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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


First patient dosed with AFNT-211 targeting KRAS G12V oncogene mutation in solid tumors
Trial-in-progress poster to be presented on June 3rd at the 2024 ASCO Annual Meeting

BOSTON, MA – May 28, 2024 – 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 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.

“Dosing the first patient in our lead clinical program represents an important milestone for our company, our scientific co-founders that made this possible, and the patients we hope to serve” said Jak Knowles, M.D., Co-Founder, President and Chief Executive Officer, Affini-T Therapeutics. “With our lead programs targeting KRAS G12V in the clinic and a deep research pipeline targeting KRAS G12D and p53 under development, we are well positioned to develop multiple novel therapies for cancer patients with limited treatment options.”

“Our goal is to address the significant unmet need of patients with difficult-to-treat solid tumors” said Dirk Nagorsen, M.D., Chief Medical Officer, Affini-T Therapeutics. “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.”

Presentation details are as follows:

Title: 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.
Hall A, Abstract # TPS8650, Poster Board # 513a, Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date/Time: Monday, June 3, 2024, 1:30 PM – 4:30 PM CDT
Presenting Author: Shaunica Mitchell, M.P.A., Senior Director, Clinical Science, Clinical Development, Affini-T Therapeutics

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 precision immunotherapy company targeting oncogenic driver mutations, beginning with KRAS and TP53, to develop potentially curative therapies for patients with solid tumors. We are advancing two distinct therapeutic modalities encompassing adoptive cellular therapies and bispecific T cell engagers, each designed to harness T cell immunity with unprecedented precision and potency against solid tumors. Our TCR-T cell therapy-enabling platforms utilize state-of-the-art engineering, synthetic biology, and gene editing capabilities to rewrite the rules of the tumor microenvironment and optimize T cell functions. Our bispecific T cell engager platform combines high throughput affinity maturation TCR discovery and biologics format constructions to target oncogenic driver mutations. Building on the world-class innovation inherent in our leadership team, founders, and technologies, we are powered to develop transformational medicines that last. For more information, visit affinittx.com and follow us on LinkedIn and X, formerly known as Twitter.

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