Effort will support a new clinical trial for fibrolamellar carcinoma, a rare cancer that primarily impacts children and young adults

GREENWICH, CT – (April 21, 2025) – The Fibrolamellar Cancer Foundation (FCF) is pleased to announce its partnership with Dialectic Therapeutics to supply the experimental drug DT2216 for a clinical trial involving 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 launch of the clinical trial this year.

DT2216 is Dialectic Therapeutic’s 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 clinically 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 upcoming clinical trial, sponsored by the Children’s Oncology Group (COG), is scheduled to open next month at 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. While the Phase 2 portion of the trial will be open exclusively to fibrolamellar patients, the initial Phase 1 portion will be open to patients with any solid tumor. More information about the trial is available at clinicaltrials.gov/study/NCT06620302.

“The Fibrolamellar Cancer Foundation is focused on driving fibrolamellar research and turning discoveries into life-changing therapies for fibrolamellar patients,” said Kurt Losert, CEO of the Fibrolamellar Cancer Foundation. “We are thrilled that our partnership with Dialectic Therapeutics will dramatically accelerate fibrolamellar patients’ access to an innovative new treatment.”

About the Fibrolamellar Cancer Foundation:
The principal purpose of the Fibrolamellar Cancer Foundation (FCF) is to encourage, drive and fund research that will substantially improve outcomes for patients with fibrolamellar carcinoma (FLC), a rare form of liver cancer that primarily occurs in children and young adults who have no history of liver disease. FCF, a public 501(c)(3) nonprofit organization based in Greenwich, CT, was founded in 2009. Today, FCF is the leading non-governmental funder of FLC research. By supporting cutting-edge research, institutional collaboration, and patient engagement, FCF hopes to develop more effective therapies and ultimately a cure for FLC. 100% of all donations to the Foundation directly fund FLC research.

About Dialectic Therapeutics:
Dialectic Therapeutics is a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer. Their goal is to relieve the suffering of patients with cancer and prolong their productive lives through targeted therapies with limited toxicities and complications. Based in Dallas, Texas, Dialectic has research partners and facilities at UT Health San Antonio and University of Florida Health.

For more information about Dialectic, please visit www.dtsciences.com.

For further information, please contact:
Kurt Losert
Fibrolamellar Cancer Foundation
klosert@fibrofoundation.org