MEDICAL

MindMed Announces the start of the First Ever Clinical Trial Measuring and Evaluating MDMA and LSD

MindMed | January 21, 2021

MindMed, a main psychedelic medication biotech organization, reported today the beginning of the principal ever clinical preliminary estimating and assessing MDMA and LSD utilized in mix in the human body. The preliminary will be directed at the University Hospital Basel Liechti Lab, in Basel, Switzerland.

If administered in combination with LSD, MDMA may expand positive abstract medication impacts, including positive state of mood and empathy, and lessen the negative feelings and nervousness that are sometimes associated with LSD - creating a general more good experience.

MindMed is undertaking a Phase 1 clinical preliminary to assess if MDMA, when adjusted and utilized in combination with LSD, can help offset a portion of the known expected horrendous impacts of LSD that happen in treatment or clinical settings. MindMed is keen on arrangement how to adjust both MDMA and LSD in a strong manner to make better patient results, and grow further developed hallucinogenic helped treatments, as MindMed extends the two its R&D and commercial drug improvement pipeline. The examination is foreseen to take around one year to finish.

Spotlight

Novamont, the Italian company world leader in the development and production of bioplastics, has created Mater-Biotech. First plant in the world dedicated to the production of bio-butanediol (1,4 BDO) through fermentation of sugars, Mater-Biotech has made possible the conversion of a former decommissioned industrial site, starting from a technology developed by Genomatica, a U.S. company leader in bioengineering innovation, and NOVAMONT’s unique skills and know-how in developing low-impact manufacturing processes.

Spotlight

Novamont, the Italian company world leader in the development and production of bioplastics, has created Mater-Biotech. First plant in the world dedicated to the production of bio-butanediol (1,4 BDO) through fermentation of sugars, Mater-Biotech has made possible the conversion of a former decommissioned industrial site, starting from a technology developed by Genomatica, a U.S. company leader in bioengineering innovation, and NOVAMONT’s unique skills and know-how in developing low-impact manufacturing processes.

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MEDICAL

Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

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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Aptorum Group Joins the BEAM Alliance To Combat Antimicrobial Resistance

Business Wire | September 08, 2020

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group”), a biopharmaceutical company focused on novel therapeutics including the development of next-generation therapeutics targeting antimicrobial resistance, today announced it joined the Biotech companies in Europe combating Antimicrobial Resistance Alliance based in Europe (the “BEAM Alliance”) as full member. The BEAM Alliance is a network of approximately 70 small and medium-sized European companies involved in developing innovative products and kits to tackle antimicrobial resistance (“AMR”), including small molecule antibiotics, biologics, products with a prophylaxis indication, microbiome-based and phage-based therapies, immune targeting therapies, anti-biofilm agents, and medical devices, including in-vitro diagnostics.

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MEDICAL

Fresh from raising $200M, British biotech with an HQ in Raleigh mulls targeting COVID-19

Verona Pharma | November 19, 2020

A British clinical-stage biotech firm with U.S. base camp in Raleigh is investigating the alternative of repurposing its leading drug candidate to treat COVID-19 patients. Flush with $200 million after a July raise, the London-based Verona Pharma is now making large walks with its "first-in-class" drug, ensifentrine, targeting chronic obstructive pulmonary disease (COPD). Now, against the backdrop of a pandemic, it’s pushing ahead with a pilot clinical trial on hospitalized COVID-19 patients at the University of Alabama at Birmingham.

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