Prokarium Achieves Major Milestone with FDA’s IND Approval for Bladder Cancer Program

November 2, 2023 |

3 min read

Prokarium announces that the U.S. Food and Drug Administration has granted the company’s Investigational New Drug application for their immunotherapy ZH9.

FDA’s Green Light for Lead Program in Non-Muscle Invasive Bladder Cancer Marks a Significant Milestone
Strategic Appointment of Dara Henry, PhD, as Chief Operating Officer, Strengthens Operations and Business Development

LONDON--(BUSINESS WIRE)-- Prokarium, a biopharmaceutical company at the forefront of applying synthetic biology to create novel cancer treatments, today announces that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for their immunotherapy ZH9. The approval enables initiation of the clinical development program for ZH9 in the U.S., focusing on patients with non-muscle invasive bladder cancer.

“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 Prokarium’s CEO, Kristen Albright, PharmD. “Importantly, it also validates the innovative design of the PARADIGM-1 study, paving the way for collaboration with top-tier research centers in the U.S.”

“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. “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.”

In a strategic move, Prokarium strengthens their leadership team with the appointment of Dara Henry, PhD, as Chief Operating Officer. Dara brings over two decades of experience in biotech and large pharma. His recent role as an entrepreneur-in-residence at Evotec, and prior senior positions in operations and business development at Achilles Therapeutics and GlaxoSmithKline, demonstrate his commitment to advancing biopharmaceutical innovation.

“Prokarium is uniquely positioned in the biotech landscape with a compelling lead program targeting an underserved population of bladder cancer patients,” stated Henry, “and beyond the immediate value of this program, Prokarium’s Living Cures platform has the potential to be a game-changer in the field of immunotherapy, enabling a new generation of highly innovative, off-the-shelf programmable therapeutics.”

“I’m excited to welcome Dara to our team during this transformative phase, as Prokarium enters clinical development, solidifying our status as a leader in synthetic biology and immuno-oncology,” said Albright.

About Prokarium

Prokarium is a biopharmaceutical company at the forefront of applying synthetic biology to create novel cancer treatments. Prokarium’s lead program, currently advancing in clinical trials for bladder cancer, is redesigning the treatment paradigm for patients. The Company’s Living Cures platform aims to transform precision medicine into off-the-shelf programmable therapeutics, promising a new class of immunotherapies that are sustainable, accessible and highly effective. Prokarium is based in London, UK. For further information, visit https://www.prokarium.com.

About ZH9

The investigational immunotherapy ZH9 is being developed as an intravesical monotherapy treatment for the prevention of recurrences in bladder cancer. The PARADIGM-1 study is expected to enroll in H1 2024 across multiple centers in the United States.