Clinical Trial News

4SC AG announced the Data Safety Monitoring Board recommends continuing the RESMAIN study without changes. This study evaluates resminostat for advanced-stage cutaneous T-cell lymphoma maintenance treatment. Recruitment is closed, with unblinding and top-line data expected in Q1 2023. Resminostat aims to prolong progression-free survival and improve quality of life.

Regeneron announced the FDA extended its review of REGEN-COV for COVID-19 treatment and prophylaxis, setting a new target action date of July 13, 2022. REGEN-COV, not currently authorized in the U.S., is part of Regeneron's efforts to combat COVID-19 with next-generation antibodies, including a first-in-human trial.

Scott T. Tagawa discusses a phase 1/2 trial (NCT04886986) investigating 225Ac-J591 and 177Lu-PSMA-I&T in metastatic castration-resistant prostate cancer. Initial findings show 225Ac-J591 is tolerable, with no dose-limiting toxicities in early cohorts, though one patient experienced grade 3 thrombocytopenia.

A recent open-label, single-centre, randomised controlled trial conducted in Australia has shown that drug treatment can be effective for Crohn's disease strictures, traditionally treated with surgery or endoscopic balloon dilation. The study compared intensive high-dose adalimumab plus thiopurine treatment with standard adalimumab monotherapy, finding that most patients experienced improved symptoms and stricture morphology with the intensive treatment.

Direct Biologics announced positive Phase II trial results for ExoFlo, a treatment for COVID-19 related ARDS, showing a 37.6% reduction in 60-day mortality and no adverse events. ExoFlo, derived from MSCs, offers anti-inflammatory and regenerative benefits without the drawbacks of stem cell transplantation. The company is preparing for a Phase III study amidst ongoing COVID-19 challenges.

Pacritinib, a JAK2/IRAK1 inhibitor, received FDA approval for treating PET-MF and PPV-MF patients with low platelet counts, based on PERSIST-2 trial results showing significant spleen volume and symptom reduction. It offers a full-dose option for patients with severe thrombocytopenia, marking a significant advancement in myelofibrosis treatment.

Sequana Medical has successfully completed the implantation of the alfapump system in patients for the POSEIDON study, aiming for regulatory approval in the U.S. and Canada. The study shows promising preliminary survival rates and is on track for primary endpoint reporting by Q4 2022.

CanSino Biologics Inc's mRNA COVID-19 vaccine approved for clinical trials in China, joining other domestic candidates. China, with 88% of its population vaccinated, has not approved foreign mRNA vaccines. CanSinoBIO's candidate showed high-level antibodies against variants, including Omicron, in pre-clinical studies.

Junshi Biosciences received FDA approval for its anti-CD112R monoclonal antibody (TAB009/JS009) to treat advanced solid tumors. This antibody targets CD112R, a new immune checkpoint, enhancing T and NK cells' ability to fight tumors. It shows synergistic effects with other treatments, aiming to maximize anti-tumor potential.

Pipeline Watch provides a weekly overview of late-stage clinical trial events and approvals from pharmaceutical and biotech companies, shared via medical conferences, financial presentations, and company releases.