cesalatamig (AI-081) / OncoC4 - LARVOL DELTA

OncoC4 Receives FDA Fast Track Designation for Cesalatamig, an Investigational PD-1/VEGF Bispecific Antibody (PRNewswire) - "Cesalatamig is Currently Being Evaluated in Phase 1/2 Studies in the United States (NCT06635785) and in China (CTR20253261); Fast Track Designation Supports Expedited Development of Cesalatamig for Non-small Cell Lung Cancer (NSCLC) that Progressed after Concurrent or Sequential PD-(L)1-targeted Immunotherapy and Platinum-based Chemotherapy...The global BiPAVE-001 Phase 1/2 trials are designed to evaluate the safety, efficacy and pharmacokinetics of cesalatamig in patients with advanced cancer. Part A is Phase 1 dose escalation and expansion study. Part B is the Phase 2 dose optimization studies consisting of multiple cohorts evaluating the safety and clinical activities of cesalatamig either as monotherapy or in combination therapy with standard of care or novel agents."

Fast track • Non Small Cell Lung Cancer • Solid Tumor

BiPAVE-001: Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=387 | Recruiting | Sponsor: OncoC4, Inc. | Trial primary completion date: Jun 2026 ➔ Jun 2027 | N=204 ➔ 387

Enrollment change • First-in-human • Trial primary completion date • Oncology • Solid Tumor

OncoC4 Doses First Patient with Potential Best-in-Class PD-1/VEGF Bispecific Antibody AI-081 in Phase 2 Portion of BIPAVE-001 Trial for Advanced Solid Tumors in US (GlobeNewswire) - "OncoC4...announced the first patient has been dosed in the Phase 2 portion of the Phase 1/2 BIPAVE-001 trial (NCT06635785) evaluating AI-081, a potentially best-in-class PD-1 and VEGF bispecific antibody....'We look forward to further dose optimization in the Phase 2 trial with initial focus in non-small cell lung cancer (NSCLC)'....The BIPAVE-001 Phase 1/2 trial is designed to evaluate the safety, pharmacokinetic, and efficacy of AI-081 in two integrated parts....The study is being carried out in the United States with 11 clinical sites actively enrolling patients. The Chinese regulatory agency also cleared the study."

Trial status • Non Small Cell Lung Cancer • Solid Tumor

OncoC4 Selected to Present at the 2025 AACR Meeting's Showcase Session (GlobeNewswire) - "Oral presentation will feature AI-081, a potentially best-in-class PD-1/VEGF bispecific antibody and ONC-841, a first-in-class anti-Siglec-10 antibody....Initial clinical data for both AI-081 and ONC-841 in solid tumors expected 2H 2025."

Clinical data • Oncology • Solid Tumor

BiPAVE-001: Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=204 | Recruiting | Sponsor: OncoC4, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment open • Trial primary completion date • Oncology • Solid Tumor

OncoC4 Announces FDA Clearance of IND Application for Potential Best-in-Class PD-1/VEGF Bispecific AI-081 in Advanced Solid Tumors (GlobeNewswire) - "OncoC4, Inc...announced that the United States Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for AI-081, a potentially best-in-class PD-1 and VEGF bispecific antibody for the treatment of advanced solid tumors. Following receipt of a Study May Proceed notification from the FDA, OncoC4 expects to initiate the BIPAVE-001 Phase 1/2 trial for advanced solid tumors in the first quarter of 2025...'We look forward to initiating clinical development of AI-081 with the dosing of the first patient in our BIPAVE-001 Phase 1/2 trial in early 2025.'....BIPAVE-001 is a Phase 1/2 trial designed to evaluate the safety, pharmacokinetic, and efficacy of AI-081. The Part A portion is a first-in-human dose escalation study that will determine the recommended Phase 2 dose of AI-081 monotherapy in patients with advanced solid tumors."

IND • Trial status • Oncology • Solid Tumor

Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=204 | Not yet recruiting | Sponsor: OncoC4, Inc.

New P1/2 trial • Oncology • Solid Tumor

OncoC4 and AcroImmune Announce Merger (GlobeNewswire) - "OncoC4, Inc...and AcroImmune...announced that the companies, which are under common control, have entered into a definitive merger agreement to combine in an all-stock transaction (the Merger). Under the terms of the agreements, OncoC4 will acquire 100% of the outstanding equity interests of AcroImmune. Upon completion of the Merger, the combined company is expected to operate under the name OncoC4, Inc., will be headquartered in Rockville, Maryland, and led by Yang Liu, PhD, Co-Founder, Chief Executive Officer (CEO)....'This Merger seamlessly bolsters OncoC4’s wholly owned immunotherapy pipeline and adds investigational new drug (IND)-ready PD-1/VEGF bispecific antibody AI-081'...'We are very excited to file an IND application for AI-081 in the fourth quarter of the year'."

IND • M&A • Oncology