PhotonPharma has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical trial of its investigational autologous cell-based vaccine therapy, Innocell, to treat Stage III/IV ovarian cancer.
The trial will assess the tolerability, safety, and initial immune response of the cell-based therapy that uses the patient’s own tumour cells, rendered inactive through a unique process involving UV light and riboflavin.
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This innovative approach aims to stimulate the immune system into recognising and fighting the cancer cells effectively.
PhotonPharma aims to commence subject enrolment soon, with a focus on establishing a safety profile and identifying indicators of the vaccine’s ability to elicit an immune response in patients with advanced ovarian cancer.
PhotonPharma CEO Alan Rudolph said: “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.”
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By GlobalDataManufacturing of the vaccine will take place at the City of Hope’s Los Angeles campus, in its biological and cellular GMP manufacturing facility in the US.
Innocell represents a personalised therapeutic approach, leveraging autologous tumour tissue that has been inactivated using PhotonPharma’s proprietary photochemical method.
The technology promises to maintain the metabolic and antigen-presenting functions of the tumour cells, thereby enhancing the immune system’s ability to recognise and target the cancer.
PhotonPharma CSO and co-founder Ray Goodrich said: “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.”
In 2021, the company signed a memorandum of understanding with Terumo Blood and Cell Technologies for developing Innocell for solid tumours.
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