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.

(Filing, 10-K, Biogen, FEB 3, 2016, View Source [SID:1234508961])

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(Filing, 10-Q, Immunomedics, FEB 3, 2016, View Source [SID:1234508966])

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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.

On February 2, 2016 Eagle Pharmaceuticals ("Eagle" or the "Company") (NASDAQ:EGRX) reported the shipment and commercial availability of Alcohol-Free Docetaxel Injection ("Docetaxel Injection") (Press release, Eagle Pharmaceuticals, FEB 2, 2016, View Source [SID:1234508934]). Docetaxel Injection is approved for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

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"We are excited to announce the shipment and commercial availability of Docetaxel Injection, which, as the first alcohol-free formulation approved in the U.S., addresses a compelling need in the docetaxel market. Eagle believes that this novel formulation has the potential to improve the lives of patients, resolve concerns among health care professionals at hospitals and infusion centers, and ultimately drive value for our stakeholders," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Docetaxel Injection is the first alcohol-free formulation approved in the U.S. Additional features of this product are:

presents as one, pre-filled vial that does not require mixing;
is available in three different dosages: 20mg/1ml, 80mg/4mL, and 160mg/8mL; and
24 hours of stability at final dilution strength.1
The need for an alcohol-free docetaxel gained visibility in June 2014 when the FDA issued a Drug Safety Communication warning patients that docetaxel may cause symptoms of alcohol intoxication after treatment. Manufacturers of docetaxel formulations for domestic use were subsequently required to revise their product labels to reflect alcohol content and include a drug safety warning. Some U.S. hospitals and clinics require patients to wait two or more hours after treatment with docetaxel before they can be released. Eagle’s formulation of docetaxel was specifically developed to address these concerns.

Eagle estimates that annual sales of generic docetaxel are approximately $75 million.

About Docetaxel

Docetaxel is a taxane product indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Docetaxel was originally developed by Sanofi and marketed under the Taxotere brand. Since its patent expiration in 2011, several generics have entered the market. The alcohol content of these docetaxel formulations, including Taxotere, ranges from 2.0 to 6.4 grams in a 200 mg dose.2