IND submitted for cell-based immunotherapy in prostate cancer

An investigational new drug (IND) application has been submitted to the FDA for FK-PC101, a novel individualized cell-based immunotherapy for patients with prostate cancer who are at high risk for recurrence following prostatectomy, announced Theragent, the manufacturing partner for the compound, in a news release.¹

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

According to the release, FK-PC101 contains autologous human cancer cells that have been modified ex vivo to express major histocompatibility complex (MHC) 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.

A response by the FDA to the IND application is expected by February 2024. Acceptance of the IND submission would initiate a phase 2 clinical trial of the immunotherapy, with plans to begin patient recruitment in March 2024. The trial would enroll approximately 230 patients across 20 sites in the Unites States.

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

Fernando Kreutz, PhD, CEO of CellVax, said in the news release, "We are proud and excited for this IND submission of FK-PC101. This submission signals the next step in our company's journey, and we are eager to initiate this adaptative Phase 2 trial for prostate cancer patients upon FDA clearance. In the future, we envision the CellVax technology may also be used to treat patients with other types of cancer. We are also grateful to our CDMO partner, Theragent, whose expertise enabled this IND submission."¹

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

The phase 1 study of the therapy demonstrated initial safety and positive immune cellular response with the treatment in patients with prostate cancer who underwent radical retropubic prostatectomy or transurethral resection of the prostate.³

The phase 2 trial demonstrated low toxicity of the immunotherapy, with 13% (3/23) patients in the trial experiencing intense adverse events.⁴ 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 phase 2 study in the US would assess the efficacy of FK-PC101 in reducing PSA recurrence in patients with locally advanced prostate cancer following surgery.

References

1. CellVax submits IND application for individualized cell-based immunotherapy FK-PC101 with support of Theragent. News release. Theragent. Published online and accessed December 20, 2023. https://www.prnewswire.com/news-releases/cellvax-submits-ind-application-for-individualized-cell-based-immunotherapy-fk-pc101-with-support-of-theragent-302019646.html

2. CellVax selects Theragent as manufacturing partner for phase 2 clinical trial for prostate cancer immunotherapy. News release. Theragent. November 16, 2022. Accessed December 20, 2023. https://www.prnewswire.com/news-releases/cellvax-selects-theragent-as-manufacturing-partner-for-phase-2-clinical-trial-for-prostate-cancer-immunotherapy-301679632.html

3. 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

4. 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