The company is also presenting two trial-in-progress posters for its Phase 1 clinical-stage programs targeting KRAS G12V at the conference

Affini-T Therapeutics, Inc., a precision immunotherapy company unlocking the power of T cells against oncogenic driver mutations, today announced that management is presenting data from the company’s oncogenic driver programs targeting HLA-A*11:01 KRAS G12D and HLA-A*02:01 p53 R175H at this year’s American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego. In addition, the team is presenting 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 at AACR.

“We are excited to be at AACR unveiling new preclinical data, which includes a closer look at the promise of our novel non-viral TRAC-knocked-in T cell therapy for the treatment of p53 R175H-mutant solid tumors,” said Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics. “We are also proud to present preclinical data from our cell therapy targeting KRAS G12D, which highlights the promising potential of our proprietary non-viral knock-in THRIVE™ platform. These findings continue to motivate our team as we advance programs leveraging TCR-engineered T cells as potential paradigm-shifting treatments for patients with solid tumor cancers.”

Poster presentation details are as follows:

AFNT-212: A TRAC-knocked-in KRAS G12D-specific TCR-T cell product enhanced with CD8αβ and a chimeric cytokine receptor for treatment of solid cancers

• Abstract #5973, Session: Adoptive Cell Therapies 1: Tumor Antigen-Specific T-cells and TCR-T
• Session Date/Time: Sunday, April 7, 2024, 1:30 PM - 5:00 PM
• Presenting Author: Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics
• Summary: AFNT-212-engineered TCR-T cells showed high functional avidity and in vitro cytotoxicity against KRAS G12D-positive tumor cell lines, including CL40 (colon), PANC-1 and HPAF-II (pancreas), SK-LU-1 (lung), HuCCT1 (cholangiocarcinoma), etc. Additionally, engineered TCR-T cells demonstrated robust and durable anti-tumor activity in vivo and low risk of off-target/off-tumor toxicity. Affini-T’s proprietary non-viral knock-in (KI) THRIVE™ platform achieved high transgene integration efficiency and cell growth to yield relevant numbers of engineered TCR-T cells for clinical application. The study supports the planned clinical investigation of the novel KRAS G12D mutant TCR-engineered CD4+ and CD8+ T cell therapy in 2024.

Non-viral engineered T cell therapy specific for the hotspot mutation p53 R175H that integrates signal 1 (TCR), signal 2 (co-stimulation) and signal 3 (cytokine) and co-opts FasL-dependent apoptosis to achieve a coordinated antitumor CD4/8 T cell response

• Abstract #7242, Session: Adoptive Cell Therapies 1: Tumor Antigen-Specific T-cells and TCR-T
• Session Date/Time: Sunday, April 7, 2024, 1:30 PM - 5:00 PM
• Presenting Author: Gary Shapiro, Ph.D., VP Biology Discovery, Affini-T Therapeutics
• Summary: The tumor suppressor TP53 is the most frequently mutated gene across human cancers, with a highly recurrent arginine to histidine hotspot alteration in codon 175 leading to novel tumor-dependent functions. In this study, we reported the use of a novel CRISPR-Cas nuclease system to knock in a six-gene multi-cistronic cassette into the TRAC locus with high efficiency. We employed several strategies to maximize the potency and durability of a TCR-T cell product targeting the p53 R175H oncogenic driver, TCR, co-stimulation and cytokine signaling – which delivered full stimulation of both CD8+ and CD4+ T cells. These data support the planned clinical development of a novel non-viral TRAC-knocked-in T cell therapy for the treatment of p53 R175H-mutant solid tumors.

About Affini-T Therapeutics

Affini-T is a leading 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 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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