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Affini-T Therapeutics Begins Phase I Trial of T-Cell Receptor Therapy in KRAS G12V-Mutant Tumors

NEW YORK – Affini-T Therapeutics said on Tuesday that it has started treating patients with KRAS G12V-mutated advanced solid tumors who are also HLA-A*11:01-positive with the investigational KRAS G12V-targeting T-cell receptor therapy AFNT-211 in a Phase I trial.

The trial will enroll 100 participants. In the dose-escalation portion of the study, Affini-T will enroll patients with previously treated advanced or metastatic unresectable solid tumors who are HLA-A*11:01 positive and whose tumors harbor a KRAS G12V mutation. In the dose-expansion portion of the trial, researchers will enroll pancreatic, colorectal, and non-small cell lung cancer patients with these biomarkers.

Boston-based Affini-T developed AFNT-211 using its THRIVE platform, which produces engineered CD4 T cells and CD8 T cells directed against KRAS G12V mutations. The autologous, engineered T cells are designed to have enhanced potency in the presence of tumor-specific antigens and to reduce T-cell exhaustion in the tumor microenvironment.

"Our goal is to address the significant unmet need of patients with difficult-to-treat solid tumors," Affini-T Chief Medical Officer Dirk Nagorsen said in a statement. "AFNT-211 is specifically designed to leverage precision immunotherapy and synthetic biology approaches to target the oncogenic driver mutation KRAS G12V in patients who are HLA-A*11:01-positive. We have made great progress with our clinical trial work since we started enrolling and treating patients across our two programs, AFNT-111 and AFNT-211, earlier this year."

Affini-T's AFNT-111 is another autologous T-cell receptor therapy comprising autologous CD8- and CD4-positive transgenic T cells that express KRAS G12V mutation-specific T-cell receptors. Investigators at the Fred Hutchinson Cancer Center are conducting a Phase I study evaluating AFNT-111 in patients with KRAS G12V-mutant metastatic pancreatic, colorectal, and NSCLC tumors.

The company also has several preclinical and discovery-stage programs in cancers with KRAS G12C, KRAS G12D, p53, and PIK3CA mutations. Affini-T previously partnered with Metagenomi to advance its pipeline of T-cell receptor therapies and with ElevateBio to manufacture these treatments.