Omnix Medical Ltd.

Plus, news about Scynexis, Step Pharma, Eradivir, J&J, Omnix Medical and Mission Therapeutics: 💼 Boehringer Ingelheim does another cancer deal: The German drugmaker will pay up to $991 million to Seoul-based AimedBio for access to an antibody-drug conjugate that is slated to enter Phase 1 next year. The companies didn’t disclose any details about the ADC, other than saying it’s for cancer. Boehringer has done a series of deals in recent years to boost its oncology footprint, including with Nerio Therapeutics , Tessellate Bio and Accent Therapeutics. — Kyle LaHucik 👁️ EyePoint Pharmaceuticals’ $150M offering: The company is selling 11 million shares for $12.00 apiece to help progress Duravyu as a treatment for wet age-related macular degeneration and diabetic macular edema. — Jaimy Lee 💰 Scynexis gets $22M from GSK, to terminate Phase 3 trial: The biotech said the payment resolves a dispute with the British drugmaker, and it will now wind down the late-stage study testing SCY-247 in invasive candidiasis. The companies will continue to work together on vaginal infection drug Brexafemme, which was pulled from the market in 2023 over contamination concerns. The payment extends Scynexis’ cash runway for two years. Its stock price $SCYX was up 6% at market open on Wednesday. — Jaimy Lee 💶 Step Pharma’s €38M Series C: The money will help the French biotech continue work on its early-phase CTPS1 inhibitor called dencatistat in certain blood cancers and solid tumors. The raise was led by new investor V-Bio Ventures, with existing investors Bpifrance, Hadean Ventures, Inserm Transfert Initiative, Kurma Partners, Pontifax Venture Capital and Sunstone Life Science Ventures also pitching in. The biotech raised €35 million in 2021. — Reynald Castaneda Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. 🌡 Eradivir’s flu candidate clears Phase 2a trial: Influenza patients treated with a 300 mg dose of the biotech’s EV25 demonstrated a “significant reduction” in symptom duration and severity compared with placebo. Furthermore, more than 80% of placebo patients went on to develop lower respiratory tract infection versus about 35% of treated patients. Eradivir said it is planning to start a large Phase 2b study in the US and Europe during next year’s flu season. — Ayisha Sharma ⚠️ Johnson & Johnson’s Carvykti gets black box warning for intestinal inflammation: The FDA added the warning for immune effector cell-associated enterocolitis following cases reported in clinical trials and post-marketing data. The agency noted that some cases resulted in death from gut perforation and sepsis. The multiple myeloma CAR-T therapy’s label was also updated with overall survival benefit. J&J and Legend Biotech developed Carvykti. — Lei Lei Wu 💰 Omnix Medical’s $25M Series C: The Israeli company said the round was co-led by Harel Insurance & Finance and the EIC Fund. It’s developing a drug called OMN6 to treat infections caused by Acinetobacter baumannii and other Gram-negative bacteria. — Jaimy Lee 💸 Mission Therapeutics corrals $13.3M: The Cambridge, UK-based drugmaker will use the proceeds to run a Phase 1b study to investigate its lead asset, codenamed MTX325, for Parkinson’s disease. The study is set to start in the first half of 2026. Its latest raise is from existing investors. — Reynald Castaneda

Designation underlines the need for novel, first-in-class antimicrobials for the treatment of infections with Gram-negative bacteria JERUSALEM, Israel, February 20, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the Company has received fast-track designation for its novel anti-infective OMN6 from the U.S. Food and Drug Administration (FDA). Fast track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need. OMN6 is Omnix Medical´s lead compound and a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) fundamentally differs from conventional anti-infectives by physically destroying bacterial cell membranes and allowing a fast and effective onset of action regardless of bacterial genotype or resistance phenotype. In November 2023, Omnix Medical had been granted an IND for a Phase II trial of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). Both are life-threatening infections that currently lack fast and effective treatments, most of which fall short due to antimicrobial resistances. "We are excited that the U.S. FDA has granted fast-track designation for our lead compound OMN6," said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. "This allows us to accelerate the development of game-changing anti-infectives that are designed to be fast-acting and effective without triggering antimicrobial resistances. We are looking forward to obtaining Phase II results." “The fast-track designation brings us one step closer to saving the lives of patients with life-threatening hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) that do not respond to conventional antibiotics and currently have no further therapeutic options,” added Niv Bachnoff, CSO of Omnix Medical. ### About Omnix Medical Omnix Medical was founded in 2015 to address the urgent unmet need for new life-saving anti-infective drugs. Omnix´ proprietary technology eliminates bacteria by mimicking the innate immune system of insects which uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ technology, kills bacteria upon contact and has successfully evolved over 200 million years. The Company’s lead compound is being developed for the treatment of life-threatening hospital-acquired infections (HIA) and has shown significantly higher potency than currently available treatments. Most importantly, Omnix´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR. About OMN6 OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on disruption of bacterial cell membranes and is therefore effective regardless of bacterial genotype or resistance phenotype, and unlike conventional bacteriostatic antibiotics, it is fast acting and bactericidal. OMN6 has been optimized from the original AMP by Omnix Medical´s proprietary technology to exhibit not only remarkable efficacy, potency, and safety, but also high stability while maintaining bioactivity. As a result, Omnix Medical believes that its novel peptides can be considered a new class of antimicrobial drugs. OMN6, the Company's lead compound, is intended for the treatment of life-threatening infections caused by Gram-negative bacteria such as Acinetobacter baumannii. Corporate Contacts Moshik Cohen-Kutner, CEO +972-50-8698218 Niv Bachnoff, CSO +972-54-238-6023 contact@omnixmedical.com Media Inquiries akampion Dr. Ludger Wess / Ines-Regina Buth Managing Partners info@akampion.com Tel. +49 40 88 16 59 64 / Tel. +49 30 23 63 27 68 Related Links Twitter LinkedIn