On November 24, 2014 Bioniche Life Sciences Inc. (TSX: BNC PNK:BNHLF) reported the accomplishment of another major milestone in the execution of its strategic plan to become a focused late stage human therapeutics company with near term commercial potential. Effective immediately, the Company will begin operating under its new corporate name and identity, Telesta Therapeutics Inc (Press release, Telesta Therapeutics, NOV 25, 2014, View Source [SID:1234510522]).

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Along with this name change, the Toronto Stock Exchange (TSX) will be initiating a ticker in the next week to TSX:TST from TSX:BNC. This ticker change will be automatic and will be seamless for all current and future investors. All previously issued securities remain fully legal and valid.

Commenting on this new corporate brand, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted that: "Our decision to implement this corporate rebranding comes on the heels of our achievements over the last 12 months to implement a concrete plan to focus our company on what we believe to be our core value driver – the commercialization of MCNA1 for the treatment of high-grade non-muscle invasive bladder cancer patients who have failed BCG therapy. This has meant the divestment of two non-core businesses, the sale of unproductive assets and the reduction of corporate overhead through a significant workforce reduction and global expenditure review. With many of those objectives achieved, it is now appropriate to move forward with a new brand and to be much more aggressive in our delivery of the new Telesta story and opportunity to our two key audiences – potential strategic and commercial partners and current and future investors."

Telesta Therapeutics will be announcing the launch of its new website in the weeks to come.

On November 25, 2014 OncoSec Medical reported that it has entered a clinical collaboration with the University of California, San Francisco (UCSF), to evaluate the safety, tolerability and efficacy of the combination of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, and OncoSec’s ImmunoPulse (intratumoral IL-12) in metastatic melanoma (Press release OncoSec Medical, NOV 25, 2014, View Source [SID:1234501019]).

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Recent data suggest that patients who are PD-L1 positive and have increased tumor-infiltrating lymphocytes (TILs) are more likely to respond to anti-PD-1/PD-L1 mAbs compared to patients who are PD-L1 negative. Therefore, therapies that promote TIL generation and PD-L1 positivity may play an important role in augmenting the clinical efficacy of these agents.

Interleukin-12 (IL-12) is an inflammatory cytokine believed to be a master regulator of the immune system, promoting up-regulation of both the innate and adaptive immune responses. More specifically, IL-12 stimulates the production of another cytokine, interferon gamma (IFN-γ), which results in the stimulation of antigen processing and presentation machinery, leading to increased TILs and anti-tumor cytotoxic T-cell (CTL) activity.

ImmunoPulse, an investigational intratumoral immunotherapy, uses plasmid DNA that encodes for IL-12 and delivers it directly into the tumor using a proprietary electroporation device. Preclinical and clinical data suggest that local delivery and expression of IL-12 with ImmunoPulse promotes tumor immunogenicity and increases TILs without the toxicities associated with systemic IL-12 administration. Recent interim data from OncoSec’s ongoing Phase II study have demonstrated that plasmid IL-12 electroporation treatment increases IFN-γ production and increased expression of genes related to antigen processing and presentation, including the expression of PD-L1.

Punit Dhillon, President and CEO of OncoSec, said, "This collaboration with Dr. Algazi and UCSF with support from Merck marks the first clinical trial to evaluate the combination of an anti-PD-1 antibody with an intratumoral therapy using electroporation. Over the course of the last year, OncoSec has continually stated the need to evaluate intratumoral therapies that have the ability to convert the anti-PD-1 non-responder population to responders. The design of this clinical trial will assess this hypothesis, and we believe the combination of OncoSec’s intratumoral immunotherapies and checkpoint inhibitors holds significant promise for the treatment of melanoma and other cancers. We look forward to sharing the results from this clinical trial in the future."

Dr. Robert Pierce, Chief Scientific Officer of OncoSec, said, "There is a strong rationale for combining a treatment like ImmunoPulse, which increases TILs, with a T cell checkpoint therapy like pembrolizumab, which then acts on those TILs. This study is designed to test whether this combination increases patients’ TILs and improves anti-tumor efficacy in low-TIL melanoma patients."

Dr. Alain Algazi, principal investigator at UCSF, said, "The PD-1 antibody pembrolizumab takes the brakes off of the anti-melanoma immune responses. ImmunoPulse with IL-12 has the potential to bring immune cells and signals into the tumor so that, when pembrolizumab takes the brakes off the immune response, the results could be devastating for the tumor and great for our patients."

This Phase II clinical trial will be conducted as a multicenter Investigator Sponsored Trial (IST), with UCSF and Dr. Alain Algazi as the sponsor. Merck will supply pembrolizumab, and OncoSec will provide electroporation devices and plasmid IL-12. Enrollment is expected to begin in Q1 2015.

The TCR constructs used by Juno are selected by screening healthy donors for naturally-occurring high-affinity TCRs against a MHC/peptide combination of interest (Company Pipeline Juno, NOV 25, 2014, View Source [SID:1234501011]). Depending on the binding affinity of the selected TCR construct, it is either used directly or modified by mutating a specific region, the hypervariable domain, of the TCR binding pocket to create a higher affinity construct. Due to the variability of MHC types across the human population, different TCRs will be required for various segments of the population.

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JCAR016 is a high-affinity TCR T cell product candidate targeting WT-1 which is under development by Juno Therapeutics for the treatment of cancer (Company Pipeline Juno, NOV 25, 2014, View Source [SID:1234501012]).

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New pipeline entries: L1CAM product candidate, MUC-16/IL-12 product candidate, ROR-1 product candidate (Company Pipeline Juno, NOV 25, 2014, View Source [SID:1234501013]).

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