PhotonPharma, Inc. Receives FDA Clearance for a First in Human Clinical Study for Stage III/IV Ovarian Cancer Treatment with the Investigational Autologous Vaccine Therapy, Innocell™

2024-03-05

疫苗临床1期临床申请

FORT COLLINS, Colo., March 5, 2024 /PRNewswire/ -- PhotonPharma, a biotechnology company dedicated to revolutionizing cancer treatment, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with its Phase I clinical study for the treatment of Stage III/IV ovarian cancer using Innocell, its investigational groundbreaking autologous cell-based vaccine therapy. This therapeutic approach employs inactivated tumor cells, prepared by a proprietary process based on UV light and riboflavin, after isolation of the cells from a patient's tumor. These inactivated cells are used in a treatment designed to recruit the patient's own immune system to fight the cancer. The vaccine therapy will be manufactured at City of Hope's Los Angeles campus in its Biological and Cellular GMP Manufacturing Facility.

This milestone achievement underscores PhotonPharma's commitment to advancing innovative therapies that have the potential to transform the lives of patients battling aggressive forms of cancer.

PhotonPharma CEO, Alan Rudolph, expressed his enthusiasm, stating, "We are thrilled to have reached this pivotal moment in our journey toward providing a novel treatment option for patients facing advanced ovarian cancer. This milestone speaks to the dedication and expertise of our team, as well as the potential of Innocell to make a meaningful impact in oncology."

Ray Goodrich, CSO and co-founder of PhotonPharma, added, "The FDA's clearance to proceed into our clinical study with Innocell marks a significant step in developing this new therapy. We remain committed to advancing an innovative therapy that may address unmet needs in cancer treatment."

Taby Ahsan, Ph.D., Vice President of Cell and Gene Therapy Operations at City of Hope in Los Angeles, said, "We are excited to collaborate with PhotonPharma in advancing Innocell towards clinical development. We look forward to contributing our decades of experience in cell- and gene-based therapies to the progress of this important program."

The Phase 1 clinical trial for Innocell will evaluate its safety, tolerability, and potential immune response indicators in patients with Stage III/IV ovarian cancer. PhotonPharma anticipates initiating patient enrollment in the near future, with the aim of profiling the therapeutic potential of this innovative autologous vaccine therapy.

About PhotonPharma

PhotonPharma is developing the Innocell therapeutic cancer vaccine, designed as a personalized therapy using autologous tumor tissue. The technology is based on a photochemical inactivation platform, designed to use riboflavin (Vitamin B2) and UV light in a proprietary method to render tumor cells incapable of replication but can still metabolize, express proteins, present antigen and stimulate immune recognition and response mechanisms.

In combination with selected adjuvants, PhotonPharma's Innocell has demonstrated the ability of this technology to prevent metastatic tumor formation, reduce the growth of tumors and stimulate cellular immune response pathways in preclinical development animal models.

PhotonPharma is based in Fort Collins, Colo., U.S.A., at the Research Innovation Center of Colorado State University. www.PhotonPharmaceuticals.com

Contact: Media Relations PhotonPharma [email protected].

SOURCE PhotonPharma Inc.

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