Dialectic Receives FDA Clearance for Lead Antiapoptotic Protein Targeted Degradation Candidate

Dialectic Therapeutics announced 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.