Cullinan Oncology to Present First Monotherapy Clinical Data for CLN-619, a Novel Anti-MICA/B Antibody, at ASCO 2023

Advancing Cancer Treatment: Breakthrough Results of CLN-619 Monotherapy to be Unveiled at ASCO 2023

Cullinan Oncology, Inc., a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced first monotherapy clinical data from its Phase 1 study of CLN-619 in patients with advanced solid tumors. Findings from the clinical trial will be shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting as a poster presentation during the “Developmental Therapeutics—Immunotherapy” session (poster 2532) on June 3, 2023 from 8:00 AM-11:00 AM Central Time. CLN-619 is being studied in an ongoing Phase 1 clinical trial both as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. Monotherapy dose escalation demonstrates acceptable safety profile of CLN-619 across all doses assessed (0.1, 0.3, 1, 3, 6, 10mg/kg). No dose-limiting toxicities were observed. Consistent with other monoclonal antibodies, infusion-related reactions were limited to the first dose and all grade 1/2 in patients receiving mandated pre-medication.

We are encouraged by the first clinical data for CLN-619 monotherapy, which demonstrates broad potential across a range of tumor types. Objective responses and sustained stable disease were observed, including in patients whose tumors had relapsed on or were not amenable to checkpoint inhibitor therapy,” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology. “Notably, clinical activity was observed in multiple gynecologic cancer types of high unmet need. Based on these initial efficacy observations, we will initiate expansion cohorts in endometrial and cervical cancer and look to expand in additional tumor-specific cohorts as the data matures. Additionally, the Phase 1 trial continues to evaluate CLN-619 in combination with pembrolizumab, and we look forward to sharing the results at a future medical meeting.”

“These data demonstrate the potential of CLN-619 to treat a range of solid tumors. Along with the monotherapy efficacy of CLN-619, we also observed a favorable safety profile, with most adverse events being grade 2 or lower,” said Judy Wang, MD, Florida Cancer Specialists and Research Institute. “We need new ways to help overcome immune evasion mechanisms, and CLN-619 is an antibody that is designed to render cancer cells visible to the immune system by binding to MICA and MICB, stress-induced ligands that engage the activating receptor NKG2D present on both innate and adaptive immune cells, representing a novel approach to enable immune-mediated elimination of tumors.”

“Over 66,000 new cases of endometrial cancer are diagnosed every year in the United States. The incidence has been rising for more than a decade, particularly in the more aggressive subtypes, and uterine cancer is projected to surpass colorectal cancer as the fourth leading cause of cancer death among women by 2040. Despite recent advances in endometrial cancer therapeutics, this patient population is often affected by other co-morbidities, so safer and more effective treatment options are urgently needed to address a growing unmet need” said Vicky Makker, MD, Section Head of the Endometrial Cancer Program at Memorial Sloan Kettering Cancer Center. “That need extends across gynecologic cancers. In cervical cancer, treatment options remain limited, and even with improvements in screening to reduce incidence rates, approximately 13,000 new cases of cervical cancer are diagnosed annually and greater than 4,000 women die of this malignancy each year in the U.S.

Published on : 26th May, 2023