New milestones for life sciences startups

BioVersys AG is a clinical stage, multi-asset Swiss pharmaceutical company focusing on research and development of therapies for life-threatening multidrug-resistant bacterial infections and targeted microbiome modulation. The company is developing a pipeline of novel AMR therapeutic programs, including BV100, a potential breakthrough hospital antibiotic targeting the most drug-resistant bacterial pathogen, Acinetobacter baumannii. The Basel-based startup has now launched its long-term research partnership with the Helmholtz Centre for Infection Research (HZI) and its site Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) in Germany. This research collaboration includes the group of Prof. Rolf Müller and collaborators, and aims at developing new generations of innovative AMR projects for addressing serious life-threatening infections caused by resistant bacteria. 

FDA clearance of an Investigational New Drug (IND) application for CDR-Life 
Schlieren-based startup CDR-Life is a biotechnology company pioneering a new and differentiated class of highly tumor-specific immuno-oncology therapeutics. The startup now announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CDR404, its lead program in development as a precision immunotherapy for solid tumors. CDR404 is an antibody-based, bivalent and bispecific MAGE-A4 T-cell engager (TCE), which is based on the company's unique M-gager technology for targeting intracellular tumor antigens through the major histocompatibility complex (MHC). Pharmaceutical companies submit an IND application to the FDA to initiate clinical trials of a new drug in humans. This approval allows CDR-Life to initiate Phase 1 trial enrollment in the coming months. 

ONWARD Medical announces launch of clinical study 
ONWARD Medical, founded in Lausanne in 2014, develops therapies to restore movement, independence, and health in people with spinal cord injuries (SCI). Its ARC therapy can be delivered by an implantable system called ARC-IM and an external system called ARC-EX. Both platforms are designed to deliver targeted, programmed stimulation of the spinal cord to restore movement, independence, and health in people with spinal cord injuries. In late 2023, a study participant was implanted with an investigational ARC-IM Neurostimulator and Lead to assess the safety and effectiveness of ARC-IM Therapy to address hemodynamic instability after SCI – as part of the HemON clinical feasibility study (NCT05111093). The surgery was performed by neurosurgeon Erkan Kurt, medical doctor at Radboud University Medical Center, which has a neurosurgery department affiliated with Sint Maartenskliniek. The company is about to start the HemON NL clinical feasibility study at Sint Maartenskliniek in Nijmegen, the Netherlands. HemON NL prepares the company for expected initiation of a global pivotal trial, called Empower BP, which is designed to provide the evidence necessary to submit a pre-market approval (PMA) to the US-Food and Drug Administration (FDA) and other global regulatory authorities. The company plans to enroll participants in both HemON and HemON NL as it finalizes the design of the Empower BP pivotal study.  

(press releases / SR)