Alignment with FDA obtained on study design to advance two Ph 3 trials in gastroesophageal cancers (FAPI-GO) and PDAC (FAPI-PRO), with [18F] FAPI-74
“The successful FDA engagement brings us closer to making FAPI a reality for patients in areas of unmet need across multiple tumor types”, said Sherly Mosessian, Ph.D., Chief Scientific Officer of SOFIE Biosciences. “Unlike conventional imaging and FDG PET, FAPI targets cancer-associated fibroblasts in the tumor microenvironment, giving us a key target for determination of disease. FAPI PET has tremendous potential in many oncologic and non-oncologic diseases. We are looking forward to focusing our initial efforts on the cancers of the GI tract, specifically gastroesophageal cancers and PDAC, where we see tremendous unmet need that can be successfully addressed with FAPI PET. We are excited to advance into Phase 3 and continue building the evidence that will establish FAPI PET/CT as a transformative tool in precision oncology.”
Share:
More News
“Initiation of the TEADCO Phase 1b/2 basket trial is another important milestone for the ODM-212 clinical development program and reflects our commitment to patients with difficult-to-treat cancers,” said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion. “Together with the ongoing TEADES study, TEADCO highlights the versatility of
“In this study, tovecimig showed an impressive overall response rate which translated into a clinically meaningful and highly statistically significant improvement in PFS for patients with previously treated BTC. The remarkable 56% reduction in the risk of disease progression is unprecedented in this patient population without an actionable mutation in
“We are encouraged to see taletrectinib (IBTROZI) added to the NCCN Guidelines® for CNS Cancers given its demonstrated high rates of intracranial response that are durable in ROS1+ NSCLC patients with brain metastases,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “Given the prevalence of
Daniel Getts, Ph.D., CEO of CREATE, added “MT-304 is proof of what our platform can do, and what our team can execute. Our mRNA-LNP leadership enables us to move from concept to clinic with remarkable speed. Just last weekend at AACR, we presented compelling preclinical data across our in vivo