(Press release, Second Genome, OCT 7, 2014, View Source [SID:1234503356])

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On October 7, 2014 OXiGENE reported that the first patient has been enrolled in a Phase 1b/2 clinical study that will evaluate fosbretabulin in combination with Votrient (pazopanib) in patients with recurrent ovarian cancer (Press release OXiGENE, OCT 7, 2014, View Source [SID:1234500802]).

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The randomized, controlled clinical study consists of a Phase 1b dose escalation portion with the combination of fosbretabulin and pazopanib and a Phase 2 portion comparing fosbretabulin and pazopanib versus pazopanib alone. The study is estimated to enroll up to 128 patients at sites in the United Kingdom. The primary endpoint is progression-free survival, and secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.

"This study is an important first step to evaluate the potential combination of a vascular disrupting agent (VDA) with an oral anti-angiogenic agent," said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the study. "Recent clinical data suggest that combining fosbretabulin with the anti-angiogenic agent bevacizumab may provide a complementary effect in ovarian cancer patients, and we are hopeful to see a positive result in this new study that would further advance non-chemotherapeutic treatment approaches for patients with relapsed ovarian cancer."

The study is sponsored by The Christie Hospital NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). Fosbretabulin and pazopanib are being provided by OXiGENE and GlaxoSmithKline, respectively.

"The data from this trial will further the body of knowledge about fosbretabulin as part of a non-chemotherapeutic regimen in treating ovarian cancer," said Dai Chaplin, Ph.D., CEO at OXiGENE. "We are delighted to support this important study, along with others, as it provides OXiGENE an important development opportunity in Europe and delivers on our strategy to leverage collaborations that advance the clinical knowledge about fosbretabulin."

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.

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.

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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.

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]).

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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.