Vaxess Technologies | October 27, 2021
Vaxess Technologies, a biotechnology startup developing the MIMIXTM sustained-release intradermal microneedle patch, celebrated the grand opening of their 3,600 square feet pilot GMP (Good Manufacturing Practices) manufacturing facility on Monday. The facility, which is located in Woburn, MA at one of the Cummings Park properties, will feature a state-of-the-art cleanroom where manufacturing of vaccine patches for clinical trials will take place. Using the clinical-grade patches produced in the facility, Vaxess plans to enter the clinic in 2022. In addition to the manufacturing suite, Vaxess has announced plans to expand their Woburn footprint by another 6,300 square feet to provide additional GMP space as well as lab space for a host of other development activities to further the MIMI“ platform.
After years of development, the company is thrilled to establish GMP manufacturing capabilities in Massachusetts for both our lead MIMIX-Flu vaccine program as well as a host of other pipeline products to follow,” said Vaxess CEO Michael Schrader.
Vaxess has experienced tremendous growth over the past year beyond the opening of the manufacturing facility including technological advancement of the platform and the expansion of the organization from 15 full time employees to 35 with additional future growth planned. All the progress that Vaxess has made this past year would not have been possible without the help of the Massachusetts Life Sciences Center (MLSC), which has supported Vaxess’ efforts since its inception. MLSC President and CEO, Kenn Turner, attended the Grand Opening and shared a few words.
“I want to congratulate the Vaxess team on their latest expansion to Woburn Since the Life Science Center’s initial investment in Vaxess, the company has exemplified the type of growth trajectory we aim to accelerate here in the Commonwealth. We will continue to lean in, and support companies seeking to create jobs and expand their footprint regionally, particularly in the manufacturing space.”
Massachusetts Life Sciences Center President and CEO Kenn Turner
In addition to Turner, numerous other individuals from both the Massachusetts biotechnology and political communities attended the event, including Joe Boncore, President of MassBio, Bill Cummings, Founder of Cummings Properties, Eric Anderson, President of Cummings Properties, Scott Galvin, Mayor of Woburn, Representative Richard Haggerty and Senator Cindy Friedman.
“I want to congratulate Vaxess Technologies on their continued job growth and expansion, which offers further proof that opportunities for innovation in life sciences are truly statewide in Massachusetts,” said Massachusetts Housing and Economic Development Secretary Mike Kennealy, who serves as Co-Chair of the MLSC Board of Directors. “The Baker-Polito Administration remains committed to supporting life sciences companies that recognize Massachusetts as the ideal place for companies to grow and thrive.”
About the MIMIX™ Technology
The MIMIX patch is designed to be the easiest and most effective way to deliver vaccines and therapeutics. The patch releases treatments to the body at their most beneficial rate and duration. For vaccines, the controlled release simulates the pace of a natural infection, helping the body produce a slow, strong, and enduring ramp-up of immune response, ultimately boosting a vaccine’s effectiveness. Engineered for stability, Vaxess’ patch does not require refrigeration and can be shipped to and applied in low resource settings. It is virtually painless and resembles an adhesive bandage. After the minutes-long prescribed wear time, the MIMIX patch is removed and discarded while leaving behind microscopic intradermal depots to present the therapeutic payloads to the immune system over ensuing days or weeks.
About Vaxess Technologies
Vaxess Technologies is developing the MIMIX™ sustained release patch technology, originally conceived at MIT and Tufts University. MIMIX™ uses the unique qualities of silk proteins and breakthrough immune activating biology to enable best-in-class vaccines and therapeutics. Vaxess has raised more than $60M in grant and venture capital funding from groups such as The Engine, BARDA, DARPA, NIH, NSF and the Gates Foundation. A MIMIX Phase I proof-of-concept trial using seasonal flu and COVID-19 antigens is slated to begin in the first half of 2022.
CELL AND GENE THERAPY
Vipergen | February 18, 2021
Vipergen ApS announced today a published study depicting a ground-breaking new medication revelation approach that empowers, interestingly, screening DNA-encoded small-molecule libraries (DELs) inside living cells. The study, published in the peer-reviewed Journal of the American Chemical Society, highlights the potential of Vipergen's Cellular Binder Trap Enrichment® (cBTE) technology to significantly grow the ability to discover novel small molecules, including against difficult-to-drug targets, and reduce attrition rates in drug discovery. Vipergen is offering its cBTE DNA-encoded library drug disclosure platform as a service to biotechnology and pharmaceutical company partners to accelerate and improve their drug discovery processes.
"This research validates the potential for Vipergen's Cellular Binder Trap Enrichment platform to become a revolutionary tool in small-molecule drug discovery based on its ability to successfully screen DELs against drug targets inside living cells, with no requirement for purified active target protein," said Nils Hansen, Ph.D., Chief Executive Officer of Vipergen. "We expect the ability to perform DEL screening under the more physiologically relevant conditions of a living cell to significantly lower attrition rates in drug discovery. Furthermore, by uniquely allowing us to eliminate the requirement for highly purified active target protein, this technology will improve timelines and bring about new options for novel drug development by allowing us to screen many more targets, prioritize those giving the most promising screening results, and screen DELs against challenging targets that are difficult to express and purify in an active form. We look forward to providing this new tool to biotechnology and pharmaceutical partners to substantially improve the efficiency and success of their small-molecule drug discovery efforts."
About Vipergen's Cellular Binder Trap Enrichment®(cBTE) Technology
Vipergen's proprietary Cellular Binder Trap Enrichment®(cBTE) is the first and only technology for screening DNA-encoded small-molecule libraries (DELs) inside a living cell. The platform is designed to accelerate and improve the success rate for discovering novel, high-quality small molecules for drug development—including against challenging drug targets that are difficult to express and purify in an active form.
About Vipergen ApS
Vipergen is a world-leading provider of small-molecule drug discovery services based on DNA-encoded library (DEL) technologies and is the first and only company capable of screening DELs inside a living cell. Vipergen provides its proprietary suite of leading-edge DEL technologies as a service to biotechnology and pharmaceutical company partners, including top pharmaceutical companies in the U.S., EU, and Japan.
Novavax, Inc. | January 31, 2022
Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.
The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.
"We're extremely proud of the work of our teams and we look forward to FDA's review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic. I'd like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today's milestone of EUA request submission."
Stanley C. Erck, President and Chief Executive Officer, Novavax
Novavax conducted two pivotal Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico and published results in the New England Journal of Medicine (NEJM) and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed in authorized markets. As part of the PREVENT-19 trial, a booster study is ongoing to evaluate the safety and effectiveness of a third does of the vaccine, as well as a study in adolescents aged 12-17.
NVX-CoV2373 has been granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission, and emergency use listing (EUL) from the World Health Organization (WHO), with additional filings currently under review.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain 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 formulated with Novavax' patented saponin-based Matrix-M™ adjuvant 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.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).
A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.
PREVENT-19 is being conducted with support from the U.S. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement.
About Matrix-M™ Adjuvant
Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and generally 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.
Novavax, Inc. 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 harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, received Conditional Marketing Authorization from the European Commission, Emergency Use Listing from the World Health Organization, Emergency Use Authorization in Indonesia and the Philippines, and has been submitted for regulatory authorization in multiple markets globally.