Elucida Oncology Announces First Patient Dosed in Phase 1/2 Study of ELU001 in Patients with Advanced, Recurrent, or Refractory Cancers Overexpressing Folate-Receptor Alpha (FRα)
MONMOUTH JUNCTION, N.J., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Elucida Oncology, a biotechnology company pioneering the next frontier in targeted cancer therapy, announced today that it has completed the initial dosing of the first patient in its Phase 1/2 clinical study of ELU001, 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).
ELU001 is Elucida Oncology’s lead CDC therapeutic candidate designed to enhance efficacy and reduce off-target toxicity in the treatment of patients with FRa expressing tumors. CDCs are unique in their ability to deliver a higher concentration of drug payload to solid tumors, penetrate the tumor for greater distribution of that payload, and achieve higher target avidity as compared with antibody-drug-conjugates (ADCs), which have proven effective in the treatment of many cancer types. In pre-clinical studies, ELU001 outperformed an anti-FRα ADC across multiple cancer models expressing lower copy numbers of FRα.
“Over the past two decades there has been an evolution of targeted therapeutics that recently culminated with the clinical success of next-generation antibody-drug-conjugates. With today’s announcement of dosing the first patient with ELU001, we have taken a meaningful step closer to a new frontier in precision oncology with our C’Dot-Drug-Conjugate platform that we believe has the potential to revolutionize the field,” stated Geno Germano, President and CEO of Elucida Oncology. “We look forward to advancing ELU001 and additional CDCs that have the potential to offer more effective and better tolerated therapies for patients with cancer.”
"ELU001 represents an exciting new class of targeted cancer therapeutics. ELU001 uses the novel C’Dot platform to target tumors that overexpress folate-receptor alpha including ovarian, endometrial, non-small cell lung and triple negative breast cancers, and has the potential to help the many patients suffering from these diseases. I am very pleased to see ELU001 entering clinical trial testing, and am particularly excited about its promise in treating ovarian cancers as folate-receptor alpha is expressed in a significant majority of these tumors," added Dr. Lainie Martin, Leader of Medical Gynecologic Oncology at Hospital of the University of Pennsylvania.
The open-label, multi-center clinical study 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 is a basket study and will enroll 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, and cholangiocarcinoma. The most promising tumor types studied in Part 1 will proceed to investigation in Part 2. More information about the trial is available at www.clinicaltrials.gov: NCT05001282.
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 nanoparticle C’Dot drug delivery platform. The company’s C’Dot-Drug-Conjugates, or CDCs, are novel drug candidates that are designed to substantially increase delivery of highly potent drugs to difficult to treat tumors with minimal systemic exposure due to their rapid clearance in the kidneys. CDCs enable precise tumor targeting and deep tumor penetration as demonstrated in preclinical studies, resulting in enhanced efficacy 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.
Source: Elucida Oncology, Inc
Released September 17, 2021