On November 30, 2015 Heptares Therapeutics ("Heptares"), the clinical-stage GPCR structure-guided drug discovery and development company and wholly-owned subsidiary of Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), reported that it has entered into a strategic drug discovery collaboration with Pfizer Inc. (NYSE: PFE) to research and develop potential new medicines directed at up to 10 G protein-coupled receptor (GPCR) targets across multiple therapeutic areas (Press release, Heptares, NOV 30, 2015, View Source [SID1234552774]).

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Heptares will use its proprietary GPCR structure-guided platform to help deliver stabilised GPCRs (StaR proteins), high-resolution crystal structures and other technologies to support the discovery of potential novel agents directed to the GPCR targets selected by Pfizer. Pfizer will be responsible for developing and commercialising any potential therapeutic agents (small molecules or biologics derived from StaR antigens) for each target and will have exclusive global rights to any potential resulting agents.

Heptares will receive an initial payment on signing the agreement in return for delivering certain StaR proteins and structures for targets selected by Pfizer that it has already generated.

Heptares is eligible to receive potential research, development, regulatory and commercial milestone payments of up to USD189 million per target. In addition, Heptares is eligible to receive potential tiered royalties on the net sales of any products that are commercialised by Pfizer.

In addition, Sosei and Pfizer Seiyaku KK ("Pfizer KK") have entered into an equity agreement under which Pfizer KK will purchase USD33 million of newly issued Sosei common stock at a premium of 25% to the average closing price during the 20-day period prior to the closing date. The closing is expected to be in December 2015. The investment will represent approximately 3.02% of the enlarged Sosei share capital and is subject to review by Japanese financial authorities.

"This extensive partnership with Pfizer is an important step toward realizing full potential of Heptares’ technology. Alliances of this kind also play an important role in achieving Sosei’s ambition for becoming a leading global biopharmaceutical company of Japanese origin," commented Shinichi Tamura, CEO of Sosei Group.

Commenting on the agreement, Malcolm Weir, Chief Executive Officer of Heptares and Chief R&D Officer of Sosei Group, said: "This strategic collaboration with Pfizer, spanning as it does many targets and indications, is another significant achievement for Heptares and recognises the potential clinical benefit that may be realisable through the combination of our continuing leadership in GPCR structure-based design technology and Pfizer’s global therapeutic drug discovery and development capabilities. We are delighted to be embarking on this new collaboration and look forward to an exciting and productive relationship."

"Pfizer looks forward to this collaboration with Heptares to help us more quickly screen and identify lead GPCR programs across multiple therapeutic areas within our preclinical portfolio and, ultimately, help us increase the speed at which we bring potential new therapies to patients," said Rod MacKenzie, senior vice president, PharmaTherapeutics Research & Development at Pfizer.

On November 30, 2015 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will present clinical data at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting this weekend in Orlando, Florida (Press release, Dynavax Technologies, NOV 30, 2015, View Source [SID:1234508366]). The details for the poster presentation are as follows:

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Date and Time: Saturday, December 5, 2015, 5:30pm – 7:30pm EST
Abstract Title: Regulatory T Cells Are Depleted in Low-Grade Lymphoma By the Combination of Local Low-Dose Radiation Followed By Intratumoral CpG-ODN.
Session Number: 616
Session Name: Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I
Abstract Number: 1539
Location: Hall A, Level 2 (Orange County Convention Center)

Please click here for the full abstract. The poster presentation with updated data will be made available on or after December 5, 2015.

About SD-101

SD-101, the subject of ASH (Free ASH Whitepaper) abstract 1539, is Dynavax’s proprietary, second-generation, TLR 9 agonist CpG-C class oligodeoxynucleotide. SD-101 activates multiple anti-tumor activities of innate immune cells and activates plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and provide potent Type 1 interferon induction and maturation of plasmacytoid dendritic cells to antigen-presenting cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its preliminary safety and activity.

On November 30, 2015 Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported the Company, in partnership with its collaborators, will present data from its product candidates and process development activities with six oral and poster presentations at the upcoming 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Juno, NOV 30, 2015, View Source;p=RssLanding&cat=news&id=2118842 [SID:1234508362]). Senior management will also review the data and provide an update on Juno’s ongoing clinical development strategy during an analyst and investor event and webcast.

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The first of two oral presentations will report updated data from the ongoing trial of JCAR014 in adults with relapsed or refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). This translational clinical research trial focuses on how optimization of the pharmacokinetics or exposure of JCAR014 relates to clinical outcomes. The second presentation will discuss the implications of prior allogeneic stem cell transplant and achievement of minimal residual disease negative complete remission in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) treated with JCAR015. Additionally, initial data from the anti-CD22 chimeric-antigen receptor (CAR) product candidate in pediatric and young adult relapsed or refractory ALL will be highlighted in one of four poster presentations.

"The clinical data in ALL, NHL, and CLL continue to be encouraging. The response rates and durability of responses across a range of B cell malignancies provide important insights on how persistence and depth of response translate into improved clinical outcomes, and are applicable to our portfolio broadly," said Hans Bishop, Juno’s President and Chief Executive Officer. "We are also looking forward to the first presentation of early results from the anti-CD22 CAR study in pediatric ALL patients, a study which appears to be of increasing relevance with the ongoing emergence, particularly in pediatric patients, of CD19 epitope loss with treatment."

The following data will be presented at ASH (Free ASH Whitepaper):

Oral Presentations

Anti-CD19 Chimeric Antigen Receptor-Modified T Cell Therapy for B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Fludarabine and Cyclophosphamide Lymphodepletion Improves In Vivo Expansion and Persistence of CAR-T Cells and Clinical Outcomes (Abstract #184)

Presenter: Cameron J. Turtle, M.B.B.S., Ph.D., Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, and Department of Medicine, University of Washington, Seattle, WA

Date: Sunday, December 6, 2015: 8:15 a.m. Eastern Time

Implications of Minimal Residual Disease Negative Complete Remission (MRD-CR) and Allogeneic Stem Cell Transplant on Safety and Clinical Outcome of CD19-Targeted 19-28z CAR Modified T Cells in Adult Patients with Relapsed, Refractory B-Cell ALL (Abstract #682)

Presenter: Jae H. Park, M.D., Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
Date: Monday, December 7, 2015: 3:30 p.m. Eastern Time

Poster Presentations

Clinical Activity and Persistence of Anti-CD22 Chimeric Antigen Receptor in Children and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (Abstract #1324)

Presenter: Terry J. Fry, M.D., Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD

Date: Saturday, December 5, 2015: 5:30 p.m. – 7:30 p.m. Eastern Time

Functional Characterization of a T Cell Stimulation Reagent for the Production of Therapeutic Chimeric Antigen Receptor T Cells (Abstract #1901)

Presenter: Keenan T. Bashour, Ph.D., Department of Process & Analytical Development, Juno Therapeutics, Inc., Seattle, WA; Ryan P. Larson, Ph.D., Department of Translational Sciences, Juno Therapeutics, Inc., Seattle, WA

Date: Saturday, December 5, 2015: 5:30 p.m. – 7:30 p.m. Eastern Time

Multi-center Clinical Trial of CAR T Cells in Pediatric/Young Adult Patients with Relapsed B Cell ALL (#2533)

Presenter: Kevin J. Curran, M.D., Department of Pediatrics and Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY

Date: Sunday, December 6, 2015: 6:00 p.m. – 8:00 p.m. Eastern Time

Addition of Fludarabine to Cyclophosphamide Lymphodepletion Improves In Vivo Expansion of CD19 Chimeric Antigen Receptor-Modified T Cells and Clinical Outcome in Adults with B Cell Acute Lymphoblastic Leukemia (Abstract #3773)

Presenter: Cameron J. Turtle, M.B.B.S., Ph.D., Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, and Department of Medicine, University of Washington, Seattle, WA

Date: Monday, December 7, 2015: 6:00 p.m. – 8:00 p.m. Eastern Time

ASH Investor and Analyst Event and Webcast
The Juno ASH (Free ASH Whitepaper) Investor and Analyst Event and webcast will be held Monday, December 7, 2015, at 8:30 p.m. Eastern Time. The webcast can be accessed live on the Investor Relations page of Juno’s website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the event.

On November 30, 2015 Varian Medical Systems reported that clinicians in Melbourne have commenced advanced radiotherapy treatments for prostate cancer using a real-time tumor tracking system from Varian Medical Systems (NYSE: VAR) (Press release, InfiMed, NOV 30, 2015, View Source [SID:1234508361]). Epworth HealthCare, the largest not-for-profit private hospital group in Victoria, has become the first care provider in Australia to utilize Varian’s Calypso transponders to enhance precision during image-guided radiotherapy treatments as standard of care.

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"The Calypso system gives us information about internal movement of the prostate during treatment that we’ve never had before," says Anne Perkins, senior medical physicist at Epworth HealthCare. "Reviewing the data for the first five patients we treated shows that the prostate moved outside the limits specified by the radiation oncologist on 20 percent of the treatment visits. The Calypso system can automatically turn off the radiation beam until the prostate returns to its planned position and if necessary radiation therapists can move the treatment couch to reposition the patient before resuming treatment. More than 25 patients have now been treated with Calypso at Epworth."

"Calypso is a user-friendly system that gives us precise real-time information about the location of the prostate during treatment. Before we had Calypso, we relied on x-ray imaging to determine that our patients were in the correct position for treatment. Calypso is proving to be at least as accurate as x-ray imaging and has the advantage of providing continuous information during treatment, rather than just a snapshot in time."

Dr. Pat Bowden, Epworth HealthCare’s director of radiation oncology, adds, "The Calypso system enables us to reduce margins for our prostate cancer patients, with an expectation this will reduce long-term toxicity. With Calypso, we feel we are providing our patients with the most advanced radiotherapy treatment techniques available."

Calypso continuously pinpoints the location of a tumor similar to the way that GPS works in navigation system for cars. The prostate is not a stationary target. It can shift by as much as several millimeters during a radiotherapy treatment session.

Epworth HealthCare provides advanced radiotherapy and radiosurgery treatments using four Varian linear accelerators, including a state-of-the-art TrueBeam STx system installed in February this year. Doctors at the center are planning to introduce Calypso-guided treatments for patients with lung and gastro-intestinal cancers, as well as surface tracking beacons for DIBH (deep inspiration breath hold) breast treatments. It is estimated there will be 128,000 new cancer cases diagnosed in Australia this year and this number is expected to rise to 150,000 by 2020.

On November 30, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the European Patent Office (EPO) has granted European Patent No. 2 049 109 B1, claiming certain combined uses of vosaroxin and cytarabine, at doses of 10-120 mg/m2 and 5-1500 mg/m2, respectively, for the treatment of acute myelogenous leukemia and acute myeloblastic leukemia (Press release, Sunesis, NOV 30, 2015, View Source;p=RssLanding&cat=news&id=2118591 [SID:1234508360]). The patent further provides for combinations of vosaroxin and cytarabine with other therapies, such as radiation, or other chemotherapeutics, including anti-cancer agents, in hematologic disorders, whether administered simultaneously or sequentially. Sunesis is proceeding to validate this patent in multiple EPO member states. The resulting national patents would expire in the third quarter of 2027, but could be eligible for supplementary patent term in EPO member states beyond this date. Related patent applications are pending in several countries, including the United States and Japan.

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"This patent adds important value to a European commercial opportunity for vosaroxin, as it covers a wide range of its contemplated commercial use with cytarabine out to 2027," said Eric Bjerkholt, Executive Vice President, Corporate Development and Finance of Sunesis. "Granting of this European patent is particularly timely, as we prepare to file a European Marketing Authorization Application for vosaroxin in combination with cytarabine in AML by year end. It also provides us with greater certainty in pursuing the full clinical and commercial potential of vosaroxin using various therapeutic combinations in AML and other hematologic malignancies."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.