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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]).

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."

Lilly to Discontinue Development of Tabalumab Based on Efficacy Results in Phase 3 Lupus Studies

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]).

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).

8-K – Current report

On October 2, 2014 Heat Biologics reported that it has dosed the ninth and final patient required in the Phase 1 portion of its Phase 1/2 clinical study for Vesigenurtacel-L (HS-410) in patients with high-risk non-muscle invasive bladder cancer (Filing 8-K , Heat Biologics, OCT 2, 2014, View Source [SID:1234500780]). The Company expects to commence the Phase 2 portion of the bladder cancer clinical trial during the fourth quarter of 2014.

Melissa Price, Ph.D., Heat’s Vice President of Clinical and Regulatory Affairs commented, "I am pleased we have met our study timeline objectives for the Phase 1 dosing to enable us to advance to Phase 2. Most importantly, there have been no reported serious adverse events related to our vaccine. We are on track to begin Phase 2 a full quarter sooner that originally reported."

Heat recently modified the Phase 1/2 Vesigenurtacel-L study treatment regimen to include a more robust dose-response analysis and the expedited advancement into Phase 2 trials following completed enrollment of a single cohort of Phase 1 data.

"Heat’s clinical team and principal investigators are now in a position to quickly progress Vesigenurtacel-L into Phase 2 enrollment," said Jeff Wolf, Chief Executive Officer. "The initiation of the Phase 2 dosing will provide Heat and its stakeholders with much awaited key data on top-line recurrence-free survival for our ImPACT bladder cancer vaccine even earlier than we anticipated. We believe this accelerated timeline has the potential to benefit high-risk patients with non-muscle invasive bladder cancer and brings us one step closer to providing a much needed viable treatment option."

Patient enrollment and dosing in the Vesigenurtacel-L Phase 2 study for the treatment of bladder cancer is expected to be completed in the third quarter of 2015. Heat then anticipates reporting top-line recurrence-free survival results in the third quarter of 2016 after the protocol’s twelve-month patient observation period ends.

For patients and physicians interested in enrollment information for the Phase 2 portion of the study of Vesigenurtacel-L in patients with high-risk non-muscle invasive bladder cancer, please visit clinicaltrials.gov and use Identifier NCT02010203.

DELCATH COMMENCES U.S. PHASE 2 STUDY OF MELPHALAN HEPATIC DELIVERY SYSTEM IN PRIMARY LIVER CANCER

On October 2, 2014 Delcath Systems reported the opening of its United States (U.S.) Clinical Development Program for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) or primary liver cancer (Press release Delcath Systems, OCT 2, 2014, View Source;p=RssLanding&cat=news&id=1973316 [SID:1234500779]). Moffitt Cancer Center in Tampa, Florida is the first U.S. center to open for patient enrollment. Johann Wolfgang Goethe University Hospital (JWG) in Frankfurt, Germany opened for enrollment in the European HCC Phase 2 trial in July. The Company’s Clinical Development Program is expected to include four to seven centers in Europe and United States and will seek to enroll approximately 30 patients.

HCC is the most common primary cancer of the liver, with approximately 700,000 new cases diagnosed worldwide annually. Surgical removal is not possible for an estimated 80-90 percent of primary liver cancer patients. In the U.S., the Phase 2 program will investigate the safety and efficacy of Melphalan/HDS treatment followed by sorafenib in patients with unresectable liver cancer confined to the liver, evaluate tumor response (objective response rate), as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), assess progression-free survival, safety, and the safety of sorafenib following treatment with Melphalan HDS. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan HDS, as well as an assessment of patient-reported clinical outcomes, or quality-of-life.

"Moffitt Cancer Center is an early pioneer in the clinical trial use of the Melphalan/HDS to treat patients with liver cancers. We are pleased that Moffitt will play a leading role in our HCC Phase 2 program," said Dr. Jennifer Simpson, Delcath’s Interim President and CEO. "We now have two centers one in each of the U.S. and Europe participating in our HCC Phase 2 program, and we expect to add additional sites in both regions in the coming months. Subject to timely enrollment of eligible patients, we anticipate having interim data from this trial available in the first half of 2015."