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Tolero Pharmaceuticals announces Worldwide Agreement with Sanofi for the In-license of Alvocidib (Flavopiridol)

On May 1, 2013 Tolero Pharmaceuticals reported that it has entered into a license agreement with Sanofi in which it received exclusive worldwide rights to develop and commercialize alvocidib (flavopiridol) (Press release Tolero Pharmaceuticals, MAY 1, 2013, View Source [SID:1234500706]). Alvocidib is a small molecule inhibitor of the cyclin-dependent kinases that has demonstrated activity in clinical trials in several malignancies, including chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML).

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Under the terms of the agreement, Tolero Pharmaceuticals will pay Sanofi an undisclosed upfront payment, and future payments on the successful achievement of milestones related to the commercialization of alvocidib. Sanofi will also receive tiered royalties on sales of alvocidib and maintains certain negotiation rights with respect to manufacturing the pharmaceutical product for Tolero and becoming a commercialization partner.

"We are tremendously excited about this new opportunity and feel fortunate to partner with Sanofi on this highly promising asset with near-term commercialization potential," said Dallin Anderson, Chairman and President of Tolero.

Dr. David Bearss, Tolero’s Chief Executive Officer, added, "Alvocidib has been evaluated in more than forty Phase I and Phase II clinical trials and has demonstrated remarkable activity in multiple studies of acute and chronic leukemia as both a single agent and in combination with chemotherapy." Tolero continues to advance various preclinical assets targeting areas of unmet need and strong commercial opportunity in the treatment of various cancers.

(Press release, Evotec, APR 30, 2013, View Source [SID:1234505358])

(Press release, Cannabis Science, APR 26, 2013, View Source [SID:1234506798])

Bristol-Myers Squibb Reports First Quarter 2013 Financial Results

The FDA has granted Fast Track designation for nivolumab in three tumor types: non-small-cell lung cancer, renal cell carcinoma and advanced melanoma (Press release Bristol-Myers Squibb, APR 25, 2013, View Source [SID:1234500641]).

Merck Announces Breakthrough Therapy Designation for Lambrolizumab an Investigational Antibody Therapy for Advanced Melanoma

On April 24, 2013 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types (Press release, Merck & Co, APR 24, 2013, View Source [SID1234525947]).

"We are pleased that the FDA has designated lambrolizumab a Breakthrough Therapy for patients with advanced melanoma," said Gary Gilliland M.D., Ph.D., senior vice president and oncology franchise head, Merck Research Laboratories. "The FDA’s decision to place lambrolizumab in a category that may enable expedited development and review is an important milestone for Merck as we advance ongoing programs in multiple cancer indications."

The designation of an investigational drug as a Breakthrough Therapy is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that an investigational drug be designated as a Breakthrough Therapy. The implications of Breakthrough Therapy Designation cannot be determined at this time.

In November 2012, early interim results from a single-arm, open-label Phase Ib study of lambrolizumab (MK-3475) administered to 85 patients with advanced (inoperable and metastatic) melanoma were presented at the Society for Melanoma Research of the 9th International Congress of the Society for Melanoma Research (SMR) in Hollywood, Calif. (see news release).

Advanced melanoma

Advanced melanoma accounts for more than 80 percent of skin cancer-related deaths and one to two percent of all cancer deaths in the United States1. According to the American Cancer Society, in 2012 in the U.S. an estimated 9,180 people died from advanced melanoma.

About PD-1

Researchers have shown that several tumor types are able to hide in plain sight by establishing a "molecular camouflage" that deceives the body’s immune system into thinking they are normal and therefore allow them to grow unchecked. The interaction between the immune checkpoint receptor PD-1 (programmed death) and its ligands represents a potentially important tumor-specific immunomodulatory mechanism. By utilizing the PD-1 pathway, a tumor cell can prevent the activation of T-cells and therefore may block a key step that triggers the immune system.

About lambrolizumab

Lambrolizumab is an investigational antibody therapy designed to disrupt the action of the immune checkpoint protein PD-1 and therefore inhibit the ability of some cancers to evade the body’s immune system. Lambrolizumab is being studied in multiple cancer types including melanoma and non-small cell lung cancer