INDUSTRY OUTLOOK
BIOMEDICAN | December 03, 2020
BIOMEDICAN, a biotech organization planning patented minimal methods for developing high-value compounds at scale with proprietary yeasts, has entered the Astaxanthin market to diversify products outside of Cannabinoids. This new advancement permits BIOMEDICAN's biosynthesis platform to focus on any high-value compound and fundamentally disturb the current advances.
Astaxanthin is a widely used, high-value compound known as a powerful antioxidant and anti-inflammatory. The Astaxanthin market comprises of three primary segments: fish feed, animal feed, and human utilization. Astaxanthin's worth is developing astronomically: its market was worth over $1 billion in 2019 and is projected to be worth $3.3 billion by 2027.
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MEDICAL
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.
About NVX-CoV2373
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.
About Novavax
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.
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CELL AND GENE THERAPY
EVONETIX LTD | March 02, 2022
EVONETIX LTD the synthetic biology company bringing semiconductor technology to DNA synthesis, announced it has achieved enzymatic DNA synthesis capability with its proprietary, thermally controlled synthesis chemistry. The culmination of a three-year development program, supported by Innovate UK and in collaboration with Durham University, the results demonstrate that Evonetix’s unique, semiconductor array-based platform is compatible with both chemical and enzymatic DNA synthesis, enabling the production of scarless DNA sequences that are directly compatible with downstream processing.
Synthetic biology is expected to impact many industries, but the production of high-fidelity DNA at scale, without the need for post-synthesis error correction, has remained a challenge. Evonetix‘s unique approach re-engineers traditional phosphoramidite synthesis chemistry to use thermal, rather than acidic, control of deprotection reactions. This approach enables parallel synthesis of thousands of sequences on a single chip.
The research was directed by Dr Raquel Sanches-Kuiper, VP of Technology at Evonetix, whose enzyme engineering team has focussed on the development of enzymes that can incorporate Evonetix modified nucleotides efficiently. The programme was completed in collaboration with Dr David Hodgson, Associate Professor of Chemistry at Durham University, whose group was involved in developing the modified nucleotides for enzymatic synthesis in Evonetix silicon arrays.
“We have, for the first time, demonstrated thermally controlled enzymatic DNA synthesis. Our approach brings together thermally controlled synthesis and error detection, allowing for high-throughput assembly of high-fidelity gene-length DNA at scale. Our synthesis platform can now be used with both enzymatic and chemical synthesis, allowing us to smoothly integrate our enzymatic approach as this technology develops. Our unique, on-chip, synthesis and error correction platform will overcome many of the existing challenges in current approaches to de novo gene synthesis.”
Dr Raquel Sanches-Kuiper, VP of Technology at Evonetix
Dr David Hodgson, Associate Professor of Chemistry at Durham University, added: “We have been able to combine our world leading expertise in nucleotide chemistry with the novel Evonetix approach for enzymatic DNA synthesis, enabling cleaner, simpler synthesis reactions that will ultimately allow for scaled production of high-quality synthetic DNA with revolutionary applications across industry and research.”
Simon Rowland, Innovate UK, commented “Engineering Biology was identified in the 2021 UK Innovation Strategy as one of the key technologies that will deliver future economic success in the UK. The rapidly growing synthetic biology market is estimated to reach $40 billion by the mid-2020s. Innovate UK supports businesses and research institutions to drive business investment into R&D and is proud to have supported Evonetix and the development of this game changing innovation in DNA synthesis.”
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