On April 5, 2022 Dialectic Therapeutics, Inc. (Dialectic), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, reported 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) (Press release, Dialectic Therapeutics, APR 5, 2022, View Source [SID1234611479]). DT2216 is Dialectic’s first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD) technology platform.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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
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.