Archive: Company News
selectION, Inc. Advances Lead Program for Treatment of T Cell Mediated Autoimmune Diseases to Clinical Development
– Novel ion channel blocker designed to combine high efficacy and durable response while maintaining full immune system functionality
San Diego, CA, USA, and Munich, Germany – May 9, 2022 – selectION, Inc., a biopharmaceutical company developing novel peptide therapies for the treatment of T cell mediated autoimmune diseases and rare lymphomas, today announced that Germany´s regulatory agency has authorized the Company’s clinical trial application for a Phase 1b trial evaluating the safety and efficacy of selectION´s clinical candidate, si-544, in patients diagnosed with mild to severe atopic dermatitis.
Omnix Medical Starts Phase I Clinical Trial of Novel Anti-Infective; First Healthy Volunteers Dosed
– New mechanism of action (MoA) addressing global increase of antimicrobial resistance (AMR) burden and shortage of potent anti-infectives
Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced the initiation of a Dutch Phase I clinical trial with its lead compound OMN6. Since March 28, 2022, six healthy volunteers have been administered the novel antimicrobial, which is based on a naturally occuring mechanism of action (MoA) leading to a targeted, effective destruction of the cell membrane of pathogens. The trial is being conducted in Groningen, The Netherlands. OMN6 is being evaluated in a randomized, double-blind, placebo-controlled, single ascending dose trial assessing safety, tolerability, and pharmacokinetics of single and repeat IV infusion of the compound in healthy subjects. Results are expected by Q4, 2022.
Neonatal Diagnostics Company InfanDx AG Launches US Operations
— Incorporated US subsidiary & hired US VP Operations
— Preparing pre-submission meeting with US-FDA
— Received Notice of Allowance for key patent by USPTO
InfanDx AG, a privately-held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, today announced that it has set up US operations to gain access to the US market for its HypoxE® Test. The test is designed for the early detection of Hypoxic-Ischemic Encephalopathy (HIE) and is currently in clinical development.
T-knife Therapeutics Announces New TCR-T Program Targeting KRAS G12V and Presents Data at the American Association for Cancer Research (AACR) Annual Meeting
T-knife Therapeutics, Inc., a biopharmaceutical company dedicated to developing novel therapeutics to fight cancer, today announced it is advancing its second TCR-T program, TK-2504, toward the clinic and presented preclinical data on its ability to generate novel TCRs targeting the KRASG12V antigen. The poster titled, “Generating optimal-affinity T cell receptors targeting the shared neoantigen KRASG12V using the humanized TCR transgenic mouse platform HuTCR” is being presented today at the American Association for Cancer Research (AACR) Annual Meeting and will be available for 30 days on the T-knife website at www.t-knife.com.