Affini-T Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of precision immunotherapies for treatment of patients with solid tumors, 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.

“We are going after cancers with tumor driver mutations like KRAS,” said Dirk Nagorsen, M.D., Chief Medical Officer, Affini-T Therapeutics. “Our two clinical stage programs, AFNT-111 and AFNT-211, are specifically designed to leverage precision immunotherapy and synthetic biology approaches to target oncogenic driver mutation KRAS G12V in HLA-A*11:01-positive patients. We started treating patients across these trials earlier this year and we continue to advance these programs through Phase 1.”

“Our mission is to address the significant unmet needs of patients with hard-to-treat solid tumors by advancing precision engineered T cell and bispecific T cell engager immunotherapies that target oncogenic driver mutations,” said Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics. “We believe that our non-viral multi-kilobase size gene targeted knock-in platform, THRIVE^TM, will enable us to cost-effectively engineer safe and effective T cell therapy products. We look forward to presenting new preclinical data for THRIVE^TM-engineered TP53 R175H-targeting TCR T cells (AFNT-313). We will also be disclosing, for the first time, preclinical data for T cell engagers targeting TP53 R175H and KRAS G12V/D mutations from Affini-T’s TETHER^TM bispecific platform.”

Poster presentation details are as follows:

Title: A Phase 1 Study of Autologous 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

Abstract #662, Primary Category: Clinical Trials in Progress

Presenting Author: Soumit Basu, M.D., Senior Medical Director, Clinical Development, Affini-T Therapeutics

Session Date/Time: Saturday, November 9, 2024, 12:15 PM – 1:45 PM CST and 7:10 PM – 8:30 PM CST

Title: A Non-Virally Engineered T Cell Therapy Targeting the Hotspot Mutation R175H in TP53 with Signals 1, 2, and 3 (TCR, Co-stimulation, and Cytokine) Drives a Coordinated Antitumor CD4/8 T Cell Response

Abstract #393, Primary Category: Cellular Therapies

Presenting Author: Santosh Narayan, Ph.D., Senior Scientist, Immunology & Gene Editing, Affini-T Therapeutics

Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Friday, November 8, 2024, 12:15 PM – 1:45 PM CST and 5:30 PM – 7:00 PM CST

Title: T Cell Engagers Targeting HLA-A*11:01 KRAS-G12D and KRAS-G12V Mutations for Cancer Immunotherapy

Abstract #1066, Primary Category: Immuno-Conjugates and Chimeric Molecules

Presenting Author: Mark Ng, MS, Senior Scientist II, TCR Discovery, Affini-T Therapeutics

Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Saturday, November 9, 2024, 12:15 PM – 1:45 PM CST and 7:10 PM – 8:30 PM CST

Title: A Novel T Cell Engager Targeting HLA-A*02:01 TP53-R175H for Cancer Immunotherapy

Abstract #1315, Primary Category: Novel Single-Agent Immunotherapies

Presenting Author: Mark Ng, MS, Senior Scientist II, TCR Discovery, Affini-T Therapeutics

Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Friday, November 8, 2024, 12:15 PM – 1:45 PM CST and 5:30 PM – 7:00 PM CST

About AFNT-211

AFNT-211 is an investigational autologous T cell therapy that is being administered to patients for the first time. AFNT-211 is currently being evaluated in a Phase 1 clinical trial open to adult patients with solid tumors who have a KRAS G12V mutation. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov, NCT06105021.

About Affini-T Therapeutics

Affini-T is a leading clinical stage precision immunotherapy company targeting oncogenic driver mutations, beginning with KRAS, to develop potentially curative therapies for patients with solid tumors. We are advancing two distinct T Cell Receptor (TCR) based therapeutic modalities encompassing adoptive cellular therapies and bispecific T cell engagers (TCEs), each designed to harness T cell immunity with unprecedented precision and potency against solid tumors. Our most advanced TCR T-cell therapies are built on proprietary state-of-the-art engineering, synthetic biology, and gene editing platforms to overcome the challenges of treating solid tumors and persist in the tumor microenvironment. Building on the world-class innovation inherent in our leadership team, founders, and differentiating technologies, we are powered to develop transformational medicines that last. For more information, affinittx.com follow us on LinkedIn and X, formerly known as Twitter.

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