FDA Clears IND of Investigational Immunotherapy for NMIBC Development Program

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With an investigational new drug granted to ZH9 by the FDA, a clinical development program for the treatment of patients with non-muscle invasive bladder cancer can be initiated.

  • ZH9 is an immunotherapy being evaluated for the treatment of non-muscle invasive bladder cancer (NMIBC).

  • Preclinical data have shown that antitumor activity was observed with ZH9 when given as a single intravesical dose.

  • A clinical development program for ZH9 will be initiated and the agent will be further assessed in the PARADIGM-1 study.

The FDA has granted an investigational new drug (IND) application to the immunotherapy ZH9, which will be developed for patients with NMIBC, according to Prokarium.1

With this IND approval, a clinical development program for ZH9 in the treatment of patients with NMIBC in the United States can begin.

womans bladder cancer: © vitanovski - stock.adobe.com

womans bladder cancer: © vitanovski - stock.adobe.com

"The FDA’s approval of our IND application is an important milestone and a clear recognition of the preclinical data already generated for ZH9,” stated Kristen Albright, PharmD, chief executive officer of Prokarium, in a press release. “Importantly, it also validates the innovative design of the PARADIGM-1 study, paving the way for collaboration with top-tier research centers in the [United States].”

ZH9 is an investigational immunotherapy currently being developed as an intravesical monotherapy to help recurrences in bladder cancer. Preclinical data of the agent were shared at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting in 2021.2

In preclinical models, ZH9 given as a single intravesical dose 4 days after tumor challenge demonstrated significant survival benefit vs the control group and Bacillus Calmette-Guérin (BCG)-treated animals. With ZH9, the median survival was 30 days vs 20.5 days in the control group (P =.003) and 23.5 days in the BCG-treated group (P =.025), respectively.

Among the ZH9-treated animals who survived, a 100% protection in a tumor rechallenge model was seen. This suggests lasting antitumor immunity with ZH9 treatment. Further, intravesical ZH9 as a single treatment demonstrated strong local immune response, which were characterized by recruitment of NK cells, CD4+ and CD8+ T cells, and dendritic cells with an activated, cross-presenting phenotype.

Investigators plan to further evaluate the immunotherapy in the PARADIGM-1 study.1 The trial is expected to enroll in the first half of 2024 and plans to recruit patients across multiple centers in the United States.

“Urologists are excited to see the emergence of new therapies in clinical development for bladder cancer patients,” stated Sam S. Chang, MD, chief surgical officer at the Vanderbilt Ingram Cancer Center, in a press release.1 “The urgent and continuous need to prevent bladder cancer recurrence, especially given the ongoing shortage of BCG, the standard treatment option for high-risk patients, makes the development of innovative alternatives a matter of utmost importance.”

REFERENCES
  1. Prokarium achieves major milestone with FDA's IND approval for bladder cancer program. News release. Prokarium. November 2, 2023. Accessed November 3, 2023. https://tinyurl.com/yzbrfr5c
  2. Prokarium shares preclinical proof-of-concept data on its microbial immunotherapy bladder cancer program at SITC 2021. News release. November 11, 2021. Accessed November 3, 2023. https://tinyurl.com/47mnm99e
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