Medigene announces indication selection for the clinical development of its TCR-T therapy program in solid tumors

“The selection of these cancers as targets for MDG1015 is an important step as we advance towards the first-in-human trial. Following recent positive EU and US preliminary regulatory interactions, we remain on track for an IND/CTA approval in the second half of 2024,” said Dr. Selwyn Ho, Chief Executive Officer at Medigene. “While clinical data for engineered cell therapies still in development has shown benefits in some of the selected indications, we believe there is still significant room for improvement in terms of efficacy and durability of progression-free survival. We are confident that MDG1015 as a first-in-class armored and enhanced TCR-T therapy has the potential to address these challenges and improve the quality of life of patients suffering with cancer.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is