DTIL — Expected Completion of Phase 1 Clinical Trial for PBGENE-HBV

Expected Completion of Phase 1 Clinical Trial of BHV-1530

Biohaven Therapeutics Ltd. is expected to complete the Phase 1 clinical trial of BHV-1530, an open-label, multicenter study for adults with advanced or metastatic solid tumors, by March 1, 2029. The trial, which is currently in the recruiting stage, has a planned enrollment of 95 participants. BHV-1530 is noted as a first-in-human study and aims to assess safety and potential efficacy in this patient population. This event could have implications for Biohaven's pipeline potential and investor interest as the trial progresses.

• www.clinicaltrials.gov/study/NCT06874335

Expected Completion of Phase 1/2 Study of BHV-1510

Biohaven Therapeutics Ltd. is expected to complete its Phase 1/2 study of BHV-1510, a Trop-2 directed antibody-drug conjugate (ADC), on February 1, 2028. The study aims to evaluate the safety and tolerability of BHV-1510 in patients with previously treated advanced solid tumors. It is designed as a multicenter, open-label trial comprising a Phase 1 dose escalation followed by a Phase 2 dose expansion, with a total enrollment of 280 participants. The drug is being investigated both as monotherapy and in combination with cemiplimab, as the company seeks to establish recommended doses for further expansion and assess preliminary efficacy in specific cohorts.

• www.clinicaltrials.gov/study/NCT06384807

Expected Completion of Phase 1/2 Clinical Trial for BDC-4182

Bolt Biotherapeutics, Inc. is expected to complete a Phase 1/2 clinical trial for BDC-4182, a drug aimed at treating advanced gastric and gastroesophageal cancer, on May 1, 2029. The study is a dose escalation trial designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose. As of now, the trial is in the recruiting phase, with an enrollment count of 122 participants. The completion of this trial may significantly impact the company's pipeline and future product offerings.

• www.clinicaltrials.gov/study/NCT06921837

Expected Completion of Phase 1b Clinical Trial for TBio-4101 and Pembrolizumab

Phase 1b clinical trial evaluating TBio-4101, a tumor-infiltrating lymphocyte therapy, in combination with pembrolizumab for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) is expected to conclude on August 1, 2026. The trial, sponsored by H. Lee Moffitt Cancer Center and Research Institute, is currently in the recruiting phase with an enrollment goal of 15 patients. This study aims to assess the safety of TBio-4101 following lymphodepleting chemotherapy, with the additional treatment of intravenous bolus aldesleukin (IL-2) and pembrolizumab for patients who progressed on prior therapies. The outcome may have implications for treatment strategies in advanced HNSCC, especially for patients who are not responding to existing therapies.