Biotech startups make clinical progress

The U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application from Anaveon to conduct a Phase I/II study evaluating the safety and clinical activity of their drug candidate ANV600. As the company’s second drug candidate, ANV600 combines a unique non-blocking PD-1 targeting antibody with an IL-2Rβ/γ selective agonistic principle. This molecule is unique because it can be used in combination with anti PD-1 therapy which is the standard of care for immunotherapy of several tumor types. The clinical study aims to evaluate the safety and anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab in participants with relapsed/refractory advanced solid tumors. 

The Basel-based sartup will initiate the first two dose escalation cohorts with ANV600 monotherapy and combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as part of a multi cohort study to evaluate the safety and efficacy of ANV600 in multiple cancer indications. In March 2024, Anaveon entered into a clinical trial collaboration and supply agreement with MSD, to test Anaveon’s proprietary drug candidate ANV600 in combination with KEYTRUDA, supplied by MSD, in clinical trials. 

Positive Phase 2b clinical trial results for Oculis
EPFL-spinoff Oculis, a biopharmaceutical company dedicated to saving sight and improving eye care, announced positive results from their Phase 2b RELIEF trial with licaminlimab, a novel anti-TNFα biologic eye drop with an established dual anti-inflammatory and anti-apoptotic mechanism of action in patients with dry eye disease (DED). The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of licaminlimab in subjects with signs of DED. The trial also evaluated the efficacy and safety of licaminlimab in a subpopulation of subjects with a TNFR1-related genotype as prespecified in the protocol. A total of 122 patients were randomized 1:1 to either licaminlimab (n=62) or vehicle (n=60) across 4 sites for a 6-week treatment period and a 2-week follow up. Out of this group, 23 patients carried a specific TNFR1 genetic biomarker. Patients were evaluated for efficacy endpoints at baseline, Day 15 and Day 43.  

During the trial, treatment effect favoring licaminlimab and a good tolerance for the drug were observed and additionally for the patients with the TNFR1 genetic biomarker a rapid and favorable treatment effect in favor of licaminlimab on corneal inflammation was observed as early as Day 15 that was significant at Day 43. 

Eric Donnenfeld, Clinical Professor of Ophthalmology at New York University and Chair of Oculis’ Cornea Scientific Advisory Board, commented: “The precision medicine approach with licaminlimab could be a groundbreaking paradigm shift in ophthalmology and the treatment of DED. The current approach of ‘trial and error’ and our inability to predict response for this highly heterogenous population leads to a low level of patient satisfaction. To my knowledge, Licaminlimab is the first dry eye disease medication to demonstrate in a clinical trial a predictive treatment effect in patients with a common genetic biomarker to potentially solve this problem.” 

MoonLake prepares phase 3 studies
MoonLake Immunotherapeutics, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced the successful outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), as well as positive feedback from its interactions with the E.U. European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody^® sonelokimab in psoriatic arthritis (PsA).

The Phase 3 program, named IZAR, is expected to enroll around 1,500 patients and in combination with data from the Phase 2 ARGO trial is designed to support both a Biologics License Application (BLA) and E.U. Marketing Authorization Application. Two global, randomized, double blind, placebo-controlled trials are planned (IZAR-1 and IZAR-2) to evaluate the efficacy and safety of the Nanobody^® sonelokimab over one year. IZAR-1 will enroll a biologic naïve population and include an evaluation of radiographic progression, while IZAR-2 will enroll a TNF-IR population and will be the first trial to include a risankizumab active reference arm. The IZAR program will assess a 60mg sonelokimab dose as well as a 120mg sonelokimab dose. The primary endpoint (ACR50) compared to placebo and key secondary endpoints for both trials will read out at week 16. The readout of the primary endpoint is anticipated at the end of 2026.

(Press releases / SR)