Myeloid Therapeutics Begins Phase 1 Dosing of MT-303 for Advanced HCC

Myeloid Therapeutics, Inc., an emerging leader in immunology and RNA therapeutics, has initiated a Phase 1 clinical trial by dosing the first patient with MT-303 for hepatocellular carcinoma (HCC). MT-303 is part of Myeloid's innovative line-up of in vivo mRNA CAR programs designed to treat cancer by directly programming immune cells within the patient. This milestone marks a significant advancement in delivering novel treatments for liver cancer.

Dr. Matthew Maurer, Chief Medical Officer at Myeloid, expressed enthusiasm about the rapid progression of MT-303 into clinical trials. He highlighted the potential of MT-303 to treat a majority of liver cancers and other cancers expressing GPC3. Dr. Maurer emphasized that MT-303 could be administered like standard intravenous therapy without the need for pretreatment conditioning, potentially initiating a coordinated immune response against cancer with the possibility of sustained effectiveness through repeat dosing.

The target of this innovative therapy, GPC3, is of global interest due to its high expression in HCC and minimal expression in normal tissues. Unlike autologous cell therapies, Myeloid’s approach programs immune cells directly in vivo using mRNA-encoded CAR technology that selectively expresses in myeloid cells. MT-303 equips these cells with a chimeric antigen receptor, enabling them to eliminate HCC and stimulate an adaptive immune response. This process is crucial for maintaining long-term immune surveillance and preventing tumor recurrence.

Dr. Timothy Humphries, the lead principal investigator on the MT-303 trial, voiced his optimism for this new therapy. He noted the high lethality of HCC and the limited effective treatments currently available. Dr. Humphries hopes that MT-303 will offer a tolerable and durable clinical benefit for patients.

Daniel Getts, Ph.D., CEO of Myeloid, stated that the company is pioneering cancer treatment by developing the world’s first clinical-stage in vivo mRNA CAR therapies. He highlighted Myeloid’s ongoing clinical trials, including MT-302 for TROP2-targeting, and the addition of MT-303, reinforcing the company’s capability to translate advanced mRNA CAR technology into viable clinical treatments. Dr. Getts expressed excitement about the transformative potential of Myeloid's in vivo immune cell programming for liver cancer patients and indicated that these clinical programs provide valuable insights for expanding their therapeutic portfolio.

Myeloid’s in vivo programming candidates are designed to offer personalized therapy, reducing time and costs by eliminating the need for ex vivo handling of patient cells. The platform integrates validated antibody/antigen binding with novel myeloid signaling domains, coded within simple mRNA delivered repeatedly using lipid nanoparticles (LNPs). This versatility supports a broad range of combination therapeutic approaches.

Liver Cancer Overview

Liver cancer is a major global health issue, with over 850,000 new cases annually, making it the third leading cause of cancer death. Existing treatment options are limited, especially for patients who do not respond to first-line therapies, resulting in a significant unmet medical need. Myeloid aims to address this gap with its new CAR therapies, which are designed to provide a coordinated and sustained immune response against advanced liver cancer, potentially expanding treatment options for healthcare providers.

Phase 1 Study Details

The Phase 1 study of MT-303 (NCT06478693) is an open-label dose escalation trial intended to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-303 in adults with advanced or metastatic HCC that overexpresses GPC3. This study also aims to determine the recommended Phase 2 dose (RP2D) of MT-303.

About MT-303

MT-303 is a pioneering therapeutic candidate targeting HCC, characterized by its strong preclinical profile and first-in-class designation. It is designed to address tumors with high GPC3 expression, a trait linked to tumor growth. Preclinical models have shown that MT-303 can effectively combat GPC3/HCC even without T cells, demonstrating its potency and safety in myeloid cells. This novel approach offers the potential to trigger a comprehensive immune response by presenting tumor neoantigens to stimulate T cells.

Myeloid Therapeutics continues to innovate in cancer treatment, building on their advanced RNA technology to reprogram immune cells and tackle challenging diseases.

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