FDA Clears Clinical Study of Vaccine Therapy for Ovarian Cancer
The first-in-human study that has received FDA clearance will investigate the novel autologous Innocell vaccine in stage III/IV ovarian cancer.
Ovarian cancer in woman: © blueringmedia - stock.adobe.com
- A phase 1 clinical trial of Innocell, an investigational autologous vaccine, for the treatment of stage III/IV ovarian cancer, has been cleared by the FDA.
- Innocell uses inactivated tumor tissue from the patient that is prepared with riboflavin and ultraviolet (UV) light with the goal of stimulating an antitumor immune response.
- Patient enrollment is expected to begin soon.
The FDA has granted clearance to a first-in-human phase 1 clinical trial of Innocell, an investigational autologous vaccine therapy, for the treatment of stage III/IV ovarian cancer.1
“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, chief scientific officer and cofounder of PhotonPharma, in a press release.
PhotonPharma, Innocell’s manufacturer, will collaborate with City of Hope Comprehensive Cancer Center to manufacture the vaccine at its Los Angeles campus.
In the phase 1 clinical trial, investigators will evaluate the safety and tolerability of Innocell. Investigators will also look at potential immune response in patients with stage III/IV ovarian cancer.
"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,” said Alan Rudolph, chief executive officer of PhotonPharma, in a press release.
Patient enrollment is expected to begin in the near future, according to ProtonPharma.
About Innocell
The Innocell vaccine uses inactive tumor cells isolated from the patient that are engineered with a proprietary process using UV light and riboflavin. The therapy is designed to recruit the patient’s immune system to fight the cancer.1
Preclinical research on Innocell was published in 2020 and showed that proteins were preserved on the surface of the riboflavin and UV-inactivated tumor cells, and the cells were immunogenic through the induction of dendritic cell maturation.2 There was also an observed increased in interferon gamma and tumor cell-specific immunoglobulin G production. Additionally, Innocell showed decreased tumor growth and metastatic disease while prolonging survival.
REFERENCES:
1. 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™. News release. PhotonPharma, Inc. March 5, 2024. Accessed March 5, 2024. https://tinyurl.com/2usd9ccr
2. Park H, Gladstone M, Shanley C, Goodrich R, Guth A. A novel cancer immunotherapy utilizing autologous tumour tissue. Vox Sang. 2020;115(6):525-535. doi:10.1111/vox.12935
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