FCF is pleased to announce its partnership with Dialectic Therapeutics to supply an experimental drug, DT2216, for a planned clinical trial for fibrolamellar patients. Under the agreement, FCF will fund the production of the DT2216 necessary to support the trial. The Foundation’s funding of the manufacturing costs of the drug was crucial to ensure the timely launch of the clinical trial this year.
Dialectic Therapeutics, Inc. is a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer. DT2216 is their first-in-class anticancer agent that targets a protein called BCL-XL, the most commonly over-expressed anti-apoptotic protein in cancer. Anti-apoptotic proteins help prevent programmed cell death (apoptosis) in cells, allowing them to survive longer than they normally would. They play a crucial role in cell survival and cancer development. By degrading BCL-XL, DT2216 can stimulate cancer cells to commit suicide or become more susceptible to chemotherapy. The drug is currently being evaluated both as a single agent and as part of a combination therapy in liquid and solid cancer tumors.
“We believe that DT2216 has the potential to improve the effectiveness of chemotherapy in fibrolamellar and other cancers” said John D. Harkey, Jr., Dialectic Therapeutic’s Executive Chairman & Co-founder. “We are excited about our partnership with the Fibrolamellar Cancer Foundation which will provide Dialectic the financial backing necessary to allow the clinical testing of this drug in fibrolamellar patients.”
The new clinical trial, sponsored by the Children’s Oncology Group (COG) and led by Dr. Michael Ortiz of the Memorial Sloan Kettering Cancer Center and Dr. Allison O’Neill from the Dana-Farber Cancer Institute, is scheduled to open soon at major medical centers throughout the U.S. This phase 1/2 study, DT2216 in Combination with Irinotecan for Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors: A Phase I Study with Phase II Feasibility Cohort for Fibrolamellar Carcinoma, will test the safety, side effects and best dose of DT2216 in combination with the chemotherapy agent, irinotecan. This study’s availability in a broad network of pediatric institutions will allow many FLC patients to join the trial at medical centers within reasonable distances from their homes.
This clinical study was based on research led by Sanford Simon, PhD of Rockefeller University that was published several years ago. In a survey of over 5,000 existing drugs, the Rockefeller team observed that cancer cells from certain FLC patients could be killed by some chemotherapy drugs, including irinotecan. They also noted that susceptibility to the chemotherapy treatment correlated inversely with the FLC cells’ expression of BCL-XL. Fibrolamellar cells with low levels of BCL-XL were killed, while higher amounts of BCL-XL appeared to protect the cancer cells from the chemotherapy. Additional preclinical studies confirmed that the combination of DT2216 and irinotecan can synergize and shrink human FLC tumors with elevated levels of BCL-XL.
While the Phase 2 portion of the new trial will be open exclusively to fibrolamellar patients, the initial Phase 1 portion will be open to patients with any solid tumor. FLC patients who are interested in participating in the study should consult their medical oncologist as soon as possible about the trial, since enrollment will be limited.
More information about the trial is available at clinicaltrials.gov/study/NCT06620302.