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

UF startup Dialectic Therapeutics, Inc. (Dialectic^®), 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.

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