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DelMar Pharmaceuticals Announces Issuance of New Patent on First-in-Class DNA-targeting Agent, VAL-083

On September 20, 2017 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported that the U.S. Patent and Trademark Office (USPTO) has issued to DelMar, United States Patent No. 9,759,698 covering improved analytical methods for analyzing and determining impurities in dianhydrogalactitol (VAL-083) (Press release, DelMar Pharmaceuticals, SEP 20, 2017, View Source [SID1234520572]).

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DelMar’s new patent strengthens the Company’s control over the VAL-083 manufacturing process and related controls. DelMar is establishing broad new intellectual property protection around VAL-083, a first-in-class DNA targeting agent that demonstrated clinical activity against a range of tumor-types in prior clinical trials sponsored by the U. S. National Cancer Institute (NCI).

VAL-083 is currently protected by eight US patents and eight patents outside of the US, with issued claims providing patent protection into 2033 in the United States. DelMar has made patent filings under 14 separate patent families encompassing more than 100 individual patent applications.

AVEO Oncology and EUSA Pharma Announce TiNivo Combination Study Opt-in

On September 20, 2017 AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma reported that EUSA Pharma, under its multi-territory licensing agreement with AVEO for FOTIVDA (tivozanib), has opted into the Phase 1/2 TiNivo study. Under terms of the agreement, EUSA may utilize data from the study for regulatory or commercial purposes in exchange for a research and development funding payment totaling $2.0 million (Press release, AVEO, SEP 20, 2017, View Source [SID1234520570]). EUSA’s decision follows approval in August of tivozanib by the European Commission for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland.

The TiNivo trial is a Phase 1/2 trial of tivozanib in combination with Bristol-Myers Squibb’s OPDIVO (nivolumab), an immune checkpoint, or PD-1, inhibitor, for the treatment of RCC. The TiNivo trial is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. In June, AVEO announced the advancement of the trial into the Phase 2 expansion portion following successful completion of the Phase 1 dose escalation portion. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The expansion portion of the trial is expected to enroll an additional 20 subjects. Phase 1 results from the ongoing study have been submitted for presentation at a scientific meeting taking place in the fourth quarter.

"We look forward to working with EUSA in helping shape the future direction of FOTIVDA in an evolving treatment landscape for advanced RCC," said Michael Bailey, president and chief executive officer of AVEO. "Immunotherapy is defining an important role as an early treatment option for this disease, creating an opportunity to investigate the role of TKIs following immunotherapy or in combination with immunotherapy. Having already demonstrated superior PFS and an improved side effect profile compared to sorafenib in the pivotal TIVO-1 study, FOTIVDA is currently being evaluated in an ongoing third line pivotal trial stratifying for prior immunotherapy, and is well positioned to play a role in this evolving treatment landscape."

Lee Morley, EUSA Pharma’s Chief Executive Officer said, "Following the recent European approval of FOTIVDA for the first-line treatment of patients with advanced RCC, emerging data from the TiNivo study indicates the potential for FOTIVDA in this setting. With our partner AVEO and the RCC community, we are committed to the ongoing development of FOTIVDA and look forward to investigating new and innovative treatment options for patients with advanced RCC."

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $388 million in future milestone payments and research and development funding, assuming successful achievement of specified development, regulatory and commercialization objectives. In addition, a tiered royalty will be due to AVEO ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. With European approval, AVEO will be eligible for up to $12 million in milestones from EUSA based on reimbursement and regulatory approvals. In the territories licensed to EUSA, thirty percent of milestone and royalty payments received by AVEO, excluding research and development payments such as the one announced today, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee. In the territories retained by AVEO, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

About Tivozanib (FOTIVDA)

An over-expression of VEGF protein, and a resulting increase in tumour blood supply (angiogenesis), is a common feature of RCC.1 VEGFR-TKIs reduce the supply of blood to the tumour and are the recommended first-line treatment for advanced RCC in Europe, however, patients often experience significant side effects, including fatigue, diarrhoea, and hand-foot syndrome.

In the global Phase III trial (TIVO-1)1 of over 500 patients with advanced RCC, tivozanib demonstrated a significant PFS benefit versus sorafenib (11.9 vs. 9.1 months in the overall patient population [HR, 0.797; 95% CI, 0.639 to 0.993; P =.042], and 12.7 vs. 9.1 months in treatment-naïve patients [HR, 0.756; 95% CI, 0.580 to 0.985; P =.037]).1 There was also an improved side-effect profile versus sorafenib, with significantly fewer patients on tivozanib (14% versus 43%) requiring a dose reduction due to AEs; and less than 5% of patients experiencing severe side effects (grade 3&4, such as diarrhoea, asthenia (physical weakness) and hand-foot syndrome. Hypertension (44%) and dysphonia (21%) were the most commonly reported AEs on tivozanib.1

Under EUSA Pharma’s license agreement with AVEO, announced in December 2015, the company holds exclusive commercialization rights to tivozanib in RCC in Europe and in a number of other territories outside North America, including South America and South Africa. Under the terms of the agreement, EUSA Pharma will undertake and fund the commercialization of the product in its territories, assuming licensing. AVEO retains the rights to commercialize the product in North America. Tivozanib was discovered by Kyowa Hakko Kirin.

Realist Pharma and GlycoNet Announce Collaboration

On September 19, 2017 Realist Pharma ("Realist" or "the Company") reported that it has entered into a collaboration and contribution agreement with the Canadian Glycomics Network ("GlycoNet") to assist in development of Realist’s glycomimetic vaccines targeting multiple cancers (Press release, realist pharma, SEP 19, 2017, View Source [SID1234532040]). In the context of this agreement, GlycoNet will provide a $250,000 financial contribution as well as key expertise for the scale-up of manufacturing of key precursors, for the subsequent GMP manufacturing of material for upcoming clinical studies. The funds will support the laboratory of Dr. H. Uri Saragovi at the Lady Davis Institute in Montréal, who will lead the development of these products. GlycoNet will receive an equity consideration for this contribution.

"We are indeed pleased to be collaborating with GlycoNet, an international leader in glycomics, on the development of our drug. Realist’s glycomimetic vaccines target the carbohydrate portions of well-known and widespread tumor markers, making an understanding of glycomics of signal importance to our future success," said Mark de Groot, Realist’s Chief Executive Officer. "While the initial focus of the collaboration is on the tumor marker gangliosides (TMGs) GD2 and GD3, Realist’s platform is expected to be able to address up to 20 different TMG targets in total."

"The research program developed by Realist and Dr. Saragovi at the Lady Davis Institute fits beautifully with GlycoNet’s mandate to advance glycomics for the benefit of Canadians by demonstrating the crucial role of glycomics in immuno-oncology. Realist’s novel discoveries demonstrate the relevance of glycomics for applications in human health and its potential for spurring job creation and start-up success in Canada," said Dr. Todd Lowary, GlycoNet Scientific Director. "We are extremely pleased to play a role in accelerating the commercial development of research that could lead to new cancer treatments as well as value creation in Canada."

Taiho Pharmaceutical Concludes Option and License Agreement with Arcus Biosciences

On September 19, 2017 Taiho Pharmaceutical Co., Ltd. announced today that it has entered into an option and license agreement with Arcus Biosciences, a US-based biotechnology company focused on the discovery and development of innovative cancer immunotherapies (Press release, Taiho, SEP 19, 2017, View Source [SID1234527696]).

Based on the terms of the agreement, Taiho will provide a $35mm payment to Arcus. In return for the payment, Taiho will receive an option to in-license the development and commercialization rights of product candidates in Arcus’s portfolio in Japan and certain other territories in Asia (excluding China). For any product candidate for which Taiho exercises a license, Taiho will need to provide option payments in development, regulatory and commercial milestones per molecule. Taiho is also need to pay royalties on the net sales of each product candidate that Taiho commercializes in its regions.

Taiho will attempt to continue delivering innovative new drugs to patients and medical professionals

Oncolytics Biotech® to Present at the Phacilitate Immuno-Oncology Frontiers Conference

On September 19, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, a first-in-class, intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems, reported that it will present at the Phacilitate Immuno-Oncology Frontiers Conference (Press release, Oncolytics Biotech, SEP 19, 2017, View Source [SID1234520576]). Dr. Andres Gutierrez, Oncolytics’ Chief Medical Officer, will present at 4:00 pm CEST on September 21, 2017 at the Maritim Proarte Hotel. The conference takes place on September 20th and 21st in Berlin, Germany.

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Dr. Gutierrez will highlight the role of REOLYSIN in the activation of the immune system and the induction of an inflamed tumor phenotype in the tumor microenvironment. His presentation will also review certain historical clinical programs, highlight the positive survival data from the IND 213 study in metastatic breast cancer (mBC) and the pooled safety database – the largest of any oncolytic virus.

"We want to share our extensive experience with REOLYSIN in the clinic to illustrate the specific expertise and efforts required to develop an oncolytic virus for intravenous administration and systemic exposure in oncology," said Dr. Gutierrez. "This experience helped us define a clear regulatory pathway for registration in metastatic breast cancer. With an overall agreement with the FDA on the phase 3 study design, details of the pivotal registration study will be made available following evaluation and completion of discussions with clinical advisors and potentially partners, as well as European regulators."

The Phacilitate Immuno-Oncology Frontiers conference hosts over 300 industry decision-makers and key external stakeholders to come together discuss and define a strategic roadmap to success for immuno-oncology developers, ensuring European patients gain access to the game-changing biotherapeutics of tomorrow. Immuno-Oncology frontiers Berlin is the only European event that offers extensive coverage of the latest emerging science whilst placing it in its wider strategic context as the basis of tomorrow’s successful business and commercialisation models.

About REOLYSIN
REOLYSIN is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.