FDA grants clearance to IND application for prostate cancer immunotherapy


The clearance will initiate the phase 2 CELLVX-230 trial, which will assess the therapy in patients with prostate cancer with a high risk of recurrence following prostatectomy.

The FDA has accepted an investigational new drug (IND) application for FK-PC101, a personalized prostate cancer immunotherapy for the treatment of patients with a high risk of recurrence following radical prostatectomy, announced Theragent in a news release.1

Patient recruitment is expected to begin in March 2024.

Patient recruitment is expected to begin in March 2024.

According to the release, FK-PC101 contains autologous human cancer cells that have been modified ex vivo to express major histocompatibility complex II on their surface. The cells are then irradiated to prevent replication, and the treatment is delivered as an individual immunotherapy. FK-PC101 is delivered to patients via 7 intradermal injections over 6 months.2

The acceptance of the IND application for FK-PC101 will initiate the phase 2 CELLVX-230 trial of the irradiated autologous cellular vaccine in patients with high-risk prostate cancer following surgery. The multicenter, open-label study plans to enroll up to 230 patients across 21 pre-selected sites in the US. Patient recruitment is expected to begin in March 2024, with patient treatments expected to begin in Q2 of 2024.

The trial will be conducted through a partnership with the Society of Urologic Oncology Clinical Trials Consortium, with Scott Eggener, MD, of the University of Chicago as the study’s principal investigator.

The primary end point for the study is disease-free survival. The secondary end point is the increased time to next treatment.

In November 2022, CellVax Therapeutics, the developer of the therapy, partnered with Theragent, a Contract Development and Manufacturing Organization that will help provide manufacturing and testing services to support the phase 2 study of FK-PC101.3 For the trial, Theragent will provide end-to-end manufacturing, release, and disposition of all clinical material.

Fernando Kreutz, the CEO at CellVax, said in the news release, "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."1

Additional data on FK-PC101

FK-PC101 has been previously studied in phase 1 and phase 2 trials in Brazil.

The phase 1 study demonstrated initial safety and positive immune cellular response of the therapy in patients with prostate cancer who underwent radical retropubic prostatectomy or transurethral resection of the prostate.4

The phase 2 trial demonstrated low toxicity of the immunotherapy, with 13% (3/23) patients in the trial experiencing intense adverse events.5 Regarding efficacy, 27% (6/22) patients treated with the cell-based immunotherapy demonstrated a detectable prostate-specific antigen (PSA) level (defined as over .004 ng/mL) after 5 years, compared with 53% (19/36) of patients in the control group (P = .03). The investigators also observed a positive trend toward reduced cancer-related mortality, with a rate of 4% (1/23) among patients in the immunotherapy group vs 10% (4/40) in the control group.

The current phase 2 study in the US will assess the efficacy of FK-PC101 in reducing PSA recurrence in patients with locally advanced prostate cancer following prostatectomy.3


1. CellVax Therapeutics announces FDA clearance of IND application for FK-PC101, a novel personalized cancer immunotherapy. News release. Theragent. January 29, 2024. Accessed January 30, 2024. https://www.prnewswire.com/news-releases/cellvax-therapeutics-announces-fda-clearance-of-ind-application-for-fk-pc101-a-novel-personalized-cancer-immunotherapy-302046986.html

2. CellVax Therapeutics. https://www.cellvx.com/

3. CellVax selects Theragent as manufacturing partner for phase 2 clinical trial for prostate cancer immunotherapy. News release. Theragent. November 16, 2022. Accessed January 30, 2024. https://www.prnewswire.com/news-releases/cellvax-selects-theragent-as-manufacturing-partner-for-phase-2-clinical-trial-for-prostate-cancer-immunotherapy-301679632.html

4. Berger M, Kreutz FT, Horst JL, Baldi AC, Koff WJ. Phase I study with an autologous tumor cell vaccine for locally advanced or metastatic prostate cancer. J Pharm Pharm Sci. 2007;10(2):144-52

5. Kreutz FT. Abstract A029: Cell-based cancer immunotherapy using tumor presenting cells: A phase II trial with local advance prostate cancer patients. Cancer Immunol Res. 2016;A029. doi:10.1158/2326-6074.CRICIMTEATIAACR15-A029

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