Medigene Extends Research Agreement with BioNTech

Planegg/Martinsried, May 21, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), a specialized immuno-oncology platform company with a focus on discovering and developing T cell immunotherapies for solid tumors, alongside BioNTech SE (Nasdaq: BNTX, “BioNTech”), has announced the extension of their existing collaboration. Initially set for three years from the signing in February 2022, this partnership will now continue, enabling further progress in developing novel T cell receptor (TCR) immunotherapies targeting newly identified antigens, thereby expanding BioNTech's repertoire of TCR candidates.

Dr. Selwyn Ho, CEO of Medigene, expressed his satisfaction with the extension, emphasizing that it reinforces Medigene’s leadership in TCR generation. He highlighted the promising TCR candidates developed through their collaboration, underscoring the strength and effectiveness of their partnership in combating cancer. Looking forward, both companies aim to make significant strides in improving cancer treatment outcomes.

The partnership, initiated in February 2022, involves a global multi-target collaboration to develop TCR immunotherapies against several cancer targets, including PRAME (PReferentially expressed Antigen in MElanoma). The agreement also grants non-exclusive licenses to certain proprietary technologies from Medigene’s End-to-End Platform, such as the PD1-41BB costimulatory switch protein.

Medigene AG is dedicated to developing innovative T cell therapies designed to eliminate cancer effectively. The company's End-to-End Platform comprises multiple proprietary technologies that generate optimal TCRs, enhance T cells to overcome the tumor microenvironment’s immunosuppressive nature, and ensure that the T cells’ composition maximizes safety, efficacy, and response durability. This comprehensive approach aims to create best-in-class TCR-T therapies for various solid tumor indications, both for Medigene’s internal pipeline and through partnerships. Their leading TCR-T program, MDG1015, is on track for an IND filing in the third quarter of 2024 and a CTA filing in the fourth quarter of 2024.

Medigene’s End-to-End Platform integrates several exclusive technologies to develop distinguished TCR-T therapies. These include TCR generation and optimization technologies, like Allogeneic-HLA (Allo-HLA) TCR Priming, and product enhancement technologies, such as PD1-41BB and CD40L-CD28 Costimulatory Switch Proteins, and iM-TCR. These technologies address the challenges associated with developing effective, durable, and safe TCR-T therapies. Their collaborations with companies like BioNTech and Regeneron continue to validate the capabilities and assets of their platform.

The PD1-41BB costimulatory switch protein developed by Medigene addresses the issue of checkpoint inhibition via the PD-1/PD-L1 pathway. Solid tumors often evade immune response by expressing checkpoint proteins like PD-L1, which inactivates T cells by binding to their PD-1 receptors. The PD1-41BB switch receptor replaces the inhibitory signaling domain of PD-1 with the activating domain of 4-1BB, thus converting the tumor's immune evasion tactic into an activation signal for TCR-T cells. This enhancement leads to better T cell proliferation and tumor cell killing, even in hostile tumor microenvironments characterized by low glucose and high TGFß levels.

PRAME, a tumor antigen from the cancer-testis-antigen family, is over-expressed in several solid and blood cancers but has limited expression in normal tissue, making it an ideal target for TCR-T therapies. The unique expression pattern of PRAME renders it particularly suitable for targeting by engineered T cells, allowing for focused and effective cancer treatment without harming healthy tissues.

The ongoing collaboration between Medigene and BioNTech represents a significant effort to advance T cell-based cancer therapies. Their combined expertise and technologies hold promise for developing innovative treatments that can significantly impact cancer patient outcomes.