The lead candidate from DynamiCure’s anti-CD93 program, DCBY02 targets a wide range of metastatic solid tumors
Phase 1 trial aims to assess the safety and anti-tumor activity of the candidate in dose-escalation and dose-expansion phases of the study
WALTHAM, Mass., Nov. 08, 2022 (GLOBE NEWSWIRE) -- DynamiCure, a private biopharmaceutical company translating pioneering immuno-normalization insights into a pipeline of innovative therapeutic antibody candidates, today announced that it has dosed the first patients in its Phase 1 clinical trial evaluating the safety and anti-tumor activity of the first of the company’s two anti-CD93 monoclonal antibody candidates, DCBY02, in adults with a wide range of advanced cancers.
CD93 is a novel target downstream of VEGF-A (vascular endothelial growth factor) that has been shown to play a critical role in the abnormal development of tumor vasculature, limiting the body’s natural immune defenses and the efficacy of cancer therapies, including checkpoint inhibitors.
In pre-clinical studies, DCBY02 demonstrated the ability to bind to CD93, normalizing tumor vasculature, reducing hypoxia, and turning the tumor microenvironment (TME) from immunosuppressive to immunostimulatory. These changes led to improvements in both immune system response and the effectiveness of certain anti-cancer therapies.
“The initiation of our first clinical trial is a significant achievement for DynamiCure, which we launched in 2019 to focus on novel targets and intractable diseases and to build a pipeline of candidates with first-in-class and best-in-class potential,” said Oliver Rosen, MD, President & Chief Medical Officer of DynamiCure. “By targeting CD93, DCBY02 represents a new and differentiated approach to vascular normalization and to improving the trafficking and infiltration of T cells into tumors. We look forward to advancing this trial rapidly to explore the full potential of DCBY02, first as monotherapy and then, should the Phase 1 trial achieve success, in combination with other anti-cancer treatments.”
DynamiCure continues to expect to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration for its second anti-CD93 candidate, DCSZ11, in the fourth quarter of this year. The Phase 1 clinical protocol for DCSZ11 is expected to mirror the protocol for DCBY02, assessing whether targeting different epitopes of the CD93 receptor results in differences in safety and/or anti-tumor activity.
About the DCBY02 Phase 1 Clinical Trial
The Phase 1 clinical trial (NCT05496595) is a multicenter, open-label, Phase 1 study to assess the effects of anti-CD93 monoclonal antibody DCBY02 in participants across North America with advanced or metastatic solid tumors. The study consists of an Escalation Phase (Part 1) and an Expansion Phase (Part 2). In Part 1, up to 36 participants are expected to receive escalating doses of DCBY02 intravenously as monotherapy to establish a recommended Phase 2 dose (RP2D). Part 2 is expected to enroll up to 60 participants to further evaluate the safety, pharmacokinetics, pharmacodynamics, and evidence of anti-tumor activity of DCBY02 at the RP2D. People with recurrent, locally advanced, or metastatic solid tumors (including colorectal, gastric, non-small cell lung, renal cell, breast, hepatocellular, ovarian, cervical, or head and neck cancers, or those with glioblastoma multiforme) are expected to be enrolled.
About DynamiCure
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, 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 focus, programs, and team, please visit www.dynamicure.com.
Contacts:
Oliver Rosen M.D. (Corporate)
President & Chief Medical Officer
contact@dynamicure.com
Susan Heins (Media)
864-346-8336
susanheins1@gmail.com
