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.

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."

Manufacturing 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.