FDA Clears IND Application for SynKIR-310 Trial in R/R B-NHL

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With the FDA clearance of an investigational new drug application for SynKIR-310, a phase 1 trial evaluating the agent in relapsed/refractory B-cell non-Hodgkin lymphomas will begin.

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  • The FDA has cleared an investigational new drug (IND) application for SynKIR-310.
  • With this clearance, a phase 1 clinical trial evaluating SynKIR-310 for the treatment of patients with relapsed/refractory B-cell non-Hodgkin lymphomas (B-NHL) may proceed.
  • The phase 1 CELESTIAL-301 trial plans to begin in the second half of 2024.

The FDA has granted clearance to an IND application for SynKIR-310, and a phase 1 trial will evaluate the agent for the treatment of patients with relapsed/refractory B-NHL, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.1

"Verismo Therapeutics is uniquely positioned with SynKIR™-310 to address the significant challenges in treating relapsed/refractory B-cell NHL. This includes cases where patients have relapsed after receiving approved [chimeric antigen receptor (CAR)] T therapies," said Laura Johnson, PhD, chief scientific officer of Verismo Therapeutics, in a press release.

SynKIR-310 relies on DS191, which is a proprietary CD19 binder specifically made for the KIR-CAR platform technology to enable treatment of B-cell associated disorders and malignancies. The agent is being developed by Verismo Therapeutics.

Blood cancer cells under the microscope: © stock_acc - stock.adobe.com

Blood cancer cells under the microscope: © stock_acc - stock.adobe.com

Like commercially approved CAR T-cell therapies, SynKIR-310 is directed by DS191 to target a similar epitope of CD19. However, SynKIR-310 has an added potential to prolong antitumor T-cell function and persistence.

"The SynKIR-310 technology is designed to enhance the antitumor activity and extend the efficacy of T cells. This could potentially improve persistence and prevent early disease relapse in patients with aggressive lymphomas. SynKIR™-310 could be especially beneficial for patients that relapsed after previous infusions of CAR T cell therapies," added Johnson.

CELESTIAL-301 is the company's second study investigating the KIR-CAR platform technology. The phase 1 trial plans to evaluate the safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with relapsed/refractory NHL.

Patients previously treated with CAR T-cell therapy will be included in the study if they have since relapsed or become refractory to it. Patients who never received CAR T-cell therapy also will be included.

The CELESTIAL-301 trial is expected to begin in the second half of 2024.

In addition to SynKIR-310, the company is also evaluating SynKIR-110 in a phase 1 clinical trial titled STAR-101 (NCT05568680).2 This trial is assessing the agent at 2 sites, and there are plans to open additional sites in 2024.

REFERENCES:
1. Verismo Therapeutics receives IND clearance from the FDA for SynKIR™-310 in relapsed/refractory B-cell NHL. News release. Verismo Therapeutics. May 14, 2024. Accessed May 14, 2024. https://tinyurl.com/2pctdrte
2. Verismo Therapeutics secures fast track designation from the U.S. food and drug administration (FDA) for SynKIR-110. News release. Verismo Therapeutics. April 5, 2023. Accessed May 14, 2024. https://prn.to/3UjcFij
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