non-cash adjustment in the quarter ending April 30, 2021.

The ACOA loans are interest-free and repayments are calculated as 10% of the future revenues and are payable on June 30th of each year. The carrying value has been discounted using a rate of 35% based on the expected timing and amounts of future repayments of the loans. Consequently, the carrying value of the ACOA loans requires regular assessment and adjustment based on management’s estimate of future revenues, with any adjustment being recorded as finance cost on the statement of comprehensive income with an equal increase in the ACOA debt liability on the statement of financial position. In light of the recent press releases announcing future and recurring order for customers in Mexico, Philippines, and Thailand, management increased its estimate of future revenues and therefore adjusted the carrying value of the ACOA loans accordingly.

The Company’s working capital increased by $949,353 as management invested in additional volumes of inventory to support future sales and increased prepaids expenses and trade receivables.

As at April 30, 2021, the Company reported total assets of $5,985,104 (current assets of $5,675,117), total liabilities of $7,163,307, and shareholders’ deficit of ($1,178,203).

Significant financing inflows during the quarter ending April 30, 2021, was an offering of 15,000,000 units of the Company at $0.50 per unit for aggregate gross proceeds of $7,500,000. The offering closed on February 16th, 2021.

Each unit consisted of one common share in the capital of the Company (each a “Common Share”) and one half of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant will be exercisable to acquire one Common Share until February 16, 2024 at an exercise price of $0.75 per share. The net proceeds of the Offering have been and will be used to fund research and development expenses, sales and marketing costs, product registration, interest expense, working capital and general corporate purposes.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s expectations as to future growth and results, the anticipated continuation of shipments to customers based on recurring orders, future plans for sales in the United States, the planned use of proceeds of the financing discussed above, Avivagen’s expectations as to growth in demand for Avivagen’s products, the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded and the size of market opportunities are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, initial orders may not result in new orders for Avivagen’s products, despite receipt of the purchase order timing, delivery or fulfilment of orders of product could be delayed for a number of reasons, some of which are outside of Avivagen’ s control, which could result in anticipated revenues from such sales being delayed or in the most serious cases eliminated, actions taken by Avivagen’ s customers and factors affecting the business and financial viability of Avivagen’ s customers can have a negative impact on the expectation of future sales and revenues, customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: [email protected]

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Ocugen Expands COVAXIN™ Commercialization Rights to Include Canada

 

• Ocugen to have exclusive co-development, manufacturing, and commercialization rights to COVAXIN™ in Canada, in addition to its existing US rights
  

MALVERN, Pa. and HYDERABAD, India, June 03, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, and Bharat Biotech, a global leader in vaccine innovation, today announced that they have entered into an amendment to their Co-development, Supply, and Commercialization Agreement to expand Ocugen’s exclusive territory to commercialize COVAXIN™ to now also include Canada, in addition to Ocugen’s existing rights to commercialize COVAXIN™ in the United States.

“This amendment to expand our rights to commercialize COVAXIN™ into Canada speaks to our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries. As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorization under interim order for emergency use in Canada. We believe COVAXIN™ has the potential to play a key role in saving lives from COVID-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“COVAXIN™ has demonstrated an excellent safety record in human clinical trials and in vaccine administration under emergency use in India. Our goal for all vaccines developed at Bharat Biotech is to provide global access. With its potential effectiveness against multiple existing and emerging variants, we believe that COVAXIN™ is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring COVAXIN™ to the US market and now to the Canadian market,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.

As consideration for Bharat Biotech’s grant of the rights to commercialize COVAXIN™ in Canada, Ocugen will make an upfront payment and milestone payment upon first commercial sale in Canada to Bharat Biotech, in addition to sharing the profit from sales of COVAXIN^TM in Canada. Similar to the US profit share arrangement, Ocugen will retain 45% of the profits from sales of COVAXIN^TM in Canada.

About COVAXIN™

COVAXIN™, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. This platform has an excellent safety track record of more than 300 million doses of various vaccines supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN™ continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN™ is packaged in multi-dose vials that can be stored at 2-8^?C.

COVAXIN™ studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

Based on the more than 30 million doses supplied in India and other countries, COVAXIN™ has an excellent safety record. COVAXIN™ is currently being administered under emergency use authorizations in 13 countries, and applications for emergency use authorization are pending in more than 60 additional countries.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit http://ocugen.com/

About Bharat Biotech:

Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries, and World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 6 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.

Bharat’s commitment to global social innovation programs and public private partnerships resulted in the introduction of path breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The recent acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine manufacturer in the world. To learn more about Bharat Biotech visit https://www.bharatbiotech.com/.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data referred to in this press release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN and whether and when an application for authorization under interim order for emergency use will be filed in Canada; whether and when any such applications may be approved by the FDA or Health Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
[email protected]

Media Contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+1 9783955970

Lineage Cell Therapeutics To Host Webinar With Therapeutic Area Experts To Discuss Retinal Tissue Restoration Observed In Dry AMD Patients Treated With Opregen®

 

Webinar Scheduled for June 10, 2021 at 4pm Eastern Time / 1pm Pacific Time

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 3, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that it plans to host a webinar featuring external therapeutic area experts in age-related macular degeneration (AMD), on 
June 10, 2021 at 
4pm ET /
1pm PT. Lineage recently reported that restoration of retinal tissue has been observed in three patients enrolled in the Company’s Phase 1/2a study of its lead product candidate, OpRegen, an allogeneic retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of AMD with geographic atrophy (GA), or dry (atrophic) AMD. These new findings occurred in three of the four better baseline vision (Cohort 4) patients for whom surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen RPE cells. Outer retinal layer restoration, which was observed using high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells. These effects were most prominent in the transitional areas around the primary area of GA. The webinar will feature therapeutic area experts who will discuss these findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen. Interested parties can access the webinar on the Events and Presentations section of Lineage’s website.

Therapeutic Area Experts, External Reviewers & Contributors

Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology, Hadassah-Hebrew University Medical Center.

Dr. Banin is a graduate of the 
Hebrew University-Hadassah School of Medicine, holds a Ph.D. in Neurobiology from the 
Hebrew University, and completed his ophthalmology residency at 
Hadassah Medical Center. Following a post-doctoral and medical retina fellowship at the University of Pennsylvania’s 
Scheie Eye Institute in 
Philadelphia, he was appointed head of the Medical Retina Service and the CRMD at Hadassah. His main clinical and research focus is in the field of retinal and macular degenerations, including the development and application of novel cell- and gene-based therapies for these diseases. The recipient of many research grants from Israeli and foreign institutions,  Dr. Banin has authored and published over 150 peer-reviewed articles in leading medical and scientific journals.

Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula, Director and Principal Investigator, Barcelona Macula Foundation: Research for Vision.

Dr. Monés is an ophthalmologist, macula and vitreoretinal specialist, and macular and retinal degeneration researcher. Dr. Monés earned his medical degree at the 
University of Barcelona and subsequently specialized in ophthalmology at Barraquer Ophthalmology Centre. He completed his retinal specialist training at the 
Massachusetts Eye and Ear Infirmary at 
Harvard University, and at Hospital San José, 
Monterrey Institute of Technology and Higher Education. He earned his PhD degree in Medicine and Surgery at the 
University of Barcelona. Dr Monés is dedicated to fighting blindness by supporting and conducting research in retinal disease. For the last 15 years he has been one of the foremost researchers involved in clinical trials for the treatment of age-related macular degeneration. He is currently conducting Phase I, II and III clinical trials. His work has been widely published in scientific journals and he has given more than 200 presentations at international congresses. He is a member of 12 scientific societies.

Brandon Lujan, M.D., Associate Professor of Ophthalmology, School of Medicine, OHSU Casey Eye Institute.

Dr. Lujan is a medical retina specialist, scientist, and Director of the Casey Reading Center. Dr. Lujan’s area of expertise is Optical Coherence Tomography (OCT) retinal imaging, and he is the first-named inventor and co-developer of Directional OCT, a technique and device capable of creating optical contrast in photoreceptors.  Dr. Lujan has published and spoken internationally on diagnosis and management of macular diseases and has brought that expertise to bear on clinical trials. He is the creator of OCTMD, an educational resource focused on the present and future of OCT.  Dr. Lujan is a member of the 
Macula Society, 
Retina Society, the 
Association for Research and Vision in Ophthalmology, and the 
American Society of Retina Specialists.

Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine.

In collaboration with the other retinal surgeons at CEI,  Dr. Riemann is a principal investigator or co-investigator for many Phase II and Phase III clinical trials. He specializes in medical and surgical vitreoretinal diseases including diabetic retinopathy, macular degeneration, retinal detachment, retinopathy of prematurity, vascular diseases of the retina, uveitis, histoplasmosis, complications of anterior segment surgery, endoscopic posterior segment surgery, and ocular trauma.  Dr. Riemann is a member of the 
American Society of Retina Specialists, 
American Academy of Ophthalmology, 
Ohio State Medical Association, 
Cincinnati Academy of Medicine, 
Cincinnati Ophthalmology Society, and the 
Association for Research in Vision and Ophthalmology. His original research in the fields of Ophthalmology, Cardiology, and Endocrinology has been published in international peer reviewed scientific journals and has been presented at national scientific meetings.  Dr. Riemann has several patents for innovative surgical technologies and enjoys sharing his passion for the blend of engineering and medicine.

Michael S. Ip, M.D., Professor, Department of Ophthalmology at the David Geffen School of Medicine at the University of California – Los Angeles.

Dr. Ip is a member of the 
Doheny Eye Institute and currently serves as the Medical Director of the Doheny Image Reading Center. His research focuses on the design and conduct of clinical trials investigating treatments for diabetic retinopathy, AMD, and retinal venous occlusive disease and other retinal diseases.  Dr. Ip has assisted with the collection, analysis, and dissemination of important primary and secondary outcomes in ophthalmic clinical trials. In 2003,  Dr. Ip was selected to serve as the national protocol chair for the clinical trial conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema (protocol B). This was a landmark study and changed practice patterns in the field of ophthalmology. In 2003, his independent and investigator-initiated research group received a U-10 cooperative agreement award from the 
National Eye Institute, 
National Institutes of Health to conduct the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study. This was a multicenter, randomized, 
NIH-defined phase 3 trial which led to over 15 publications in the peer-reviewed literature and provided much needed Level 1 evidence to guide our management of retinal venous occlusive disease. In 2013, this group received funding from the NEI to conduct the SCORE2 Study. The SCORE2 Study is an 
NIH-defined phase 3 clinical trial designed to evaluate the comparative efficacy and safety of bevacizumab versus aflibercept for the treatment of macular edema secondary to central retinal vein occlusion. It has been designed to answer several questions of significant public health importance. Currently, this study group has extended the SCORE2 follow up phase to evaluate long-term safety and efficacy outcomes in central retinal vein occlusion.

Allen C. Ho, M.D. FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research, Professor of Ophthalmology, Thomas Jefferson University.

Dr. Ho maintains special interests in macular diseases, diabetic retinopathy, surgical retinal diseases and clinical trials investigating new treatments for vitreoretinal diseases including gene and cell therapies and new surgical drug delivery devices and techniques. His experience includes collaborative translational and clinical trial clinical research with expertise in study design, methodological testing, data analyses, surgical instrumentation and procedure development, execution and communication of these studies and their study results. He is the current President of The 
Retina Society and serves on its Executive Committee.  Dr. Ho has been Study Chair, Steering Committee Member or Principal Investigator of over 50 clinical trials.  Dr. Ho has served on the 
US FDA Ophthalmic Device Panel, 
American Academy of Ophthalmology (AAO) Ophthalmic Retina Technology Assessment Committee, 
AAO Retina Measures Group, AAO IRIS Registry Committee and is past Chair of the AAO Retina Subspecialty Days and Vail Vitrectomy meetings. Through the Wills Eye Hospital Retina Fellowship he has mentored over 60 retina fellows and international research trainees.  Dr. Ho has authored over 200 peer reviewed publications and several textbooks and is Editor-in-Chief of Current Opinion in Ophthalmology and Chief Medical Editor of Retina Today.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration, or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
([email protected])
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
[email protected]
[email protected]
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

PDS Biotechnology Expands VERSATILE-002 study of PDS0101 and KEYTRUDA® in Advanced Head and Neck Cancer to Include Patients Who Have Failed Prior Treatment with Checkpoint Inhibitors

 

FLORHAM PARK, N.J., June 03, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the protocol amendment to expand its Phase 2 VERSATILE-002 study to include patients, in an additional arm, who have failed prior checkpoint inhibitor (CPI) therapy (CPI refractory patients). The VERSATILE-002 study is designed to evaluate PDS0101 in combination with KEYTRUDA
^® (pembrolizumab) in the treatment of advanced human papillomavirus (HPV)-associated head and neck cancer and is currently being run at approximately 20 clinical sites in the US.

VERSATILE-002 was initially opened to checkpoint inhibitor naive HPV16-associated head and neck cancer patients in first line treatment of recurrent or metastatic cancer.   The trial is actively recruiting patients who have the option to receive the two immunotherapies rather than chemotherapy as their first line of treatment for recurrent disease. The additional study arm will evaluate the objective response to the combination among approximately 40 patients with advanced head and neck cancer who have failed multiple treatments, including checkpoint inhibitor therapy. Objective response is measured by radiographic tumor responses according to RECIST 1.1. In the expansion arm, the first 21 patients will be evaluated for safety and objective response before the arm progresses to full enrollment.

The inclusion of CPI refractory patients in VERSATILE-002 follows the publication of an abstract and subsequent presentation of interim data in another Phase 2 trial (NCT04287868) being led by the National Cancer Institute (NCI) evaluating the combination of PDS0101 (Versamune^®-HPV16) in combination with two investigational immunotherapies. That trial recently reported clinical responses with objective responses (tumor reduction of 30% or more) in 63% (5/8) of HPV16-positive cancer patients who had failed chemotherapy, radiation, and checkpoint inhibitor therapy.

“There is an enormous unmet medical need in advanced head and neck cancer patients who have failed multiple therapies, including chemotherapy, radiation and checkpoint inhibitor therapy. We believe the combination of PDS0101 and KEYTRUDA^® has the potential to significantly improve clinical outcomes for these patients who have limited treatment options,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.

Dr. Jared Weiss, Associate Professor of Medicine, Division of Oncology, University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Principal Investigator of this Phase 2 clinical trial in advanced HPV16-associated head and neck cancer. For patients interested in learnings more about this clinical study, please visit the website: https://pdsbiotech.com/versatile-002.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune
^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]