DALLAS, March 3, 2021 /PRNewswire/ -- Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based biotechnology company focused on creating innovative new technologies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has concluded that Dialectic may proceed with its clinical investigation for its lead product candidate, DT2216, a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology. In pre-clinical studies supported through a Seed Award from the Cancer Prevention & Research Institute of Texas (CPRIT), DT2216 selectively induces cancer cells to degrade B-cell lymphoma extra-large, or BCL-XL, stimulating the cells to commit suicide or become more susceptible to chemotherapy.
"FDA clearance of our IND represents an important milestone as it transitions Dialectic into a clinical-stage company and further advances us toward our goal of making a real difference in difficult to treat cancers and providing hope for patients who suffer," said Dr. David Genecov, Dialectic's President and Chief Executive Officer. "We believe DT2216 has the potential to be a first-in-class anticancer agent targeting BCL-XL, the most commonly over-expressed antiapoptotic protein in cancer."
Dialectic expects to initiate a Phase1 clinical trial for DT2216 in the first half of 2021. The study is designed as an open-label, first in human, dose escalation study in patients with histologically or cytologically confirmed advanced or metastatic solid tumors who are no longer responsive to commonly accepted standard-of-care interventions. The study will consist of a dose escalation phase followed by confirmation of the recommended phase 2 dose (RP2D). The primary endpoint of the Phase 1 study is to evaluate safety and tolerability of DT2216 and establish the maximum tolerated dose (MTD) and the RP2D. Secondary endpoints include characterizing pharmacokinetics and exploring anti-tumor activity. Other objectives include assessment of biomarkers and characterization of dynamic changes in platelet count.
About Dialectic Therapeutics, Inc.
Dialectic is a biotechnology company focused on creating innovative new technologies to treat cancer. Our goal is to relieve the suffering of patients with cancer and prolong their productive lives through targeted therapies with limited toxicities and complications. Based in Dallas, TX, Dialectic has research partners and facilities at UT Health San Antonio and University of Florida Health. Biotech venture investors John D. Harkey, Jr. and Dr. David Genecov capitalized the Company in 2018 and are co-founders along with Dr. Robert Hromas, Dean of the Long School of Medicine at UT Health San Antonio, Dr. Daohong Zhou at University of Florida Health Cancer Center, and Dr. Guangrong Zheng at University of Florida College of Pharmacy. Dialectic and the pre-clinical development of DT2216 have also been supported through a Seed Award for Product Development Research from the Cancer Prevention & Research Institute of Texas (CPRIT).
For more information regarding Dialectic, please visit www.dtsciences.com.
Dialectic is a registered trademark of Dialectic Therapeutics, Inc.
Josh Sills, EVP of Operations
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SOURCE Dialectic Therapeutics