On November 26, 2014 Cancer Research Technology Limited (CRT), The European Investment Fund (EIF) and BACIT Limited (BACIT) reported that BACIT is seeking shareholder approval to permit an investment into the CRT Pioneer Fund (CPF) (Press release, Cancer Research Technology, NOV 26, 2014, View Source [SID1234523218]). BACIT would invest alongside CPF’s two existing investors, taking the total capital committed to the Fund to £70m.

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BACIT’s commitment is subject to obtaining the approval of its shareholders at a shareholder meeting which is scheduled for 15 December 2014.

The CPF was established in 2012 by the EIF and CRT as a specialist fund focused on investing in oncology assets to take them from late discovery through to entry to Phase II clinical trials thereby plugging a gap in the UK funding of drug discovery. Through its relationship with CRT, the Fund has access to drug discovery and development programmes supported by Cancer Research UK, the world’s largest independent funder of oncology research.

BACIT’s potential commitment follows a decision earlier in the year by EIF and CRT to commit a further £25m to double the size of the Fund from its initial first close of £25m.

To date the CPF has invested in four novel cancer projects, comprising early stage lead optimisation and later stage pre-clinical assets. The Fund is managed by Sixth Element Capital LLP (6EC), an FCA authorised fund manager set up to implement novel solutions to bring finance and innovation together within the healthcare sector.

Commenting on today’s announcement, Dr Robert James, Managing Partner of 6EC, said: "We are delighted that BACIT has chosen the CPF as the vehicle through which it can best manage its investments in oncology drug discovery. This decision validates the approach that we have been adopting to identify investment opportunities in the oncology sector. By increasing the size of the CPF to £70m we will be able to further diversify the portfolio of investments made by the Fund thereby increasing the chances of benefiting the cancer patient and maximising the chances of a successful outcome for all of our investors".

Dr Piyush Unalkat, Principal – Equity Investments, commented: "Since its inception the CPF has met its milestones for establishing what is becoming an increasingly diversified and commercially attractive portfolio with CRT continuing to deliver a pipeline of outstanding projects. The EIF will be very pleased to welcome BACIT as a like-minded, long-term investor committed to bring oncology treatments to the market faster for the benefit of patients."

Dr Keith Blundy, CEO of Cancer Research Technology, said: "This additional investment in the CPF will enable us to fund more projects in drug discovery and early development to bring potential new treatments to patients as quickly as possible. Through our research, Cancer Research UK has contributed to the discovery or development of nearly 50 drugs now being tested in clinical trials. These drugs could, if successful, save many thousands of lives in the future."

On November 25, 2014 Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported an update on recent patent grants and allowances worldwide (Press release, Xenetic Biosciences, NOV 25, 2014, View Source [SID1234537817]).

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Since May 2014, the Company has been issued 10 patents, including six in the U.S., two in Japan and one each in New Zealand and India. In addition, 13 patents have been allowed, including seven in the U.S., two each in Japan and South Korea, and one each in Russia and Canada. Xenetic Biosciences now has over 140 issued patents worldwide and approximately 80 pending patents.

Select key patents issued recently by the U.S. Patent and Trademark Office include Patent No. 8,796,207, Derivatisation of erythropoietin (EPO), which relates to novel polysaccharide derivatives of EPO and methods for producing such derivatives. The derivatives are useful for improving the stability, pharmacokinetics and pharmacodynamics of EPO. This same patent was also issued in Japan during the third quarter.

U.S. Patent No. 8,735,557, Activated sialic acid derivatives for protein derivatisation and conjugation, was also recently granted and relates to polysialic acid and derivatives of polysialic acids which have terminal sialic acid units. This patent covers the targeted conjugation of polysialic acid and its derivatives to therapeutics such as peptides, proteins, drugs, drug delivery systems, etc.

Also issued during the third quarter was U.S. Patent No. 8,828,405, Method to Enhance an Immune Response of Nucleic Acid Vaccination. This patent relates to a composition comprising liposomes associated with a nucleic acid operatively encoding an antigenic protein and with an assistor protein. The composition provides an improved immune response compared with mixtures of liposomes, some of which are associated with the nucleic acid and some of which are associated with the assistor protein.

"Xenetic Biosciences has a substantial patent portfolio to rival any biotech company many times our size. This work results directly from our previous strategy focused on research. Now that we have transformed into a clinical development company, we are well positioned for potentially monetizing our extensive intellectual property portfolio. We expect to add 13 additional patents over the next three months," said M. Scott Maguire, chief executive officer of Xenetic Biosciences. "We are particularly pleased with our intellectual property position in Japan as those patent grants are typically difficult to secure. Our IP relates not only to our ‘bio-better’ EPO, our lead candidate, but also to improving availability of a number of protein-based drugs. We recently received an allowance for a U.S. patent relating to novel polysaccharide derivatives of granulocyte colony-stimulating factor (GCSF) and methods for producing such derivatives. The derivatives are useful for improving the stability, pharmacokinetics and pharmacodynamics of GCSF. Our expectations are that we will have strong intellectual property protection for many years after our lead compounds have progressed through the U.S. regulatory process," Mr. Maguire added.

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.