Clinical Trials

Date: 2016-11-17

Type of information: Recruitment of the first patient

phase: 1b

Announcement: recruitment of the first patient

Company: Neon Therapeutics (USA - MA)

Product: NEO-PV-01 and nivolumab

Action mechanism:

• monoclonal antibody/immune chekcpoint inhibitor/immunotherapy prodct/therapeutic vaccine. Opdivo® (Nivolumab) is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. PD-1, a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body. Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them.
• NEO-PV-01 is a personalized cancer vaccine designed specifically for each patient based on the neoantigen mutations unique to that patient’s tumor.

Disease: measurable metastatic melanoma, non-small cell lung cancer, bladder cancer.

Therapeutic area: Cancer - Oncology

Country: USA

Trial details: (NCT02897765)

Latest news:

• • On November 17, 2016, Neon Therapeutics announced that it has enrolled the first patient at the University of Texas MD Anderson Cancer Center in its first company-sponsored clinical trial evaluating its lead program, NEO-PV-01. Neon Therapeutics’ first clinical study is a multicenter Phase 1b clinical trial evaluating the safety, tolerability and efficacy of NEO-PV-01 combined with Opdivo® (nivolumab) in patients with measurable metastatic melanoma, non-small cell lung cancer and bladder cancer. The trial will evaluate both clinical responses and immune responses in serial samples of peripheral blood and tumor tissue. This clinical trial is anticipated to enroll a total of 90 patients in up to ten sites across the U.S. Patients undergo an initial biopsy, and a vaccine is manufactured that is customized to each patient’s tumor. While the vaccine is produced, patients receive nivolumab, then subsequently receive NEO-PV-01 in combination with nivolumab.
• • On July 29, 2016, Neon Therapeutics announced that the FDA has accepted the company’s Investigational New Drug  application for its lead program, NEO­PV­ 01.

 

Is general: Yes