Category: Health

Lineage Cell Therapeutics And Cancer Research UK Announce Encouraging Preliminary Phase 1 Study Results With Vac2 For The Treatment Of Non-Small Cell Lung Cancer

 

• Potent Induction of Immune Responses Observed with VAC2 Vaccine
• Peripheral Antigen-specific Immunogenicity Above 3% Observed at Multiple Timepoints
• VAC2 Appears Well Tolerated with No Unexpected Adverse Events

CARLSBAD, Calif. & LONDON–(BUSINESS WIRE)–Oct. 13, 2020– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research, today announced encouraging preliminary results from an ongoing Phase 1 clinical study of VAC2 in non-small cell lung cancer (NSCLC). VAC2 demonstrated remarkably potent induction of immune responses in all patients dosed to date, with high levels of peripheral antigen-specific immunogenicity observed at multiple time points and confirmed by multimer staining. On the basis of these findings, and following completion of the ongoing VAC2 clinical study in NSCLC, Lineage will seek to evaluate VAC2 in combination with therapies considered biologically complementary to VAC2, such as chemotherapy and the immune cell protectant properties offered by anti-PD1 immunotherapy.

Lineage recently conducted an early exercise of its option to acquire data from Cancer Research UK and assumed responsibility for further development of the VAC2 product candidate as well as future development opportunities derived from the VAC platform, while Cancer Research UK’s Centre for Drug Development concludes the ongoing clinical study.

“Based on review of all available data, the therapy was safe and well tolerated in all patients. While the safety profile was expected, the immunogenicity data are remarkable and highly provocative,” stated Christian Ottensmeier, MD, PhD, FRCP, Professor of Experimental Medicine at the University of Southampton and Chief Investigator on the VAC2 clinical study. “Antigen-reactive pentamer staining data induced by VAC2 suggest that the vaccine is highly potent, inducing significantly higher levels of antigen-specific T cells, compared with that invoked by alternative vaccine approaches, such as DNA- and RNA-based vaccines. From my perspective as an immuno-oncologist these data support rapid phase II testing, focused on clinical benefit.”

Brian Culley, Chief Executive Officer of Lineage, said: “Interestingly, one patient experienced a radiological response following chemotherapy subsequent to VAC2 treatment. Although anecdotal and occurring after the patient had completed the VAC2 trial, responses in this setting are rare and support further investigation. Dendritic cells are the most potent antigen-presenting cells in the body and harnessing their power to accurately deliver information about foreign material is re-emerging as an attractive therapeutic modality based on their consistent safety profile and increasing knowledge of how to deploy them in the clinical setting. As a leader in the field of cell therapy, Lineage aims to advance the current VAC2 product candidate and identify ways to expand the VAC platform through internally-owned and externally-partnered antigens.”

Dr. Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: “We are pleased to see, after several years of development, the clinical progress that VAC2 has made and the impact it could have for people with lung cancer, which is the third most common cancer in the UK. We are excited to continue our support of the next phase of development of VAC2 and assist with the expansion of those efforts into additional cancers, and other potential areas with significant unmet medical need.”

About VAC2

VAC2 is an allogeneic, or non-patient specific, off-the-shelf cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry any antigen, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 clinical study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

About T Cell Induction

Lopes A, Vandermeulen G, Préat V. Cancer DNA vaccines: current preclinical and clinical developments and future perspectives. J Exp Clin Cancer Res. 2019;38(1):146.; Sebastian M, Schröder A, Scheel B, et al. A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer. Cancer Immunology, Immunotherapy 2019;68(5):799-812.

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

About Cancer Research UK

• Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
• Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
• Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
• Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
• Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
• Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

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) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s plans to advance the VAC2 platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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.

Dyadic Updates Market on COVID-19 Initiatives

 

• C1 Expression of SARS-CoV-2 Monoclonal Antibody Achieved
• Ten On-going Animal Trials of C1 Expressed SARS-CoV-2 Receptor Binding Domain (RBD) Antigen by Seven Different Collaborators
• Record Expression Level of C1 SARS-CoV-2 RBD Antigen (3 g/l in 5 days)
• Non-Exclusive Technology Usage Agreement with Epygen Biotech of India

JUPITER, FL / ACCESSWIRE / October 12, 2020 / Dyadic International, Inc. (“Dyadic” or the “Company”) (NASDAQ:DYAI), a global biotechnology company focused on further applying its proprietary C1 gene expression platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today is updating the market on the progress made in certain of its coronavirus (COVID-19) programs globally.

Dyadic’s C1 Rapid Recombinant Protein Manufacturing Platform has demonstrated that it can manufacture monoclonal antibodies (mAbs) more efficiently and faster than currently existing CHO mAb technology, potentially broadening access to this therapeutic treatment. Dyadic has expressed a SARS-CoV-2 monoclonal antibody in collaboration with a biotech company that is developing antibody cocktails to treat COVID-19 patients.

“The recent successful use of monoclonal antibody cocktails for the treatment of COVID-19 has also highlighted important production and supply constraints. Our C1 platform has the potential to generate 3x to 4x greater quantities of monoclonal antibodies in the same timeframe when compared to the current production methods using CHO cells. While that is still not yet enough to meet anticipated global demand, it certainly is a significant step in potentially helping to ensure greater access to patients, and at a lower cost,” said Dyadic CEO, Mark Emalfarb.

Dyadic has developed a COVID-19 vaccine antigen from its proprietary and patented C1 cell line that can be produced at three grams per liter (3 g/l) in only five days. The proprietary C1 expressed receptor binding domain (RBD) of the SARS-CoV-2 spike protein is being used in animal trials by seven different research groups, governmental agencies and biopharma companies (including the Israel Institute for Biological Research (IIBR) and a collaboration of European Union scientists that participated with Dyadic in the ZAPI program). These parties are testing the C1 expressed RBD vaccine candidate(s) in animal trials on a stand-alone basis as well as testing the C1 RBD with nanoparticles and adjuvants. The Company currently expects up to ten animal trials to be completed by the end of 2020. These programs are in addition to the previously announced activities with the Frederick National Laboratory, Jiangsu Hengrui Medicine and other third-party collaborations which are working with Dyadic’s C1 expression platform to express their own COVID-19 and other vaccine and antibody candidates for a number of animal and human health applications.

Data generated by a number of these third parties confirmed that the C1 expressed RBD has the correct structure resulting in high binding and neutralizing capacity. Additionally, the recently concluded IIBR mice study shows that the C1 RBD has the potential to generate excellent immunogenicity responses with very high titers and neutralizing antibodies against the SARS-CoV-2 coronavirus.

“The initial mice trial, as reported to us by the IIBR, was very successful, and we expect to have additional data to disclose after a number of these animal trials are completed and their data is analyzed further. Going forward, we expect there will be follow-on animal studies which will include challenge studies with hamsters and human Ace2 transgenic mice, as well as additional studies including a toxicology study,” continued Mr. Emalfarb. “Further, our C1 technology can express high levels of proteins more rapidly at flexible commercial scales more affordably using single use or stainless-steel bioreactors. We believe that our C1 platform, developed initially for high-volume low-cost industrial use, easily enables affordable, regional production of vaccines, antibodies and other therapeutic proteins, which has driven a heightened interest in our C1 technology.”

Dyadic has recently entered into a non-exclusive technology usage agreement with Epygen Biotech of India, who after obtaining required funding, expects to produce cGMP clinical trial material at their facility and conduct clinical trials in India using Dyadic’s C1 expressed RBD antigen of the SARS-CoV-2 Spike Protein.

“The Epygen agreement demonstrates how potential collaborators globally can develop and eventually manufacture vaccines and drugs on a regional basis that are affordable, safe and effective. Debayan Ghosh, President and Founder of Epygen, is intimately familiar with our technology from his work at Biocon as a biotechnologist, his time spent working for Dyadic in the late 90’s and, most recently, as a result of Epygen’s interest in the manufacturing of cGMP clinical grade C1 expressed RBD antigens. It is especially gratifying for us to be working with someone who understands, firsthand, C1’s success in industrial biotech and appreciates how the technology can be broadly applied to biopharmaceuticals,” concluded Mr. Emalfarb.

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

Please visit Dyadic’s website at http://www.dyadic.com for additional information, including details regarding Dyadic’s plans for its biopharmaceutical business.

Safe Harbor Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at http://www.dyadic.com.

Contact:

Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: mailto:[email protected]

SOURCE: Dyadic International, Inc.

 

Does it Matter if the President and FDA Disagree on What’s Best?

Vaccines and therapeutics typically require years, even decades, of research and laboratory testing before being elevated to clinical trials.  Today, pharmaceutical companies, with support from the government, are racing to produce an effective SARS-CoV-2 vaccine by year-end 2020.  Researchers are now evaluating for safety and efficacy 44 vaccines in clinical trials on humans, 91 preclinical vaccines are at an earlier stage where they are being tested in animals.

This is a rampant pace. Work began deciphering the COVID-19 genome as early as January. The first human vaccine safety trials began just a few months later; by any measure, this is a fast track pace, fraught with uncertainty as short-term and long-term results are unknowable.

Role of the FDA

The Food and Drug Administration (FDA) regulates vaccines and other medications. After a rigorous review of laboratory and clinical results to ensure safety, benefits, and side effects, a product may be approved to be used for a specific illness. There are currently no vaccines available for the prevention of COVID-19. An approval cycle that typically takes years is being expedited. In the case of the 2020 pandemic, the FDA  has shortened standard testing periods and is providing timely advice and closer than normal interactions with vaccine developers. The FDA is also supporting product development and scaling up of manufacturing capacity for high-priority vaccines to be used against COVID-19.

Can You Rush Success?

Some things cannot be known with any vaccine or therapeutic without years of study. Certainty only comes with approved use in the broader population over time. The FDA has allowed an emergency pace for the development of treatment and preventatives to the novel coronavirus, and first-generation treatments are in the final phase of testing. The results and approved products are expected to become available in the coming months. The FDA guidelines related to COVID-19 allow a fast pace by any measure; however, the White House believes the country would be served better if the rollout was accelerated even quicker.

Are the White House and the FDA at Odds?

The FDA’s instructions are that vaccine developers follow test-case patients for at least two months to rule out safety issues before they seek emergency approval. This requirement does not sit well with the White House as they believe there is “no clinical or medical reason” for the additional requirement. They have taken steps to “overrule” this two-month step.

On the FDA side, Commissioner Stephen Hahn has been acting to shore up public confidence in the FDA’s vaccine fast pace review for weeks. He has vowed not to be swayed by any political agenda to get a cure or preventative out sooner than prudence would dictate. He believes career scientists, not politicians, are best suited to decide if a new product is safe and effective for mass vaccination.

President Trump has insisted that a vaccine could be authorized before Election Day; his motivations are based more on returning the country to a pre-COVID state as soon as humanly possible. Scientists involved at the FDA are not as comfortable ignoring cautionary protocols.

Actual Impact of White House Impatience

Beyond the strained relationship and perception of overruling the Food and Drug Administration, the impact of the White House action to block current vaccine guidelines may be inconsequential.

Only one drug maker, Pfizer (PFE) has suggested it meets all the criteria and could provide data on the safety and effectiveness of its vaccine before November. Afterward, the FDA would need to closely review the scientific studies and approve or reject their product. This would take time. Pfizer’s competitors Moderna (MRNA), AstraZeneca (AZN), and Johnson & Johnson (JNJ) are working on longer researcher timelines.

It is not out of the question that therapeutics currently under study will reach the approval process sooner than a vaccine. Any vaccine approval may be followed by more effective options later on by companies working on a longer timeline.

 

Suggested Videos:

Genprex Virtual Road Show

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Dyadic Int’l C-Suite Series

 

Dyadic International (DYAI) Wednesday October 14 1:00pm EDT Virtual Meeting With: Mark Emalfarb – President & CEO Register Now

 

Sources:

White House nixes updated FDA guidelines on vaccine approval

Everything you need to know about what it would take for the FDA to approve a COVID-19 vaccine

Coronavirus Vaccine Tracker

When Will You Be Able to Get a Coronavirus Vaccine?

White House Takes Issue With FDA’s Plans for Authorizing a Covid-19 Vaccine

Photo: Jernej Furman,  Vaccine Syringes With Flag of the United States of America (Changes made to height)

Tuesday, October 06, 2020

PDS Biotechnology Corp (PDSB)

PDS’s Diverse Portfolio in Broad Therapeutic Areas Is Highly Appealing

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

What do we like? The applicability of the platform technology. In our view, PDS remains under the Street’s radar with a clinical pipeline as well as a versatile technology platform enabling growth in new directions. As we look forward, we believe that both oncology and infectious disease portfolios may provide dynamic catalysts for the medium term, while the technology platform with multiple Phase 2 clinical trials provides fundamental depth to future value.


Portfolio diversification is utmost in the near-term.  The value-generating catalyst in the near-tear is predominantly based on the commencement of two Phase 2 clinical trials in Q4 2020 – PDS0101 for the treatment of i) recurrent/metastatic head and neck cancer (HNC) and ii) advanced cervical cancers. The company also broadened infectious disease programs to include the development of vaccines for …

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. 

Cocrystal Pharma Announces Notice of Pendency and Proposed Settlement of Stockholder Derivative Actions

 

BOTHELL, WA, Oct. 02, 2020 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (NASDAQ: COCP) The following is being released by Cocrystal Pharma, Inc. pursuant to an order of the United States District Court, District of New Jersey, regarding Agreement of Settlement.

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

TRENT NICHOLS and SHARON NICHOLS, derivatively on behalf of COCRYSTAL PHARMA, INC. F/K/A BIOZONE PHARMACEUTICALS, INC.,                 Plaintiffs,                 vs. ELLIOTT MAZA, GARY WILCOX, JEFFREY MECKLER, GERALD MCGUIRE, JAMES MARTIN, CURTIS DALE, RAYMOND SCHINAZI, DAVID BLOCK, PHILLIP FROST, JANE H. HSIAO, STEVEN RUBIN, BRIAN KELLER, BARRY C. HONIG, JOHN STETSON, MICHAEL BRAUSER, JOHN O’ROURKE III, MARK GROUSSMAN, and JOHN H. FORD,                 Defendants,                 and COCRYSTAL PHARMA, INC. F/K/A BIOZONE PHARMACEUTICALS, INC.,                 Nominal Defendant.

Case No.: 2:19-cv-16751-KM-JBC       NOTICE OF PROPOSED SETTLEMENT OF DERIVATIVE ACTION TO CURRENT COCRYSTAL STOCKHOLDERS

NOTICE OF PROPOSED SETTLEMENT OF DERIVATIVE ACTION

TO: ALL OWNERS OF COCRYSTAL PHARMA, INC. F/K/A BIOZONE PHARMACEUTICALS, INC. (“COCRYSTAL” OR THE “COMPANY”) COMMON STOCK (TICKER SYMBOL: COCP) AS OF AUGUST 20, 2020, WHO CONTINUE TO OWN SUCH SHARES THROUGH DECEMBER 16, 2020 (“CURRENT COCRYSTAL STOCKHOLDERS”).

PLEASE READ THIS NOTICE CAREFULLY AND IN ITS ENTIRETY. THIS NOTICE RELATES TO A PROPOSED SETTLEMENT AND DISMISSAL OF STOCKHOLDER DERIVATIVE LITIGATION AND CONTAINS IMPORTANT INFORMATION REGARDING YOUR RIGHTS.

IF THE COURT APPROVES THE SETTLEMENT AND DISMISSAL OF THE DERIVATIVE LITIGATION, CURRENT COCRYSTAL STOCKHOLDERS WILL BE FOREVER BARRED FROM CONTESTING THE APPROVAL OF THE PROPOSED SETTLEMENT AND FROM PURSUING RELEASED CLAIMS.

THIS ACTION IS NOT A “CLASS ACTION.” THUS, THERE IS NO COMMON FUND UPON WHICH YOU CAN MAKE A CLAIM FOR A MONETARY PAYMENT.

PLEASE TAKE NOTICE that this action is being settled on the terms in a Stipulation and Agreement of Settlement, dated August 20, 2020 (the “Stipulation”). The purpose of this Notice is to inform you of:

• the existence of the above-captioned derivative action and the related derivative actions captioned Church v. Maza, et al., Case No. 2:19-cv-00080 and Tutschek v. Schinazi, et al., Case No. 2:19-cv-01775, pending in the United States District Court, Western District of Washington, Seattle Division (collectively, the “Derivative Actions” or “Derivative Litigation”),
• the proposed settlement between the Plaintiffs¹ and Defendants reached in the Derivative Actions (the “Settlement”),
• the hearing to be held by the Court to consider the fairness, reasonableness, and adequacy of the Settlement,
• certain Individual Defendants’ agreement to pay Plaintiffs’ Counsel’s fees and expenses, and
• Plaintiffs’ applications for Service Awards.

This Notice describes what steps you may take in relation to the Settlement. This Notice is not an expression of any opinion by the Court about the truth or merits of Plaintiffs’ claims or Defendants’ defenses. This Notice is solely to advise you of the proposed Settlement of the Derivative Actions and of your rights in connection with the proposed Settlement.

Summary

On August 20, 2020, Plaintiffs, Cocrystal, in its capacity as a nominal defendant, and Elliot Maza, Gary Wilcox, Jeffrey Meckler, Gerald McGuire, James Martin, Curtis Dale, Raymond Schinazi, David Block, Phillip Frost, Jane H. Hsiao, Steven Rubin, Brian Keller, Barry C. Honig, John Stetson, Michael Brauser, John O’Rourke III, Mark Groussman, Todd Brady, and John Ford entered into the Stipulation in the above-captioned action filed derivatively on behalf of Cocrystal, in the United States District Court for the District of New Jersey (the “Court”) against all of the Individual Defendants except for Todd Brady. The Settlement, as documented in the Stipulation and subject to the approval of the Court, is intended by the Settling Parties to fully, finally, and forever compromise, resolve, discharge, and settle the Released Claims and to result in the dismissal of the Derivative Actions with prejudice, upon the terms and subject to the conditions set forth in the Stipulation. The proposed Settlement requires the Company to adopt certain corporate governance enhancements, as described in Exhibit A to the Stipulation, and provides that certain Individual Defendants shall pay a Fee and Expense Amount to Plaintiffs’ Counsel of two hundred seventy-five thousand dollars ($275,000.00) from which Service Awards to four Plaintiffs of one thousand dollars ($1,000.00) each, shall be paid (“Fee and Expense Award”).

¹ All capitalized terms used in this notice, unless otherwise defined herein, are defined as set forth in the Stipulation.

This notice is a summary only and does not describe all of the details of the Stipulation. For full details of the matters discussed in this summary, please see the full Stipulation posted on the Company’s website, https://ir.Cocrystalpharma.com/, contact Plaintiffs’ Counsel at the address listed below, or inspect the full Stipulation filed with the Clerk of the Court.

What is the Lawsuit About and Why is it being Settled?

Cocrystal is a publicly traded Delaware corporation with principal executive offices located in Bothell, Washington. The Derivative Actions were brought derivatively on behalf of Cocrystal and allege that the Individual Defendants breached their fiduciary duties by allegedly making and/or causing Cocrystal or its predecessor, BioZone Pharmaceuticals, Inc. (“BioZone”) to make misrepresentations and/or omissions of material fact in public statements, failing to maintain internal controls at Cocrystal or BioZone, engaging in allegedly improper promotion or manipulation of the market for BioZone’s securities, or aiding and abetting such breaches of fiduciary duty.

Defendants deny that a pre-suit demand on Cocrystal’s board of directors would have been futile and, therefore, excused. The Individual Defendants have denied, and continue to deny, any wrongdoing or liability arising out of or relating in any way to the events, conduct, statements, acts, or omissions alleged in the Derivative Actions. The Individual Defendants deny that Cocrystal or its shareholders were harmed by the conduct alleged in the Derivative Actions, and further assert that, at all times, they acted in good faith, and , to the extent they were officers or directors, in a manner they reasonably believed to be and that was in the best interests of Cocrystal and Cocrystal’s stockholders. The Individual Defendants assert that they have meritorious defenses to the claims in the Derivative Actions. Nonetheless, Defendants have entered into the Stipulation, without admitting or conceding any fault, liability, wrongdoing, or damage whatsoever, in order to avoid the burden and expense of further litigation.

The Court has not decided in favor of the Individual Defendants or Plaintiffs. Instead, both sides agreed to the Settlement to avoid the distraction, costs, and risks of further litigation. Plaintiffs and the Company believe that the corporate governance enhancements that the Company will adopt as part of the Settlement provide a substantial benefit to Cocrystal and its stockholders, and Plaintiffs and Plaintiffs’ Counsel believe the Settlement is in the best interests of Cocrystal and its stockholders.

The Settlement Hearing and Your Right to Object to the Settlement

On September 22, 2020, the Court entered an order preliminarily approving the Stipulation and the Settlement contemplated therein (the “Preliminary Approval Order”) and providing for the notice of the Settlement to be made to Current Cocrystal Stockholders. The Preliminary Approval Order further provides that the Court will hold a hearing (the “Settlement Hearing”) on December 16, 2020 at 3:00 p.m. before the Honorable Kevin McNulty, U.S. District Court, District of New Jersey, Courtroom PO 04, located at the Martin Luther King Building and United States Courthouse, 50 Walnut Street, Newark, New Jersey 07102, to among other things: (i) determine whether the proposed Settlement is fair, reasonable and adequate and in the best interests of the Company and its stockholders; (ii) consider any objections to the Settlement submitted in accordance with this Notice; (iii) determine whether a judgment should be entered dismissing all claims in the Derivative Actions with prejudice, and releasing the Released Claims against the Released Persons; (iv) determine whether to approve the Fee and Expense Amount to Plaintiffs’ Counsel; (v) determine whether to approve the Service Awards to Plaintiffs, which shall be funded from the Fee and Expense Award; and (vi) consider any other matters that may properly be brought before the Court in connection with the Settlement.

The Court may, in its discretion, change the date and/or time of the Settlement Hearing without further notice to you. The Court also has reserved the right to hold the Settlement Hearing telephonically without further notice to you. If you intend to attend the Settlement Hearing, please consult the Court’s docket on https://pacer.uscourts.gov/find-case and/or the website of Cocrystal, https://ir.Cocrystalpharma.com/, for any change in date, time or format of the Settlement Hearing.

Any Current Cocrystal Stockholder who wishes to object to the fairness, reasonableness, or adequacy of the Settlement as set forth in the Stipulation, or to the Fee and Expense Award, may file with the Court a written objection. An objector must at least fourteen (14) calendar days prior to the Settlement Hearing: (1) file with the Clerk of the Court and serve upon the below listed counsel a written objection to the Settlement setting forth (a) the nature of the objection; (b) proof of ownership of Cocrystal common stock as of August 20, 2020 and through the date of the objection, including the number of shares of Cocrystal common stock held and the date of purchase; (c) any and all documentation or evidence in support of such objection; and (d) the identities of any cases, by name, court, and docket number, in which the stockholder or his, her, or its attorney has objected to a settlement in the last three years; and (2) if intending to appear and requesting to be heard at the Settlement Hearing, he, she, or it must, in addition to the requirements of (1) above, file with the Clerk of the Court and serve on the below counsel (a) a written notice of his, her, or its intention to appear at the Settlement Hearing; (b) a statement that indicates the basis for such appearance; (c) the identities of any witnesses he, she, or it intends to call at the Settlement Hearing and a statement as to the subjects of their testimony; and (d) any and all evidence that would be presented at the Settlement Hearing. Any objector who does not timely file and serve a notice of intention to appear in accordance with this paragraph shall be foreclosed from raising any objection to the Settlement and/or the Fee and Expense Award and shall not be permitted to appear at the Settlement Hearing, except for good cause shown.

IF YOU MAKE A WRITTEN OBJECTION, IT MUST BE ON FILE WITH THE CLERK OF THE COURT NO LATER THAN DECEMBER 2, 2020. The Clerk’s address is:

Clerk of the Court
U.S. DISTRICT COURT, DISTRICT OF NEW JERSEY
Courtroom PO 04
50 Walnut Street
Newark, NJ 07102

YOU ALSO MUST DELIVER COPIES OF THE MATERIALS TO PLAINTIFFS’ COUNSEL AND DEFENDANTS’ COUNSEL SO THEY ARE RECEIVED NO LATER THAN DECEMBER 2, 2020. Counsel’s addresses are:

Counsel for Plaintiffs:

Timothy Brown THE BROWN LAW FIRM, P.C. 240 Townsend Square Oyster Bay, NY 11771	Gregory M. Nespole LEVI & KORSINSKI, LLP 55 Broadway, 10th Floor New York, NY 10006
Counsel for Defendants Gary Wilcox, Jeffrey Meckler, Gerald McGuire, James Martin, Curtis Dale, Raymond Schinazi, David Block, Jane H. Hsiao, Steven Rubin, and Todd Brady, and Nominal Defendant Cocrystal Pharma, Inc.: Ron Berenstain Sean Knowles PERKINS COIE LLP 1201 Third Avenue, Suite 4900 Seattle, WA 98101	Counsel for Defendant Barry Honig: Michael Sommer Adam Toporovsky WILSON SONSINI GOODRICH & ROSATI Professional Corporation 1301 Avenue of the Americas, 40th Floor New York, New York 10019
Counsel for Defendant John O’Rourke III Randy Luskey ORRICK, HERRINGTON & SUTCLIFFE LLP 405 Howard Street San Francisco, CA 94105	Counsel for Defendant John Stetson Daniel Walfish WALFISH & FISSELL PLLC 405 Lexington Avenue, 8th Floor New York, NY 10174
Counsel for Defendant John Ford A. Ross Pearlson One Boland Drive West Orange, NJ 07052	Counsel for Defendant Michael Brauser Dennis Richard Melissa Mackiewicz RICHARD & RICHARD, P.A. 825 Brickell Bay Drive Tower III, Suite 1748 Miami, FL 33131
Counsel for Defendant Mark Groussman Kevin Walsh GIBBONS PC One Gateway Center Newark, NJ 07102	Counsel for Defendant Phillip Frost Robert J. Anello Edward M. Spiro MORVILLO ABRAMOWITZ GRAND IASON & ANELLO P.C. 565 Fifth Avenue New York, NY 10017
Defendant Elliot Maza 550 Sylvan Avenue, Suite 102 Englewood Cliffs, NJ 07632	Defendant Brian Keller 5058 Nortonville Way Antioch, CA 94531

An objector may file an objection on his, her or its own or through an attorney hired at his, her or its own expense. If an objector hires an attorney to represent him, her or it for the purposes of making such objection, the attorney must serve a notice of appearance on the counsel listed above and file such notice with the Court no later than fourteen (14) calendar days before the Settlement Hearing. Any Current Cocrystal Stockholder who does not timely file and serve a written objection complying with the above terms shall be deemed to have waived, and shall be foreclosed from raising, any objection to the Settlement and/or the Fee and Expense Award, and any untimely objection shall be barred.

Any objector who files and serves a timely, written objection in accordance with the instructions above, may appear at the Settlement Hearing either in person or through counsel retained at the objector’s expense. Objectors need not attend the Settlement Hearing, however, in order to have their objections considered by the Court.

If you are a Current Cocrystal Stockholder and do not take steps to object to the proposed Settlement and/or the Fee and Expense Award, you will be bound by the Judgment of the Court and will forever be barred from raising an objection to the Settlement and the Fee and Expense Award, and from pursuing any of the Released Claims.

If you held Cocrystal common stock as of August 20, 2020 and continue to hold such stock, you may have certain rights in connection with the proposed Settlement. You may obtain further information by contacting counsel for Plaintiffs at: Timothy Brown, The Brown Law Firm, P.C., 240 Townsend Square, Oyster Bay, NY 11771, Telephone: (516) 922-5427, Email: [email protected]; Gregory M. Nespole, Levi & Korsinsky, LLP, 55 Broadway, 10th Floor, New York, NY 10007, Telephone: (212) 363-7500, Email: [email protected].

PLEASE DO NOT CALL THE COURT, DEFENDANTS, OR DEFENDANTS’ COUNSEL WITH QUESTIONS ABOUT THE SETTLEMENT.

All questions regarding this matter should be made to the Company’s Counsel at the addresses listed below:

Sean Knowles
Perkins Coie LLP
1201 Third Avenue Suite 4900
Seattle, WA 98101-3099

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, SARS-CoV-2 virus, hepatitis C viruses, and norovirus infections. Cocrystal employs unique structure-based technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor and Media Contact:

JTC Team, LLC
(833) 475-8247
[email protected]

Dyadic and VTT Are Developing an Efficient New Production Method for Covid-19 Vaccines

 

September 24, 2020 During the last three years Dyadic (Dyadic International, Inc.; NASDAQ: DYAI) and VTT have developed a more efficient and lower cost alternative to produce therapeutic proteins, vaccines and valuable metabolites. The method is based on exploiting the Thermothelomyces heterothallica C1 fungal strain. The partners are now developing a new production method for a number of SARS-CoV-2 coronavirus vaccines.

Currently, the BioPharmaceutical industry is producing therapeutic proteins mainly in the CHO (Chinese hamster ovary) cell system with the current production processes are both time consuming and expensive. In the Dyadic-VTT collaboration, rapid progress and significant advances have been made to develop a new production platform in the industrialized C1 host cell. The C1 gene expression platform provides the possibility to bring affordable medicines to patients sooner and at a lower cost.

“We are at the right time in history to disrupt the biological production of healthcare for vaccine and drugs and it couldn’t have come at a better time because COVID19 came. We are doing our best to work with as many players around the globe to make sure we can help to eradicate this horrific disease and prolong life and reduce pain and suffering in the process”, says Dyadic’s CEO Mark A. Emalfarb. Click here to listen to his thoughts of drug and vaccine development in VTT’s new video.

Dyadic’s industrially proven filamentous fungal strain of Thermothelomyces heterothallica, nicknamed C1 is known as an extremely robust and efficient protein production organism. In addition to being able to produce high levels of enzymes and other proteins, C1 produces glycan structures similar to the human glycan forms making the glycoengineering work quicker and easier.

In the C1 development program, VTT is utilizing its strong competence in fungal molecular biology and bioprocesses that has been accumulated during more than 30 years of research on a variety of fungi. This collaboration has shown that the C1 system has excellent prospects for becoming a game changing platform for therapeutic protein production. See also press release, 25 November, 2019: Dyadic Int. announces achieving human like glycan structures from its engineered C1 cell line

Further information:

VTT Technical Research Centre of Finland Ltd

Christopher Landowski, Research Team Leader, tel. +358 40 482 0856, [email protected]

Markku Saloheimo, Senior Principal Scientist, tel. +358 405760892, [email protected]

Dyadic International, Inc.

Mark A. Emalfarb, Chief Executive Officer, Tel. +1 (561) 743-8333, [email protected]

Monday, September 21, 2020

Onconova Therapeutics Inc. (ONTX)

CDK4/6 Program Advances into Clinic in China

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

Trial initiation in China by research partner Hanx. Onconova announced the commencement of trial of its CDK4/6 and ARK5 inhibitor ON 123300 in China by its partner, HanX Biopharmaceuticals. Hanx and Onconova established the research collaboration in 2017.


What else is there for Onvonova?  The company anticipates filing for the investigational new drug (IND) application to evaluate ON 123300 in the United States in Q4 2020 for this program. We believe this will be…










Click to get the full report

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. 

Monday, September 21, 2020

Onconova Therapeutics Inc. (ONTX)

CDK4/6 Program Advances into Clinic in China

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

Trial initiation in China by research partner Hanx. Onconova announced the commencement of trial of its CDK4/6 and ARK5 inhibitor ON 123300 in China by its partner, HanX Biopharmaceuticals. Hanx and Onconova established the research collaboration in 2017.


What else is there for Onvonova?  The company anticipates filing for the investigational new drug (IND) application to evaluate ON 123300 in the United States in Q4 2020 for this program. We believe this will be…










Click to get the full report

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. 

 

The Roles of Notch Pathways and Notch Signaling in Cancers

 

Notch signaling regulates a diverse array of functions in the hematopoietic system and other tissues, including lineage commitment, differentiation, cell cycle progression, and maintenance and self-renewal of stem cells. The Notch receptor was first identified by Thomas Hunt Morgan in 1917 with the observation of a Drosophila strain, then cloned by Spyros Artavanis-Tsakonas and Michael Young decades later in 1980. Notch plays an important role in many types of cancer, particularly in the regulation of stem and progenitor cells.

The effect of Notch signaling is highly context-dependent. It is capable of acting as an oncogene or tumor-suppressor gene dependent on the presence of other genetic lesions and other factors. Multiple mutations in Notch genes are identified in a broad spectrum of cancers. They reflect various roles for Notch in different cancer contexts. Remarkably, functional studies implicate the importance of Notch signaling in all of the hallmarks of cancer (Exhibit 1), roles that range from oncogenic to tumor suppressive depending on cancer type.

 

Exhibit 1. Cancer hallmarks potentially in?uenced by Notch signaling. Positive (oncogenic) effects (green) and tumor-suppressive effects (red) are shown.

 Notes: ACC, adenoid cystic carcinoma; breast Ca, breast carcinoma; CLL, chronic lymphocytic leukemia; SCCa, squamous cell carcinoma; T-ALL, T cell acute lymphoblastic leukemia; TIC, tumor-initiating cell.

Source: Annu. Rev. Pathol. Mech. Dis. 2017. 12:245–75

 

Notch pathway activation has been implicated in cancer (solid tumor and hematological cancers) and associated with more aggressive cancers. Gamma secretase is a protease (a type enzyme) complex responsible for Notch activation via cleavage of numerous transmembrane proteins, including amyloid precursor protein (APP), Notch, HER4, E-cadherin, N-cadherin, BCMA, and CD44. These substrates have been associated with a variety of diseases, including cancer and Alzheimer’s diseases. Hence, these provide a foundation and rationale for evaluating gamma-secretase and Notch as a therapeutic target.

 

Exhibit 2. Notch signaling and strategies for pharmacological targeting of this pathway

Source: Moore G. et al. Cells 2020, 9, 1503

 

There are numerous strategies to pharmacologically target Notch signaling, including Notch receptor monoclonal antibodies, ligand-targeted antibodies (e.g., DLL-4 antibodies), gamma-secretase inhibitors (GSIs), and Notch transcript complex small molecules. Among the multiple gamma-secretase/Notch inhibitors:

• Ayala Pharmaceuticals (AYLA)’ pan-Notch/gamma-secretase inhibitor AL101 is being assessed in an open-label Phase 2 clinical trial (Accuracy) for the treatment of recurrent/metastatic adenoid cystic carcinoma (R/M ACC) for patients bearing Notch-activating mutations.
• SpringWorks Therapeutics (SWTX)’ gamma-secretase inhibitor nirogacestat is evaluated in a registrational Phase 3 (DeFi) clinical trial for the treatment of desmoid tumors.
• Cellestia Biotech (Private)’s pan-Notch inhibitor CB-103 is evaluated in a Phase 1/2A study in adult patients (pts) with advanced or metastatic solid tumors and hematological malignancies characterized by alterations of the Notch signaling, including breast cancer, colorectal cancer, cholangiocellular carcinoma, sarcoma, desmoid tumor, adenoid cystic carcinoma, non-Hodgkin lymphoma, and malignant glomus tumor.

 

Suggested Content:

Genprex Virtual Roadshow (Video)

PDS Biotechnology C-Suite Interview (Video)

Neovasc C-Suite Interview (Video)

 

Subscribe to Channelchek’s YouTube Channel

 

Photo: Cancer Cells

Dyadic Announces Collaboration with Jiangsu Hengrui Medicine for Biologic Drug Development

 

LIANYUNGANG, CHINA & JUPITER, FL / ACCESSWIRE / August 17, 2020 Dyadic International, Inc. (“Dyadic” or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on further applying its proprietary C1 gene expression platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced collaboration with Jiangsu Hengrui Medicine Co., Ltd. (“Hengrui”) (SSE:600276) to apply Dyadic’s C1 technology to the development of selected Hengrui biologic drug(s).

“We are very excited to partner with Hengrui, one of the most innovative and inventive global biopharmaceutical companies. This collaboration also highlights the appeal of C1’s value proposition, producing cell lines at higher expression levels and lower cost, to address global demand for more efficient biomanufacturing processes of biologic vaccines and drugs. We are looking forward to a successful collaboration with Hengrui,” said Dyadic’s CEO, Mark Emalfarb.

Dr. Lianshan Zhang, Hengrui’s R&D President, commented, “We are interested in Dyadic’s C1 technology, which has potential to help us produce biotherapeutics in a more cost-effective fashion. As a result, we are leveraging our combined expertise and working closely with Dyadic as we share their vision of creating biomedicines to benefit patients globally.”

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

Please visit Dyadic’s website at http://www.dyadic.com for additional information, including details regarding Dyadic’s plans for its biopharmaceutical business.

About Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui Medicine Co., Ltd. is a global biopharmaceutical company, headquartered in China, with 24,700 employees devoted to empowering healthier lives through research. With over $3.3 billion in revenue in 2019, Hengrui has 6 new molecular entities approved in China as well as 30 plus programs in clinical development in China, US, EU and Australia across oncology, anesthesiology & analgesics, autoimmune, and metabolic & cardiovascular therapeutic areas. Driven by internal R&D and global licensing and collaboration, Hengrui is committed to bringing high quality products to patients. For more information, please visit http://www.hrs.com.cn/index.html.

Safe Harbor Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at http://www.dyadic.com.

Contact:

Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: [email protected]

 

Thursday, September 17, 2020

Lineage Cell Therapeutics (LCTX)

Initiating Coverage, Eye of Stem Cell Treatments and Beyond

Lineage Cell Therapeutics, Inc. (NYSE American: LCTX) 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) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

Topline. We like how strategic and forward-looking Lineage has been recently with its pipeline programs. The management team implemented multiple changes in the corporate structure including the acquisition of Asterias Biotherapeutics – prepended two additional cell therapy product candidates, OPC1 and VAC2 in its pipeline. We believe that the value-driving components of the pipeline have been in flux and have not been on investors’ radar. Our analyses show that out of the pipeline, OpRegen and VAC2 may be subject to the largest near and medium-term value inflections which could be transformational for the company and its investors.


The What.  In this report, we highlight the company’s innovative cell therapy pipeline as it begins to yield data. The lead program, OpRegen, is the largest contributor to our valuation with >$0.5B projected sales at peak in the age-related macular degeneration (AMD) market, which is expected to reach $18.7B sales in 2028. The second lead asset, OPC1, is in a small market of acute spinal cord …

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. 

 

Novus Therapeutics Announces Acquisition of Anelixis Therapeutics

 

Acquisition includes lead clinical-stage compound AT-1501, a next generation anti-CD40L antibody, in development for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases

Senior management team with extensive drug development and commercialization experience, including Dr. David-Alexandre “DA” C. Gros as CEO and Dr. Steven Perrin as President and CSO, to lead Novus

Company completes private placement financing with proceeds of $108 million to be used to advance AT-1501 Phase 2 clinical trials in up to four indications

Conference call tomorrow at 8:30 a.m. EDT

 

IRVINE, Calif. & BOSTON–(BUSINESS WIRE)–Sep. 14, 2020– Novus Therapeutics, Inc. (“Novus”) (NASDAQ: NVUS) today announced it has completed the acquisition of Anelixis Therapeutics, Inc. (“Anelixis”), a privately held clinical stage biotechnology company developing a next generation anti-CD40 Ligand (CD40L) antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases. Concurrent with the acquisition of Anelixis, Novus entered into a definitive agreement for the sale of non-voting convertible preferred stock (the “Preferred Stock”) in a private placement to a group of institutional accredited investors led by BVF Partners L.P., with participation from Cormorant Asset Management, Ecor1 Capital, Logos Capital, Fidelity Management and Research Company, Adage Capital Partners L.P., Woodline Partners LP, Ridgeback Capital, Janus Henderson Investors, and Samsara BioCapital, as well as additional investors. The private placement is expected to result in gross proceeds to Novus of approximately $108 million before deducting placement agent and other offering expenses. The proceeds from the private placement will be used to fund the Company’s operations, including to advance Phase 2 clinical trials of AT-1501, a humanized IgG1 anti-CD40L antibody with high affinity for CD40L, in renal transplantation, islet cell transplantation, autoimmune nephritis, and amyotrophic lateral sclerosis (ALS).

“We are excited about AT-1501 and the potential to develop and commercialize the next generation anti-CD40L antibody, a well-validated target with broad therapeutic possibilities,” said Keith A. Katkin, Chairman of the Board of Directors of Novus. “After exploring a range of strategic options to maximize shareholder value, we believe this acquisition represents the greatest value creation opportunity for Novus stockholders, and we are confident that we have the management and scientific leadership team to fully realize this opportunity for patients in need of new treatment options.”

Leadership & Organization

In addition to the strategic acquisition and private placement, Novus announced its Board of Directors has previously appointed David-Alexandre “DA” C. Gros, M.D. to serve as Chief Executive Officer and Director. Dr. Gros joins Novus from Imbria Pharmaceuticals Inc., where he served as Co-Founder, Chief Executive Officer and Director. Prior to Imbria, Dr. Gros was President and Chief Operating Officer of Neurocrine Biosciences, Inc., Chief Business and Principal Financial Officer of Alnylam Pharmaceuticals, Inc., and Chief Strategy Officer of Sanofi, S.A. Before Sanofi, Dr. Gros held leadership positions in healthcare investment banking at Centerview Partners, LLC, and Merrill Lynch, Pierce, Fenner & Smith, Inc., and in healthcare consulting at McKinsey & Company. Dr. Gros earned a Doctor of Medicine from Johns Hopkins University School of Medicine, a Master of Business Administration from Harvard Business School, and a Bachelor of Arts from Dartmouth College.

“I am both thrilled and humbled to join the Novus management team and Board during this new phase of the company’s evolution, as we prepare to initiate multiple Phase 2 trials for AT-1501” said Dr. Gros. “Through this acquisition and financing, we now have the scientific, organizational and financial resources to build upon a deep historical understanding of the CD40/CD40L pathway, as well as Anelixis’ preclinical and Phase 1 data, to address the needs of people undergoing organ or cellular transplantation, or living with autoimmune and neurodegenerative diseases.”

Joining Dr. Gros on the Novus management team and Board of Directors is Steven Perrin, Ph.D., Founder and Chief Executive Officer of Anelixis, who will take on the role of President and Chief Scientific Officer. Dr. Perrin brings 20 years of drug development experience to Novus, having held R&D positions at the Hoechst-Ariad Genomics Center, Aventis Pharmaceuticals, Inc., and Biogen Idec, Inc. Over the past decade, Dr. Perrin has worked with the ALS Therapy Development Institute to develop the world’s largest ALS drug development program, bridging preclinical and clinical programs. Dr. Perrin received a Ph.D. in biochemistry from Boston University Medical Center, where he also started his career as Associate Professor of Medicine, and a Bachelor of Science from Boston College.

“The activation of CD40/CD40L signaling is critical to mediating antibody and cellular inflammatory response. We are developing antibodies to inhibit the activation of this pathway with the hope of offering new treatment modalities for people living with conditions such as autoimmune nephritis and ALS, or those requiring a potentially life-saving transplant,” said Dr. Perrin. “I have dedicated my career to developing better medicines for these patients and their families, and I look forward to working with the team to advance these clinical programs.”

Concurrent with the acquisition, former Anelixis Chairman of the Board Walter Ogier has been appointed to the Novus Board of Directors. Mr. Ogier has more than 30 years of experience developing therapeutic medical products ranging from pharmaceuticals to medical devices, stem and immune cell therapies, and gene therapies. He has served in multiple CEO roles including Genetix Pharmaceuticals, Inc. (now bluebird bio, Inc.) and Acetylon Pharmaceuticals, Inc., which Celgene Corporation acquired in 2016. In addition to Novus, he serves as a director of Biothera Pharmaceuticals, Inc., Thetis Pharmaceuticals, LLC, and Nemucore Medical Innovations, Inc., and as Board advisor to Kodikaz Therapeutic Solutions, Inc., and ME Therapeutics, Inc.

Novus Board members will also include Keith A. Katkin, Chairman of the Board; Gary A. Lyons; and John S. McBride. The company will continue to maintain its executive offices in Irvine, Calif. and will have research and development facilities in Boston, Mass.

About the Transactions

The acquisition of Anelixis was structured as a stock-for-stock transaction whereby all of Anelixis’ outstanding equity interests were exchanged in a merger for a combination of shares of Novus common stock and shares of Preferred Stock. Concurrently with the acquisition of Anelixis, Novus entered into definitive agreements for a PIPE investment with existing and new investors to raise approximately $108 million in which the investors will be issued shares of Preferred Stock at a price of approximately $500 per share (or, $0.50 per share on an as-converted-to-common basis). The PIPE offering is expected to close on September 14, 2020. Subject to stockholder approval, each share of Preferred Stock will, at the option of the holder, be convertible into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. The acquisition was approved by the Board of Directors of Novus and the equity holders of Anelixis.

Ladenburg Thalmann & Co. Inc. is serving as exclusive financial advisor and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Novus. Goodwin Procter LLP is serving as legal counsel to Anelixis. SVB Leerink is serving as financial advisor and lead placement agent for the private placement, and Noble Life Science Partners, a division of Noble Capital Markets, Inc., is acting as co-placement agent.

Additional details are available in an updated corporate presentation that can be found online at www.novustherapeutics.com.

Webcast Details

Novus will host an audio webcast on Tuesday, September 15, 2020, at 8:30 a.m. EDT to discuss the acquisition. The live audio webcast will be accessible through a direct link and the investor section of www.novustherapeutics.com. To access via phone, please dial (833) 614-1390 (toll-free) or (914) 987-7111 (international) and provide the conference ID 4046285. Please visit the investor section of the Novus website at www.novustherapeutics.com for the archived webcast and for more information on the acquisition.

About AT-1501

AT-1501 is a humanized IgG1 anti-CD40L antibody with high affinity for CD40L, a well-validated target with broad therapeutic potential. The CD40/CD40L pathway plays a central role in generating pro-inflammatory responses in autoimmune disease, allograft transplant rejection, and neuroinflammation. In a Phase 1 safety study of healthy volunteers and patients with ALS, AT-1501 was well tolerated at all doses tested.

About Novus Therapeutics

Novus Therapeutics, Inc. is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for people requiring an organ or cell-based transplant, and for people with autoimmune and neurodegenerative disease. Novus is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.novustherapeutics.com.

Follow Novus Therapeutics on social media: @Novus_Thera and LinkedIn.

Notice of Issuance of Inducement Grants

Pursuant to their employment agreements, Drs. Gros and Perrin have been awarded options to purchase a total of 18,279 and 7,857 shares of Preferred Stock, respectively, subject to time-based vesting (the “Inducement Grants”). The Inducement Grants have an exercise price of $500 per share of Preferred Stock, which is equal to the price at which the Preferred Stock is being offered and sold in the PIPE financing and represents (on an as-converted basis) a premium of approximately 30% over the last reported closing price of the Novus common stock prior to grant. The Inducement Grants have been approved by the Novus Board of Directors and the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company’s stockholder-approved equity incentive plans as an inducement grant in accordance with Nasdaq Listing Rule 5635(c)(4).

Forward-Looking Statements

This press release contains forward-looking statements that involves substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward-looking statements include such identifying words. Forward-looking statements include, but are not limited to statements regarding: risks related to market conditions; expectations regarding the timing for the commencement of future clinical trials; expectations regarding the success of clinical trials; the rate and degree of market acceptance and clinical utility of the company’s products; the company’s estimates regarding expenses and cash runway; and the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the SEC, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005852/en/

Amanda Sellers
[email protected]
301.332.5574

Source: Novus Therapeutics, Inc.

 

 

Targeting Ovarian and Breast Cancer Through Another Innovative Therapy

 

The ovarian cancer landscape has experienced a paradigm shift from chemotherapy to targeted therapy with the approvals of Poly (adenosine diphosphate–ribose) polymerase (PARP) inhibitors and other late-stage assets in development. The mechanism of action of PARP inhibitors is based on trapping PARP on DNA at sites, which generates unrepairable DNA breaks. These breaks lead to the accumulation of DNA damage and tumor-cell death in cancer cells due to defective recombination repair systems (e.g., tumors with mutations in BRCA1 or BRCA2 genes). BReast CAncer (BRCA) genes 1 and 2 are linked to high-risk breast and ovarian cancers.

Breast cancer is the most frequently occurring cancer in women worldwide; ovarian cancer is the second most common gynecological cancer in developed countries, including the United States. BRCA1 and BRCA2 tumor suppressor genes are linked to cellular damage through activation of specific DNA repair processes. DNA replication and error-repair are critical components of cancer cell survival. PARP inhibitors are believed to inhibit both PARP1 and PARP2. The suppression of PARP activity prevents the formation of PAR polymers and blocks the binding of NAD+ at the site of DNA damage, ultimately compromising a cell’s ability to defeat DNA-dependent damage. There are currently 4 FDA-approved PARP inhibitors—niraparib (Zejula, PARP 1 and 2 inhibitors), olaparib (Lynparza, PARP 1 and 2 inhibitors), and rucaparib (Rubraca, PARP1, and PARP 3 inhibitor)— to treat patients with ovarian cancer who are refractory or resistant to platinum-based chemotherapy, and talazoparib (Talzenna, PARP 1 and 2 inhibitor) for the treatment of gBRCAm HER2- locally advanced or metastatic breast cancer.

 

Focusing on ovarian cancer treatment

Astra Zeneca’s (AZN) olaparib is approved in the United States and Europe as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer. SOLO-1, the first pivotal study of a PARP inhibitor in an early-stage setting, showed promising results. The data was presented at ESMO and published in NEJM. In a 391-patient trial, Lynparza was superior to placebo, as demonstrated by a clinically and statistically significant improvement in progress-free survival (PFS). Patients participating in the study were diagnosed with deleterious or suspected deleterious BRCA1 or BRCA2 mutations. Patients treated with Lynparza group did not reach the median PFS at 41 months of follow-up, while the placebo group hit median PFS at 13.8 months. At 36 months of follow up, 60% of patients treated with Lynparza showed progression-free disease compared to 27% in the placebo group. In addition to SOLO-1 study, the company conducted a Phase 3 clinical trial, PAOLA-1, to evaluate Lynparza in combination with Genentech’s Avastin (bevacizumab) as the first-line maintenance therapy for advanced ovarian cancer. In May 2020, Lynparza was approved in the first-line setting based on the results from the PAOLA-1 trial that showed patients treated with Lynparza and bevacizumab lived without disease progression for 37.2 months compared to 17.7 months median for bevacizumab alone.

Tesaro’s (TSRO) Zejula (niraparib) was approved for maintenance use in patients who had a complete or partial response to platinum chemotherapy in March 2017. The Phase 3 PRIMA (NCT02655016) study evaluated Zejula versus placebo as maintenance therapy after frontline chemotherapy in ovarian cancer patients. PRIMA study has enrolled patients regardless of BRCA mutation, while Astra Zeneca’s SOLO-1 trial only includes patients harboring BRCA mutation. Based on PRIMA results, Zejula was approved as monotherapy for women with advanced ovarian cancer beyond those with BRCAm disease in the first line and recurrent maintenance treatment settings, as well as late-line primary treatment settings on April 2020. The results showed that a 57% reduction in the risk of disease progression or death compared to placebo (HR 0.43; 95% CI, 0.31 to 0.59; p<0.0001) in the homologous recombination deficient (HRd) population (biomarker identified), and a 38% reduction in the risk of disease progression or death versus placebo in the overall population (HR 0.62; 95% CI, 0.50 to 0.76; p<0.0001).

Clovis (CLVS) ‘s Rubraca is a PARP1, PARP2, and PARP3 enzyme inhibitor, approved for the maintenance treatment of adult patients with recurrent epithelial ovarian cancer who responded (complete or partial response) to platinum-based chemotherapy. The ARIEL3 clinical trial evaluating Rubraca in 564 patients showed that patients treated with Rubraca have an average of 13.7 months without cancer progression compared to 5.4 months for those who did not receive Rubraca.

The ovarian cancer landscape has evolved to targeted therapy from chemotherapy with the approvals of PARP inhibitors and other late-stage assets in development. Lynparza has emerged first in the market and dominating the market with $982 million in sales, followed by Zejula with $292 million in sales and Rubraca with $143 million. There are multiple other late-stage assets- including ImmunoGen’s mirvetuximab soravtansine, Mersana Therapeutics’s XMT-1536, Fluzoparib Jiangsu Hengrui Medicine’s fluzoparib and others expected to enter into the market in the next several years.

 

Exhibit 1. Worldwide sales (in millions) of PARP inhibitors in ovarian cancer

Source: Evaluate Pharma

 

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