News

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.

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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.

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TolerogenixX Receives Approval to Start Phase IIb Trial for its Immune Tolerance-Inducing MIC-Lx Cell Therapy

— Multi-centric clinical study in patients with stage 5 chronic kidney disease (CKD) receiving a living donor kidney

— Study of MIC-Lx cell treatment, a potentially curative approach to achieve sustained immune tolerance in transplanted and autoimmune patients as shown in previous Phase Ib study

TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, today announced that the German regulatory authority Paul-Ehrlich-Institut has approved a Phase IIb clinical trial for TolerogenixX’s MIC-Lx cell therapy designed to induce immune tolerance. Read more…

Omnix Medical Advances Novel Anti-Infective Program into Clinical Development

– Entirely novel therapeutic principle to combat alarming worldwide rise of antimicrobial resistance (AMR)

Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced it received approval by Dutch authorities to initiate a Phase I clinical trial with its lead compound OMN6 in healthy volunteers. The trial will be conducted in Groningen, The Netherlands.

OMN6, the lead compound of Omnix, is a first-in-class antimicrobial peptide for the treatment of life-threatening infections caused by Gram-negative bacteria. Read more…

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