The pandemic wasn’t going to slow JLABS down. Two years after announcing a new location, Johnson & Johnson’s incubator arm opened its doors in the nation’s capital on Monday, right on time.

The new hub, dubbed JLABS @ Washington, D.C., will host up to 50 startups spanning pharmaceuticals, medical devices, consumer and health tech companies, including those working on pediatric care. The first group of companies moving in includes spinouts from the Children’s National Hospital, J&J’s partner in running the site, startups local to the D.C. area, and those from other parts of the country.

“We’ve selected companies that are here in the [D.C., Maryland and Virginia] region and we’ve also selected a company from New York and one from Alabama that are looking specifically to expand in the D.C. area,” said Sally Allain, head of JLABS @ Washington, D.C. “We have two international companies coming in as part of the first group of companies.”

Though it’s home to the National Institutes of Health and federal agencies like the FDA, the D.C. area doesn’t always spring to mind as a biotech hub the way Boston, San Diego or the Bay Area do.

“It’s unfortunate, because the capital region has so much here. I think it’s untapped,” said Allain, who figures that with the growth in manufacturing and investing in the area, the region could catapult into the top five biotech hubs pretty soon.

Click here to read more via FIERCE Biotech.

Ceres Nanosciences, a Northern Virginia bioscience company spun out of George Mason University that specializes in diagnostic products and workflows, has opened a 12,000-square-foot advanced particle manufacturing plant in Prince William County’s Innovation Park. The new facility increases the manufacturing capacity of Ceres’ Nanotrap^® Magnetic Virus Particles, which improve diagnostic testing for viruses like SARS-CoV-2, influenza, and respiratory syncytial virus.

The completion of the new facility also reflects the partnership between Mason and the Prince William County Department of Economic Development (PWCDED).

“The PWCDED has a long-standing relationship with Mason, specifically with the Science and Technology Campus that anchors our bioscience hub in Innovation Park,” said Christina Winn, executive director of PWCDED. “Ceres was the first company to graduate our Science Accelerator, and we are invested in their growth as a leader, collaborator and innovator in our life sciences industry cluster.”

The construction of the facility, which was completed in under four months, was funded by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative to expedite the production and commercialization of diagnostic tests for the SARS-CoV-2, the virus that has become known as COVID-19. Prince William County also supported the swift development of the site.

“We’re immensely grateful for the NIH funding that supported this new facility,” said Ross Dunlap, Ceres Nanosciences CEO. “Not only are we now able to deliver a robust supply of this critical reagent that the industry needs, but the facility also is a major element of Ceres’ long-term growth plan.”

Click here to read more via George Mason University.

Collaboration to use Gain’s proprietary Site-Directed Enzyme Enhancement Therapy (SEE-Tx™) computational platform technology to identify new and previously difficult-to-drug oncology targets

BETHESDA, Md., April 20, 2021 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (NASDAQ: GANX) (“Gain”) today announced a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ: ZNTL) to discover new product candidates for the treatment of cancer. Gain will use its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology. SEE-Tx applies a proprietary computational algorithm and supercomputer processing to the published 3D structure of proteins to discover new binding sites with the ability to modulate protein function. The intended output is newly-discovered targets or target protein interactions that can then be drugged for therapeutic benefit to intervene on protein misfolding.

“We are pleased to enter into a relationship with Zentalis, an oncology company at the forefront of developing differentiated treatments for patients,” said Eric Richman, Chief Executive Officer at Gain. “Our unique algorithm, based on a patented method to analyze molecular dynamics and powered by supercomputers, is designed to enable discovery of novel targets in various therapeutic areas. Zentalis’ team brings extensive industry experience and a proven track record in the discovery and clinical development of innovative cancer therapies, which will be beneficial as we work to further validate SEE-Tx for use in combating cancers and other devastating diseases. Together, we are looking forward to changing the way the industry thinks about drug discovery in oncology.”

Prof. Xavier Barril, Chief Scientific Officer of Gain, added, “Over the past several decades, the evidence linking protein misfolding and cancer has continued to grow, with chaperones that mediate protein folding being identified as critical modulators of proper cellular function. Of particular note, while most proteins have a half-life of one to two hours, many oncogenes have half-lives of just a few minutes, meaning that they are continually being synthesized, folded and degraded, offering significant opportunities for misfolding. We are excited to collaborate with Zentalis with its promising pipeline of oncology therapeutic candidates. Zentalis sees the potential of our SEE-Tx platform technology to address this challenge in cancer.”

Under the terms of the agreement, Gain will pursue binding site identification on target proteins that will be selected and agreed upon by both parties. Next, Gain will identify and determine the potential suitability of these sites as drug targets, as well as their prospective therapeutic use. Selected compounds will be tested in the lab by Zentalis against the target protein to confirm binding and action to identify and characterize novel compounds for development.

About SEE-Tx™

SEE-Tx is the first proprietary technology platform exclusively designed use the 3D structure of proteins to systematically identify allosteric binding sites never described previously and predict their druggability. Powered by supercomputers, its novel algorithm orchestrates molecular modeling at a speed and efficiency that has the potential to redefine drug discovery.

About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

Forward-Looking Statements
Any statements in this release that are not historical facts may be considered to be “forward-looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain’s product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain’s ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Gain Therapeutics Investor Contact:
Daniel Ferry
LifeSci Advisors
+1 617-430-7576
daniel@lifesciadvisors.com

Gain Therapeutics Media Contact:
Cait Williamson, Ph.D.
LifeSci Communications
+1 646-751-4366
cait@lifescicomms.com

Partnership Leverages Lineage’s Investigational VAC Allogeneic Cancer Vaccine Platform and Immunomic’s Proprietary Tumor Associated Antigen to Generate a Novel Oncology Product Candidate

ROCKVILLE, Md. & CARLSBAD, Calif.–(BUSINESS WIRE)– Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today a worldwide license and development collaboration agreement with Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions. The collaboration will generate a novel product candidate derived from Lineage’s investigational allogeneic VAC cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to an upfront payment of $2 million paid in the first year and development and commercial milestones totaling $67 million across multiple indications. Lineage also will be eligible to receive royalties up to 10% on future product sales.

“We’re very pleased to collaborate with Lineage, a well-recognized cell therapy company, to expand our pipeline with the development of a novel product candidate to treat GBM,” commented Dr. William Hearl, CEO of ITI. “Over the last several years, ITI has invested significant capital and development resources to identifying multiple novel paths forward in GBM. By teaming up with Lineage, we are hoping to expand our efforts in this difficult to treat indication and look forward to the benefit that the VAC immunotherapy platform can bring to our antigen constructs.”

“The VAC platform provides us with the opportunity to generate a broad pipeline of product candidates, each targeting a different type of cancer,” stated Brian Culley, Lineage CEO. “This collaboration represents the first of many partnerships we hope to enter into with our platform and we believe it helps further validate VAC as a promising new therapeutic vaccine platform. Our objective is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline, as well as in collaboration with partners, capitalizing on the strength of Lineage’s recent manufacturing and cell transplant success. These alliances also will diversify our oncology pipeline across more programs, providing new opportunities for success without the financial burden of independent development. We appreciate ITI selecting our antigen delivery platform for this collaboration and look forward to a productive partnership on this new VAC-derived product candidate. We also are eager to collaborate with additional partners on future versions of VAC.”

About Glioblastoma multiforme (GBM)

Glioblastoma multiforme (GBM) (also called glioblastoma) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is often referred to as a grade IV astrocytoma. These are the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. GBMs can arise in the brain “de novo” or evolve from lower-grade astrocytomas or oligodendrogliomas. In adults, GBM occurs most often in the cerebral hemispheres, especially in the frontal and temporal lobes of the brain. GBM is a devastating brain cancer that typically results in death in the first 15 months after diagnosis, with only 25% of glioblastoma patients surviving more than one year, and only 5% of patients surviving more than five years.

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 selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

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. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its investigational proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including targeting viral antigens, cancer antigens, neoantigens and producing antigen-derived antibodies as biologics. In 2020, an investment of over $77M by HLB Co., LTD, a global pharmaceutical company, enabled ITI to accelerate application of its immuno-oncology platform, in particular to glioblastoma multiforme, and rapidly advance other key candidates in the pipeline, including the most recent initiative into infectious diseases with development of its vaccine candidate for COVID-19. The Company has built a large pipeline from UNITE with eight oncology programs, multiple animal health programs and a SARS-CoV-2 program to prevent and treat COVID-19. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Duke University and the University of Florida. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.

MOU builds on presence of 50 local federal facilities to support increased collaboration and tech transfer for Montgomery County companies 

Rockville, Md. — The Montgomery County Economic Development Corporation (MCEDC) and the Federal Laboratory Consortium (FLC) have signed a Memorandum of Understanding (MOU) to formalize a strategic partnership to help build a stronger local relationship between federal labs and Montgomery County’s private sector, particularly small businesses.

This FLC/MCEDC partnership will help advance technology transfer (T2) opportunities for Montgomery County businesses, bringing new cutting-edge technology to the marketplace. As increased engagement between the labs and businesses leads to more research collaboration and tech commercialization, the partnership has the exciting potential to accelerate the local economy and aid in job creation.

This is the first FLC MOU signed with a county economic development organization. With its significant concentration and diversity of major federal facilities, Montgomery County, MD is a natural choice for a formalized joint agreement between the FLC and a local economic development organization. According to the recent FLC draft census, Maryland is home to around 95 federal labs—of which approximately 50 are in Montgomery County. Their presence creates many potential opportunities to help drive the local economy and support emerging industry sectors such as immunology and quantum computing.

In a strengthened relationship with MCEDC, the FLC member laboratories can advance their national mission through greater collaboration with local and regional businesses. As an example, Maryland’s TEDCO recently won two FLC National Awards specifically for their work with federal labs NIST and NCI, resulting in new business and job creation.

“By maximizing our local federal presence, we are creating greater opportunities for Montgomery County businesses to partner and commercialize exciting new technologies being developed by some of our top federal scientists,” said Benjamin H. Wu, MCEDC President & CEO. “This timely partnership with FLC charts another path for us to support more cross-over, content-rich innovation projects to benefit our diverse business community—resulting in a stronger economy for all.”

The connecting opportunities created by this first-ever FLC partnership with a local economic development entity like MCEDC can serve as a model for other jurisdictions, creating a formal process to share resources and enhance the transfer of federal laboratory research and technology.

“Partnerships are the key to successful technology transfer programs. We work with many labs and learn best practices for engaging partners and building meaningful relationships to move federal discoveries out of the labs and into the marketplace,” said John Dement, FLC Chair. “Year after year, the T2 community engages in partnerships benefitting research, innovation and public health, leading to greater value for the next generation.”

Some key elements of the new partnership include stronger collaboration between FLC and MCEDC to find collaborative opportunities, create a larger presence in each partner’s marketing outreach, educate businesses on federal programs, and jointly sponsor events to widen the outreach to new companies.

The FLC promotes, facilitates and educates labs and industry about the tech transfer process. More than 300 federal laboratories and agencies develop and generate technologies that ultimately benefit the welfare of the public, and support the military at home and abroad. See examples of public/private partnerships facilitated by the FLC.

The FLC/MCEDC Memorandum of Understanding can be found here.

ABOUT MCEDC

The Montgomery County Economic Development Corporation (MCEDC) is the official public-private economic development organization representing Montgomery County, Maryland. Created in 2016, MCEDC is led by a Board of Directors of business executives. Its mission is to help businesses start, grow and relocate in Montgomery County by helping them gain access to top talent, business and market intelligence and prime locations. For more information, visit our website. Follow us on Twitter, Facebook and LinkedIn.

ABOUT FLC

The Federal Laboratory Consortium for Technology Transfer (FLC) is a formally chartered, nationwide network of more than 300 federal laboratories, agencies, and research centers that foster commercialization best practice strategies and opportunities for accelerating federal technologies from out of the labs and into the marketplace. To learn more, visit www.federallabs.org.

LUND, Sweden, April 15, 2021 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that it has entered into a joint research collaboration with MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The research collaboration will lead to the expansion of Alligator’s proprietary patient specific immunotherapy Neo-X-Prime™ by incorporating MacroGenics’ proprietary DART^® and TRIDENT^® multi-specific platforms against two undisclosed targets.

Under the joint research collaboration agreement, which covers activities from candidate drug generation up until IND-enabling studies, each company will be responsible for its own costs. The parties may continue further development of the resulting bispecific molecule under a separate co-development collaboration and licensing agreement.

“We are truly excited to start this collaboration with MacroGenics, validating the Neo-X-Prime drug concept. The aim is to create a drug candidate that takes advantage of a unique mechanism of a patient’s own immune system to fight cancer. We look forward to working collaboratively to expand the Neo-X-Prime concept with MacroGenics’ antibodies, their proven DART technology, and extensive capabilities,” says Malin Carlsson, interim CEO of Alligator Bioscience.

The Chairman of Alligator Bioscience, Peter Benson stated “MacroGenics is widely viewed as a leader in the antibody field as evidenced by their extensive pipeline of antibody-based molecules in clinical testing that are based on various platform technologies. Furthermore, MacroGenics’ capabilities are an excellent fit with Alligator’s strategy to develop next generation tumor specific immunotherapies to improve the lives of cancer patients.”

Neo-X-Prime is a drug concept for more personalized immunotherapy, launched by Alligator in 2020. The concept builds on bispecific antibodies that physically link circulating tumor material to the immune system, to allow neoantigen-specific T cell priming with potential for superior anti-tumor efficacy.

MacroGenics’ DART and TRIDENT multi-specific platforms enable the creation of potential medicines comprised of a single molecule designed to simultaneously bind to two or more targets, each with antibody-like specificity, with the goal of creating a more significant biological effect.

For further information, please contact:

Malin Carlsson, interim CEO
E-mail: mcn@alligatorbioscience.com
Phone: +46 46 540 82 00

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on April 15, 2021.

About Alligator Bioscience

Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s pipeline includes the two key assets ATOR-1017 and mitazalimab. Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc. In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden. For more information, please visit www.alligatorbioscience.com.

This information was brought to you by Cision http://news.cision.com

GAITHERSBURG, Md., April 13, 2021 (GLOBE NEWSWIRE) – – Arcellx, a privately held clinical-stage biopharmaceutical company, today announced that it raised $115 million in a Series C financing to advance its pipeline of adaptive and controllable cell therapies. The proceeds will support the company’s development of CART-ddBCMA, a BCMA-specific CAR-modified T-cell therapy currently in Phase 1 and anticipated to begin a pivotal trial in 2022. In addition, the funding will support initiation of clinical trials evaluating ACLX-001 and ACLX-002, cell therapies derived from Arcellx’s uniquely controllable ARC-SparX platform, in multiple myeloma (MM) and acute myelogenous leukemia (AML), respectively.

This financing follows FDA clearance of Arcellx’s IND for ACLX-001, the first ARC-SparX program to enter clinical trials, and Arcellx’s initial release of clinical results at the 2020 American Society of Hematology (ASH) meeting. In the ASH release, the CART-ddBCMA data showed all six multiple myeloma patients responded per IMWG criteria, with four of those patients achieving stringent complete response. The therapy was also well-tolerated, and CAR-T related toxicities resolved rapidly.

Participants in the Series C financing include both existing and new investors to Arcellx. The financing was co-led by Samsara BioCapital and CAM Capital, joined by new investors Adage, Asymmetry, CaaSCapital, Cambrian Bio, Sixty Degree, Soleus Capital, Surveyor Capital (a Citadel company), Suvretta, and Terra Magnum Capital Partners, and existing investors NEA, Novo Holdings, SR One, Takeda Ventures, LG Tech, and Clough Capital.

“With support from this high caliber syndicate, Arcellx is poised to elevate the field of cell therapy by advancing our treatments for a range of cancers,” said Rami Elghandour, Chairman and Chief Executive Officer of Arcellx. “Our platform of both single infusion and controllable CAR-Ts based on our novel synthetic binding domain is built to address the limitations of cell therapy with the opportunity to improve efficacy, reduce toxicity, and shorten the time to intervention while expanding into new indications. This financing positions us to advance to a registrational study in multiple myeloma and to initiate a Phase 1 study in AML in 2022 as well as progress our solid tumor targets toward the clinic. It’s alsoa reflection of our incredibly talented and diverse team that is powering Arcellx forward. We appreciate the support of our new and existing investors as we advance our novel therapies to the benefit of cancer patients most in need.”

“Based on the early clinical data, we believe that CART-ddBCMA represents a potential best-in class therapy for multiple myeloma and with the support of this financing will be positioned to move into pivotal trials next year. We’re also excited about the opportunity for CART-ddBCMA to move into earlier lines of treatment for multiple myeloma based on the safety profile in this early data set. In addition, the ARC-SparX platform will be the first adaptive and controllable CAR-T system to enter the clinic and provides a unique approach to building next generation cell

therapies. We look forward to partnering with the Arcellx team to help bring these important therapies to patients,” said Mike Dybbs, Ph.D., Partner, Samsara BioCapital.

About Arcellx, Inc.

Arcellx is a clinical-stage biopharmaceutical company developing adaptive and controllable cell therapies for the treatment of patients with cancer and autoimmune diseases. The Arcellx vision is to utilize our novel proprietary platform to bring superior cell therapies to more patients through the care of academic and community practices worldwide. More information can be found at www.arcellx.com.

Media:

Zara Lockshin Solebury Trout 646-378-2960

zlockshin@soleburytrout.com

Investors:

Alan Lada Solebury Trout 646-378-2927

alada@soleburytrout.com

John Graziano Solebury Trout 646-378-2942

jgraziano@soleburytrout.com

The military wants to stop pandemics. Many of the innovations and breakthroughs deployed to combat COVID-19 began years ago as Pentagon-funded research programs to protect soldiers, some spearheaded by the Defense Advanced Research Projects Agency. Bill Whitaker and 60 Minutes cameras were allowed in to report on some of the technologies the Department of Defense is developing to defend against future pandemics — including a single vaccine to ward off all coronaviruses. Whitaker’s report will be broadcast on 60 Minutes, Sunday, April 11 at 7 p.m. ET/PT on CBS.

https://www-cbsnews-com.cdn.ampproject.org/c/s/www.cbsnews.com/amp/news/last-pandemic-science-military-60-minutes-2021-04-09/

GAITHERSBURG, Md., April 5, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company’s COVID-19 vaccine candidate. Crossover ensures the administration of active vaccine to all participants in the trials and has begun for Novavax’ Phase 2b trial in South Africa and its pivotal Phase 3 trial in the United Kingdom.

Under Novavax’ updated clinical trial protocols[1], all participants in the UK and US Phase 3 trials will be offered the opportunity to receive an additional round of injections. Participants who elect to do so will receive an additional two-dose regimen of either vaccine (for those who originally received placebo) or placebo (for those who originally received vaccine). Participants in the South Africa Phase 2b trial will receive either active vaccine for those who initially received placebo, or a booster dose of active vaccine for those who initially received active vaccine. Participants across all three trials will remain blinded to their courses of treatment to preserve the ability to assess efficacy in each trial, and all will be followed for up to two years to monitor the safety and durability of protection the vaccine. In the trials taking place in South Africa and the United Kingdom, half of the participants initially received the active vaccine while two-thirds of participants in PREVENT-19, the trial being conducted in the US and Mexico, initially received active vaccine.

“The crossover arms ensure that all participants have access to an active vaccine candidate while allowing Novavax to continue to monitor the safety and efficacy of our vaccine over the long term,” said Filip Dubovsky, M.D., Chief Medical Officer, Novavax. “We are grateful to the volunteers who stepped forward to take part in our clinical trials, without whom we would be unable to develop, study and ultimately deliver what we hope will be a significant tool in the fight against COVID-19.”

The company is also planning a crossover in the PREVENT-19 study, for which the company expects to read out initial clinical data during the second quarter. In addition, the company is planning to expand the trial to include pediatric and adolescent arms, which are also expected to begin in the second quarter.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 48.6% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-M™
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release s0peak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:
Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com

Solebury Trout
Jennifer Porcelli | 617-974-8659
jporcelli@soleburytrout.com

Media
Laura Keenan | 410-419-5755
Amy Speak | 617-420-2461
media@novavax.com

April 5, 2021 – Silver Spring, MD. BioIT Solutions announced that it has developed and launched a mobile application to support the COVID-19 testing efforts of the Cambridge Consortium for Rapid COVID-19 Tests (CCRCT), a partnership of LabCentral, BioInnovation Labs (BioLabs), and E25Bio.

“BioIT Solutions is pleased to have been selected by the CCRCT to develop the application to support data collection in an IRB-approved human research study to compare an at-home COVID-19 antigen test against nasal samples processed by qRT-PCR in a laboratory,” said BioIT Solutions’ President, Mike Fannon. The longitudinal study was rolled out to determine if antigen testing at home allows employees to safely report for in-person work. Users are able to scan a QR code label on a test kit, enter relevant health information, and submit a camera image of the test strip from their homes. The antigen test was developed by E25Bio as a rapid home test for COVID-19, with easily readable results in 15 minutes. Test results are confirmed by a laboratory-based PCR test, facilitated by a laboratory management system also built by BioIT Solutions.

Celina Chang, LabCentral’s Vice President of Science Operations and Strategic Relationships, notes that “BioIT Solutions has been a valuable partner through the planning, implementation and deployment of a critical customized LIM system. They adapt quickly to changing needs and deliver high-quality systems in a remarkably short time. Users of BioIT’s mobile application consistently report that it is reliable, easy to use, and convenient, resulting in a positive user experience and reliable data to help us reduce disease transmission and provide a safe work environment.”

About BioIT Solutions
BioIT Solutions delivers highly effective data management and workflow systems ready-made for today’s fast-paced life science laboratories. We apply our decades of experience in the biopharmaceutical industry with our flexible 1PLATFORM4® Software Suite to engineer rapidly deployed and customized solutions in a cost-effective manner. With BioIT Solutions, your scientific data are safely managed by a logical, consistent and responsive system.

Our customers benefit from tailored and adaptable solutions while avoiding rigidity, expense and operational inefficiencies. We have the tools and expertise to translate your procedures into practical and adaptable workflow applications with modern and easy-to-use interfaces.