OncoC4 Inc. has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to cesalatamig, also known as AI-081, for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) whose disease has progressed following concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.

Cesalatamig is a PD-1/VEGF bispecific antibody being evaluated in the global BiPAVE-001 Phase 1/2 clinical programme. The programme is assessing the safety, efficacy and pharmacokinetics of cesalatamig in patients with advanced cancers.

BiPAVE-001 consists of two parts. Part A is a Phase 1 dose-escalation and expansion study, while Part B comprises Phase 2 dose-optimisation studies across multiple cohorts. The Phase 2 cohorts are evaluating cesalatamig as a monotherapy and in combination with standard-of-care or investigational therapies.

The trials are being conducted at more than 50 clinical sites across the United States and China, with the majority of patients enrolled in the United States.

According to OncoC4, cesalatamig is designed to simultaneously target PD-1 and VEGF. The company states that the antibody has high affinity for PD-1 and more than 40-fold higher affinity for VEGF compared with bevacizumab-based PD-(L)1/VEGF bispecific inhibitors. It also incorporates Fc-silencing modifications intended to reduce depletion of PD-1-positive effector T cells.

Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer, OncoC4, said the Fast Track designation follows safety and efficacy signals observed in the company's global Phase 1/2 BiPAVE-001 trials in the United States and China. He added that the company is advancing cesalatamig toward Phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications.

Fast Track Designation is an FDA programme intended to facilitate the development and review of therapies for serious conditions where there is an unmet medical need. The designation can provide opportunities for more frequent interactions with the FDA during drug development and may support expedited review mechanisms when applicable.

OncoC4, based in Rockville, Maryland, is a privately held, late clinical-stage biopharmaceutical company developing biologics for cancer and immunological diseases.