Ultrafast CAR-T Manufacturing

Collaboration with Kure.ai to develop ultrafast CAR-T manufacturing process for Hemogenyx Pharmaceuticals' AML Treatment

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical company developing innovative therapies for blood malignancies, and Kure.ai ("Kure"), a leader in ultrafast CAR-T manufacturing technology, are pleased to announce a strategic collaboration to advance the production of CAR-T cell therapies for acute myeloid leukemia (AML) and a subset of acute lymphoblastic leukemia (ALL).

This partnership aims to integrate Kure's ultrafast manufacturing (UM) technology with Hemogenyx Pharmaceuticals's proprietary CAR-T therapy, HG-CT-1 (formerly known as HEMO-CAR-T) to enable faster, more efficient production of CAR-T cells, significantly reducing manufacturing timelines while maintaining therapeutic potency.

Key Highlights of the Collaboration

Clinical Study:

Hemogenyx Pharmaceuticals will initiate a clinical study to evaluate its CAR-T therapy for AML and KMT2A-rearranged ALL, utilizing Kure's UM process.

Process Development:

Both parties will collaborate on developing a customized UM process for Hemogenyx Pharmaceutical's CAR-T therapy, optimizing its application in AML treatment.

Material and Expertise Sharing:

Hemogenyx Pharmaceuticals will provide critical materials, including lentiviral vectors, and necessary technical know-how to facilitate process development.

In Vitro Testing:

Hemogenyx Pharmaceuticals will conduct in vitro testing to assess the potency and vector copy number (VCN) of CAR-T cells manufactured using Kure's ultrafast platform.

Adaptation of Manufacturing Technology:

Kure will adapt and refine its ultrafast CAR-T manufacturing process specifically to the Company's CAR-T therapy requirements.

Licensing Option:

Upon successful completion of process development, Hemogenyx Pharmaceuticals will have the option to license Kure's UM technology for clinical trial production, with licensing terms to be negotiated.

• Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:

"One of the most significant challenges in CAR-T therapy is the time and cost associated with manufacturing. Our partnership with Kure.ai allows us to explore and integrate a cutting-edge ultrafast manufacturing process that has the potential to revolutionize CAR-T production. This collaboration is an important step toward accelerating patient access to life-saving therapies."

• David Wald, Founder of Kure.ai and Professor at Case Western Reserve University, added:

"We are excited to partner with Hemogenyx Pharmaceuticals to adapt our ultrafast manufacturing platform to their innovative CAR-T therapy. This collaboration not only advances next-generation CAR-T solutions but also demonstrates the real-world clinical utility of our technology in addressing urgent unmet medical needs."

About AML and CAR-T Therapy

About Kure.ai

Kure.ai is a clinical stage privately owned biotechnology company specializing in ultrafast CAR-T manufacturing technology. Founded by Dr. David Wald, a professor at Case Western Reserve University, Kure focuses on optimizing CAR-T production timelines while maintaining therapeutic quality and efficacy.