Protara and CG Oncology Highlight Encouraging Results for Bladder Cancer Treatments
During the 25th annual meeting of the Society of Urologic Oncology held in Texas on Thursday, both Protara Therapeutics and CG Oncology showcased promising new data regarding their treatment innovations, highlighting positive efficacy results in cases of non-muscle invasive bladder cancer.
Protara disclosed Phase II trial results for its experimental cell therapy, TARA-002, which functions by mobilizing both innate and adaptive immune mechanisms within the tumor or cyst, instigating a pro-inflammatory response.
As stated in the company’s press release, TARA-002 demonstrated a remarkable 72% complete response (CR) rate among 18 evaluable patients after six months, irrespective of their previous BCG immunotherapy treatments, which is the current standard approach for bladder cancer.
Among the four patients identified as BCG-unresponsive, TARA-002 achieved a 100% CR rate at the six-month mark. This particular subgroup holds significant importance for Protara, as it was established to support regulatory approval processes.
On Thursday, Protara’s shares rose by 87% in premarket trading following the announcement, as reported by Seeking Alpha.
The company also provided early data supporting the efficacy of TARA-002 in BCG-naïve patients, where a CR rate of 64% was observed at six months. In terms of safety, TARA-002 exhibited an encouraging tolerability profile, with no adverse events of grade 2 or higher noted, and none of the participants withdrew due to toxicity issues.
CEO Jesse Shefferman expressed excitement over the outcomes, remarking that initial data from the 12-month follow-up is anticipated by mid-2025.
Additionally, CG Oncology shared Phase III results for its oncolytic immunotherapy, cretostimogene grenadenorepvec, a novel treatment that selectively replicates within cells with defective retinoblastoma gene pathways, thereby inducing cell lysis and attracting immune agents to elicit an antitumor response.
The late-stage BOND-003 trial revealed that cretostimogene grenadenorepvec achieved a CR rate of 74.5% among BCG-unresponsive patients. Although the median duration of response had yet to be determined at this readout, it was noted to be over 27 months as of September 30.
Similar to TARA-002, cretostimogene grenadenorepvec also had a favorable safety profile, with BOND-003 reporting no treatment-related adverse events of grade 3 or higher and zero discontinuations due to side effects.
CG Oncology’s president and COO, Ambaw Bellete, commented that the findings “emphasize our novel investigational oncolytic immunotherapy’s distinctive product profile,” particularly highlighting its dual action mechanism, which reportedly sets it apart from current and experimental therapies for non-muscle invasive bladder cancer.
Bellete further noted that the data from BOND-003 suggest that cretostimogene grenadenorepvec is “well positioned to meet the unmet needs of patients as a prospective backbone bladder-sparing treatment pending FDA approval,” he concluded.