HiberCell, Inc. is a clinical-stage biotechnology company developing therapeutics to address therapeutic resistance, cancer relapse and metastasis. HiberCell has multiple compounds in development focused on modulating the immunosuppressive tumor microenvironment and modulating adaptive stress biology. Currently HiberCell has three therapies in clinical testing. One of its therapies, Odetiglucan (Imprime PGG), an innate and adaptive immune modulator, has advanced into clinical testing (Phase 2). Clinical studies evaluating the safety and efficacy of Odetiglucan (Imprime PGG) in combination with immune checkpoint inhibitors, tumor-targeting, and anti-angiogenic antibodies for the treatment of multiple cancers have been conducted. HiberCell’s second therapy, HC-5404, PERK inhibitor, has entered into clinical testing (Phase 1) and the first clinical study evaluating the dose, safety and efficacy of HC-5404 is underway. HiberCell’s third therapy, HC-7366, GCN2 modulator, has entered into clinical testing (Phase 1) and the first clinical study evaluating the dose, safety and efficacy of HC-5404 is underway.  At this time, HiberCell does not have a compassionate use program; however, it will consider providing Imprime PGG, HC-5404, or HC-7366 for individual patients (Single Patient IND) on a case-by-case basis. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and for whom there are no comparable or satisfactory alternative therapy options.

In determining whether single patient access is appropriate outside of a clinical trial, HiberCell will consider many factors, including: the strength of available efficacy and safety data; the patient’s medical condition and history; the benefit-risk profile of our drug in relation to the patient’s case; the potential impact on the clinical development program; and the ability and willingness of the patient’s physician to sponsor the treatment application.

If you are physician or a potential patient and your physician believes you may be a candidate for single patient access to Odetiglucan (Imprime PGG), HC-5404, HC-7366, please ask your doctor to contact Michele Gargano, VP Clinical Operations, HiberCell at mgargano@hibercell.com, who will respond within 5 working days.

Available Therapies via Single-Patient EA

Odetiglucan (Imprime PGG), for multiple oncology indications, in combination with checkpoint inhibitor, tumor-targeting- or anti-angiogenic antibodies.

HC-5404 for the treatment of renal cell carcinoma and other solid tumors including gastric cancer, metastatic breast, and small-cell lung carcinoma, or other select tumors.

HC-7366 for the treatment of advanced head and neck squamous cell carcinoma, colorectal cancer, bladder cancer, and other solid tumors.