Milestones achievements for life sciences startups

Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, has presented the safety and immunogenicity results from a Phase Ib/II study evaluating NOUS-209 in individuals with Lynch Syndrome (LS) a common inherited condition that significantly increases a person’s risk of developing microsatellite instability (MSI)-associated cancers over their lifetime. Managing LS is limited to frequent screenings or elective organ removal surgery. NOUS-209 is an investigational off-the-shelf cancer immunotherapy that targets tumors with mismatch repair deficiency (dMMR) and/or MSI. 

The Phase Ib/II study found that NOUS-209 monotherapy was safe, well-tolerated and induced potent, broad and durable immune responses in all LS carriers evaluated. These data support the further clinical development of NOUS-209 as a monotherapy in LS carriers. Following positive Type B and C meetings with the US Food and Drug Administration (FDA), Nouscom has a clear path forward for the advancement of NOUS-209 to a potentially registration-enabling Phase 2/3 clinical study for cancer interception in those living with LS.

Clinical advancements for CUTISS denovoSkin
CUTISS, a leader in tissue therapeutics and regenerative medicine, continues to advance the clinical development of denovoSkin™, its personalized bio-engineered skin graft, currently being evaluated in a Phase 3 trial for the treatment of severe burns. The first patients have been successfully grafted at clinical sites in the Netherlands and Spain, with further recruitment ongoing in France and Italy. In total, eight sites across the EU are participating in this pivotal study. Meanwhile, Swissmedic has approved the trial in Switzerland, where preparations for patient recruitment are actively underway. 

Novaremed completes recruitment for its Phase 2b study
Novaremed AG is developing a pipeline of innovative medications for chronic pain management to address the high unmet medical need for better pain relief and as an alternative to opioids. Its lead product is NRD.E1, an orally active non-opioid small molecule with a novel mechanism of action, has FDA Fast Track Designation. The company has completed the recruitment in the National Institutes of Health (NIH) -sponsored Phase 2b EN21-01 trial (ClinicalTrials.gov identifier NCT05480228). The study evaluates Novaremed’s non-opioid investigational drug NRD.E1 for the treatment of chronic pain associated with diabetic peripheral neuropathy, and is funded by the NIH Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. Topline Phase 2b data readout is expected in Q4 2025. 

The Phase 2b study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial with the primary objective to demonstrate that a once daily dose of NRD.E1 80 mg is superior to placebo in relieving chronic pain among patients with painful diabetic peripheral neuropathy. The study will further assess safety, tolerability, pharmacokinetics, and the compound’s impact on sleep and quality of life. Study completion, with the last patient’s last visit (LPLV), is anticipated in Q3 2025 and the topline results are expected in Q4 2025.

Medyria advanced into the clinical stage
Medyria, a Swiss medtech company engineering technologies for endovascular catheter navigation and sensing. The startup has ecently achieved several significant milestones in the development and clinical validation of its PyCath microcatheter, a device uniquely designed to provide simultaneous pressure and blood flow velocity measurements for comprehensive coronary assessment. In March 2025, Medyria, in collaboration with Clinical Accelerator, launched the KENOBI Trial, a pilot clinical study aimed at evaluating the safety and efficacy of PyCath for integrated assessment of both obstructive and microvascular ischemia, marking a crucial step toward regulatory approval and clinical adoption. The company has most recently completed the preclinical phase for its PyCath microcatheter, paving the way for to enter the clinical phase.