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Halozyme Announces Issuance Of U.S. Patent For Companion Diagnostic For PEGPH20

On October 7, 2014 Halozyme Therapeutics reported the issuance of U.S. Patent No. 8,846,034 claiming methods for selecting a subject for treatment of a hyaluronan-associated disease with an anti-hyaluronan agent, such as PEGPH20, as well as diagnostic agents for the detection and quantification of hyaluronan in a biological sample in patients (Press release Halozyme, OCT 7, 2014, View Source [SID:1234500800]). Combinations and kits for use in practicing the methods are also provided. PEGPH20 is an investigational PEGylated form of rHuPH20 under development by Halozyme, which degrades the hyaluronan coating that may provide a supportive environment in many solid tumors.

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"We are pleased to receive recognition for these biotechnology innovations," commented Dr. Helen Torley, President and CEO. "This companion diagnostic will provide important data for identifying and evaluating those patients and tumors that can benefit most from PEGPH20 therapy."

The issued U.S. patent is anticipated to expire on October 28, 2032, which includes the patent term adjustment. To date, similar claims are pending in eleven countries, as well as the Eurasian and European regions. Additional information about these patents may be found on the U.S. Patent and Trademark Office and on the European Patent Office Web sites.

NeoStem Announces USAN Approval of Generic Name ‘Eltrapuldencel-T’ for Investigational Patient-Specific Targeted Cancer Immunotherapy

On October 6, 2014 NeoStem reported that the United States Adopted Name Council (USAN) has approved the generic name "eltrapuldencel-T" for the Company’s patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma (Press release NeoStem, OCT 6, 2014, View Source [SID:1234500876]). This investigational treatment, planned to be evaluated in the Company’s Phase 3 Intus study, has been granted Orphan Drug, and Fast Track designations by the U.S. Food and Drug Administration and will be conducted under a protocol that has been granted Special Protocol Assessment (SPA). NeoStem plans to begin the trial by the end of 2014.

Eltrapuldencel-T is an autologous immunotherapy intended to eliminate cancer-initiating (stem) cells capable of causing disease recurrence and progression. Creation of the therapy begins with cancer initiating (stem) cells that have been isolated from the patient’s resected tumor sample, enriched and inactivated. These newly created cancer initiating (stem) cells are then combined with dendritic cells (antigen-presenting immune cells) derived from the patient’s own blood, and granulocyte-macrophage colony stimulating factor (GM-CSF, a natural growth factor that stimulates white blood cells in the body). The product is then introduced back into the patient via a series of subcutaneous injections.

"We welcome the receipt from USAN of the generic name for use in this important program and look forward to the launch of our pivotal Phase 3 trial to evaluate eltrapuldencel-T," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

Eltrapuldencel-T was developed by recent NeoStem acquisition California Stem Cell, Inc., based on a technology developed over the course of 10 years at Hoag Memorial Hospital Presbyterian in Newport Beach, California. Two previous Phase 2 clinical studies conducted at Hoag had resulted in a combined median 5-year survival of 50% in patients with Stage IV melanoma, double that of any current treatment.

Following on the success of those trials, the Intus study is a multi-national randomized, double-blind Phase 3 clinical trial in which patients will be randomized in a 2:1 ratio to receive either eltrapuldencel-T or a control treatment (autologous mononuclear cells in GM-CSF). An expected 250 enrolled patients throughout the U.S., Canada, Australia and New Zealand will receive weekly injections for three consecutive weeks, and then once monthly for five months.

8-K – Current report

On October 3, 2014 Sorrento Therapeutics reported that China Oncology Focus Limited, an Affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharma), has licensed Sorrento’s fully human immune-oncology anti-PD-L1 monoclonal antibody (mAb) STI-A1014 (Filing 8-K , Sorrento Therapeutics, OCT 6, 2014, View Source [SID:1234500791]).

Under the terms of the agreement, Lee’s Pharma received exclusive rights to develop and commercialize the antibody for the greater Chinese market, including Mainland China, Hong Kong, Macau, and Taiwan. In turn, Sorrento will receive an up-front payment, potential future milestone payments and high single digit to double digit royalties on future net sales. In total, Sorrento has the potential to receive more than $46 million upon the successful attainment of key milestones. Additionally, Lee’s Pharma will invest $3.6 million by purchasing common stock in Sorrento at a substantial premium to the current market price.

Sorrento’s proprietary G-MAB library platform was used to identify and generate STI-A1014. The theoretical diversity of the library has been calculated to be more than one quadrillion unique antibodies, making it one of the largest fully human antibody libraries available to pharmaceutical and biotechnology companies for drug discovery and development partnerships.

The immuno-oncology field has emerged as the most exciting and fastest developing pharmaceutical market in decades. Antibodies targeting CTLA-4, PD-1, and PD-L1, thus, harnessing the cancer patient’s own immune system for treatment of various solid and hematological malignancies have demonstrated tremendous therapeutic potential rarely seen with conventional oncolytic drugs. A recent forecast by Citigroup predicts this market to become the biggest blockbuster drug class in history with potential sales of up to $35 billion a year over the next 10 years.

"Lee’s commitment to addressing high unmet oncology needs by bringing new effective immuno-oncology therapy to the Chinese market is reflected in this transaction. Sorrento’s antibody technologies as well as its therapeutic mAb programs are truly cutting edge. We look forward to working closely with Sorrento. Our long standing development and commercial experience in the Chinese pharmaceutical industry together with Sorrento’s immunotherapy expertise will ensure timely and efficient development of this exciting therapy, with special focus on cancers with high prevalence in China. We expect to start a Phase 1 clinical trial of the anti-PD-L1 antibody in China in 2015," said Dr. Xiaoyi Li, Chief Executive Officer and Executive Director of Lee’s Pharma.

"We are extremely pleased to work with Lee’s Pharma, a leading Chinese pharmaceutical company with an excellent track record in drug development and commercialization. This partnership further validates our G-MAB antibody technology and underscores Sorrento’s commitment for seeking strategic alliances in bringing its diverse portfolio of fully human monoclonal antibodies, antibody-drug conjugates (ADCs) and bi-specific antibodies into the clinic," said Henry Ji, President and CEO of Sorrento.

Data to Be Presented at CRI Immunotherapy Conference Show PS-Targeting Antibodies Enhance the Anti-Tumor Activity of Immune Checkpoint Inhibitors by Decreasing Levels of Myeloid Derived Suppressor Cells (MDSC) in the Tumor Microenvironment

On October 6, 2014 Peregrine Pharmaceuticals reported the presentation of preclinical data related to the company’s immuno-oncology development program and its lead drug candidate bavituximab, a phosphatidylserine (PS)-targeting antibody (Press release Peregrine Pharmaceuticals, OCT 6, 2014, View Source [SID:1234500797]). Data show that PS-targeting agents in combination with immune checkpoint inhibitors, such as anti-PD-1 or anti-CTLA-4, promote a robust and localized anti-tumor response in models of melanoma and breast cancer and decrease levels of myeloid derived suppressor cells (MDSC) in the tumor microenvironment. Newly generated data show that the combination of a PS-targeting antibody equivalent to bavituximab administered with an anti-PD-1 antibody displayed statistically significant tumor growth suppression compared to anti-PD-1 antibody treatment alone in an animal model of melanoma. These data will be presented this morning at the Cancer Research Institutes’ “Cancer Immunotherapy: Out of the Gate” conference being held at the Grand Hyatt Hotel in New York, New York.

“We are pleased to be presenting this exciting data to this immuno-oncology focused audience,” said Jeff T. Hutchins, Ph.D. vice president, preclinical research at Peregrine Pharmaceuticals “These data are impressive and consistent in their findings across several tumor types and further build on the rationale for additional collaborative studies such as the ongoing investigator-sponsored Phase Ib trial of bavituximab in combination with ipilimumab (Yervoy) in advanced melanoma.”

The poster titled: “Antibody-mediated blockade of phosphatidylserine enhances the anti-tumor activity of immune checkpoint inhibitors by affecting myeloid-derived suppressor cell (MDSC) and lymphocyte populations in the tumor microenvironment” will be presented by Rolf Brekken, Ph.D., Effie Marie Cain Research Scholar in Angiogenesis Research and an Associate Professor, in the Departments of Surgery and Pharmacology at the Hamon Center for Therapeutic Oncology Research, University of Texas Southwestern Medical Center in Dallas, Texas. Data from these studies show that the PS-targeting antibody ch1N11, the preclinical equivalent to bavituximab, significantly enhances tumor growth inhibition of anti-CTLA-4 or anti-PD-1 in the B16 and K1735 melanoma models and the efficacy of anti-PD-1 in the EMT-6 breast tumor model. New data show that the combination of ch1N11 and an anti-PD-1 antibody produce a statistically significant difference (p=0.018) in tumor growth suppression over anti-PD-1 alone in the B16 melanoma model. In addition, PS blockade with ch1N11 combined with either anti-CTLA-4 or anti-PD-1 resulted in greater T cell infiltration into B16 and K1735 tumors than tumors treated with either antibody alone. Consistent with these results, ch1N11 combined with anti-PD-1 showed an enhanced percentage of T cells producing the cytokines IL-2 and IFNg, factors associated with immune activation, when compared with T cells from tumors being treated with anti-PD-1 alone. In summary, the targeting and blocking of PS with ch1N11 significantly improved the anti-tumor efficacy of immune checkpoint blockade in robust models of melanoma and breast cancer in immunocompetent animals.

Teva Announces Results of Strategic Review of Core Specialty Therapeutic Areas

On October 6, 2014 Teva Pharmaceutical Industries reported the results of its strategic review of core therapeutic areas for the Company (Press release Teva, OCT 6, 2014, View Source [SID:1234500790]). The review included an extensive evaluation of Teva’s current and future capabilities to address unmet patient needs, the competitive landscape, barriers to entry and profitability with the purpose of creating a winning strategy to achieve global leadership in each of the company’s core therapeutic areas.

The Company reaffirmed its long-term commitment to develop patient-centric solutions and significantly grow its specialty medicines business through investment in research & development, marketing, business development and innovation, while strengthening its commercial infrastructure and expanding its offering of patient centric solutions. The core therapeutic areas on which Teva will focus and where it has been establishing a leading position are Central Nervous System (including multiple sclerosis, neurodegenerative diseases and pain) and Respiratory (including asthma and chronic obstructive pulmonary disease).

“Teva is committed to being a world-leader in CNS and Respiratory, both areas underpinned by significant and growing unmet patient needs. With our existing portfolio, integrated global R&D and innovation capabilities, we are in a strong position to deliver for patients and payers, and to generate long-term value for our shareholders,” stated Teva’s President and CEO, Erez Vigodman. “Our late-stage pipeline assets are expected to generate great value – out of the 30 plus product launches we anticipate by 2019, with a total of over $4 billion in new revenue on a risk-adjusted basis, over 20 products will be launched in these two core therapeutic areas.”

In other therapeutic areas, such as Women’s Health and Oncology, where Teva has a significant commercial presence, the Company will focus on market-ready or close-to-market assets to maximize sustainable profitability. In addition, Teva will continue to evaluate opportunities for commercially-oriented activities and collaborations.

As a result of the strategic review, Teva has identified 14 pipeline projects for discontinuation or divestment. These projects amount to more than $150 million in R&D costs in 2015 and in excess of $200 million for each of 2016 and 2017. These cost savings will be directed, in part, to increasing resources in Teva’s core therapeutic areas, while another part of which will support the company’s efficiency objective. This increased investment in core therapeutic areas will increase R&D productivity, without increasing the overall R&D budget.

Mr. Vigodman continued, “The decision announced today demonstrates progress in our efforts to solidify the foundation of the company, drive organic growth and ensure that we are pursuing the highest potential opportunities, both for patients and for the company. It will allow us to more efficiently and effectively focus and build leadership in key disease areas and deliver sustainable long-term value.”

The company will discuss this decision following its strategic review as well as other financial information as part of its third-quarter earnings presentation.