TARIS Bio™ announced the dosing of the first patient in a Phase 1b clinical trial evaluating the investigational product TAR-200 in combination with Opdivo® (nivolumab), a programmed death-1 (PD-1) immune checkpoint inhibitor from Bristol-Myers Squibb. The combination will be assessed for safety, tolerability and preliminary efficacy in patients with muscle-invasive bladder cancer (MIBC). This trial is being conducted as part of a clinical collaboration between the companies; Bristol-Myers Squibb is also an equity investor in TARIS.

Bladder cancer affects more than 2.7 million patients worldwide and is among one of the most expensive types of cancers to treat on a per-patient lifetime basis. MIBC is an aggressive and often lethal form of the disease, with the potential for rapid progression and metastasis. The preferred standard of care for MIBC is radical cystectomy (surgical removal of the bladder) with a neoadjuvant course of platinum-based chemotherapy. This neoadjuvant therapy has been shown to confer a survival benefit to patients versus cystectomy alone. Unfortunately, this therapy is utilized in less than 15% of patients scheduled for cystectomy, due primarily to concerns around patient frailty and potential delays to surgery. A neoadjuvant regimen such as the combination of TAR-200 plus Opdivo®, which has the potential to be used in the large majority of patients not receiving platinum-based therapy, would address a substantial unmet need.

"This clinical trial will be the first to evaluate the combination of the locally-administered TAR-200 system with a systemic PD-1 checkpoint inhibitor, approved for previously treated adults with advanced bladder cancer," said Christopher J. Cutie, M.D., Chief Medical Officer of TARIS. "We are eager to evaluate the potential antitumor and immunologic synergy of this product combination administered prior to surgery."

"We are excited to be working with BMS, an industry leader in oncology, on this clinical study," said Tony Kingsley, President and Chief Executive Officer of TARIS. "It illustrates TARIS' commitment to advancing new therapies for this serious disease, and the potential of TAR-200 to improve outcomes for patients. In parallel, TARIS continues to study TAR-200 as a single agent for the treatment of MIBC patients not receiving surgery."

The open-label, multi-center, single group assignment Phase 1b clinical study will enroll up to 25 patients with MIBC who are scheduled for radical cystectomy. TAR-200 and Opdivo® will each be administered on day one of four consecutive 21-day dosing cycles, for a total dosing period of 84 days prior to radical cystectomy.

TARIS' lead investigational product, TAR-200, is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder for multiple weeks. TARIS believes that TAR-200 has the potential to harness gemcitabine's both direct antitumor and immuno-oncologic activity without meaningful systemic drug exposure, yielding a powerful therapy and mitigating systemic side-effects. TAR-200 has been granted Fast Track status by the U.S. Food and Drug Administration for the potential treatment of MIBC patients unfit for curative-intent therapy.

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