The US Food and Drug Administration (FDA) has approved an investigational new drug application (IND) from CellVax Therapeutics to begin a Phase II clinical trial for FK-PC101.

FK-PC101 is a cancer immunotherapy that aims to treat prostate cancer patients at high risk of recurrence post-prostatectomy.

The drug uses tumour cells collected from patients during surgical procedures and modified in the lab to express Major Histocompatibility Complex (MHC) Class II on their surface.

These cells are then irradiated to make them incapable of replication, before being returned to the patient as a tailored treatment.

The CELLVX-230 trial will begin recruiting subjects in March this year, with the first treatments expected to start in the second quarter.

The randomised, open-label study will be carried out in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC).

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It aims to enrol up to 230 subjects from 21 pre-selected US sites.

Contract development and manufacturing organisation Theragent will handle the end-to-end manufacturing, release and disposition of all clinical material from its CGMP cell therapy manufacturing facility in Arcadia, California.

Disease-free survival is the trial’s primary clinical endpoint, while its secondary endpoint is increased time to the next treatment.

CellVax CEO Fernando Kreutz said: “We are thrilled to receive FDA clearance of our FK-PC101 IND.

“We have worked diligently throughout the pre-IND and IND process with our reliable partner Theragent, as well as our other consultants, who have brought process development expertise, regulatory know-how, and alignment with our core values.

“As CellVax reaches this important milestone, it represents over 20 years of work from discovery to clinical development, creating a new class of therapy for the most in-need patients.”

Despite advancements in treatments such as radiation and surgery, recurrence rates of prostate cancer post-prostatectomy remain as high as 30%.

The existing standard of care after recurrence involves salvage radiotherapy and/or androgen deprivation therapy.