NEW YORK – Elucida Oncology, a New Jersey-based biotechnology firm, on Monday said it has submitted an investigational new drug application to the US Food and Drug Administration that will allow it to begin human trials of its C'Dot drug conjugate ELU-001 in advanced solid tumors overexpressing folate-receptor alpha.
If the IND is accepted by the FDA, Elucida will begin an open label, Phase I/II trial of ELU-001. The first part of the study will be a basket trial to evaluate the drug's activity and establish the maximum tolerated dose in patients with various tumor types known to overexpress folate-receptor alpha, such as ovarian, endometrial, colorectal, gastric, gastroesophageal junction, triple-negative breast, non-small cell lung, and bile duct cancers. In the second part of the trial, researchers will further evaluate ELU-001 in the tumor types in which the drug showed the most promising activity in part one.
Elucida's CSO said in a statement that the company's C'Dot drug conjugates, designed using the company's C'Dot platform, have shown in preclinical studies to precisely target the tumor and deliver high levels of the anti-tumor payload. ELU-001 "could pave the way to an entirely new frontier in precision cancer therapy," Elucida CEO Geno Germano said in a statement.