On October 24, 2014 ARIAD Pharmaceuticals reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted its final opinion on Iclusig (ponatinib) following the recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC) earlier this month (Press release Ariad, OCT 24, 2014, View Source;p=RssLanding&cat=news&id=1981265 [SID:1234500874]). The PRAC conducted an 11-month review of the available data on Iclusig and consulted with a scientific advisory group in oncology. This week, the EMA recommended that Iclusig continue to be used in accordance with its already approved indications as a treatment of certain leukemias and confirmed that the benefit-risk profile of Iclusig continues to be positive in each of these indications. The EMA also recommended additional warnings in the European product information to minimize the risk of vascular events.

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"We are now well positioned to complete pricing and reimbursement negotiations in Europe and to ensure that Iclusig is available to appropriate Philadelphia-chromosome positive leukaemia patients," said Jonathan E. Dickinson, general manager, ARIAD Pharmaceuticals (Europe). "The authorized indications and the favorable benefit-risk balance of Iclusig give healthcare providers the ability to optimize the use of Iclusig in patients with resistant or intolerant CML."

The authorized indications of Iclusig in Europe, as approved in July 2013, are as follows:

The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or
The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

"Over the past year, we have closely monitored patients on Iclusig and are confident that the updated safety information will help us provide this important therapy to patients who have become resistant or intolerant to certain other tyrosine-kinase inhibitors," said Giuseppe Saglio, M.D., professor of internal medicine and haematology at the University of Turin and director of the Department of Internal Medicine and head of the Division of Haematology at the San Luigi University Hospital of the University of Turin in Italy. "The flexibility to reduce the dose after achievement of response is an important factor for physicians in treating CML patients with Iclusig."

The CHMP is a scientific committee composed of representatives from the 28-member states of the EU, and Iceland and Norway. The CHMP reviews medical product applications on their scientific and clinical merit and provides advice to the European Commission, which has the authority to approve medicines for the EU. The European Commission is expected to issue a final legally binding decision on Iclusig in December 2014, which will be valid throughout the EU.

On October 23, 2014 Biothera reported that a phase 1b clinical trial at the University of Illinois at Chicago (UIC) will evaluate a new combination therapy for advanced pancreatic cancer that includes two Biothera cancer immunotherapy drug candidates (Press release Biothera, OCT 23, 2014, View Source [SID:1234500878]).

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The investigator-sponsored study combines Biothera’s Imprime PGG and mucin-1 (MUC1) targeted monoclonal antibody BTH1704 with the chemotherapy gemcitabine (Gemzar) in patients with advanced, previously treated pancreatic ductal adenocarcinoma (PDAC).

"There is an urgent and unmet need for effective treatments for patients with advanced pancreatic cancer after first-line chemotherapy fails," said Dr. Neeta Venepalli, UIC assistant professor of hematology/oncology and principal investigator of the study.

Advanced PDAC has a five-year survival rate of less than 5% and is the fourth-leading cause of cancer deaths in the U.S., claiming nearly 40,000 lives each year.

Mucin-1 (CD 227) is a tumor-associated antigen that is both overexpressed and aberrantly glycosylated in more than 60% of pancreatic cancers, and has been associated with poor clinical outcomes and resistance to chemotherapy. BTH1704 is a monoclonal antibody that binds to Mucin-1 on the surface of pancreas cancer cells, resulting in opsonization of the tumor cells, effectively marking them for destruction by innate immune cells.

Imprime PGG is a biologic immune modulator that targets the innate immune system, enabling neutrophils via a complement receptor 3 (CR3)-dependent mechanism to exert anti-tumor activity against complement opsonized tumor cells. This novel mechanism synergizes with anti-tumor monoclonal antibodies, with significant therapeutic potential in a wide range of cancer indications.

"We are excited to see two promising Biothera products advance into clinical development in pancreas cancer – an area of particularly high unmet medical need," said Ada Braun, M.D., Ph.D., Biothera’s chief medical officer. "This study is designed to provide important safety and translational research information as well as proof of concept efficacy data for this innovative combination therapy approach."

Phil L’Huillier, director of business development for Cancer Research Technology, which exclusively licenses BTH1704 to Biothera, said: "Recent research has highlighted the potential to treat cancer by combining immunotherapies with other targeted treatments and we welcome the opportunity to collaborate with companies working in this promising area of research."

Study Design
This phase 1b open-label dose escalation study will evaluate weekly treatment with BTH1704 at assigned doses (3, 6 or 9 mg/kg) and Imprime PGG 4 mg/kg, in combination with gemcitabine 1000 mg/m2 administered on days 1, 8, and 15 of each 28-day cycle, in up to 24 patients with locally advanced, recurrent or metastatic PDAC. The primary objective of the study is to determine the maximum administered dose of BTH1704 in combination with gemcitabine and Imprime PGG when given to patients with advanced and previously treated PDAC. Secondary objectives are to evaluate clinical response, time to progression, progression-free survival and overall survival. For more information on this trial, please visit View Source using the identifier NCT 02132403.

On October 23, 2014 Epizyme reported that the US Patent and Trademark Office has granted Notices of Allowance for US Patent Applications, Nos. 14/136,551 and 14/136,738, both entitled "PRMT5 Inhibitors and Uses Thereof" (Press release Epizyme, OCT 23, 2014, View Source [SID:1234500863]). The allowed claims cover inhibitors of PRMT5 and methods of cancer treatment with PRMT5 inhibitors. PRMT5 is implicated in several cancers, including blood cancers.

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Epizyme also announced the publication of 10 patent applications covering chemical matter targeting several additional HMTs: CARM1, PRMT1, PRMT3, PRMT6 and PRMT8. These additional HMT targets are implicated in a variety of solid tumors and hematologic malignancies.

"These notices of allowance and publications further solidify our leadership position in the HMT space, and we continue to advance our dominant intellectual property position. Epizyme now has patents and patent applications for 13 of the 20 prioritized targets that comprise the Company’s pioneering HMT platform, covering therapeutic and diagnostic methods, combination therapy methods and pharmaceutical compositions," said Robert Gould, Ph.D., President and Chief Executive Officer, Epizyme. "We believe these patents and pending applications place us in the strongest possible position to build our company over the long-term and accelerate our efforts to bring life-saving drugs to patients."

On October 23, 2014 Genmab reported that it has reached the fourth milestone in its daratumumab collaboration with Janssen Biotech (Press release Genmab, OCT 23, 2014, View Source [SID:1234500865]). The USD 10 million milestone payment was triggered by progress in the ongoing Phase III study ("CASTOR" MMY3004) of daratumumab in combination with bortezomib and dexamethasone compared to bortezomib and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma.

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"We are very pleased with the firm progress being made in the daratumumab development program under the direction of our strategic partner Janssen. At Genmab we are committed to developing differentiated therapeutics to fight cancer, and it is therefore rewarding to see one of our antibodies moving rapidly through clinical development," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

This milestone payment is included in Genmab’s 2014 financial guidance as published on August 13, 2014.

On October 23, 2014 Pfizer reported that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT (sunitinib malate) capsules (Press release Pfizer, OCT 23, 2014, http://www.pfizer.com/news/press-release/press-release-detail/pfizer_wins_sutent_patent_case_in_delaware_district_court [SID:1234500866]). This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021.

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"The Court’s decision acknowledges the validity and infringement of our patents and affirms the value of SUTENT, a standard of care in the treatment of advanced renal cell carcinoma," said Douglas M. Lankler, executive vice president and general counsel for Pfizer. "Defending our intellectual property is crucial to our ability to discover and develop innovative new medicines, which is at the very core of what we do."

Pfizer filed suit in June 2010 after Mylan Pharmaceuticals Inc. applied to the U.S. Food and Drug Administration (FDA) to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.

The patents at issue are U.S. Patent Nos.6,573,293 and 7,125,905.