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July 29, 2014
Bioniche Announces Submission of Orphan Drug Designation Application for MCNA in the United States

July 18, 2014
Bioniche Announces Intention to File for Marketing Approval of MCNA in the United States

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*Open label single arm Phase 3 registration trial

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About our Lead Product - MCNA

Bioniche has developed MCNA suspension (Mycobacterial Cell Wall-Nucleic Acid Complex), a complex biologic immunotherapy/immunomodulator designed for the treatment of non-muscle-invasive bladder cancer in humans. MCNA is a cell wall-nucleic acid composition prepared from the fractionation of a pure culture of Mycobacterium phlei. The resulting cell wall complex contains nucleic acids and other cell wall constituents known to elicit an immunomodulatory and anti-proliferative response.

The components of MCNA have been shown to activate innate immune receptors known as pattern recognition receptors (PRRs). Activation of PRRs is thought to be responsible for the range of immunomodulatory and direct anti-cancer activities of MCNA.

Pre-clinical data generated with MCNA have shown that MCNA induces immune stimulatory effects through the induction of co-stimulatory molecules on monocytic lineage cells (macrophages and dendritic cells) and inflammatory cytokines that polarize immune response and activate cytotoxic T cells, leading to local anti-tumour immunity in the bladder. In addition to its primary immunomodulatory effects, MCNA has been shown to exert anti-proliferative and pro-apoptotic effects on human bladder cancer cell lines in vitro.

MCNA - Clinical Studies

Following completion of Phase I and Phase II studies with earlier formulations of MCNA, Bioniche completed an open-label, single-arm Phase III trial with MCNA suspension. The objective of this Phase III trial was to evaluate the efficacy and safety of MCNA in patients with non-muscle-invasive bladder cancer (NMIBC) at high risk of recurrence and progression who had failed intravesical Bacillus Calmette- Guérin (BCG) therapy. A total of 129 patients with high grade papillary and/or carcinoma in situ (CIS) who had failed to respond to one or more courses of BCG were enrolled across 25 centers in the U.S. and Canada.

The overall 1-year disease-free survival (DFS) rate* was 25%. Durable responses were also observed, as well as a noticeably lower rate of progression and cystectomies in patients who responded to MCNA as compared to those who did not respond. In terms of safety, the results showed that intravesical administration of MCNA was well tolerated, with most adverse events being mild to moderate in severity and few leading to discontinuation of treatment.

In a high-risk, BCG-failure patient population where limited treatment options beyond cystectomy are available, MCNA, characterized by a clinically meaningful activity and excellent safety profile,  has the potential to provide an alternative to patients who are unfit for or who decline a cystectomy.

A second Phase III clinical trial comparing MCNA with mitomycin C in patients with BCG recurrent or refractory NMIBC was initiated in 2011 but was discontinued  due to challenges related to patient recruitment.  

Requirements for further trials in NMIBC patients will be evaluated as part of the evolving global regulatory and commercial strategies. Bioniche remains committed to establishing a clear regulatory path for the approval of MCNA in select jurisdictions, particularly the U.S. and Canada.
    
* DFS is defined as lack of recurrence or progression, as confirmed by biopsy.

MCNA – Exploratory Opportunities

Bioniche is evaluating opportunities to expand MCNA uses based on considerations such as the mechanism of action, the competitive landscape and the status of the MCNA development/regulatory package. Opportunities being contemplated and evaluated include the combination of MCNA with approved targeted drugs or emerging immunotherapies as well as the potential use of MCNA as a cancer vaccine adjuvant.

About Bladder Cancer

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