Image credit: S. Pincus, E. Fischer, Austin Athman (NIH)

Improved Method to Identify B or T cells that Interact with Viral or Bacterial Proteins

Anne Trafton | MIT News Office

The human body has millions of unique B and T cells that roam the body, looking for microbial invaders. These immune cells’ ability to recognize harmful microbes is critical to successfully fighting off infection.

MIT biological engineers have now devised an experimental tool that allows them to precisely pick out interactions between a particular immune cell and its target antigen. The new technique, which uses engineered viruses to present many different antigens to huge populations of immune cells, could allow large-scale screens of such interactions.

“This technique leads the way to understand immunity much closer to how the immune system itself actually works, will help researchers make sense of complex immune recognition in a variety of diseases, and could accelerate the development of more effective vaccines and immunotherapies,” says Michael Birnbaum, an associate professor of biological engineering at MIT, a member of MIT’s Koch Institute for Integrative Cancer Research, and the senior author of the study.

Former MIT graduate student Connor Dobson is the lead author of the paper, which appears in Nature Methods.

A Simple Screen for a Complex System

Both B and T cells play critical roles in launching an immune response. When a T cell encounters its target, it starts proliferating to produce an army of identical cells that can attack infected cells. And B cells that encounter their target begin producing antibodies that help recruit other components of the immune system to clear the infection.

Scientists who study the immune system have several tools to help them identify specific antigen-immune cell interactions. However, these tools generally only allow for the study of a large pool of antigens exposed to one B or T cell, or a large pool of immune cells encountering a small number of antigens.

“In your body, you have millions of unique T cells, and they could recognize billions of possible antigens. All of the tools that have been developed to this point are really designed to look at one side of that diversity at a time,” Birnbaum says.

The MIT team set out to design a new tool that would let them screen huge libraries of both antigens and immune cells at the same time, allowing them to pick out any specific interactions within the vast realm of possibilities.

To create a simple way to screen so many possible interactions, the researchers engineered a specialized form of a lentivirus, a type of virus that scientists often use to deliver genes because it can integrate pieces of DNA into host cells. These viruses have an envelope protein called VSV-G that can bind to receptors on the surface of many types of human cells, including immune cells, and infect them.

For this study, the researchers modified the VSV-G protein so that it cannot infect a cell on its own, instead relying on an antigen of the researchers’ choosing. This modified version of VSV-G can only help the lentivirus get into a cell if the paired antigen binds to a human B or T-cell receptor that recognizes the antigen.

Once the virus enters, it integrates itself into the host cell’s genome. Therefore, by sequencing the genome of all the cells in the sample, the researchers can discover both the antigen expressed by the virus that infected the cell and the sequence of the T or B-cell receptor that allowed it to enter.

“In this way, we can use viral infection itself as a way to match up and then identify antigen-immune cell parings,” Birnbaum says.

Interactions Identified

To demonstrate the accuracy of their technique, the researchers created a pool of viruses with antigens from 100 different viruses, including influenza, cytomegalovirus, and Epstein-Barr virus. They screened these viruses against about 400,000 T cells and showed that the technique could correctly pick out antigen-T-cell receptor pairings that had been previously identified.

The researchers also screened two different B-cell receptors against 43 antigens, including antigens from HIV and the spike protein of SARS-CoV-2.

In future studies, Birnbaum hopes to screen thousands of antigens against B and T cell populations. “Our ideal would be to screen entire viruses or families of viruses, to be able to get a readout of your entire immune system in one experiment,” he says.

In one study that is now ongoing, Birnbaum’s lab is working with researchers at the Ragon Institute of MGH, MIT, and Harvard to study how different people’s immune systems respond to viruses such as HIV and SARS-CoV-2. Such studies could help to reveal why some people naturally fight off certain viruses better than others, and potentially lead to the development of more effective vaccines.

The researchers envision that this technology could also have other uses. Birnbaum’s lab is now working on adapting the same viruses to deliver engineered genes to target cells. In that case, the viruses would carry not only a targeting molecule but also a novel gene that would be incorporated exclusively into cells that have the right target. This could offer a way to selectively deliver genes that promote cell death into cancer cells, for example.

“We built this tool to look for antigens, but there’s nothing particularly special about antigens,” Birnbaum says. “You could potentially use it to go into specific cells in order to do gene modifications for cell and gene therapy.”

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Lineage to Present at the NobleCon18 Investor Conference on April 20, 2022

Research, News, and Market Data on Lineage Cell Therapeutics

CARLSBAD, Calif.–(BUSINESS WIRE)–Apr. 11, 2022–

Lineage Cell Therapeutics, Inc.

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at NobleCon18 – Noble Capital Markets’ Eighteenth Annual Investor Conference on
April 20th, 2022 at
4:30pm ET
in Seminole Ballroom A. NobleCon18 is taking place at the
Hard Rock Hotel & Casino in
Hollywood, Florida
,
April 19th – 21^st, 2022.

An archived webcast of the corporate presentation will be available starting
April 21st, 2022 on the Events and Presentations page of the Lineage website, and as part of a complete catalog of presentations available on the conference website: www.nobleconference.com and on Channelchek www.channelchek.com, the investor portal created by
Noble Capital Markets. Additional videos are available on the Media page of the Lineage website.

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 four 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, which is now being developed under a worldwide collaboration with Roche and
Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a 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 and (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

View source version on businesswire.com:
https://www.businesswire.com/news/home/20220411005035/en/

Lineage Cell Therapeutics, Inc. IR Ioana C. Hone (
ir@lineagecell.com)
(442) 287-8963

Solebury
Trout IR Mike Biega (
Mbiega@soleburytrout.com)

(617) 221-9660

Russo
Partners – Media Relations Nic Johnson or David Schull Nic.johnson@russopartnersllc.com

David.schull@russopartnersllc.com

(212) 845-4242

Source:
Lineage Cell Therapeutics, Inc.

Avivagen Announces AGM Results and Update to Shareholders

Research, News, and Market Data on Avivagen

Record Year of Progress for OxC-beta™ Adoption Worldwide

• Supply agreement with AB Vista in United States, Brazil and Thailand compliments existing partnerships in Asia and Mexico

• Continued positive animal trial results leading to orders, new customer wins and growing recognition from the scientific community

OTTAWA, Ontario, April 08, 2022–(BUSINESS WIRE)–Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Company”), 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, today announced the results of its annual general meeting of shareholders and highlighted the significant progress made in the Corporation’s efforts to drive further adoption of OxC-beta™ worldwide.

At the Company’s AGM held today, Avivagen’s Corporation’s shareholders voted to support all of the resolutions that came before the meeting. The resolutions included the election of directors and the reappointment of McGovern Hurley LLP as Avivagen’s auditor.

The voting results in respect of the election of directors are detailed below:

“Like every business we’ve had to overcome the challenges that the extended Covid-19 pandemic brought over the past year, but our growth since early 2021 is a testament to the opportunities for OxC-beta™,” says Kym Anthony, Chief Executive Officer, Avivagen. “The past year has seen a series of important milestones, including growth throughout the countries we service in the Americas and Asia, new customer wins and distribution agreements, important leadership appointments and strong recognition from the scientific and investment communities. Avivagen is in its strongest position yet, and we’ve only scratched the surface of the potential for OxC-beta™ adoption.”

The past 12 months have seen a series of key milestones achieved in furthering adoption of OxC-beta™ in markets worldwide, including:

Distribution Agreements and Market Development Efforts

In October 2021, Avivagen struck an eight-year supply agreement with AB Vista, a leading global animal nutrition technology company. The agreement saw AB Vista become the exclusive distributor of OxC-beta™ for use with poultry, swine, ruminants and aquaculture in the United States, Brazil and Thailand, and also presents opportunities to collaborate on development efforts. It is believed that the agreement will drive greater adoption of OxC-beta™ in two of the world’s three largest feed production markets.

In July 2021 Avivagen retained the services of industry leader Lesley Nernberg as a technical sales and marketing consultant focused on accelerating adoption of OxC-beta™ in Asia. Avivagen also secured regulatory approval for use of the Corporation’s oxidized carotenoid-based feed additive product in Vietnam in February 2022, creating new market opportunities.

In February 2021, Avivagen signed an agreement with Meyenberg International Group to expand its OxC-beta™ sales efforts into five Central and South American markets. Meyenberg has been instrumental in securing new customer interest, driving trails of OxC-beta™ locally and finalizing new and recurring sales throughout Mexico, with continued progress in Central and South America.

Record Orders and Large Recurring Customers

In April 2021 Avivagen secured the largest OxC-beta™ order to date (4.4 metric tonnes) with long-standing customer UNAHCO in the Philippines. This was later followed up by another record 6.3 tonne order, as UNAHCO continues to gain market share despite current difficult economic conditions.

The Corporation has also secured and fulfilled first purchase orders with a number of landmark customers over the past year, including sales with a large integrated producer in Asia, and an initial order with a large, influential and industry-leading poultry producer in Mexico. Avivagen believes that the order size and volume of initial orders signals an opportunity for growth in OxC-beta™ adoption over the coming years.

Recognition from the Scientific Community and Trials

The growing interest and demand for new and innovative solutions for replacing AGP’s (Antibiotics as Growth Promoters) in feeds, has led to a number scientific papers from Avivagen being accepted and published in top-tier scientific publications over the past year. Of note, scientific papers written by Avivagen representatives have appeared recently in such esteemed publications as Poultry Science, the British Journal of Nutrition, Food and Chemical Toxicology, the Canadian Journal of Chemistry and the New Zealand Veterinary Journal.

The scientific community is now recognizing what distribution partners and customers have seen firsthand via trials of OxC-beta™ over the past several years – that the safety and utility of using OxC-beta™ in broilers, swine and cows is conclusive. Trials with several AB Vista customers in Brazil are currently underway which, if successful, could lead to a pipeline of new customer activity. Trials by two of Mexico’s most important and influential livestock fed and dairy production associations, Asociación Nacional de Fabricantes de Alimentos Para Consumo Animal. S.C (ANFACA) and Asociación Mexicana de Productores de Alimentos, A.C. (AMEPA), are also underway.

Results from a dairy trial in New Zealand showing positive outcomes for use against sub-clinical mastitis were published in the New Zealand Veterinary Journal and have played a key role in driving purchasing decisions for customers as far away as Mexico. Similar trials with large industry leaders have also returned positive results that are expected to lead to continued adoption over the coming years.

Positive Corporate Developments

Along with continued customer and market success for OxC-beta™, Avivagen has focused on strengthening its leadership and financials over the past year. The Corporation announced the appointment of James (Jamie) Nickerson, PhD as President of Avivagen in January 2022 after 15 years of success in roles supporting the Corporation’s business development and innovation efforts.

Avivagen also completed a bought deal financing of $7.5 million in February 2021, and a private placement of debentures and shares for gross proceeds of $5.678 million in March 2022. The proceeds from the debenture and share offering were used by Avivagen to retire principal and interest outstanding pursuant to existing debentures and for transaction expenses.

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications. By unlocking an overlooked facet of ?-carotene activity, a path has been opened to safely and economically support immune function, thereby promoting general health and performance in animals. Avivagen is a public corporation traded on the TSX Venture and OTCQB® Venture Market exchanges under the symbols VIV and VIVXF, and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada and Charlottetown, Prince Edward Island. 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, Mexico, Philippines, Taiwan, New Zealand, Thailand, 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 the market opportunities for the Company, the expectation that Avivagen’s current position positions it for future growth, expectation as to further adoption of or orders for the Company’s products, the possibility that trials underway could lead to additional orders in the future and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are 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, unforeseen factors could limit the growth of the Company and the adoption of its products, customers are under no obligation to make additional orders and may not order increasing quantities of the Company’s products, partnerships may not be as successful as hoped, trials may not be successful or may not lead to additional adoption of the Company’s products, 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 as growth promoters in livestock feeds, all of which could occur 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.

Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Contacts

Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

PDS Biotechnology Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Research, News, and Market Data on PDS Biotech

FLORHAM PARK, N.J., April 08, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced that on April 6, 2022 PDS Biotech granted nonstatutory stock options to (a) Robert Imani, M.D., PhD, PDS Biotech’s Vice President Medical Director to purchase 70,000 shares of PDS Biotech common stock, and (b) Paul Ivany, PDS Biotech’s Senior Director Manufacturing Operations, to purchase 50,000 shares of PDS Biotech’s common stock, in each case, as a material inducement to their employment with PDS Biotech and in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech’s 2019 Inducement Plan, as amended, which was adopted on June 17, 2019 and provides for the granting of equity awards to new employees of PDS Biotech.

Each stock option has an exercise price of $6.09, the closing price of PDS Biotech’s common stock on April 6, 2022. Each stock option vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date and the remaining shares vesting monthly over the 36-month period thereafter, subject to continued employment with the company through the applicable vesting dates.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms. Our Versamune^®-based products have demonstrated the potential to 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. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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^® and Infectimune™-based product candidates; 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^® and Infectimune™-based product candidates 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 the Company’s ability to fully fund its 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 (including, without limitation, any preclinical results or data), 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; 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.

Versamune^® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital