On February 3, 2016 Trillium Therapeutics Inc. (NASDAQ:TRIL)(TSX:TR) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer,reported that it has initiated dosing in its Phase 1 clinical trial of TTI-621 (SIRPaFc), a novel checkpoint inhibitor of the innate immune system, in relapsed or refractory hematologic malignancies (Press release, Trillium Therapeutics, FEB 3, 2016, View Source [SID:1234508969]).

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TTI-621 is an antibody-like fusion protein that blocks the inhibitory activity of CD47, a molecule that is overexpressed by a wide variety of tumors. CD47 binds to SIRPa on macrophages and delivers a "do not eat" signal that inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that TTI-621 has anti-tumor activity across a range of hematologic tumors.

"This is an exciting time for Trillium as we now emerge as a clinical stage oncology company evaluating a novel immune checkpoint inhibitor," commented Dr. Eric Sievers, Trillium’s Chief Medical Officer. "At a fundamental level, a cancer patient’s ineffective immune response allows the tumor to propagate unchecked. By blocking CD47, a key cell-surface protein that inhibits phagocytosis, we hope to summon a durable anti-tumor response in patients who are beset by cancer."

The two-part clinical trial is designed as a multi-center, open-label Phase 1a/1b trial, evaluating TTI-621 as a single-agent in patients with relapsed or refractory hematologic malignancies. During the dose escalation phase set to enroll up to 36 subjects, the safety, tolerability, pharmacokinetics and pharmacodynamics will be characterized to determine the optimal dose for subsequent enrollment in the expansion phase. In this second part of the trial, the safety and preliminary antitumor activity of TTI-621 at the optimal dose identified in the escalation phase will be explored in 12-15 subjects per hematologic malignancy type: indolent B-cell lymphoma, aggressive B-cell lymphoma, T-cell lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

Trillium has proposed five trial sites including the Mayo Clinic, Columbia University Medical Center, City of Hope National Medical Center, The Colorado Blood Cancer Institute, and Tennessee Oncology.

On February 3, 2016 OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported it will present a company overview on February 8, 2016 at 11:30 a.m. Eastern time at the 2016 BIO CEO & Investor Forum (Filing, 8-K, OXiGENE, FEB 3, 2016, View Source [SID:1234508979]).

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OXiGENE also announced that the U.S. Food and Drug Administration (FDA) has approved the protocol for FOCUS, OXiGENE’s phase 2/3 study of CA4P for the treatment of platinum-resistant ovarian cancer. FOCUS will test whether CA4P, the company’s lead investigational drug, improves progression-free survival (PFS) when combined with bevacizumab (Avastin) and chemotherapy. If the trial is successful, data from FOCUS would be used as the basis for a new drug application to the FDA.

"I am pleased that we have approval from the FDA to proceed with FOCUS, our planned clinical trial in platinum-resistant ovarian cancer," stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. "We have engaged a well-qualified clinical research organization to assist us with this trial, and intend to begin patient enrollment in the second quarter of this year. While we continue to develop and plan for a similar study in glioblastoma multiforme, and continue to see this as an outstanding opportunity to expand our pipeline, we will not initiate this study in 2016 as most of our current efforts for developing CA4P will be on FOCUS."

FOCUS is a randomized double-blind placebo-controlled study divided into two parts to maximize the speed of data collection. During stage 1 (n= up to 80 patients), serial interim analyses will be conducted to initially assess the efficacy and safety of the combination regimen when compared to standard-of-care. Stage 2 (n= approximately 356 patients) is a confirmatory phase 3 study which would begin immediately after evidence of safety and efficacy are initially demonstrated in stage 1.

FOCUS is designed to build upon data from the GOG-0186I study, first announced in 2014, which demonstrated that CA4P improves PFS in women with recurrent ovarian cancer when combined with bevacizumab compared to bevacizumab alone. The treatment effect observed in this study was strongest in the subgroup of ovarian cancer patients with platinum-resistant disease.

To listen to a live version of the audio webcast of the 2016 BIO CEO & Investor Forum, please visit the Company’s website, www.oxigene.com. Under the "Investors" tab, select the link to "Events & Presentations." A replay of the webcast will be available at this same location approximately one hour after the conclusion of the live event.

Feb. 2, 2016– Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and AbCellera have entered into a collaborative research agreement whereby AbCellera will apply its high-throughput single cell antibody platform for the discovery of rare monoclonal antibodies (Press release, Teva, FEB 2, 2016, View Source;p=RssLanding&cat=news&id=2134715 [SID:1234508952]).

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"We are pleased to work with AbCellera utilizing this company’s novel biologics technology," said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. "This agreement will be complementary to our existing antibody discovery process with the potential to strengthen Teva’s capabilities in novel biologics discovery."

Under the terms of the agreement, AbCellera will receive an upfront payment, research payments, and is eligible to receive undisclosed downstream milestones associated with the development and approval of therapeutic antibodies.
"These are tough problems that need new technologies to move them forward. Our platform brings important advantages to enable the discovery of rare antibodies with defined specificity and functional activity against difficult membrane protein targets," said Dr. Carl Hansen, President and CEO of AbCellera. "We look forward to a close collaboration with the team of scientists at Teva, and are excited at the chance to help advance this important program."

On February 2, 2016 MISSION Therapeutics, a drug discovery and development company focused on selectively targeting deubiquitylating enzymes to treat cancer, neurodegenerative and other diseases, reported that it has raised £60 million (Press release, Cancer Research Technology, FEB 2, 2016, View Source [SID1234523506]). The financing was jointly led by Imperial Innovations Businesses LLP ("Innovations") and new investor Woodford Patient Capital Trust Plc ("WPCT"), with follow-on investment from existing shareholders Sofinnova Partners, SR One, Roche Venture Fund and Pfizer Venture Investments.

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The £60 million will enable MISSION to maximize the potential of its world leading DUB platform and advance a series of first-in-class small molecule drugs candidates targeting specific DUBs into clinical development.

Anker Lundemose, Chief Executive Officer, MISSION Therapeutics commented: "MISSION Therapeutics has attracted one of the highest profile investor syndicates in Europe. We welcome WPCT and thank our existing investors for their continued support. This is strong endorsement of our unique discovery platform and will enable us to maximize the potential of multiple lead compounds for diverse therapeutic indications. 2016 will see us progress our advanced programs into regulatory preclinical development and deepen our pipeline, from a position of increased financial strength."

Rob Woodman, Director of Healthcare Ventures, Imperial Innovations added: "We believe MISSION’s world-class DUB platform has the potential to deliver innovative treatments in indications of high unmet need including neurodegenerative diseases and cancer. The investor group are pleased to support the creative management team in realising the full potential of the ground-breaking discovery chemistry as MISSION enters its next, clinically-centred stage of growth."

DUBs are involved in multiple cellular processes, including DNA damage and cell proliferation, and the inhibition of these enzymes has considerable potential for the generation of novel drugs for treating cancer and other unmet medical needs, including neurodegenerative disease, muscle wasting and infectious disease. Despite significant efforts within the pharmaceutical sector, there is a lack of DUB inhibitors in clinical development.

(Filing, 10-Q, Cardinal Health, FEB 2, 2016, View Source [SID:1234508945])

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