FDA greenlights advancement of SAB-176 Phase 2b trial and manufacturing approach to address influenza strain change
SAB-176 is the first fully-human broadly neutralizing immunoglobulin antibody therapeutic intended to prevent or reduce severe outcomes of Type A and Type B influenza infection in patients at high risk for severe complications, including in patients who are immunocompromised
https://finance.yahoo.com/news/sab-biotherapeutics-granted-fast-track-123000158.html
Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company specializing in AI-powered immunotherapies, announces the successful publication in Frontiers of Immunology of preclinical data demonstrating the effectiveness of its proprietary AI-driven viral vaccine discovery platform. The presented preclinical study was conducted in collaboration with associate professor Girish Kirimanjeswara, Pennsylvania State University, US.
The published data showcase how Evaxion's proprietary AI-platform, RAVEN (Rapidly Adaptive Viral Response), identifies broad and robust T-cell epitopes from SARS-CoV-2 that protect against mortality and severe disease in a COVID-19 mouse model. This research demonstrates the potential of the RAVEN platform to accelerate the development of effective viral vaccines, leveraging the power of artificial intelligence.
Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for chronic migraine. The modifications to the RESILIENT and PREVENTION studies are designed to streamline the trials and to provide topline data for both programs in 2023. Target enrollment for the core TNX-102 SL fibromyalgia study remains approximately 470 participants while target enrollment for the TNX-1900 chronic migraine study will be reduced from approximately 300 participants to approximately 150 participants, to accommodate the new topline timing.
“In an effort to expedite and deliver on clinical timelines, we are modifying the designs of our confirmatory, registration-enabling Phase 3 trial in fibromyalgia and our Phase 2 trial in chronic migraine,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “By eliminating the interim analyses, we remove the statistical penalties associated with this type of analysis, conserve resources, and can plan on topline results for each of these studies in the fourth quarter of 2023. Fibromyalgia and migraine each affect millions of people, and we remain committed to aligning our operational and scientific efforts on these core CNS programs. We are excited to progress these programs closer to FDA approval, upon achieving positive topline data.”
Key Anticipated 2023 Milestones
Updated Guidance
Unchanged Guidance
Medigus Ltd. (Nasdaq: MDGS), a technology company engaged in advanced medical solutions, innovative internet technologies, and electric vehicle and charging solutions, announced today it has acquired 19.9% of Metagramm Software Ltd. (“Metagramm”), an innovative AI, machine learning (ML) communication and grammar assistant software. In return, Medigus paid Metagramm $250,000 in Medigus’ common shares.
Metagramm is one of the first companies to develop grammar and language assistance tools and technology for users. Metagramm has an advanced grammar engine based on proprietary AI algorithms and natural language processing (NLP) technology.
Metagramm offers tools for writing and reviewing, grammar, spelling, punctuation and style features as well as translation and multilingual dictionaries.
According to Market Research, the market for grammatical error corrector (GEC) and writing enhancement software is expected to reach over $750 million in 2026 with an impressive compound annual growth rate, led by companies like Grammarly and Wordtune.
The Company will issue Metagramm common shares at a total value of $250,000 at the average price of Medigus’ share in the 30 days prior to the closing. In addition, Medigus will extend Metagramm a loan in the amount of $250,000 in three installments, the first installment of which will be granted at closing. The loan will be repaid from Metagramm’s existing and future profits and is secured by the shares of all other current Metagramm shareholders.
https://finance.yahoo.com/news/medigus-acquires-19-9-innovative-124500250.html
Ocean Biomedical Inc's (NASDAQ: OCEA) co-founder, Jonathan Kurtis, has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for his U.S. patent application covering a therapeutic and prophylactic monoclonal antibody that kills falciparum malaria parasites.
What Happened: Ocean Biomedical anticipates that the USPTO will issue a patent for Dr. Kurtis' application in the coming months.
Building on his discovery that PfGARP is potentially a highly effective vaccine target for malaria, Dr. Kurtis has discovered and produced a monoclonal antibody that binds to PfGARP and triggers the malaria parasite to kill itself.
In February, Ocean Biomedical issued a press release touting the discovery of bispecific antibodies and immune checkpoint inhibitors that kill glioblastoma and melanoma cells and block the metastasis of malignant melanoma cells to the lung by over 90%.
Why It Matters: The monoclonal antibody can be used as a potential therapeutic drug for individuals with severe malaria infection and a potential short-term prophylactic treatment to prevent malaria infection in travelers, overseas deployed military and government personnel, and individuals living in areas with short malaria transmission seasons.
"With the rising resistance to artemisinin-based drugs in sub-Saharan Africa, it is imperative that we get new malaria therapeutics into the drug development pipeline," said Elizabeth Ng, Ocean Biomedical's CEO.
Last month, Ocean Biomedical's co-founder Jack Elias presented details from previously published discoveries with potential tumor suppression applications.
https://finance.yahoo.com/news/exclusive-ocean-biomedicals-co-founder-133031871.html
