Cullinan Therapeutics Releases Promising Clinical Data

Cullinan Therapeutics, Inc. (NASDAQ: CGEM) has released its first clinical data from the phase 1 dose escalation cohort of CLN-619 in combination with the checkpoint inhibitor (CPI) pembrolizumab, as well as updated results from the monotherapy dose escalation cohort in patients with advanced solid tumors.

In the combination arm of the phase 1 clinical trial, 22 patients were treated with CLN-619 in combination with pembrolizumab, with 18 patients being RECIST-evaluable for response. Of these, 3 patients treated with CLN-619 at doses ≥3mg/kg in combination with pembrolizumab showed confirmed partial responses (PR), including patients with tumor types not typically responsive to CPI treatment.

In the monotherapy arm, among 42 patients treated with CLN-619, 29 received CLN-619 at a dose ≥1 mg/kg and were RECIST-evaluable. The clinical benefit rate (CBR) was 41.4%, with 1 complete response (CR), 2 PR, and 9 stable disease (SD) ≥18 weeks.

The safety data indicated that CLN-619 was well tolerated in combination with pembrolizumab and as monotherapy, with most treatment-related adverse events being grade 1/2. The most frequently reported adverse events were infusion-related reactions and fatigue.

Dr. Jeffrey Jones, Chief Medical Officer at Cullinan Therapeutics, commented on the findings, highlighting the potential benefit of the combination of CLN-619 with pembrolizumab for patients whose cancer is not typically amenable to checkpoint inhibitor therapy. Longer-term follow-up for patients treated with CLN-619 monotherapy also showed favorable safety and durable clinical benefit across multiple tumor types.

Based on these observations, Cullinan has initiated monotherapy and combination expansion cohorts in non-small cell lung cancer (NSCLC) and continues to enroll in expansion cohorts in cervical and endometrial cancers.

CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that binds to the stress-induced ligands MICA and MICB, which are expressed on a wide variety of solid tumors and hematologic malignancies.

Cullinan Therapeutics will present the CLN-619 data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and will host an investor event on June 1, 2024, where the clinical findings will be discussed in detail.

The company's ongoing efforts in developing CLN-619, both as monotherapy and in combination with pembrolizumab, demonstrate its commitment to addressing significant unmet needs for patients with various types of cancer, particularly those who have not been responsive to existing treatments. The market has reacted to these announcements by moving the company's shares 3.9% to a price of $23.54. Check out the company's full 8-K submission here.

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