Duo Oncology Completes Favorable PreIND Meeting
Favorable Written Option Confirms Clear Roadmap for DUO-207 Develop as First-Line Therapy for Pancreatic Cancer and Other Solid Malignancies
PITTSBURGH (PRWEB) February 21, 2022 – Duo Oncology, a life science company pioneering ultra-small cancer nanomedicines, today announced that it successfully completed a pre-IND (investigational new drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the preclinical and clinical development of DUO-207. Duo Oncology has gained alignment with the FDA on a streamlined preclinical plan and accelerated clinical trial design positioning DUO-207 as a first-line therapy for treating pancreatic cancer.
Duo Oncology submitted its DUO-207 development plan for FDA review and received a favorable response to its questions. The FDA response and guidance validated key aspects of the plan including:
Single cycle toxicology studies bridged to a comparator as the anchor for clinical translation
Preclinical mechanistic pharmacology and biodistribution studies deferred until human data are gathered, and •
An accelerated titration human clinical trial design that can, after dose escalation is completed, transition to first-line patients --those most likely to benefit from treatment with DUO-207.
“We greatly appreciate the FDA’s guidance as we prepare to advance our novel combination nanomedicine into the clinic next year.”
The successful completion of this engagement with the FDA is an important milestone that provides regulatory clarity for DUO-207 and confidence with the planned development program for this first-line pancreatic cancer therapy. Pancreatic cancer (PDAC) is the deadliest solid cancer generating almost 496,000 cases worldwide each year and causing over 466,000 deaths. Chemotherapy, particularly a combined regimen, remains the primary treatment option for the 90% of patients with inoperable PDAC. In patient-derived and murine tumors, DUO-207 outperformed existing chemotherapy combinations and created a favorable tumor immune microenvironment.
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About DUO-207: DUO-207 is a fixed dose combination of copolymer-conjugated gemcitabine encapsulating paclitaxel. DUO-207 uses a patent-pending, branching copolymer chemistry that self assembles miscible or immiscible drugs into 10nm to 30nm nanoparticle micelles. Because of its small size, DUO-207 has demonstrated highly effective penetration of solid tumor in multiple murine studies, including ones with treatment-resistant, patient-derived xenograft tumors. In tumor growth studies evaluating the cancer-specific immune response, DUO-207 also enriches the ratio of cancer-killing CD8+ T cells to regulatory T cells in the tumor immune microenvironment.
About Duo Oncology: Duo Oncology develops high-potency nanomedicines that penetrate deep into tumor tissue to extend the lives of, or even cure, cancer patients. The company’s pipeline is fueled by a patent pending chemistry that borrows from the self-assembly of DNA to create tiny nanomedicines (<30nm), which penetrate treatment-resistant tumors three times more effectively than larger nanoparticles like Abraxane® (130nm) and Vyxeos® (105nm). Its lead product DUO-207, now in preclinical testing, treats solid tumors that respond to paclitaxel or gemcitabine therapy, such as pancreatic cancer, ovarian cancer, and cholangiocarcinoma. Duo Oncology media contact: Sam Rothstein, Cofounder and CEO Email: srothstein@DuoOncology.com
