Listed Swiss Biotechs at full throttle

Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, has dosed the first patient in Phase 1 first-in-human study evaluating the safety, tolerability, and efficacy of MP0533, the company’s candidate for acute myeloid leukaemia (AML). MP0533 is designed to focus an immune attack against AML in a new way that preferentially spares healthy cells, which has been a historic challenge for CD3-targeting therapeutics.

The Phase 1 open-label dose escalation study will enrol patients with relapsed/refractory AML and higher-risk myelodysplastic syndromes (MDS). It is designed to assess the safety, tolerability, and efficacy of MP0533 in addition to a range of secondary endpoints, such as the effect on LSCs, pharmacodynamics, T-cell activation, and cytokine release. Between 20-45 patients are expected to be enrolled across five sites in Switzerland and the Netherlands in collaboration with certain sites within the HOVON cooperative group. Additional clinical sites are planned as well.

For Spexis (SIX: SPEX), the first phase of its clinical studies has ended. The Allschwil-based clinical-stage biopharmaceutical company specializing in rare diseases and oncology has reported solid safety and pharmacokinetics results for murepavadin, a novel class antibiotic, delivered via the oral inhalation route (iMPV). iMPV is a macrocycle compound derived from Spexis’ proprietary platform and specifically targets the outer membrane of Pseudomonas aeruginosa (P.aeruginosa), including activity against highly resistant strains. P. aeruginosa is the key pathogen in cystic fibrosis (CF) lung infections. The Phase 1 trial was a single-center, double-blind, randomized, placebo-controlled trial to investigate the safety, tolerability, and pharmacokinetics of single ascending doses of iMPV in healthy volunteers. A total of 39 subjects participated in the trial. The observed favorable tolerability, safety and concentration profile of MPV after inhalation in the Phase 1 trial meets the company’s expectations and clears the way for further clinical trials in people with cystic fibrosis and non-cystic fibrosis bronchiectasis lunch infection.

The third Biotech making progress is Santhera Pharmaceuticals (SIX: SANN), which focuses on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. The company has announced that through a share exchange it will receive the equivalent of CHF 5 million Idorsia shares which Santhera is free to sell at its own discretion in support of its short-term financial needs. Upon completion of the share exchange transaction, Idorsia will hold a total of 13,011,275 Santhera shares representing 17.7% of Santhera’s registered share capital and 3,305,357 warrants (4.5% of Santhera’s registered share capital).

The Company has an exclusive license for all indications worldwide to vamorolone, a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. Santhera has a new drug application (NDA) under review by the U.S. FDA and a marketing authorization application (MAA) under review by the European Medicines Agency (EMA) for vamorolone for the treatment of DMD.

(Press release/RAN)