Elucida Oncology announced today that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of ELU-001
MONMOUTH JUNCTION, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- Elucida Oncology, a biotechnology company pioneering the next frontier in targeted cancer therapy, announced today that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of ELU-001, the company’s C’Dot Drug Conjugate (CDC) being developed as a treatment for patients with advanced, recurrent, or refractory cancers overexpressing folate-receptor alpha (FRα).
“This is a tremendous accomplishment for our team, and a great step forward in developing newer, potentially more effective, and better tolerated therapies for patients with cancer. This first C’Dot-Drug-Conjugate, using the innovative C’Dot platform, could pave the way to an entirely new frontier in precision cancer therapy,” stated Geno Germano, President and CEO of Elucida Oncology.
“We are extremely excited about advancing ELU-001 into the clinical phase of development. Our preclinical studies have generated compelling data that suggests this novel targeted therapy can overcome many of the limitations associated with currently available cancer therapeutics. CDCs are designed to enable precise tumor targeting, deep solid tumor penetration, and delivery of high levels of drug payload, which distinguish this platform from others, including antibody-drug-conjugates. We anticipate beginning our Phase 1/2 trial as soon as possible after FDA review,” noted Gregory Adams, Ph.D., Chief Scientific Officer of Elucida Oncology.
The open-label, multi-center clinical trial has two parts: Part 1 Dose Escalation Safety Study to identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and Part 2 Tumor Group Expansion Cohort(s) where specific cancer types will be evaluated for efficacy and safety at the RP2D. Part 1 will enroll a basket of patients with advanced cancers known to overexpress FRα, including ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, or cholangiocarcinoma. The most promising tumor types will proceed to investigation in Part 2.
About Elucida Oncology
Elucida Oncology, Inc., is a biotechnology company pioneering the next frontier in targeted cancer therapy with its first-in-class, ultra-small C’Dot drug delivery platform. The company’s C’Dot-Drug-Conjugates, or CDCs, are novel drug candidates designed to substantially increase the concentration of highly potent drugs in difficult to treat tumors with minimal systemic exposure due to their unique Target or Clear™ properties. CDCs enable precise tumor targeting and deep tumor penetration as demonstrated in preclinical studies, resulting in enhanced tumor reduction with reduced off-target toxicity, thereby potentially addressing the limitations of antibody-drug-conjugates (ADCs) and more traditional drug carriers. For more information on Elucida Oncology, Inc., please visit www.elucidaoncology.com.
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