Medigene AG, an oncology platform company, announced a strategic refocus on T cell receptor (TCR)-guided therapies. The strategic shift prioritizes R&D programs with the highest potential return on investment, leading to organizational realignment and a temporary pause in the MDG1015 clinical trial. This decision, announced on November 26, 2024, aims to optimize the development of sensitive, specific, and safe (3S) TCRs for off-the-shelf cancer therapies.
Portfolio Prioritization
Medigene will concentrate its resources on generating novel TCRs for TCR-guided therapies. A key focus will be advancing the TCR-guided T cell engager (TCR-TCE) MDG3010 program in collaboration with WuXi Biologics. The company plans to broaden its TCR-TCE pipeline through additional partnerships.
Selwyn Ho, CEO of Medigene, stated, "Medigene has continuously prioritized projects and optimized the allocation of our resources to the R&D work and programs that we believe create the most value for patients and shareholders." He added that the company decided to delay the MDG1015 clinical trial and pause further development of other autologous cell therapy programs while seeking future financing and partnerships to re-initiate their further development.
MDG1015 Clinical Trial Delay
Medigene is delaying the start of the Phase 1 clinical trial for MDG1015, a first-in-class, third-generation TCR-T therapy targeting NY-ESO-1/LAGE-1a. This therapy, designed to address unmet needs in solid tumor treatment, co-expresses the costimulatory switch protein PD1-41BB. The company will actively seek partnerships and additional financing to advance MDG1015 into the clinic. The CTA submission is planned for Q4 2024 to enhance patient recruitment opportunities.
Deprioritization of Autologous Cell Therapy Programs
Medigene will deprioritize further work on other autologous cell therapy programs, including MDG2021 (targeting KRAS G12D with HLA-A11), MDG2011 (targeting KRAS G12V with HLA-A11), and MDG2012. Pre-clinical development work will be paused, and the company will seek partnerships to advance these programs through the pre-clinical stage to IND.
Organizational Realignment
The organizational realignment will involve a workforce reduction of approximately 40%, effective in 2025, along with other cost-reducing measures. Medigene intends to retain employees essential for supporting its refocused R&D activities and fulfilling obligations to existing partners.
"The decision to reduce personnel to match our new focus has been a difficult decision to make, but this is a necessary step to ensure the long-term success of Medigene," said Selwyn Ho.
Financial Outlook
Medigene maintains its 2024 guidance, including its cash runway guidance into July 2025. The company continues to evaluate financing and strategic options to extend its cash runway into 2026 and beyond.
