On April 6, 2022, biotechnology company Dialectic Therapeutics announced via press release that its therapeutic candidate DT2216, designed for relapsed or refractory (R/R) cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL), was granted Fast Track designation by the U.S. Food and Drug Administration. Last month, the FDA also granted Orphan Drug designation to DT2216. Because both PTCL and CTCL can be difficult to treat, this therapy offers the potential to fill a huge unmet need.
About DT2216
So what exactly is DT2216? On the company website, Dialectic Therapeutics explains that DT2216 is:
a novel Antiapoptotic Protein Targeted Degradation (APTaD™) compound that 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.
Preclinical studies highlighted the safety of intravenously-administered DT2216. It was found to have very little toxicity, high efficacy, and high tolerability. Additionally, the preclinical studies showed that cancer cells are less likely to become resistant to DT2216. Now, researchers are evaluating the therapy in a Phase 1 clinical trial. Altogether, 24 patients will enroll.
DT2216 received Fast Track designation from the FDA. This is designed to expedite the development and review of drugs which fill an unmet need and/or treat serious conditions. Learn more about Fast Track designation.
Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphoma (CTCL) consists of a group of cancers characterized by abnormal T-cell accumulation in the skin. CTCL exists under the greater umbrella of non-Hodgkin’s lymphoma. There are multiple forms of CTCL, including mycosis fungoides, primary cutaneous anaplastic large cell lymphomas, and Sézary Syndrome – among others. Admittedly, the symptoms and progression vary based on subtype. Most patients do not experience serious or life-threatening complications associated with their CTCL, although about 10% of those in later-stage CTCL do experience these. When symptoms arise, they can include:
- Tumors that are prone to ulceration
- Pruritus (intense itchiness)
- Swollen lymph nodes
- Hair loss
- Itchy plaques on the skin
- Dermatitis
- Nail dystrophy
- Enlarged spleen or liver
- Swollen or stretched skin
- Thickened skin on the palms and soles
Peripheral T-Cell Lymphoma (PTCL)
Peripheral T-cell lymphoma (PTCL) consists of a group of uncommon and aggressive lymphomas which form in natural killer (NK) and T-cells. Like CTCL, PTCL exists under the umbrella of non-Hodgkin’s lymphoma. These cancers typically form in lymphoid tissue outside of the bone marrow. While PTCL can develop in those of different ages, this cancer most often forms in those aged 60+. Males are more affected than females. Symptoms include:
- Swollen but painless lymph nodes
- Unintended weight loss
- Fever and night sweats
- Rash
