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Bristol-Myers Squibb and Lilly Enter Clinical Collaboration Agreement to Evaluate Opdivo (nivolumab) in Combination with Galunisertib in Advanced Solid Tumors

On January 13, 2015 Bristol-Myers Squibb and Eli Lilly and Company reported a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) in combination with Lilly’s galunisertib (LY2157299) (Press release Bristol-Myers Squibb, JAN 13, 2015, View Source [SID:1234501334]). The Phase 1/2 trial will evaluate the investigational combination of Opdivo and galunisertib as a potential treatment option for patients with advanced (metastatic and/or unresectable) glioblastoma, hepatocellular carcinoma and non-small cell lung cancer.

Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. Galunisertib (pronounced gal ue” ni ser’tib) is a TGF beta R1 kinase inhibitor that in vitro selectively blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread in the body. This collaboration will address the hypothesis that co-inhibition of PD-1 and TGF beta negative signals may lead to enhanced anti-tumor immune responses than inhibition of either pathway alone.

“Advanced solid tumors represent a serious unmet medical need among patients with cancer,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Our clinical collaboration with Lilly underscores Bristol-Myers Squibb’s continued commitment to explore combination regimens from our immuno-oncology portfolio with other mechanisms of action that may accelerate the development of new treatment options for patients.”

“Combination therapies will be key to addressing tumor heterogeneity and the inevitable resistance that is likely to develop to even the most promising new tailored therapies,” said Richard Gaynor, M.D., senior vice president, Product Development and Medical Affairs, Lilly Oncology. “To that end, having multiple cancer pathways and technology platforms will be critical in an era of combinations to ensure sustainability beyond any single asset.”

The study will be conducted by Lilly. Additional details of the collaboration were not disclosed.

MedImmune enters licensing agreement with Omnis Pharmaceuticals for oncolytic viruses in immuno-oncology

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."

8-K – Current report

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."

Seattle Genetics and Bristol-Myers Squibb Announce Clinical Collaboration to Evaluate Combination of Adcetris® (Brentuximab Vedotin) and Opdivo® (Nivolumab) in Hematologic Malignancies

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.

Boehringer Ingelheim and Yale University collaborate to investigate novel immunotherapy targets across several therapeutic areas

On January 13, 2015 Boehringer Ingelheim reported a collaboration with Yale University, New Haven, Connecticut, USA, with the goal of researching novel therapeutic targets in the field of immune-modulation (Press release Boehringer Ingelheim, JAN 12, 2015, View Source [SID:1234501337]). Immune-modulation refers to a range of treatments aimed at harnessing a patient’s immune system to fight disease.

Under the terms of the agreement, the research capabilities of Boehringer Ingelheim and Yale University will be brought together to identify new immune-modulatory agents for oncology, autoimmune and respiratory disorders. The company will provide research funding for a select number of projects and work closely with scientists at Yale University to advance this research. The company has an option to obtain an exclusive license for all of these programs under pre-agreed terms with Yale University.

Dr Lieping Chen, United Technologies Chair in Cancer Research and Professor of Immunobiology and Director of Cancer Immunology at the Yale Cancer Center, Yale University School of Medicine, will lead this collaborative research jointly with Boehringer Ingelheim. He is a leading investigator in the characterization of cell surface co-stimulatory and co-inhibitory molecules that modulate immune responses, and was the first scientist to apply co-stimulation as a means for cancer immunotherapy. His pioneer works in discovering the PD-L1/PD-1 pathway and anti-PD-L1/PD-1 therapy have shown to be highly promising for treating cancer patients.

“We are very much looking forward to working closely with Dr. Chen and other scientific leaders in this innovative and emerging field as part of this joint research program”, said Dr Michel Pairet, Senior Corporate Vice President of Research and Non-clinical Development at Boehringer Ingelheim. “This research collaboration affirms our commitment to the area of immune-modulation for both inflammatory diseases and oncology. In oncology, this will ideally complement our ongoing efforts in the fields of targeted therapy and cancer vaccines.

“This collaboration will help us to identify important pathways, and what the biological application of modulating those pathways will be,” Dr. Chen says. “We will investigate whether these new pathways could become future drug targets.”