Swiss biotechs on track to address key medical challenges

Onward Therapeutics SA is focused on advancing innovative cancer immunotherapies through a fast-track development model. Its portfolio includes a bispecific antibody (OT-A201) licensed from Biomunex, alongside an equity investment; and an allogeneic NK cell therapy (OT-C001) developed via its majority-owned subsidiary, Emercell. The subsidiary has now received Investigational Medicinal Product Dossier (IMPD) approval from the European Medicines Agency (EMA) to initiate a Phase 1 clinical trial of OT-C001, an allogeneic natural killer (NK) cell therapy, in combination with an anti-CD20 monoclonal antibody, Rituximab. The C00101 study will enroll patients with diffuse large B-cell lymphoma (DLBCL), who have relapsed after, or are refractory to CAR-T cell therapy, or ineligible for CAR-T cell infusion. The trial will also examine cellular kinetics and biomarkers to characterize the specific mechanism associated with therapeutic responses.

Limmatech kicks off phase 2 study in infants
LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases and its partner Valneva announced the first patient has been vaccinated in a Phase 2 infant safety and immunogenicity study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate vaccine candidate against shigellosis. The Phase 2 study, a randomized, controlled, and blinded study conducted in Kenya will be conducted in approximately 110 nine-month-old infants with the goal of identifying the best dose to be tested in a Phase 3 trial. Results of the study, which is supported by funding from the Gates Foundation, are expected in the second half of 2025.

NLS Pharma reports positive results for Mazindol
NLS Pharmaceuticals is a Swiss clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders, including ADHD, narcolepsy, and substance use disorders. The company's lead compound, Mazindol ER, is being investigated across several indications due to its unique pharmacological action on monoaminergic, opioid, serotonergic, and orexinergic systems. The company has achieved positive results from Study KO-943, a preclinical investigation evaluating the efficacy of Mazindol in mitigating fentanyl-induced conditioned place preference (CPP) in mice. The study, conducted by Key-Obs SAS, a leading preclinical CRO, provides evidence that Mazindol may offer a novel, non-opioid approach for the treatment of fentanyl use disorder — a condition contributing to over 75% of opioid-related overdose deaths in the United States.

MUVON completes patient enrollment of randomized Phase 2 trial
The recent interim readout of MUVON Therapeutics’ SUISSE MPC2 study (NCT05534269) assessing the safety and efficacy of the startup’s Muscle Precursor Cell (MPC)-based therapy in Stress Urinary Incontinence included evaluable data from 10 female patients with at least 6-months follow-up post injection of the tissue engineered product into the urethral sphincter muscle. MUVON Therapeutics has now dosed a total of 30 patients and met the study’s enrollment target. The company remains on track for the release of the final data from the completed phase 2 study in Q3 2025.

Reimbursement for AGAMREE in Germany
Santhera Pharmaceuticals, a specialty pharmaceutical company focused on rare diseases, has reached an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement for AGAMREE® (vamorolone) for the treatment of Duchenne Muscular Dystrophy (DMD). This milestone makes AGAMREE the first product to receive an agreed federal price in Germany for the treatment of DMD in patients 4 years of age and older, independent of the underlying genetic mutation. The agreed ex-factory price is EUR 3,612.50 per 100ml bottle, translating into approximately EUR 52,000 per year for an average patient when considering required rebates, patient weight and dosing.

Since its launch in Germany in January 2024, there are now more than 300 patients on continuing treatment with AGAMREE, representing almost 30% of those currently on steroid treatment. This is a significant achievement given the pivotal study of vamorolone did not include any German trial sites. Germany has 2,300 individuals living with DMD, of whom approximately 1,100 to 1,200 are treated with steroids at any one time. This highlights the potential for broader adoption and the positive impact of this reimbursement agreement.

(RAN)