FDA Approves Groundbreaking Trial: SynKIR-310 for Tough-to-Treat B-cell NHL
Key Takeaways
- FDA clears SynKIR-310 for phase 1 trial
- CELESTIAL-301 trial to begin in late 2024
- SynKIR-310 offers enhanced antitumor activity
Did You Know?
Introduction: An Exciting Step Forward
The FDA has officially cleared an investigational new drug (IND) application for SynKIR-310, a promising agent developed by Verismo Therapeutics. This clearance paves the way for a phase 1 clinical trial aimed at evaluating the efficacy of SynKIR-310 in patients suffering from relapsed/refractory B-cell non-Hodgkin lymphomas (B-NHL).
The CELESTIAL-301 Clinical Trial
The phase 1 CELESTIAL-301 trial is expected to commence in the latter half of 2024. This trial will assess the safety, tolerability, and preliminary efficacy of SynKIR-310 in patients who have either relapsed following previous treatments or have become refractory to currently available therapies.
Scope of the Study
The study will include patients with various subtypes of B-NHL such as diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma. Notably, both patients who have been previously treated with chimeric antigen receptor (CAR) T-cell therapy and those who have never received such treatment will be included in this trial.
Innovative Mechanism of Action
SynKIR-310 is based on DS191, a proprietary CD19 binder that enhances the existing KIR-CAR platform technology. This unique mechanism aims to treat B-cell associated disorders and malignancies by prolonging the antitumor function and persistence of T-cells.
Enhanced Antitumor Activity
According to Laura Johnson, PhD, chief scientific officer of Verismo Therapeutics, SynKIR-310 has the potential to significantly improve T-cell persistence and functionality. This can lead to prolonged antitumor activity and possibly prevent early disease relapse, which is a common issue in aggressive lymphomas.
Verismo Therapeutics: Leading the Way
Verismo Therapeutics is at the forefront of innovative cancer therapies. With SynKIR-310, the company hopes to address the significant challenges in treating relapsed/refractory B-cell NHL, particularly for patients who have relapsed after receiving approved CAR T-cell therapies.
Advantages Over Existing Treatments
The SynKIR-310 technology offers enhancements over existing CAR T-cell therapies. By targeting a similar epitope of CD19, SynKIR-310 is believed to provide superior antitumor activity while potentially extending the efficacy of T-cells in the body.
Other Ongoing Research
In addition to SynKIR-310, Verismo Therapeutics is also investigating SynKIR-110 in another phase 1 clinical trial named STAR-101. This trial is currently ongoing at two sites, with plans to expand to additional locations in 2024.
Next Steps
The CELESTIAL-301 trial represents a significant milestone for Verismo Therapeutics and the broader medical community. The company is committed to advancing its innovative KIR-CAR platform technology through rigorous clinical trials and research initiatives.
Conclusion: A Step Towards Better Treatments
The future seems promising with the advent of SynKIR-310 and the upcoming CELESTIAL-301 trial. If successful, SynKIR-310 could redefine the treatment landscape for relapsed/refractory B-cell NHL, offering new hope for patients and their families.
