On December 9, 2015 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported that the independent Data Safety Monitoring Board (DSMB) at Dana-Farber/Harvard Cancer Center has recommended that the Phase 2 Borealis-2 trial continue as planned after completing the pre-specified futility analysis (Press release, OncoGenex Pharmaceuticals, DEC 9, 2015, View Source [SID:1234508509]).

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Borealis-2 is evaluating apatorsen in combination with docetaxel treatment in patients with metastatic bladder cancer. It is the third clinical trial assessing the ability of apatorsen to improve outcomes for patients in this tumor type. Previously, encouraging results were observed in the Borealis-1 trial evaluating apatorsen in combination with standard of care chemotherapy in metastatic bladder cancer, as well as a trial evaluating apatorsen as monotherapy in patients with non-muscle invasive (superficial) disease.

Investigators have concluded in the bladder cancer trials conducted to date that 600mg apatorsen administered intravenously and all apatorsen doses administered intravesically have been well tolerated. Clinical trials of apatorsen across four tumor types involving over 700 patients have been conducted or are currently ongoing with patient safety monitored throughout the course of these trials.

"We are pleased with the DSMB’s recommendation to continue the Borealis-2 trial and we look forward to final results expected in 2016," said Scott Cormack, President and Chief Executive Officer of OncoGenex. "Additionally, early next year we will receive regulatory feedback on our apatorsen clinical trial design and development strategy for patients with non-muscle invasive bladder cancer."

Borealis-2 is an investigator-sponsored, randomized Phase 2 trial evaluating a survival benefit with apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in approximately 200 patients with metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. The trial is being coordinated by the Hoosier Cancer Research Network at 27 sites across the United States.

Upcoming Milestones
In addition to Borealis-2, OncoGenex expects to announce progression-free survival results for the Phase 2 Spruce trial in the first quarter of 2016 with continued overall survival follow up.

The company’s other asset, custirsen, is currently being evaluated in two ongoing Phase 3 clinical trials. The Phase 3 ENSPIRIT trial is evaluating the ability of custirsen, in combination with docetaxel treatment as second-line chemotherapy, to extend survival in patients with metastatic NSCLC. ENSPIRIT passed a rigorous final futility survival analysis in July and the trial is continuing as planned. Based on current enrollment projections, ENSPIRIT results could be available in the second half of 2016.

The Phase 3 AFFINITY trial is evaluating the ability of custirsen, in combination with cabazitaxel as second-line chemotherapy, to extend survival in men with metastatic CRPC whose disease has progressed following treatment with docetaxel. Final results from the AFFINITY trial for the intent-to-treat population are expected in the second half of 2016.

About Bladder Cancer
Worldwide, more than 429,000 cases of bladder cancer are diagnosed each year, and nearly 75,000 cases of bladder cancer will be diagnosed in the U.S. in 2015. Approximately 70 percent of patients present with superficial or non-muscle-invasive bladder cancer, with about 30 percent of patients having locally invasive or metastatic disease at the time of diagnosis. Of patients with locally invasive disease, 50 percent will relapse with metastases within two years. Limited options exist for both first- and second-line treatment of advanced bladder cancer and there continues to be a high unmet need for additional therapeutic options for this patient population.

About Apatorsen and ORCA
Apatorsen (OGX-427) is designed to inhibit production of heat shock protein 27 (Hsp27), disable cancer cells’ defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes. Both the potential single-agent activity and synergistic activity of apatorsen with cancer treatments may increase the overall benefit of existing therapies and augment the durability of treatment outcomes, which could lead to increased patient survival.

The ORCA (Ongoing Studies Evaluating Treatment Resistance in Cancer) program encompasses clinical trials of apatorsen. Phase 2 clinical trials are underway in bladder, lung and prostate cancers. For more information on apatorsen and ORCA, please visit www.OncoGenex.com or www.orcatrials.com.

On December 9, 2015 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies based on the Arcelis technology platform,reported the company will participate in the ROTH Immuno-Oncology Corporate Access Day to be held December 16, 2015 at the Park Hyatt New York in New York City (Press release, Argos Therapeutics, DEC 9, 2015, View Source [SID:1234508507]).

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Argos senior management will join a select group of companies in the immuno-oncology sector to participate in one-on-one meetings with investors. Registration is open to ROTH clients only. For more information contact [email protected].

About the Arcelis Technology Platform

Arcelis is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered via intradermal injection.

On December 9, 2015 Cancer Research Technology (CRT), the development and commercialisation arm of Cancer Research UK, has reported the appointment of Dr Deborah Harland to its board of directors (Press release, Cancer Research Technology, DEC 9, 2015, View Source [SID1234523200]).

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Deborah brings more than 25 years’ experience in the pharmaceutical sector and is currently a partner at SR One – the corporate venture capital arm of GlaxoSmithKline. In addition to her current role Deborah has held various roles spanning clinical development, medical affairs and business development throughout her career. She is currently a board member for several biotech companies in which SR One has invested including MISSION Therapeutics*.

Deborah succeeds Dr Ruth McKernan, who was appointed chief executive of Innovate UK earlier this year.

Dr Deborah Harland said: "I’m thrilled to join Cancer Research Technology at a time of exciting progress in our understanding of cancer and the development of vital new therapies for cancer patients.

"I look forward to contributing to CRT’s ambitious plans to drive delivery of the Cancer Research UK research strategy by identifying innovative scientific and business solutions to unmet needs in cancer."

Dr Keith Blundy, Cancer Research Technology’s chief executive officer, said: "I’m delighted to welcome Deborah to Cancer Research Technology. She brings a wealth of experience in industrial drug discovery, licensing and venture financing.

"I have no doubt that CRT will benefit greatly from Deborah’s guidance and expertise as we continue our work to develop and advance discoveries that help beat cancer."

On December 9, 2015 Flagship Ventures, a leading innovation and venture firm focused on healthcare and sustainability, reported it has launched Rubius Therapeutics, to develop functionalized red blood cells for the treatment of autoimmune conditions, metabolic diseases, cancer, and other serious diseases (Press release, Rubius Therapeutics, DEC 9, 2015, View Source [SID1234520729]). Flagship has made an initial capital commitment of $25 million to enable Rubius to enter clinical testing of its novel therapeutic modality.

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Rubius is pioneering Red-Cell Therapeutics (RCTs). RCTs are a new treatment modality and possess pharmacodynamic and pharmacokinetic advantages over traditional therapeutics, in part due to their natural ability to engage and modulate the immune system and circulate for extended periods in the body.
"Working together with our collaborators, technology advances made at Flagship’s innovation foundry, VentureLabs, led to the creation of a completely new therapeutic modality," said Noubar Afeyan, Ph.D., senior managing partner and CEO of Flagship Ventures and a director of Rubius. "We believe Red-Cell Therapeutics will become a new standard of care in many areas of high unmet medical need."
One of the diseases Rubius intends to initially target is phenylketonuria (PKU), a disease of metabolism that affects as many as one in 13,000 births in the U.S. and is responsible for about 300 new cases each year. People born with PKU have a genetic defect that leaves them unable to break down a particular amino acid, one
of the building blocks of proteins. Left untreated, the amino acid, phenylalanine, builds up in the body and causes severe developmental problems and long-term health issues. Newborns are routinely tested for this genetic disease within days of birth.
Currently, the most effective treatment for PKU is a strict diet that lowers the amount of phenylalanine in the body. Rubius has developed and pre-clinically validated a Red-Cell Therapeutic capable of enzymatically reducing phenylalanine levels in human serum. By continually lowering phenylalanine levels in the bloodstream, RCT therapy promises to allow PKU patients to live normally without extremely restrictive diets.
"Red blood cells can now be produced in culture and engineered to possess enormous biotherapeutic properties," said Harvey Lodish, Ph.D., professor of biology and bioengineering at MIT and a member of the Whitehead Institute, who is a scientific founder of Rubius and has joined the firm’s board of directors. "They spend as much as four months in circulation, providing an opportunity for long and tunable therapeutic treatments. Red cells also have profound effects on the immune system and may ultimately transform the way we treat autoimmune diseases and allergies."
"Through its rapid prototyping capability, Rubius has generated and tested over 50 different RCTs for a wide array of indications including autoimmunity, oncology and infectious disease" said Avak Kahvejian, Ph.D., founding CEO of Rubius and Flagship VentureLabs partner. "The company is now poised to drive lead programs into the clinic, build a drug pipeline and further develop the Rubius Erythrocyte Design platform. We are expanding our R&D and management teams, and setting the stage for our next phase of growth."
Besides Dr. Afeyan and Dr. Lodish, the Rubius board of directors includes:

• Jim Gilbert, a healthcare investor and former partner and director at Bain & Co., who serves on several boards, including the board of Nestle Health Sciences. Jim serves as chairman of Rubius.

• Robert S. Langer, Ph.D., Institute Professor at MIT and the holder of more than 1,000 patents

• Dr. Roger Pomerantz, chairman and CEO of Seres Health and former worldwide head of licensing and acquisitions, senior vice president at Merck & Co. Inc.

• Dr. Michael Rosenblatt, executive vice president and chief medical officer of Merck & Co. Inc. , and former dean of the Tufts University School of Medicine.

• Peter Hutt, senior counsel at Covington & Burling and former chief counsel of the U.S. Food and Drug Administration.

Since emerging from Flagship VentureLabs 18 months ago, Rubius has been developing its RCT platform in stealth mode. The company has established a broad patent estate covering its platform and therapeutic products. Rubius is currently testing RCTs in animal models of disease, and plans to initiate human clinical trials in the very near future.