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Bristol-Myers Squibb and MD Anderson Cancer Center Announce Novel Research Collaboration in Immuno-Oncology Focused on Leukemia and Hematologic Malignancies

On October 6, 2014 Bristol-Myers Squibb and The University of Texas MD Anderson Cancer Center reported a novel clinical research collaboration to evaluate multiple immunotherapies, including Opdivo (nivolumab), Yervoy (ipilimumab) and three early-stage clinical immuno-oncology assets from Bristol-Myers Squibb, as potential treatment options for acute and chronic leukemia as well as other hematologic malignancies (Press release Bristol-Myers Squibb, OCT 6, 2014, View Source [SID:1234500786]).

The agreement represents an innovative approach to research by focusing numerous clinical trials using multiple agents, in mono and combination regimens, on a specific disease target, in this case select hematologic malignancies. Through this approach, Bristol-Myers Squibb and MD Anderson aim to benefit patients by expediting the delivery of new therapies. The collaboration will launch up to 10 phase 1 and 2 clinical trials, conducted by MD Anderson, focused on evaluating investigational immune-based approaches for acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS) and myelofibrosis (MF). Additional studies will be determined by the collaboration at a later date.

Opdivo (nivolumab) is an investigational PD-1 immune checkpoint inhibitor currently approved in Japan for the treatment of patients with unresectable melanoma, and Yervoy (ipilimumab) is a CTLA-4 immune checkpoint inhibitor approved in the U.S. and more than 40 countries for patients with unresectable or metastatic melanoma. Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trademark for nivolumab.

“Collaborations between industry and academia can offer a faster and broader spectrum of clinical trials to benefit patients,” said Hagop Kantarjian, M.D., chair of leukemia at MD Anderson. “We hope innovative collaborations such as this can help lead to a higher likelihood for success across the board and will speed up the clinical development of new compounds for delivery to the patients who need them.”

“Immunotherapy is an extremely promising area of research and a key area of focus for MD Anderson’s Moonshots Program,” said MD Anderson President Ron DePinho, M.D. “Partnerships between academia and industry have the potential to significantly advance the application of new discoveries to cancer treatment.”

“Bristol-Myers Squibb is committed to advancing the field of immuno-oncology and complementing our broad research and discovery programs through innovative collaborations with partners who share our commitment to patients,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. “Cooperation between industry and academia offers a tremendous opportunity to strengthen our scientific and clinical understanding of the role of the immune system in treating cancer.”

Immuno-oncology is an innovative approach to cancer research and treatment that is designed to harness the body’s own immune system to fight cancer. Hematologic malignancies represent significant areas of high unmet need marked by poor outcomes among the elderly, high-risk patients and for those with multiple relapses. Existing clinical research, including studies by MD Anderson, support further research into the potential of immunotherapies as treatment options for leukemia and other hematologic malignancies.

ARIAD and Bellicum Announce Revised License Agreement for ARIAD’s Cell-Signaling Technology

On October 6, 2014 ARIAD Pharmaceuticals and Bellicum Pharmaceuticals reported a restructuring of their license agreement for ARIAD’s cell-signaling technology (Press release Ariad, OCT 6, 2014, View Source [SID:1234500785]). ARIAD will receive $50 million in exchange for a fully paid up license to this technology and return of its equity stake in closely held Bellicum. The scope of the license and the field of use were also expanded as part of the amendment.

Under the terms of the revised agreement, ARIAD will receive $50 million in three installments: $15 million upon signing of the agreement, $20 million by June 30, 2015, and $15 million by June 30, 2016. The last payment may be accelerated to the fourth quarter of 2015 under certain circumstances. The restructured agreement gives Bellicum a worldwide exclusive license to ARIAD’s cell-signaling technology for broad use in human cell therapies for all diseases on a royalty- and milestone-free basis.

ARIAD’s technology involves the use of a small-molecule drug, such as AP1903, to activate cell signaling and other cellular events. Bellicum is developing controllable stem-cell transplant, chimeric-antigen receptor (CAR) T cell and cancer vaccine product candidates in a variety of blood and solid tumor cancers and in non-malignant genetic diseases.

“This license restructuring allows Bellicum to fully exploit our specialized cell signaling switches and related platforms, free of future royalty or milestone obligations to ARIAD,” stated Tom Farrell, Bellicum’s chief executive officer. “The expanded license also includes additional cell-signaling technology that may enable future products with dual control switches.”

“The amended agreement with Bellicum allows ARIAD to realize substantial non-dilutive funding from our legacy program based on small-molecule regulation of cell signaling, while maintaining our strategic focus on bringing breakthrough medicines to cancer patients in need,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.

Outside the Bellicum field of use, ARIAD has also licensed certain aspects of the technology to REGENXBIO, Inc., and Clontech Laboratories, Inc. These license agreements remain unchanged.

Kancera provides operational update on the ROR project

On October 3, 2014 Kancera reported that an initial efficacy study of KAN0439834 (a small molecule inhibitor of ROR1) has been completed in an animal model of chronic lymphocytic leukemia (Press release Kancera, OCT 3, 2014, View Source;releaseID=932197 [SID:1234500830]). Preliminary results show that KAN0439834 reduces the number of ROR-expressing leukemia cells after 7 days of treatment in the examined organs of the animals. Deeper and more comprehensive analyzes are performed in order to verify the preliminary findings and to investigate the full effect of the treatment with KAN0439834 in the lymphatic system, which often suffers from infiltrating leukemia cells that are difficult to treat. Following this a decision can be made whether to select a first candidate drug in the ROR project.

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The conducted animal study is based on primary cancer cells from patients which adds clinical relevance to the model. Further studies during Q3 2014 have been performed to characterize the pharmaceutical properties of KAN0439834. Overall, the findings suggest that oral administration of KAN0439834 can provide a concentration of the substance in the blood sufficient to reach the desired effect against cancer cells.

8-K – Current report

On October 3, 2014 Argos Therapeutics reported plans for development of a state of the art biomanufacturing facility in the Research Triangle Park area in Durham, North Carolina (Filing 8-K , Argos Therapeutics, OCT 3, 2014, View Source [SID:1234500793]). The facility will be used to support automated production of the company’s Arcelis-based personalized immunotherapy product candidates, beginning with AGS-003, the company’s lead oncology product candidate, currently being evaluated in the pivotal ADAPT phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC).

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In support of the development and implementation of the nearly 100,000 square foot facility, Argos will receive approximately $9.5 million in incentives as well as logistical and planning support from the State of North Carolina, Durham County, the City of Durham, and the North Carolina Biotechnology Center.

"Argos was initially formed based on groundbreaking research conducted at Duke University and has experienced significant growth in Durham over the past decade. We are pleased to be expanding our operations here with the construction of our new automated manufacturing facility which we believe is critical to the successful commercialization of personalized immunotherapies such as AGS-003," stated Jeff Abbey, President and Chief Executive Officer of Argos. "Support for this project is a great example showing how our leaders in state, city and county government are committed to job growth and to enhancing North Carolina’s position as a leader in biotechnology."

"Argos’ cutting edge work in personalized immunotherapy may lead to new treatments for people living with cancer, HIV and other serious illnesses," said Pat McCrory, Governor of the State of North Carolina. "It is exciting to see this biopharma company continue to grow in North Carolina. We want to help more companies like Argos bring innovative new therapies and technologies to the commercial market."

The incentive package from the North Carolina Department of Commerce to support the project totals $7.1 million, including a $4.5 million Job Development Investment Grant, $600,000 in education and on-the-job training assistance, a $1.8 million sales tax exemption on qualifying equipment, and a $200,000 Economic Development Award from the North Carolina Biotechnology Center. In addition to NC Commerce, the City of Durham and Durham County awarded an incentives package totaling $2.35 million including a cash grant of $1.85 million and $500,000 in on-the-job training assistance. Argos has entered into a lease with The Keith Corporation of Charlotte, NC, to construct the facility on T.W. Alexander Drive in Durham, NC.

"Durham, known as ‘The City of Medicine,’ prides itself on being on the cutting edge of personalized medical treatment and technology. Argos Therapeutics is one of the many forward thinking companies that maintain Durham’s position as a leader in medicine," said Bill Bell, Mayor of Durham.

"I am excited to see Argos grow in Durham and I am particularly excited, as are my fellow commissioners, that the company plans to create 236 new jobs and keep 100 existing jobs, offering a broad range of employment opportunities for all segments of Durham’s workforce," said Michael Page, Chairman of the Durham County Board of Commissioners.

"The Durham Chamber of Commerce worked in close cooperation with our economic development colleagues with Durham County, the City of Durham, the North Carolina Department of Commerce, the North Carolina Biotechnology Center, Durham Technical Community College, Duke University, North Carolina Central University with its BRITE Program and North Carolina State University to make the case that Argos Therapeutics will be most successful here in Durham, North Carolina. We are ecstatic by Argos’ decision to remain here and we applaud their plan to expand and grow in Durham, NC!" said Lisa Yarborough, Durham Chamber Board Chair.

"The North Carolina Biotechnology Center has had a long relationship with Argos dating back to the late 1990s when they had just a few employees," said Doug Edgeton, President and CEO of NC Biotech, referring to a loan that helped get the company started. "We consider Argos one of North Carolina’s great life science success stories, starting as a local university spinout. We are proud they chose to continue their growth here."

Servier new research partnership with the Walter and Eliza Hall Institute to target Achilles’ heel of many cancers

On October 2, 2014 Servier reported a collaborative partnership with the Walter and Eliza Hall Institute to facilitate the development of new agents that could be effective in treating several types of cancer, particularly blood cancers (Press release, Servier, OCT 2, 2014, View Source [SID:1234508831]).

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A research team at the Walter and Eliza Hall Institute, led by Associate Professor Guillaume Lessene, will test in preclinical models how cancer cells respond to treatment with the Mcl-1-inhibitory BH3-mimetics discovered by the Servier – Vernalis collaboration. The results will indicate whether this new class of research compounds could be useful in the future for treating people with cancer, and which types of cancer the compounds would be most effective against.

"Mcl-1 is a promising therapeutic target for many types of cancer. There is a considerable body of experimental evidence pinpointing Mcl-1 as the Achilles’ heel for many cancers, particularly blood cancers," said Associate Professor Lessene at the Walter and Eliza Hall Institute. "Institute researchers made the initial discovery explaining how Bcl-2 played a role in cancer more than 20 years ago. We have been at the forefront of research revealing how the Bcl-2 family promotes cancer development and treatment resistance and have provided considerable experience in evaluating and developing potential anti-cancer agents, including BH3-mimetics."

Jean-Pierre Abastado, Head of the Oncology Pole and Olivier Geneste, Director of Apoptosis Programs at Servier said: "the discovery of research compounds inhibiting selectively Mcl-1 reflects a long term commitment to drug discovery research targeting the Bcl-2 family of inhibitors of apoptosis. We are convinced that our collaboration with the Walter and Eliza Hall Institute will generate critical data and ideas helping the development of our anti Mcl-1 drug candidates and that our joint research efforts will facilitate bringing a highly innovative treatment to cancer patients."