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Bristol-Myers Squibb Expands International Immuno-Oncology Network (II-ON) With Addition of Columbia University Medical Center and Peter MacCallum Cancer Centre

On February 27, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported that Columbia University Medical Center and Peter MacCallum Cancer Centre (Peter Mac) have joined the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance Immuno-Oncology (I-O) science and translational medicine to improve patient outcomes (Press release, Bristol-Myers Squibb, FEB 27, 2017, View Source [SID1234517832]). Launched in 2012 by Bristol-Myers Squibb, the II-ON was one of the first networks to bring academia and industry together to further the scientific understanding of I-O, and has expanded from 10 to 15 sites including more than 250 investigators working on over 150 projects across 20 tumor types. The II-ON has generated cutting-edge I-O data that have informed the development of new I-O agents, yielded publications and produced some of the earliest findings on a variety of biomarkers and target identification and validation.

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"Bristol-Myers Squibb has long believed the future of cancer research is dependent on investments in science and partnerships. We formed the II-ON to facilitate innovation in I-O science and drug discovery by providing a streamlined framework for peer-to-peer collaboration among global cancer research leaders," said Nils Lonberg, Head of Oncology Biology Discovery at Bristol-Myers Squibb. "The significant discoveries generated by the II-ON over the past five years have not only informed our robust early I-O pipeline, but also serve to advance the entire field. We are proud to collaborate with Columbia University Medical Center and Peter Mac, and together with the entire II-ON will continue to lead pioneering research and heighten our collective understanding of the science behind I-O."

Through the II-ON, Bristol-Myers Squibb is collaborating with leading cancer research institutions around the world to generate innovative I-O science, launch biology-driven trials and seek out cutting-edge technologies with the goal of translating research findings into clinical trials and, ultimately, clinical practice.

"I-O research may be transforming the way we treat cancer," said Charles G. Drake, MD, PhD, Professor of Medicine at Columbia University Medical Center and Director of Genitourinary Oncology and Associate Director for Clinical Research at the Herbert Irving Comprehensive Cancer Center at New York-Presbyterian/Columbia. "The II-ON offers a tremendous opportunity to work smarter and faster along with our colleagues to address fundamental scientific questions in I-O."

"We believe the collective knowledge and research power of the II-ON will generate groundbreaking findings in I-O with the potential to improve outcomes for people affected by cancer," said Professor Joe Trapani, Executive Director Cancer Research and Head of the Cancer Immunology Program at Peter MacCallum Cancer Centre, Melbourne, Australia.

Building on the success of the II-ON, Bristol-Myers Squibb has invested in several other models of scientific collaboration with academic partners across the globe, including the Global Expert Centers Initiative (GECI) and the Immuno-Oncology Integrated Community Oncology Network (IO-ICON). "We believe a one-size-fits-all research approach does not facilitate innovation," said Lonberg. "Our tailored collaborations with academic centers expand our research capabilities and accelerate our collective ability to deliver potentially life-changing results for patients."

About the International Immuno-Oncology Network (II-ON)

The II-ON, formed in 2012, is a global peer-to-peer collaboration between Bristol-Myers Squibb and academia advancing the science of Immuno-Oncology (I-O) through a series of preclinical, translational and biology-focused research objectives. The research in the collaboration is focused on three fundamental scientific pillars: understanding the mechanisms of resistance to immunotherapy; identifying patient populations likely to benefit from immunotherapy; and exploring novel combination therapies that may enhance anti-tumor response through complementary mechanisms of action. The II-ON facilitates the translation of scientific research findings into drug discovery and development, with the goal of introducing new treatment options into clinical practice.

In addition to Bristol-Myers Squibb, the II-ON currently comprises 15 leading cancer research institutions, including: Clinica Universidad Navarra, Dana-Farber Cancer Institute, The Earle A. Chiles Research Institute (Providence Health & Services), Institut Gustave Roussy, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione G. Pascale", Bloomberg-Kimmel Institute for Cancer Immunotherapy at the Johns Hopkins Kimmel Cancer Center, Memorial Sloan Kettering Cancer Center, National Cancer Center Japan, The Netherlands Cancer Institute, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, University College London, The University of Chicago, West German Cancer Center/University Hospital Essen, and now Columbia University Medical Center and Peter MacCallum Cancer Centre.

Bristol-Myers Squibb: At the Forefront of Immuno-Oncology Science & Innovation

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents – including the first combination of two I-O agents in metastatic melanoma – and our differentiated clinical development program, which is studying broad patient populations across more than 20 types of cancers with 12 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part, but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

Chugai’s ALK Inhibitor “Alecensa®” Approved in Taiwan

On February 27, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for the anti-cancer agent, alectinib hydrochloride (brand name: Alecensa) for the treatment of people with "anaplastic lymphoma kinase (ALK) positive, advanced non-small cell lung cancer (NSCLC) who have progressed on or those intolerant to crizotinib (Press release, Chugai, FEB 26, 2017, View Source [SID1234517856])."

"We believe that the approval of Alecensa by the TFDA would bring the great news to Taiwanese patients who are fighting against this disease," said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. "We are pleased that Alecensa created by Chugai will contribute to the treatment of ALK-positive NSCLC."

Taiwan’s approval was based on two clinical phase I/II studies, as summarised below:

– The NP28761 study is a phase I/II North American, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib. (Data cut-off: January 22, 2016)

– The NP28673 study is a phase I/II global, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib. (Data cut-off: February 1, 2016)

– People in the phase II studies received 600 mg of Alecensa orally twice daily. In both trials, the primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1), and evaluated by an Independent Review Committee (IRC). Secondary endpoints included duration of response (DOR) and safety.

– Efficacy Parameters

The NP28761 study (N=87) The NP28673 study (N=138)
IRC Assessment Investigator Assessment IRC Assessment Investigator Assessment
ORR (%)
(95% CI) 42.5
(32.0-53.6) 52.9
(41.9-63.7) 44.9
(36.5-53.6) 51.4
(42.8-60.0)
DOR (median in months)
(95% CI) 14.9
(7.5-NE)
13.3
(8.8-18.2)
15.2
(11.2-24.9)
15.2
(11.0-20.3)
– Alecensa demonstrated a safety profile consistent with that observed in previous studies.

– The most common Grade 3 or higher adverse events were an increase in muscle enzymes (increased blood levels of creatine phosphokinase; five percent), increased liver enzymes (alanine aminotransferase; 4.8 percent, and aspartate aminotransferase; 3.6 percent) and shortness of breath (dyspnoea; 3.6 percent).

Alecensa is a highly selective oral ALK inhibitor discovered by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells.2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases.

Alecensa is currently approved in the United States, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, the EU and Taiwan for the treatment of advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib.

In Japan, Alecensa is available to patients with "ALK fusion gene positive unresectable, recurrent/advanced NSCLC" and is marketed by Chugai.

1) Biomarker committee of The Japan Lung Cancer Society, Guidelines for ALK gene tests in lung cancer patients
2) Soda et al., Nature. 448: 561-566 (2007)
3) Takeuchi et al., Clin Cancer Res. 15: 3143-3149 (2009)
4) Sakamoto et al., Cancer Cell. 19: 679-690 (2011)

STORM Therapeutics appoints CEO and Chairman

On February 24, 2017 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies from RNA epigenetics, reported that moved to the next stage of its development with the appointment of Keith Blundy as Chief Executive Officer and Tim Edwards as Chairman (Press release, STORM Therapeutics, FEB 24, 2017, View Source [SID1234561050]).

Keith, formerly CEO of Cancer Research Technology, brings his extensive knowledge of developing and partnering early stage cancer programmes. In ten years as CEO at CRT, Keith was also involved in founding many start-up companies, including Chroma Therapeutics, Piramed, KuDos and Mission, as well as establishing the CRT Pioneer Fund and the CRUK-MedImmune alliance.

Serial entrepreneur Tim Edwards, previously Executive Chair of Atopix Therapeutics Limited, acquired by Chiesi Farmaceutici SPA in 2016, and President and Chief Executive Officer of Cellzome Inc, acquired by GlaxoSmithKline plc in 2012, adds his wealth of experience in managing growth to a seasoned board comprising investor directors from Cambridge Innovation Capital, Merck Ventures, Pfizer Venture Investments and Touchstone Innovations.

STORM’s R&D activities are driven by a drug discovery team with extensive biotech and pharma experience headed by VP of R&D, Oliver Rausch (ex Cellzome, UCB and GSK), Head of Biology, David Simmons (ex Cellzome, Celltech, Wyeth), and now strengthened by the appointment of VP of Chemistry, Wesley Blackaby (ex Charles River and MSD).

STORM’s vision is to pioneer the development of novel therapies from RNA epigenetics based on the insights of its founding scientists, Professor Tony Kouzarides and Professor Eric Miska of the University of Cambridge, who are leaders in understanding the role of RNA modifications in cellular biology.

Keith Blundy said: "With the continuing pipeline of world-class science from our founding scientists working in collaboration with STORM researchers, strong and experienced management now in place and long-term financial support from experienced investors, I am excited about the prospect of building a world-leading biotech company. We are now poised to deliver this goal – through strong relationships with academia and industry we aim to explore thoroughly the potential of this emerging field to deliver breakthrough medicines for patients."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

vTv Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, vTv Therapeutics, 2017, FEB 24, 2017, View Source [SID1234521322]).

Xynomic Pharma Has Acquired Worldwide Rights of Abexinostat

On February 24, 2017 Xynomic Pharmaceuticals, Inc., an oncology drug research and development company, reported that it has acquired exclusive worldwide rights to develop, manufacture and commercialize Abexinostat, a potentially best-in-class innovative HDAC inhibitor targeting hematological and solid tumors (Press release, Xynomic Pharmaceuticals, FEB 24, 2017, View Source [SID1234527688]).

To date a total of 17 Phase 1 and 2 clinical trials of Abexinostat in US, EU and Asia have already been completed, demonstrating that Abexinostat is clinically active in multiple tumor settings with a more favorable safety profile among HDAC products. Xynomic aims to initiate Phase 3 registrational trials worldwide in Q3’2017.

"We are honored and excited to forge this landmark agreement. We will deploy necessary resources and closely work with KOLs to expeditiously bring this innovative drug to the market to address unmet medical needs," said Mr. Y. Mark Xu, Co-Founder, Chairman and CEO of Xynomic.