San Francisco, CA – March 13, 2025 – cTRL Therapeutics, a biotechnology company redefining cell therapy for solid tumors through its proprietary IsoQore™ platform, today announced the formation of its Clinical Advisory Board (CAB). The board—comprising internationally recognized experts in immuno-oncology, cell therapy, translational research, and clinical development—will provide strategic guidance as the company advances its lead asset, cTRL-001, into a first‐in‐human study slated for the second half of 2025.

“Today marks a pivotal moment in our journey to redefine solid tumor cell therapy,” said CEO, Derrell Porter, MD of cTRL Therapeutics. “By harnessing the power of rare, circulating CD8+CD103+ T cells—cTRLs—that our IsoQore™ platform isolates from peripheral blood, we’re able to manufacture a potent and outpatient-amenable cell therapy product quickly and cost-effectively. Our newly formed Clinical Advisory Board (CAB) will be critical as we navigate clinical trial design and accelerate the transition of cTRL-001 from bench to bedside.”

Clinical Advisory Board Members

• Dr. Allison Betof Warner, M.D., Ph.D.
  Director, Solid Tumor Cell Therapy; Assistant Professor of Medicine (Oncology), Stanford University
  Dr. Betof Warner is an expert in solid tumor cell therapy, immunotherapy and clinical trial design at Stanford University. Her research focuses on developing and refining cell-based therapies, and she has a strong track record in bridging academic discoveries with clinical application.

• Dr. Alessandra Cesano, M.D., Ph.D.
  Chief Medical Officer, ESSA Pharmaceuticals
  Dr. Cesano currently serves as Chief Medical Officer and Executive Vice President at ESSA Pharmaceuticals. With over 25 years of experience in oncology drug development and tumor immunology—including key leadership roles at NanoString, Cleave Biosciences, and Nodality—she brings deep expertise in translational immunotherapy. Her career spans academic research at the Wistar Institute and executive roles at major biopharma companies.

• Dr. Stanley Frankel, M.D.
  Independent Drug Development Consultant; Former SVP Global Drug Development Cell Therapy at Celgene/Bristol Myers Squibb; Adjunct Associate Professor of Medicine, Vagelos College of Physician and Surgeons, Columbia University
  Dr. Frankel has held senior roles in both academic and biopharmaceutical settings leading to the regulatory approval of multiple cell therapies and therapeutic antibodies. As an independent consultant, he provides strategic and operational expertise in optimizing treatment regimens and integrating innovative cell therapies into clinical practice. He also serves on the boards of several biotech companies and scientific advisory boards.

• Dr. Kristen Hege, M.D.
  Former Clinical Professor of Medicine, UCSF; Former SVP Early Clinical Development, Hematology/Oncology & Cell Therapy at Celgene/Bristol Myers Squibb
  Dr. Hege is a renowned hematologist-oncologist based in San Francisco. With nearly three decades of experience in advancing cell therapies—including leading the development of BCMA CAR‑T cell programs—she has played a pivotal role in translating novel immunotherapies from bench to bedside. She also serves on the boards of several biotech companies and held an active faculty appointment at UCSF for over 25 years.

• Dr. Pamela N. Munster, M.D.
  Clinical Investigator, UCSF Helen Diller Medical Center
  Dr. Munster is a leader in early-phase and translational clinical trials for solid tumor malignancies. Her extensive experience in clinical research and her work at UCSF provide critical insights into optimizing patient selection and safety in cell therapy trials.

• Dr. Adam Schoenfeld, M.D.
  Medical Oncologist, Memorial Sloan Kettering Cancer Center
  A leading expert in development of next-generation immunotherapeutics, Dr. Schoenfeld has been instrumental in advancing cell-based therapies for solid tumors. His work focuses on designing and leading early-phase clinical trials and associated translational efforts to drive innovation and improve cancer treatment outcomes.

Advancing cTRL-001: A Next-Generation Solid Tumor Therapy

cTRL-001 represents a breakthrough in solid tumor cell therapy. Derived from rare, circulating CD8+CD103+ T cells—known as cTRLs—this product harnesses a naturally polyclonal T-cell repertoire with a high memory phenotype and robust cytolytic activity. Unlike tumor-infiltrating lymphocytes (TILs) that rely on surgically harvested starting material, cTRL-001 is generated from a simple leukapheresis.

cTRL-001 leverages the unique biological advantages of circulating tumor-reactive lymphocytes (cTRLs). Key attributes include:

• Sourcing from Blood: Isolation from peripheral blood bypasses the need for surgical tumor extraction and provides a more accessible and consistent starting material

• Superior Cellular Fitness: cTRLs exhibit high memory/low exhaustion marker expression and robust cytolytic activity.

• Broad Antigen Recognition: The natural polyclonality of cTRLs ensures coverage against hundreds of patient-specific tumor antigens.

• Efficient Manufacturing:  cTRLs have robust expansion capacity and can be manufactured into a clinical dose in a matter of days in short and cost-efficient process. These features position cTRL-001 as a next-generation therapy capable of redefining the treatment paradigm for patients with solid tumors.

About cTRL Therapeutics

cTRL Therapeutics is at the forefront of developing next-generation cell therapies for solid tumors using its proprietary IsoQore™ platform. By isolating and expanding rare, potent circulating tumor-reactive lymphocytes (cTRLs) from blood, the company offers a safer, scalable, and more accessible alternative to traditional cell therapies. With cTRL-001 as its lead asset, cTRL Therapeutics is poised to transform cancer treatment by enabling outpatient, community-based administration and significantly reducing the time-to-treatment. For more information, visit www.ctrl-tx.com.

Contacts

contact@ctrl-tx.com.