MDG2012 / Medigene - LARVOL DELTA

Medigene AG Announces Refocus of Corporate Strategy and Organizational Realignment (GlobeNewswire) - "Medigene will focus its R&D on generating new TCRs for TCR-guided therapies, and also in advancing its TCR-guided T cell engager (TCR-TCE) MDG3010 program in collaboration with WuXi Biologics. The Company expects to expand its TCR-TCE pipeline through additional partnerships in the near future; The Company will temporarily delay the start of its IND approved, clinic-ready MDG1015 Phase 1 clinical trial while actively seeking partnerships and additional financing options to advance this program into the clinic. In line with the Company’s previous communication, the CTA submission is planned for Q4 2024 to enhance the opportunity for patient recruitment; Medigene will deprioritize further work on all other autologous cell therapy programs including MDG2021...MDG2011 (targeting KRAS G12V with HLA-A*11) and MDG2012. As such, the Company will pause all pre-clinical development work and will actively seek partnerships to advance those programs through pre-clinical stage to IND."

New trial • Pipeline update • Oncology • Solid Tumor

Medigene AG Reports Half-Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Research and development expenses increased by 21% to EUR 6.3 million in the first half of 2024 (6M 2023: EUR 5.2 million). The reason for the increase is the focus on the development of TCR-T therapies (MDG1015, MDG2011 and MDG2021) for the treatment of solid tumors and preparatory activities for clinical trials (MDG1015)....Following positive EU and US preliminary regulatory interactions, the Company remains on track for IND-filing in Q3 and CTA-filing in Q4 2024. Subject to financing, the Company expects to initiate a first in-human trial for MDG1015 by the end of 2024....MDG2012: The lead selection for the Company’s third announced KRAS-targeted program MDG2012, KRAS G12V (HLA-A*03), is expected in 2025."

Commercial • IND • New trial • Pipeline update • Oncology

Medigene AG Reports Full-Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Following recent positive EU and US preliminary regulatory interactions, the Company remains on track for an IND/CTA approval in the second half of 2024. Subject to financing, the Company expects to initiate a first in-human trial for MDG1015 by the end of 2024...MDG2021 is our second candidate within the KRAS library targeting KRAS G12D (HLA-A*11) with lead selection expected in the first half of 2024. The lead selection for the Company’s third announced KRAS-targeted program MDG2012, KRAS G12V (HLA-A*03), is expected in 2025."

IND • New trial • Pipeline update • Solid Tumor

Medigene AG Announces Prioritization of Pipeline and Resource Allocation as well as Extension of Cash Runway (GlobeNewswire) - "Medigene’s lead program MDG1015 remains on track for IND/CTA approval in 2H 2024. In line with the Company’s previous communication, the clinical Phase I trial will commence as soon as possible thereafter and remains subject to financing. In 2024, Medigene will focus on the development of two of its previously announced KRAS-targeted programs. By optimizing the technology and processes for the development of MDG2011 (targeting KRAS G12V with HLA-A*11; lead selected in Q3 2023) and MDG2021 (targeting KRAS G12D-HLA-A*11; lead selection in 1H 2024), the Company expects an accelerated development for future KRAS progams as well as other cancer targets. As such, the lead selection for the Company’s third announced KRAS-targeted program MDG2012 has been moved to 2025 (previously 2H 2024)."

IND • Pipeline update • Solid Tumor

Medigene Announces Pipeline Expansion into Neoantigens with Programs Targeting Multiple KRAS Mutations and HLAs (GlobeNewswire) - "Medigene AG...today announces its pipeline expansion into neoantigens (also known as oncogenic driver mutations) with KRAS (Kirsten rat sarcoma viral oncogene homologue) as the first target in its MDG10xx program, a T cell receptor engineered T cell (TCR-T) therapy being developed in combination with the company’s PD1-41BB switch receptor technology. The first KRAS antigens and HLAs (human leukocyte antigens) of the library announced today are targeting: KRAS G12V-A11 (MDG2011); KRAS G12V-A03 (MDG2012); KRAS G12D-A11 (MDG2021)..."

Pipeline update • Oncology • Solid Tumor