#United States #Cambridge #CREATE Medicines #MT-302 #Amsterdam UMC

Pioneering In Vivo CAR Therapy Clinical Trial

Introduction
In a groundbreaking move towards the future of cancer treatment, CREATE Medicines, previously known as Myeloid Therapeutics, has announced a collaboration with the Amsterdam University Medical Center (Amsterdam UMC). This partnership has initiated an important clinical trial that marks a significant milestone in the field of oncology. The trial aims to evaluate the effectiveness of an innovative in vivo CAR therapy known as MT-302 in the treatment of advanced gastroesophageal cancer.

Background of the Trial

The clinical trial, named SPaCE-MT, is the first of its kind that incorporates in vivo CAR therapy in frontline treatment settings. The trial evaluates the potential of MT-302 in combination with traditional chemotherapy regimens, specifically capecitabine and oxaliplatin (CAPOX), along with immunotherapy agents such as nivolumab or trastuzumab. The objective is to explore how this cutting-edge therapy can enhance the therapeutic landscape for patients suffering from this challenging cancer subtype.

Significance of In Vivo CAR Therapy

CAR therapies have gained attention due to their capability to harness the body’s immune system for cancer treatment. Traditional CAR-T therapies involve extracting immune cells, modifying them, and reintroducing them into the patient’s body. In contrast, in vivo CAR therapy, particularly the mRNA-LNP platform utilized by CREATE, programs immune cells within the body itself. This innovation could potentially simplify manufacturing processes and reduce costs while offering accessible treatment options for patients.

Trial Details

In this phase 1/2 clinical trial, the first patient has been dosed, indicating a promising start to what could be a game-changer in cancer therapy. The lead investigator, Professor Hanneke van Laarhoven from Amsterdam UMC, highlights that MT-302 could significantly improve treatment outcomes for patients with advanced esophageal and gastric cancers. With over 1.3 million cases diagnosed annually, the urgency for effective treatment strategies is paramount.

Early Data and Observations

Preliminary findings from earlier studies indicate that MT-302 is safe and demonstrates activity within the body. Notable results include:

• - Confirmation of immune cells infiltrating tumors, which is crucial for effective treatment.
• - A manageable safety profile observed in over 200 doses without cumulative toxicities.
• - Evidence suggesting that CAR expression was observed in circulating immune cells, with some patients achieving stable disease and even partial responses lasting up to 16 months.

This data emphasizes the potential of CREATE's mRNA-LNP platform and paves the way for future clinical advancements.

A Vision for the Future

CREATE Medicines aims to revolutionize the treatment landscape for cancer patients through scalable and harnessable cell therapies. The combination of MT-302 with established chemotherapy and immunotherapy treatments is designed to create a coordinated attack on cancer, improving patient outcomes significantly. As Matt Maurer, Chief Medical Officer of CREATE Medicines states, “The initiation of this study underscores the need for innovative treatment strategies in gastroesophageal cancer, where outcomes still remain very poor.”
The research team's eagerness to explore the beneficial impacts of this therapy is palpable as they strive for groundbreaking discoveries that could reshape cancer management.

Conclusion

The SPaCE-MT clinical trial is poised to contribute considerably to the understanding and treatment of advanced gastroesophageal cancer. As CREATE Medicines continues to advance its vision of a future loaded with potent, off-the-shelf cancer therapies, the collaboration with Amsterdam UMC serves as a beacon of hope for millions affected by this devastating disease. With ongoing research and clinical validation, the emergence of in vivo CAR therapies could herald a new chapter in oncology, promising better treatment options and improved patient quality of life.