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.

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."

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."

On October 2, 2014 Eli Lilly reproted that it will discontinue development of tabalumab, being studied for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus), due to insufficient efficacy in two pivotal Phase 3 trials. The decision was not based on safety concerns (Press release Eli Lilly, OCT 2, 2014, View Source [SID:1234500889]).

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In the ILLUMINATE 1 study, tabalumab did not achieve the primary endpoint, at either dose studied, of statistically significant improvement on SRI-5 (SLE Responder Index-5, a measurement of lupus disease activity and response), compared to standard of care therapy. In ILLUMINATE 2, the higher dose of tabalumab met this endpoint, the first time a lupus study has achieved this efficacy measure as a primary endpoint in a Phase 3 trial. Collectively, the data from these studies did not meet expectations for efficacy in the context of existing treatments. The overall safety profile showed a similar frequency of adverse events in patients treated with either tabalumab or standard of care. Lilly intends to submit these data for disclosure in appropriate upcoming scientific venues.

Given the overall efficacy results from these two pivotal Phase 3 studies, Lilly will not move forward with submissions to global regulators. Lilly will work with investigators to appropriately conclude these studies in the interest of patient safety.

"Although we were pleased that tabalumab met the criteria for statistically significant improvement in the SRI-5 endpoint in one of our trials, we are nonetheless disappointed that the overall results did not meaningfully improve the condition of the patients in these studies," said J. Anthony Ware, M.D., Senior Vice President, Product Development, Lilly Bio-Medicines. "The ILLUMINATE trials are the largest Phase 3 clinical studies in lupus to date, and we are hopeful that our contribution of the extensive data from these studies will advance knowledge to enhance treatment in this devastating illness. Lilly remains committed to developing potential new medicines for the treatment of autoimmune conditions, including lupus."

The decision to discontinue development of tabalumab for lupus is expected to result in a third-quarter charge to research and development expense of up to $75 million (pretax), or approximately $0.04 – $0.05 per share (after-tax).