Novel immunotherapy FK-PC101 Explored in Prostate Cancer Trial

Prostate cancer, bladder cancer, men's health care: © Tom - stock.adobe.com

The first patient with prostate cancer has been dosed in a randomized, phase 2 clinical trial (NCT06636682) evaluating FK-PC101, a novel personalized cancer immunotherapy.¹

FK-PC101 is an advanced autologous cellular vaccine designed to help prevent recurrence in patients with prostate cancer who are at high risk after surgical removal of the tumor.² The personalized vaccine is made from the patient's own tumor cells collected during surgery, which are then modified in a specialized cGMP facility.

This personalized immunotherapy works by presenting unique tumor antigens to the immune system, activating both CD8-positive cytotoxic T cells and CD4-positive helper T cells. When administered, FK-PC101 introduces these cancer-specific neoantigens in the context of MHC I to activate CD8+ T cells, initiating a direct cytotoxic response. The agent also presents antigens to CD4-positive T cells through MHC II, creating a coordinated immune response, which primes the immune system for a targeted attack on cancer cells.²

“Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy," said Fernando Kreutz, chief executive officer of CellVax, in a press release.¹ "Further, after such recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT), both of which may lead to poorer health-related quality of life for patients. FK-PC101 could delay the necessity for such treatments, if not prevent them entirely.”

CELLVX-230 Study Background

CELLVX-230 is a multicenter, adaptive, randomized, open-label, phase 2 trial examining FK-PC101 in men with high-risk prostate cancer following radical prostatectomy.³ Patients will undergo a 3-step screening and enrollment process.

Enrollment is open to patients with localized high-risk or very high-risk prostate cancer based on the National Comprehensive Cancer Network v4.2023 classification, those who have at least 3 prostate biopsy cores with ≥50% tumor involvement, prostate specific antigen >4 ng/mL 28 days or less before enrollment, and no evidence of distant metastases based on PSMA-PET/CT performed at least 28 days before enrollment. Those enrolled must also have a life expectancy of greater than 5 years, be a candidate for radical prostatectomy, have a scheduled radical prostatectomy 3 to 14 days after enrollment, and have never received neoadjuvant radiation therapy, ADT, or any other anticancer therapy.

After an initial safety run-in, patients will be randomized to the experimental arm or active comparator arm. In the first group, patients will be administered up to 7 doses of FK-PC101 intradermally between day 1 and day 180. The immune adjuvant Bacillus Calmette Guérin will be administered concurrently with dose 1 given on day 1 and dose 2 given on day 8. Subjects in the control group will receive standard of care.

Further, all patients enrolled will have assessments at 60 days, 90 days, and 180 days. Follow-up visits will continue at months 10, 14, 18, and 22 post-randomization.

Disease-free survival serves as the primary end point of the trial. Secondary end points include time to next treatment, metastasis-free survival, immune response to FK-PC101, and safety and tolerability.

REFERENCES:

1. Theragent and CellVax Therapeutics announce first patient dosed in phase 2 trial of FK-PC101, a novel personalized cancer immunotherapy. News release. Theragent Inc. November 11, 2024. Accessed November 11, 2024. https://tinyurl.com/mvmphfpp

2. Pipeline. CellVax Therapeutics. Accessed November 11, 2024. https://cellvx.com/

3. FK-PC101 as adjuvant therapy for men with high-risk prostate cancer. ClinicalTrials.gov. Updated October 21, 2024. Accessed November 11, 2024. https://clinicaltrials.gov/study/NCT06636682?tab=table