AFNT-111 / Affini-T Therap, Erasca - LARVOL DELTA

Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations (clinicaltrials.gov) - P1 | N=24 | Suspended | Sponsor: Fred Hutchinson Cancer Center | Active, not recruiting ➔ Suspended

IO biomarker • Trial suspension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • HER-2 • KRAS • MSI • NTRK • TMB

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

Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Pancreatic, Colorectal and Non-Small Cell Lung Cancers With KRAS G12V Mutations (clinicaltrials.gov) - P1 | N=5 | Active, not recruiting | Sponsor: Fred Hutchinson Cancer Center | Recruiting ➔ Active, not recruiting | N=24 ➔ 5

Enrollment change • Enrollment closed • IO biomarker • Colorectal Adenocarcinoma • Colorectal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ALK • BRAF • HER-2 • KRAS • MSI • NTRK • TMB

Phase I study of autologous CD8+ and CD4+ transgenic T cells expressing high-affinity KRAS G12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) in patients with metastatic pancreatic, colorectal, and non-small cell lung cancers with KRAS G12V mutations. (ASCO-GI 2025) - P1 | "Patients undergo leukapheresis prior to treatment and receive lymphodepleting chemotherapy with either cyclophosphamide intravenously (IV) and fludarabine IV on days -6, -5, and -4 or bendamustine IV on days -4 and -3. Patients may receive an additional FHA11KRASG12V-TCR IV infusion at the same or lower dose as soon as 28 days or up to 1 year after the first infusion. The study is actively recruiting."

Clinical • IO biomarker • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • HLA-A • 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

Phase I study of autologous CD8+ and CD4+ transgenic T cells expressing high-affinity KRAS G12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) in patients with metastatic pancreatic, colorectal and non-small cell lung cancers with KRAS G12V mutations (AACR 2024) - P1 | "Patients undergo leukapheresis prior to treatment and receive lymphodepleting chemotherapy with either cyclophosphamide intravenously (IV) and fludarabine IV on days -6, -5, -4, and -3 or bendamustine IV on days -4 and -3. Patients may receive an additional FHA11KRASG12V-TCR IV infusion at the same or lower dose as soon as 28 days or up to 1 year after the first infusion. One patient enrolled to date and the study is actively recruiting (NCT06043713)."

Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • 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

Affini-T Therapeutics to Present Data from Lead Oncogenic Driver Candidate at AACR Special Conference: Targeting RAS (Businesswire) - "Affini-T Therapeutics...announced that data for its lead oncogenic driver candidate targeting KRAS G12V, AFNT-111, will be presented at the AACR Special Conference: Targeting Ras. 'We continue to see encouraging data from preclinical studies of AFNT-111 as we progress toward clinical investigation'....'We have observed high potency and specificity as well as a favorable tolerability profile, which provides encouraging support for our oncogenic driver programs'."

Preclinical • Oncology

AFNT-111, a safe and effective TCR-engineered T cell therapy targeting the oncogenic driver KRAS G12V mutation (SITC 2022) - "First-in-human clinical studies will focus on advanced or metastatic pancreatic, colorectal, and lung cancer indications. Ethics Approval These studies were approved by Affini-T Therapeutics and Fred Hutchinson Cancer Research Center Ethics Boards, approval number EB17-010-303 and PROTO000050898, respectively."

Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • KRAS

Affini-T Therapeutics to Present Preclinical Data from its Lead Programs Targeting KRAS G12V at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting (Businesswire) - "Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, today announced that data from its oncogenic driver programs targeting KRAS G12V will be presented at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting."

Preclinical • Oncology • Solid Tumor