PhotonPharma Initiates Phase 1 Trial of Innocell Autologous Immunotherapy for Recurrent Ovarian Cancer
Key Insights
PhotonPharma Inc. (search) has opened patient recruitment for a Phase 1 clinical trial evaluating Innocell, an autologous cellular immunotherapy for recurrent epithelial ovarian cancer (search).
The trial, conducted in collaboration with City of Hope (search), will assess the safety, tolerability, and immunogenicity of the investigational therapy that uses patients' own tumor cells to stimulate immune responses.
Innocell utilizes a proprietary photochemical inactivation process involving ultraviolet light and riboflavin to render tumor cells replication-incompetent while preserving antigen presentation capabilities.
PhotonPharma Inc. (search), a biopharmaceutical company pioneering personalized cancer immunotherapies, has announced the opening of patient recruitment for its Phase 1 clinical trial evaluating Innocell™ in patients with recurrent epithelial ovarian cancer (search). The trial, registered under ClinicalTrials.gov identifier NCT06366490, represents a significant milestone in developing a novel therapeutic approach that harnesses patients' own tumor cells to stimulate targeted immune responses against their cancer.
The clinical trial is being conducted in collaboration with City of Hope (search), one of the largest and most advanced cancer research and treatment organizations in the United States, with its National Medical Center ranked among the nation's top cancer centers by U.S. News & World Report.
Novel Approach to Cancer Immunotherapy
"Innocell represents a fundamentally different approach to cancer immunotherapy, presenting the complete spectrum of tumor antigens (search) to the immune system, potentially overcoming the challenge of tumor heterogeneity that limits the effectiveness of many existing treatments," said Raymond P. Goodrich, PhD, Chief Executive Officer and Chief Scientific Officer of PhotonPharma.
The Phase 1 study will assess the safety, tolerability, and immunogenicity of Innocell™ in patients with recurrent epithelial ovarian cancer (search). The trial is designed to evaluate real-time safety profiles and measure immunologic responses following treatment with the investigational autologous cellular immunotherapy.
Addressing Critical Medical Need
Ovarian cancer (search) represents a significant public health challenge, with approximately 20,000 new cases diagnosed annually in the United States and approximately 13,000 deaths per year. Approximately 70-80% of patients are diagnosed at Stage III or IV, and the five-year survival rate remains approximately 50%. Despite advances in surgical techniques and chemotherapy regimens, recurrence rates remain high, with approximately 50% of patients experiencing relapse within three to five years following initial treatment.
"Patients with recurrent ovarian cancer (search) face limited curative treatment options. City of Hope (search) is conducting translational research to address even the most challenging cancers," said Mihae Song, M.D., Assistant Professor, Division of Gynecologic Oncology, Department of Surgery at City of Hope and principal investigator for the trial. "PhotonPharma's approach offers a promising new avenue that could potentially help these patients by activating their own immune systems to recognize and attack cancer cells."
Proprietary Technology Platform
Innocell™ is an autologous cellular immunotherapy that utilizes a proprietary photochemical inactivation process involving ultraviolet light and riboflavin (vitamin B2), the same technology platform originally developed for pathogen inactivation in blood products, currently used globally. This process renders tumor cells replication-incompetent while preserving their metabolic activity, and upregulating protein expression and antigen presentation capabilities.
The patented technology enables customized treatment within approximately one week at scale, significantly faster than many current autologous cell therapies. Following tumor harvest through surgery or biopsy, cells are treated with the photochemical inactivation process and combined with an adjuvant to enhance immune activation. The processed cells are then administered intradermally to stimulate comprehensive immune responses, including activation of both cellular (T-cell mediated) and humoral (antibody-mediated) immunity.
Trial Participation and Eligibility
The study is seeking adult patients (≥18 years old) with recurrent epithelial ovarian cancer (search) who have received at least 1 line of platinum-based systemic therapy and for whom single-agent therapy is appropriate as the next line of treatment. Patients interested in learning more about participation can contact City of Hope (search) or visit ClinicalTrials.gov (NCT06366490) for detailed eligibility criteria and enrollment information.
In February 2024, PhotonPharma received FDA clearance for the company's first Phase 1 study in the US: a first-in-human clinical study for recurrent epithelial ovarian cancer (search) treatment with the investigational autologous vaccine therapy, Innocell™. The company has partnered with City of Hope (search) in Los Angeles to conduct the study, with the Phase 1 clinical trial evaluating safety, tolerability, and immune response indicators in patients with Stage III/IV ovarian cancer (search).