DynamiCure Announces IND Clearance to Advance First Antibody Candidate from its DC-6001 Anti-CD93 Program into Clinical DevelopmentAugust 22, 2022
DCBY02 to be assessed in patients with advanced or metastatic solid tumors across dose-escalation and dose-expansion parts of a Phase 1 clinical study
Waltham, MA — August 22, 2022 — DynamiCure, a private biopharmaceutical company translating pioneering immuno-normalization insights into a pipeline of innovative therapeutic antibody candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to advance the first monoclonal antibody candidate from the company’s DC-6001 anti-CD93 development program into a Phase 1 study (NCT05496595). The study is designed to evaluate the safety and efficacy of DCBY02 in adult patients with a wide range of advanced cancers.
CD93 is a novel target that has been shown to play a critical role in the abnormal development of tumor vasculature, dysfunction that often creates a hypoxic tumor microenvironment and limits the efficacy of cancer therapies, including checkpoint inhibitors. DynamiCure obtained exclusive global rights to CD93 from the laboratories of world-renowned immunologist and oncologist and DynamiCure’s scientific co- founder, Lieping Chen, MD, PhD, United Technologies Corporation Professor in Cancer Research and Professor of Immunobiology at Yale University, and Yuwen Zhu, PhD, Associate Professor of Surgical Oncology at the University of Colorado Anschutz Medical Campus.
DynamiCure’s DC-6001 program consists of two anti-CD93 monoclonal antibodies, each of which has demonstrated distinct in vitro and in vivo properties and the ability to block different epitopes of CD93 in pre-clinical development. The Phase 1 program consists of two parts: a dose-escalation phase (Part 1) to determine a recommended Phase 2 dose (RP2D), followed by a dose-expansion phase (Part 2) at the RP2D. Both parts aim to include adult patients with a variety of locally advanced or metastatic solid tumors. DynamiCure plans to submit the IND for the second monoclonal antibody from the DC-6001 program, DCSZ11, in the fourth quarter of 2022.
“Targeting this previously unexplored pathway at the crossroads of angiogenesis and the Cancer Immunity Cycle creates the potential to benefit cancer patients in need of new, impactful treatment options by more selectively targeting malignant tumor vasculature,” said Oliver Rosen, MD, President & Chief Medical Officer of DynamiCure. “A significant milestone for DynamiCure, advancement of our first candidate into clinical development is a testament to the thorough scientific foundation underlying this novel target combined with the hard work and dedication of our team, who were able to rapidly progress multiple innovative programs in just a few short years. We look forward to initiating the first part of the Phase 1 study in the coming months, as we finalize our network of cancer research centers participating in the trial.”
Dr. Chen also commented on the news: “It has been known for two decades that inadequate tumor vascularization deteriorates the outcome of chemotherapeutic agents due to hypoxia – our research has shown that normalization of malignant tumor vasculature is required to turn the tumor microenvironment from immunosuppressive to immunostimulatory. We believe that targeting the CD93 pathway holds the potential to improve hypoxia and enhance the efficacy of other anti-cancer agents. The approval of this IND marks an important step forward in our ongoing research into pioneering ways to harness the immune system and treat a number of difficult-to-treat cancers. I look forward to continuing to collaborate with the DynamiCure team as they work to advance this and additional internal programs.”
DynamiCure is employing a platform-agnostic approach to discover and develop therapeutics designed to address significant unmet medical needs in oncology and autoimmune disease. We are driven by science and passionate about advancing patient care, translating pioneering new insights on immuno- normalization into a pipeline of innovative candidates with first-in-class and best-in-class potential. Since our founding in 2019, we have identified and obtained exclusive global rights to several novel targets and are rapidly advancing into the clinic both monoclonal and bispecific therapeutic antibody candidates. For more information on our capabilities, programs, and team, please visit www.dynamicure.com.
Oliver Rosen M.D. (Corporate)
President & Chief Medical Officer
Susan Heins (Media)