AFNT-211 / Affini-T Therap - LARVOL DELTA

A phase I study of AFNT-211, autologous CD4+ and CD8+ T cells engineered to express a high avidity HLA-A*11:01-restricted, KRAS G12V-specific transgenic TCR; CD8α/β coreceptor; and FAS-41BB switch receptor in patients with advanced or metastatic solid tumors. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT06105021 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P1 data • Oncology • Solid Tumor • CD4 • CD8 • KRAS

Affini-T Therapeutics Presents Preclinical Data from its Programs Targeting Oncogenic Drivers KRAS and TP53 at AACR (Affini-T Press Release) - "Affini-T Therapeutics, Inc...today announced several presentations at this year’s American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago."

Clinical data • Preclinical • Solid Tumor

A phase I study of AFNT-211, autologous CD4+ and CD8+ T cells engineered to express a high avidity HLA-A*11:01-restricted, KRAS G12V-specific transgenic TCR; CD8α/β coreceptor; and FAS-41BB switch receptor, in patients with advanced or metastatic solid tumors (AACR 2025) - P1/2 | "Cancer Discov. 2022; 12:924-937."

Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • KRAS

A phase1 study of autologous engineered CD4+ and CD8+ T cells, HLA-A*11:01-restricted, KRAS G12V-specific, transgenic TCR; CD8α/β coreceptor and a FAS41BB switch receptor in patients with solid tumors (SITC 2024) - P1/2 | "T cell receptor (TCR)-T cell therapies targeting mutant KRAS have demonstrated proof of concept in the clinic, but duration of response remains a challenge.1 2 AFNT-211 represents a novel strategy to address the immunosuppressive tumor microenvironment and improve response rate and duration in solid tumors...This is followed by a 28-day dose-limiting toxicity observation period (dose escalation only) and a post-treatment follow-up period for 24 months/until disease progression. The study is open for recruitment in the United States (NCT06105021)."

Clinical • IO biomarker • P1 data • Oncology • Solid Tumor • CD4 • KRAS

Affini-T Therapeutics to Present Trial-in-Progress Poster and Preclinical Data from Its Oncogenic Driver Programs Targeting TP53 R175H, KRAS G12D and KRAS-G12V at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting (Businesswire) - "Affini-T Therapeutics, Inc...today announced that a Trial-In-Progress poster for the Company’s Phase 1 clinical trial evaluating AFNT-211 targeting KRAS G12V will be presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting held in Houston, TX, November 6-10. The team will present three additional posters with preclinical data from its non-viral TRAC-knocked-in T cell therapy targeting TP53-R175H and bi-specific T cell engager programs targeting TP53-R175H, KRAS G12D and KRAS G12V."

P1 data • Preclinical • Oncology • Solid Tumor

AFNT-211: A phase 1 study of autologous CD4+ and CD8+ T cells engineered to express a high avidity HLA-A*11:01-restricted, KRAS G12V-specific, transgenic TCR, a CD8α/β coreceptor, and a FAS41BB switch receptor in patients with advanced/metastatic solid tumors. (ASCO 2024) - P1/2 | "This is followed by a 28-day dose-limiting toxicity observation period (dose escalation only) and a post-treatment follow-up period for 24 months/ until disease progression. The study is open for recruitment in the United States."

Clinical • IO biomarker • Metastases • P1 data • Oncology • Solid Tumor • CD4 • CD8 • KRAS

Affini-T Therapeutics Announces First Patient Dosed in KRAS G12V Phase 1 Program and Presentation of Trial-in-Progress Poster at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting (Businesswire) - "Affini-T Therapeutics, Inc...announced that the first patient has been dosed in the Company’s Phase 1 clinical trial evaluating AFNT-211 targeting KRAS G12V. A Trial-In-Progress poster for this ongoing Phase 1 trial will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting held in Chicago, IL May 31-June 4."

Trial status • Oncology • Solid Tumor

AFNT-211: A phase1 study of autologous CD4+ and CD8+ T cells engineered to express a high avidity HLA-A*11:01-restricted, KRAS G12V-specific, transgenic TCR; CD8α/β coreceptor; and a FAS41BB switch receptor in patients with advanced/metastatic solid tumors (AACR 2024) - P1/2 | "This is followed by a 28-day dose-limiting toxicity observation period (dose escalation only) and a post-treatment follow-up period for 24 months/until disease progression. The study is open for recruitment in the United States (NCT06105021)."

Clinical • IO biomarker • Metastases • P1 data • Oncology • Solid Tumor • CD4 • CD8 • KRAS

Affini-T Therapeutics to Present Preclinical Data from its Programs Targeting KRAS G12D and p53 R175H and Two Trials in Progress at the American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "Affini-T Therapeutics, Inc...announced that preclinical data from its oncogenic driver programs targeting HLA-A*11:01 KRAS G12D and HLA-A*02:01 p53 R175H will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 held in San Diego, CA. In addition, two trial-in-progress posters for Affini-T's Phase 1 clinical-stage programs targeting KRAS G12V, the company-sponsored AFNT-211 study and the Fred Hutchinson Cancer Center investigator-initiated AFNT-111 study, will be presented at the same conference."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Affini-T Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Affini-T Therapeutics, Inc.

Metastases • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

AFNT-211: An FAS-41BB–enhanced TCR-T cell therapy with stem-like properties targeting KRAS G12V-expressing solid tumors. (ASCO 2023) - "The AFNT-211 manufacturing process generates a large number of TCR-T cells with desirable stem-like properties optimized for clinical dosing. Preclinical data demonstrated a potent and safe profile for AFNT-211 that supports clinical development in HLA-A*11:01 patients with advanced/metastatic solid tumors harboring a KRAS G12V mutation."

Immune Modulation • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • FASLG • HLA-A • KRAS

Affini-T Therapeutics to Present AFNT-211 T Cell Product Attributes Targeting KRAS G12V at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - "Affini-T Therapeutics, Inc...today announced that preclinical data for its oncogenic driver program targeting KRAS G12V, AFNT–211, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago, June 2-6....These findings establish a solid research foundation and support our ongoing effort to advance the program as a potential paradigm-shifting treatment for solid tumors....'Our IND-enabling studies have demonstrated potent and specific pharmacological action with a rigorous toxicology profile that support the advancement of the AFNT-211 program to the clinic.'"

Preclinical • Oncology • Solid Tumor