Dialectic Therapeutics Announces First-in-Human Dose in Phase 1 Clinical Trial Evaluating DT2216, its First Generation Antiapoptotic Protein Targeted Degradation (APTaD™) Compound, in Patients with Relapsed or Refractory Malignancies

October 6, 2021 |

4 min read

Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, today announced the dosing of the first patient in a first-in-human, dose escalation Phase 1 trial evaluating DT2216, the first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology.

DALLAS, Oct. 6, 2021 /PRNewswire/ -- Dialectic Therapeutics, Inc. (Dialectic^®), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, today announced the dosing of the first patient in a first-in-human, dose escalation Phase 1 trial evaluating DT2216, the first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology, in patients with relapsed or refractory solid tumor and hematologic malignancies.

“Advancing our first generation APTaD DT2216 into the clinic is the culmination of a tremendous amount foundational research conducted by our scientific team supported by extensive preclinical studies. This also marks the first time a protein degrader targeting the antiapoptotic BCL family of proteins has been administered in humans. 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, as a single agent and in combination with chemotherapy regimens and other therapeutics. We look forward to learning more about the safety, tolerability and anti-tumor activity of DT2216 in this trial and presenting future data” said Dr. David Genecov, Dialectic’s President and Chief Executive Officer. “With DT2216 in the clinic, we look forward to leveraging our novel APTaD technology platform to advance the next generations of our degrader compounds.”

The multicenter Phase 1 clinical trial is designed as an open-label, first-in-human, dose escalation study in patients with histologically or cytologically confirmed advanced or metastatic solid tumors and hematologic malignancies who are no longer responsive to approved or accepted standard-of-care interventions. The Phase 1 trial is anticipated to enroll between 20-40 patients that will receive a single intravenous (IV) infusion of DT2216 twice weekly for at least 4 weeks, with each cycle consisting of 28 days.

Renowned cancer centers participating in the trial include Mays Cancer Center at UT Health San Antonio, Mary Crowley Cancer Research in Dallas, Texas and The Lurie Cancer Center at Northwestern University in Chicago, Illinois. Additional information about the clinical trial is available at ClinicalTrials.gov (NCT04886622).

About DT2216 and the APTaD™ Technology Platform
In preclinical studies supported through a Seed Award from the Cancer Prevention & Research Institute of Texas (CPRIT), DT2216 selectively induces the degradation of B-cell lymphoma extra-large, or BCL-XL, in cancer cells and either stimulates the return of cellular apoptosis or sensitizes the cells to be more susceptible to chemotherapy, and thus cellular destruction. DT2216 has been shown to be effective in various hematologic and solid tumors as a single agent and in combination with chemotherapy. Further, these preclinical studies show cancer cells are less likely to develop resistance to DT2216 compared to other chemotherapy drugs. DT2216 accomplishes this with very little toxicity, particularly to platelets.

As with BCL-XL, there are many other significant proteins associated with cancer that cannot be targeted with current therapies. Our proprietary APTaD™ technology platform is a novel approach that can be applied to the broader BCL family and other protein targets. Our current research and preclinical efforts are focused on developing next generation APTaD candidates to address this high unmet need.

About Dialectic Therapeutics, Inc.
Dialectic is a Texas-based clinical stage 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, Texas, 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 has also been supported to date through a Seed Award for Product Development Research from CPRIT and was recently awarded a Texas Company Product Development Research grant from CPRIT for continued clinical development of DT2216.