Positive results for Swiss biotechs’ clinical studies

Molecular Partners, a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin (designed ankyrin repeat protein) therapeutics, is nearing the end of its phase 1 clinical trials for MP0317, a CD40 agonist designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP). The ongoing trial open-label, dose-escalation study assesses the safety and tolerability as well as pharmacokinetics/pharmacodynamics and antitumor activity of MP0317 monotherapy in patients with refractory/relapsed solid tumors known to express FAP and CD40 (NCT05098405). To date, the 36 patients enrolled in the Netherlands and France across eight dosing cohorts received MP0317 in every-3-weeks and weekly schedules. The data demonstrate that MP0317 shows evidence of tumor localised CD40 activation (analyses in paired tumor biopsies). The detection of MP0317 in tumors positively correlated with immune activation when comparing high vs. low doses of MP0317. This detection was associated with a statistically significant CD40-mediated increase of antigen-presenting cells and interferon γ signature. Furthermore, MP0317 has demonstrated a favorable safety profile. The current data support planning of future combination studies.

Positive Phase I clinical trial for Neurimmune
Amyloid transthyretin cardiomyopathy (ATTR-CM) is an underdiagnosed, systemic condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis. Neurimmune’s NI006, a recombinant human antibody to deplete amyloid deposits in ATTR cardiomyopathy, has been designed to target the pathology of ATTR-CM by enabling depletion of amyloid fibrils in the heart. The Phase 1 study investigated safety, tolerability, pharmacology, and efficacy at 12 months of NI006 treatment in ascending doses. Results indicate that the safety profile of NI006 is favorable up to the highest dose tested. No apparent dose-limiting toxic effects or drug-related serious adverse reactions were observed.

The pharmacokinetic profile was consistent with that of an IgG antibody, and no anti-drug antibodies were detected. At doses of at least 10 mg per kilogram, cardiac amyloid deposition (detected by either scintigraphy or cardiac magnetic resonance imaging) was substantially reduced over a period of 12 months. Reductions were also seen in levels of biomarkers measuring cardiac stress and cardiomyocyte death, N-terminal pro-B-type natriuretic peptide and troponin.

Oculis completes first results for Phase 3
Oculis, a global biopharmaceutical company purposefully driven to save sight and improve eye care, yielded positive top line results from Stage 1 of its Phase 3 DIAMOND trial of OCS-01 eye drops in Diabetic Macular Edema (DME). DME is the leading cause of visual loss and legal blindness in patients with diabetes, affecting around 37 million people worldwide, with a significant number of patients left untreated due to a lack of convenient treatment options. DIAMOND (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eye drops in DME patients. The primary objective of Stage 1 was to select the optimal dosing regimen. Stage 1 was conducted in 39 sites across the USA and Europe with 148 patients randomized 2:1 to receive OCS-01 (n=100) or vehicle (n=48) six times daily for a six-week loading phase and then three times daily for a subsequent six-week maintenance phase. OCS-01, in this 3-month trial, has met both clinical efficacy endpoints (main BCVA change, proportion of patients with 3 lines gain) that are required for regulatory approval, if met at 12 months treatment duration. The OCS-01 development program will continue as planned with Stage 2 which includes two global trials, each enrolling approximately 350-450 patients. Oculis expects to begin Stage 2 of the DIAMOND trial in the second half of this year.

(Press release/RAN)