Protara Therapeutics Inc. (NASDAQ: TARA) has announced that the US FDA has approved its Investigational New Drug application for its experimental cell-based therapy, TARA-002, for non-muscle invasive bladder cancer treatment.
Protara to commence TARA-002 study
The company expects to commence the phase 1 TARA-002 clinical study in adult patients having high-graded NMIBC later this year. NMBIC is the sixth common cancer in the US, representing around 80% of cancer diagnoses
CEO Jesse Shefferman said, “We are thrilled to have reached this important milestone and look forward to quickly initiating our Phase 1 study in patients with NMIBC. There is an urgent need for new treatments for NMIBC. We are seeing significant increases in recurrence and disease progression, as well as an escalating number of patients requiring cystectomies. Supported by the strength of the existing clinical data in NMIBC for OK-432, the originator therapy for TARA-002, we believe this treatment represents a promising new option for NMIBC patients.”
The company will study TARA-002 in treatment-naive and treatment-experienced NMIBC patients having high-grade papillary tumors (Ta) and high-grade carcinoma in situ (CIS) in a Phase 1 dose-finding, open-label study. Patients will receive six intravesical TARA-002 doses weekly throughout the trial’s initial dose-escalation phase. The trial’s main purpose is to assess TARA-002’s tolerability, safety, and preliminary anti-tumor effectiveness in order to determine a maximum suggested and tolerated dose for a future second phase clinical study.
TARA-002 and OK-432 comparable
TARA-002 is made from a similar cell bank as OK-432, an oncology therapy authorized in Japan and Taiwan for a variety of purposes. Protara established the first production comparability between TARA-002 and OK-432 last year. TARA-002 confirmatory, GMP-scale comparability data in relation to OK-432 already have been finalized, and the FDA has examined them as part of the IND clearance. When administered, TARA-002 activates innate and adaptive immune cells within the tumor or cysts to produce a robust immune cascade.
