Oncology News – July 2015

July 2015, Vol 6, No 6 - Oncology News

In This Article

Eli Lilly and Immunocore Launch New Collaboration to Develop Next-Generation Immuno-oncology Therapies

June 29, 2015—A collaboration announced by Eli Lilly & Co and Immunocore—2 leading companies involved in immunotherapies to fight cancer—is the newest example of recent efforts by major pharmaceutical companies to ramp up the development of cancer therapies by teaming up with other companies to identify the next generation of cancer drugs that use the patient’s own immune system to destroy cancer cells.

In this new venture, Eli Lilly and Immunocore will combine clinical trials to study each company’s experimental immunotherapy cancer drug in combination. This approach reflects the growing belief among oncology experts that combination therapies hold the key to the future of fighting cancer: using multidrug regimens is showing more promise than using a single drug when it comes to killing cancer cells. These immuno-oncology combination therapies are expected to transform cancer care, researchers believe.

“This collaboration with Immunocore underscores Lilly’s commitment to discovering the potential of combination therapies, which will be key to the future of cancer care for people fighting diseases such as melanoma,” said Richard Gaynor, MD, Senior Vice President, Product Development and Medical Affairs for Lilly Oncology. “Lilly is building a robust portfolio of potential advances in immunotherapy through our own research as well as with strategic collaborations like Immunocore.”

The UK-based Immunocore is already collaborating with several global pharmaceutical companies for the development of biologic therapies, many of them for cancer. According to Immunocore, the company has “a highly innovative immuno-oncology platform technology called ImmTACs. ImmTACs are a novel class of biologic drugs based on the Company’s proprietary T cell receptor (TCR) technology, which have the potential to treat diseases with high unmet medical need including cancer, viral infections and autoimmune diseases.”

This new immunotherapy-based clinical trial collaboration between Eli Lilly and Immunocore will develop a combination therapy for melanoma that includes 2 early-stage drugs from Eli Lilly—galunisertib and merestinib—and Immunocore’s IMCgp100, which is the company’s leading TCR immunotherapy in development.

The hope is that this combination regimen will enhance the efficacy and durability of the drugs in patients with metastatic melanoma. The collaboration will involve 2 trials—(1) a phase 1b/2 clinical trial of IMCgp100 in combination with the galunisertib in metastatic cutaneous melanoma, and (2) a phase 1b/2 trial that will combine IMCgp100 and merestinib in metastatic uveal melanoma.

“We are very pleased to be able to announce a second collaboration with Lilly after entering into a collaboration last year,” said Eliot Forster, Chief Executive Officer of Immunocore. “Combining our ImmTAC, IMCgp100 with Lilly’s galunisertib and merestinib has the potential to transform the treatment of metastatic cutaneous and uveal melanoma. Immunocore is committed to the development of IMCgp100 in metastatic uveal and cutaneous melanoma where there is such great unmet medical need.” He added, “We believe the best results for patients are going to come through combination therapies.”

Sources: Eli Lilly & Co (www.lilly.com); Immunocore (www.immunocore.com/about-immunocore).

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Biosimilars Focus on Oncology, Could Reach $55 Billion by 2020

June 30, 2015—According to a report by GBI Research, a healthcare research company, the global sales of biosimilars could be $20 billion by the end of 2015 and could reach $55 billion in 5 years, based on the current drug pipeline and the government efforts to curtail healthcare costs. According to this report, the value of biologic drugs currently amounts to approximately $200 billion, and biosimilars are expected to replace 70% of these agents in the next 2 decades.

Sumith Ladda, an analyst at GBI Research, said, “There are currently 642 biosimilar trials being conducted, with 146 unique molecules. Biosimilars are most focused on oncology therapy, with a 36% share, while immunology treatment comprises 21% of the pipeline, meaning these two segments account for more than half of the total trials.”

The development trend of biosimilars follows the general trend in cancer drugs, with the focus shifting from older drugs to newer therapies, which will be losing patent soon. “Historically, simple proteins, such as filgrastim and epoetin, were the prime targets of biosimilar development,” Ms Ladda said, “but the focus has now shifted to complex monoclonal antibodies (mAbs), as there are numerous blockbuster mAbs going off-patent.”

Although the value of the US market for biologics is twice the size of biologics in Europe, the biosimilar market has been nearly 4 times that of the United States. The first biosimilar to be approved by the FDA was Zarxio (filgrastim-sndz; a biosimilar to Neupogen) on March 6, 2015.

Source: GBI Research (www.gbiresearch.com/media-center/press-releases/­global-biosimilars-market-value-could-hit-55-billion-by-2020-says-gbi-research).

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ImmunoCellular Therapeutics and Novella Clinical to Collaborate on a Phase 3 Trial in Glioblastoma

July 6, 2015—ImmunoCellular Therapeutics, Ltd, announced that it has established an agreement with Novella Clinical to conduct the phase 3 clinical trial of ICT-107 to investigate the use of a dendritic cell–based cancer immunotherapy in patients with newly diagnosed glioblastoma. Novella provides clinical trial services to relatively small oncology companies involved in cancer drug development. The ICT-107 phase 3 trial is expected to include approximately 120 clinical sites globally in the United States, Europe, and Canada. The trial will include approximately 400 patients with newly diagnosed glioblastoma. The phase 3 trial is expected to be launched in the fourth quarter of 2015.

“Establishing this agreement with Novella Clinical moves us one more critical step forward in the implementation of our phase 3 ICT-107 registrational trial,” said Andrew Gengos, Chief Executive Officer of ImmunoCellular. “Novella’s special expertise in oncology clinical trials, combined with their strong international network, experience working with oncology cooperative groups, and reputation for high quality, efficiency and cost-effectiveness, make them an excellent partner for our ICT-107 program. We are rapidly building the infrastructure for our phase 3 program and remain on track to initiate the trial later this year.”

Richard Staub, Novella’s President, said, “We are proud and very pleased to be selected to support this proprietary oncology immunotherapy platform for glioblastoma. We look forward to working alongside ImmunoCellular to navigate the development and successful execution of this pivotal program to ultimately benefit patients.”

Source: ImmunoCellular press release (http://investors.imuc.com/releases.cfm).

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House Passes New Medicare Bill That Includes a Value-Based Insurance Design Pilot Project

June 24, 2015—On June 17, 2015, the US House of Representatives passed H.R. 2570, “Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act of 2015,” which also calls for the establishment of a demonstration project that allows Medicare Advantage health plans to use value-based insurance design (VBID) that bases patients’ out-of-pocket costs, such as copay, on the value instead of the cost of the service they receive.

If the bill becomes law, it would allow Medicare Advantage plans to lower members’ copay and coinsurance based on the concept of high-value, evidence-based services for patients with chronic conditions. It prevents plans from increasing the cost-sharing on any service.

Several VBID programs have been implemented by payers, employers, and business coalitions across the country. So far, the evidence validates the VBID premise in its ability to improve patient outcomes, reduce care disparities, and potentially curb overall healthcare costs.

Source: University of Michigan Health System press release (www.ihpi.umich.edu).

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