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 fast track designation to DT2216 for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
| DALLAS, April 5, 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 fast track designation to DT2216 for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). DT2216 is Dialectic’s first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology platform. Fast Track designation is an FDA program that is intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition and provide opportunities for frequent interactions with the FDA. “This is an important milestone in the development of DT2216, our lead APTaD™ compound. This, along with FDA’s recent 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. About DT2216 and the APTaD™ Technology Platform 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. For more information regarding Dialectic, please visit www.dtsciences.com. Dialectic is a registered trademark of Dialectic Therapeutics, Inc. Contact: SOURCE Dialectic Therapeutics |
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