Dialectic Therapeutics Announces DT2216 Has Received Orphan Drug Designation from the FDA for the Treatment of T-Cell Lymphoma

DALLAS, March 14, 2022 /PRNewswire/ -- Dialectic Therapeutics, Inc. (Dialectic^®), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DT2216 for the treatment of T-cell lymphoma.  DT2216 is Dialectic's first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology platform.

"This is an important milestone in the development of DT2216, our lead APTaD™ compound. The FDA's decision to grant orphan drug designation underscores our belief that DT2216 could be a promising therapeutic for T-cell lymphoma patients" said Dr. David Genecov, Dialectic's President and Chief Executive Officer. "There is a critical unmet need for people diagnosed with this rare cancer, in which current approved therapies have relatively low response rates".

Normal T-cells require BCL-XL expression to survive thymic selection during their development. After thymic selection BCL-XL normal T-cells no longer express BCL-XL. However, many T-cell lymphomas re-express BCL-XL as a mechanism of their neoplastic transformation and permits their continued survival as a malignancy. Studies have demonstrated the importance of BCL-XL in T-cell lymphoma survival. Dialectic has shown that DT2216 is an effective treatment for T-cell lymphoma in preclinical studies.

The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

About DT2216 and the APTaD™ Technology Platform
DT2216 is currently being investigated in a Phase 1 clinical trial 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. Patients in the Phase 1 trial will receive a single intravenous (IV) infusion of DT2216 twice weekly for at least 4 weeks, with each cycle consisting of 28 days. Additional information about the clinical trial is available at ClinicalTrials.gov (NCT04886622).

In preclinical studies 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 in vitro models of hematologic and solid tumors as a single agent and in combination with other chemotherapeutic agents. Further, these preclinical studies show cancer cells are less likely to develop resistance to DT2216 compared to other chemotherapy drugs. DT2216 accomplishes this with less impact on 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, Director of Center for Innovative Drug Discovery at UT Health San Antonio, 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 a recently awarded Texas Company Product Development Research grant from CPRIT for continued clinical development of DT2216.

For more information regarding Dialectic, please visit www.dtsciences.com.

Dialectic is a registered trademark of Dialectic Therapeutics, Inc.

Contact:
Joshua Sills, EVP of Operations
email: [email protected]

SOURCE Dialectic Therapeutics