On January 14, 2015 NantCell, LLC, a subsidiary of NantWorks, LLC, focusing on the discovery and development of immunology based innovative treatments for diseases through cell-based treatments at the molecular level, reported that it has entered into a licensing agreement with Amgen Inc. for AMG 479 (ganitumab), previously in Phase 3 development (Press release, NantWorks, JAN 14, 2015, View Source [SID:1234511990]). Under the agreement, NantCell acquired the exclusive rights to develop and commercialize worldwide, excluding Japan, AMG 479, a fully human monoclonal antibody that targets Type 1 insulin-like growth factor receptor (IGF-1R), a promising target for cancer therapy. Financial terms were not disclosed.

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"We are pleased to enter into this agreement with Amgen," said Dr. Patrick Soon-Shiong, founder and chief executive officer of NantCell. "We acquired an immuno-oncology compound in late-stage development, with the potential to address a number of cancers affecting significant patient populations. This month marks the 10 year anniversary of the FDA approval of Abraxane, the first protein-based chemotherapy delivery vehicle now approved in multiple countries worldwide for breast, lung and pancreatic cancer. It is our belief that the future of cancer care will involve combination therapy with low dose, metronomic use of multiple chemotherapeutic agents, but combined also with immuno-oncology molecules, or with engineered killer cells targeted at the proteomic profile of the specific tumor, regardless of the anatomical type. The development of antibody molecules such as IGF-1R will require next generation sequencing at the proteomic level with a deep level of molecular interrogation to establish the appropriate combination with other drugs."

Patients entering clinical trials conducted by NantCell would be identified after a comprehensive "omic" analysis from DNA, RNA and protein, and treated on the resulting molecular profile to maximize clinical outcome and minimize side effects.

"We are pleased to collaborate with NantCell and NantWorks in their mission to establish a new level of quantitative predictability of patient selection," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Their integrated suite of technologies may help to improve patient selection and further clinical development of AMG 479."

Scientific and medical research suggest that IGF-1R plays a role in the development and progression of many cancers, possibly due to its anti-apoptotic properties, which allow cancerous cells to resist the cytotoxic properties of chemotherapeutic drugs or radiation therapy. The novel IGF-1R antibody inhibits cancer cell proliferation through disruption of the P13K/Akt and MAPK pathways. Signaling through IGF-1R plays an important role in the regulation of cell growth and survival, and has been shown to be a critical promoter of anchorage independent growth, a well-recognized mechanism for malignancy.

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About NantCell

NantCell, a wholly-owned subsidiary of NantWorks, LLC, is an immuno-oncology company focused on the discovery of innovative antibody, T cell and NK cell based treatments by developing molecularly targeted therapeutics, based on the proteomic profile of the patient’s tumor, independent of the cancer’s anatomical type. Dr. Patrick Soon-Shiong, the creator of Abraxane and the founder of the nab technology platform established NantCell to develop a pipeline of human antibodies and inhibitors of proteins which drive tumor growth and pursue Chimeric Receptor Antigen platforms in both T and NK cells. NantCell’s mission is to make obsolete the standard method of clinical trial design of "trial and error" and replace it with a level of quantitative predictability based on both the genomic and proteomic profile performed a priori. The Company will tap into comprehensive "omic" analytic tools and "big data" generated from supercomputing to develop molecularly designed drugs in this era of genomics and proteomics and identify patients and their tumor signature at the most granular cellular, DNA and protein levels. Patients entering clinical trials would be identified after a comprehensive "omic" analysis from tissue to cell to DNA to RNA to protein to peptide to drug, and tested based on this molecular profile to maximize clinical outcome and minimize side effects. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter@solvehealthcare.

About NantWorks

NantWorks, LLC, founded by renowned physician scientist and inventor of the first human nanoparticle chemotherapeutic agent Abraxane, Dr. Patrick Soon-Shiong, is the umbrella organization for the following entities: NantHealth, NantMobile, NantMedia, NantOmics, NantBioScience, NantCell, NantPharma, NantCapital and NantCloud. Fact-based and solution-driven, each of NantWorks’ division entities operates at the nexus of innovation and infrastructure.

The core mission of NantWorks is convergence: to develop and deliver a diverse range of
technologies that accelerates innovation, broaden the scope of scientific discovery, enhance
groundbreaking research, and improve healthcare treatment for those in need. NantWorks is building an integrated fact-based, genomically-informed, personalized approach to the delivery of care and the development of next generation diagnostics and therapeutics.

On January 14, 2015 Roche licenses additional EGFR pathway-related intellectual property to QIAGEN(Press release Hoffmann-La Roche, JAN 14, 2015, View Source [SID:1234501342]).

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Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the company has entered into an agreement with QIAGEN that includes a provision of non-exclusive licenses to recently granted Roche patents pertaining to the detection of mutations in the EGFR pathway (including in the KRAS gene). Financial details were not disclosed.

The licenses apply to testing products which detect these mutations using molecular techniques including PCR, next generation sequencing (NGS) and other applications to aid in identification of cancer patients eligible for treatment with certain tyrosine kinase inhibitors. The licenses can be applied to existing and future products.

"As a leader in molecular assay development, we are pleased to provide licenses to the applicable patents so that existing and new tests can support patient treatment decisions," said Paul Brown, Head of Roche Molecular Diagnostics. "Ensuring that assays that utilize Roche proprietary information are fully licensed is a key business strategy for us."

"We are pleased with the agreement, which expands our existing intellectual property portfolio covering more than 35 biomarkers and our deep intellectual property estate in EGFR-related testing, including KRAS- testing", said Dr. Achim Ribbe, Vice President Corporate Business Development Licensing. "As a global leader in personalized healthcare, QIAGEN is working with numerous pharmaceutical companies to develop and market molecular companion diagnostics that can help improve patient outcomes and better utilize healthcare resources."

On Jan. 12, 2015– Seattle Genetics, Inc. (Nasdaq:SGEN) and Bristol-Myers Squibb Company (NYSE:BMY) reported that the companies have entered into a clinical trial collaboration agreement to evaluate the investigational combination of Seattle Genetics’ antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) and Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) in two planned Phase 1/2 clinical trials. The first trial will evaluate the combination of Adcetris and Opdivo as a potential treatment option for patients with relapsed or refractory Hodgkin lymphoma (HL), and the second trial will focus on patients with relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), including diffuse large B-cell lymphoma (DLBCL).

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Adcetris is an ADC directed to CD30, a defining marker of classical HL, which combines the targeting ability of a monoclonal antibody with the potency of a cell-killing agent. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells.

"This collaboration will expand our broad Adcetris clinical development program towards our goal of improving outcomes for patients with Hodgkin lymphoma and other CD30-expressing malignancies," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Ultimately, our vision is to advance the treatment of cancer by exploring more targeted treatment approaches that result in enhanced activity, reduced toxicities and improved long-term results for patients. We look forward to working with Bristol-Myers Squibb to define the activity and tolerability of adding Opdivo to Adcetris, and informing this potential treatment strategy in hematologic malignancies."

"Bristol-Myers Squibb continues to strengthen its broad development program for Opdivo through collaborations that explore novel combination regimens in areas of serious unmet need," said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. "We are pleased to collaborate with Seattle Genetics on clinical research focused on hematologic malignancies."

The studies are expected to begin in 2015, with Seattle Genetics conducting the HL trial and Bristol-Myers Squibb conducting the NHL trial. Additional details of the collaboration were not disclosed.

Adcetris is approved in relapsed HL and systemic anaplastic large cell lymphoma (ALCL) but is not currently approved for the treatment of relapsed, transplant eligible HL or for the treatment of other types of NHL. Opdivo is currently not approved for the treatment of lymphoma.

About ADCETRIS (Brentuximab Vedotin)

Adcetris is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

Seattle Genetics and Takeda are jointly developing Adcetris. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize Adcetris in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where Takeda will be solely responsible for development costs. Adcetris has received marketing authorization by regulatory authorities in more than 45 countries. In addition, Adcetris is being evaluated as an investigational agent in more than 30 ongoing clinical trials, including four phase 3 studies, across a variety of CD30-expressing malignances including HL.

On January 12, 2015 Sorrento Therapeutics reported that over 80 patients randomized in the ongoing TRIBECA (TRIal establishing bioequivalence [BE] between Cynviloq and Albumin-bound paclitaxel*) registrational trial have been dosed (Filing 8-K , Sorrento Therapeutics, JAN 12, 2015, View Source [SID:1234501326]). Sorrento intends to continue enrolling all qualified patients in the current screening process and anticipates having the "last patient in" by the end of January. Patients were recruited globally from over 20 sites in USA, Eastern Europe, and Asia. The initial safety assessment from treated patients revealed no unexpected adverse events and the data is consistent with the toxicity profile reported in the literature with albumin-bound paclitaxel.

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Previously, Sorrento announced positive pharmacokinetic (PK) data from the first eight (8) patients enrolled in the TRIBECA study. Based on our reported positive data, sample size estimates suggest that only 53 patients are needed to meet regulatory guidelines for BE.

"We are pleased with the imminent completion of the TRIBECA study" said Henry Ji, Ph.D., President and Chief Executive Officer of Sorrento. "Our plan is to continue to enroll patients until the end of January to have a robust safety database of patients treated with Cynviloq (paclitaxel nanoparticle polymeric micelle) at 260 mg/m2 infused over 30-minutes. The completion of patient enrollment in January will allow us to make topline pharmacokinetic results available in March, and facilitate the planned NDA submission to the FDA seeking marketing approval for Cynviloq."

On January 12, 2015 AstraZeneca reported that MedImmune, its global biologics research and development arm, has entered into a licensing agreement with Omnis Pharmaceuticals (Omnis), a privately-held biotechnology company focused on the development of oncolytic viruses (Press release AstraZeneca, JAN 12, 2015, View Source;medimmune-enters-licensing-agreement-with-omnis [SID:1234501381]). This agreement will allow MedImmune to combine key agents from its investigational immunotherapy portfolio with Omnis’ lead investigational oncolytic virus programme, a genetically engineered strain of vesicular stomatitis virus (VSV). The programme is currently being studied in a Phase I clinical trial as a monotherapy for the treatment of hepatocellular carcinoma and other cancers that have metastasised to the liver.

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Oncolytic viruses are designed to target tumour cells with the killing potency of viruses. VSV is among a group of naturally occurring viruses that can be engineered to selectively infect tumour cells and destroy them without harming healthy cells. These oncolytic viruses represent a potentially powerful new tool in the fight against cancer and may be synergistic with various immunotherapies currently being developed by MedImmune.

Under the terms of the agreement, MedImmune has the license to develop and, if successful, to commercialise Omnis’s lead oncolytic virus programme. Clinical development of the virus will be accelerated with the objective of rapidly progressing to combination studies with MedImmune’s immunotherapy molecules.

Dr. Edward Bradley, Senior Vice President, R&D, and Head of MedImmune’s Oncology Innovative Medicines Unit, said: "Oncolytic viruses combine potent tumour cell killing with increasing the visibility of the tumour cell to the immune system. Our immunotherapy molecules offer the prospect of boosting the cancer-killing abilities of these viruses by enhancing the anti-cancer effect."

"We believe that MedImmune’s portfolio of immunotherapeutic agents, which harness the ability of the immune system to attack cancer cells, will produce beneficial synergies with our VSV programme," said Stephen J. Russell, Chief Executive Officer, Omnis Pharmaceuticals. "We are taking advantage of the immense ‘intelligence’ of viruses and the immune system, which are usually in conflict with each other, to combat another resourceful adversary, the tumour."