Ovarian Cancer Vaccine Trial Gets FDA Clearance To Proceed

The FDA will OKed a phase 1 trial to investigate a novel cancer vaccine for certain patients with ovarian cancer.

The Food and Drug Administration (FDA) has granted clearance for a first-in-human phase 1 clinical study of a vaccine for the treatment of stage 3 and 4 ovarian cancer to proceed, according to an announcement from PhotonPharma.

The vaccine in question, Innocell, is a personalized therapy using inactivated cells from a patient’s tumor, prepared via a photochemical inactivation platform using riboflavin (vitamin B12) and UV light “to render tumor cells incapable of replication but can still metabolize, express proteins, present antigen and stimulate immune recognition and response mechanisms,” using a patient’s own immune system to deal with cancer, according to a news release from PhotonPharma.

"We are thrilled to have reached this pivotal moment in our journey toward providing a novel treatment option for patients facing advanced ovarian cancer,” said PhotonPharma CEO Alan Rudolph in the news release. “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."

The vaccine will be manufactured in the Biological and Cellular GMP Manufacturing Facility at City of Hope in Los Angeles. PhotonPharma anticipates initiating patient enrollment “in the near future,” with the phase 1 clinical trial set to evaluate the safety, tolerability and potential immune response indictors of the vaccine, according to the news release.

"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," said Taby Ahsan, vice president of cell and gene therapy operations at City of Hope in Los Angeles, in the news release.

Additional Cancer Vaccine Trials Underway

It was announced in 2023 that, starting with the Cleveland Clinic, patients with triple-negative breast cancer (TNBC) were enrolling in an expansion phase of an ongoing phase 1 clinical trial evaluating a novel cancer vaccine administered in combination with the immunotherapy Keytruda (pembrolizumab).

A team of researchers from the University of Washington Medicine Cancer Vaccine Institute and the Fred Hutchinson Cancer Center in Seattle announced in 2022 that a plasmid DNA vaccine “was associated with the generation of immunity in most patients,” and representatives from Fred Hutchinson Cancer Center confirmed to CURE® that the center had partnered with Amazon in an ongoing early-phase clinical trial investigating the safety and efficacy of a cancer vaccine.

Learn More: Why Kristen Dahlgren Left NBC To Advocate for Breast Cancer Vaccines

Pharmaceutical companies Moderna and Merck have initiated V940-001, a phase 3 study evaluating the mRNA vaccine mRNA-4157 and Keytruda as postsurgical treatment for stage 2B to 4 melanoma, announcing in 2023 that global patient recruitment had begun. The Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the combination for the post-surgical treatment of patients with high-risk melanoma.

Moderna and Merck have also launched the phase 3 INTERpath-002 trial evaluating the combination as a postsurgical treatment for patients with stage 2, 3A or 3B with nodal development non-small cell lung cancer, as well as V940-001, a phase 3 study evaluating mRNA-4157 and Keytruda as postsurgical treatment for stage 2B to 4 melanoma, while immunotherapy company BioNTech is evaluating mRNA-based, individualized cancer vaccines in cancer types including colorectal and pancreatic cancers and melanoma

News of the upcoming Innocell trial follows the 2022 launch of a phase 1 clinical trial evaluating the vaccine Vaxinia (CF33-hNIS), which demonstrated anti-tumor activity in lung, breast, ovarian and pancreatic tumors in pre-clinical animal studies.

Regarding Innocell, research previously determined that the inactivation of tumor cells via riboflavin and UV light “may provide an efficacious method for generating autologous whole tumor cell vaccines for use in cancer patients,” according to findings published in Vox Sanguinis: The International Journal of Transfusion Medicine, while a pilot acute safety evaluation of the vaccine in canine subjects found the treatment to be “well tolerated,” as stated in research published in the Journal of Immunology Research.

"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," said Ray Goodrich, CSO and co-founder of PhotonPharma, in the news release.

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