(Press release, Novogen, OCT 24, 2014, View Source [SID:1234506153])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Medivation and CureTech reported that Medivation has licensed exclusive worldwide rights to CureTech’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody (Press release Medivation, OCT 23, 2014, View Source [SID:1234500873]). Under the license agreement, Medivation will be responsible for all development, regulatory and commercialization activities for pidilizumab for all indications, including oncology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Immuno-oncology is a significant area of interest for researchers in the development of anti-cancer therapies, marked by its potential to stimulate the body’s immune system to fight disease," said David Hung, M.D., President and Chief Executive Officer of Medivation. "Licensing rights to pidilizumab under this agreement marks an important step in our strategy to further diversify our portfolio."

"We believe that Medivation’s expertise and accomplishments in drug development will be a tremendous advantage in the highly competitive field of oncology immunotherapy," said Michael Schickler, Chief Executive Officer of CureTech. "We are pleased that Medivation will advance this molecule to the next stage of development and potential commercialization."

The arrangement with CureTech also includes a manufacturing and supply agreement, under which CureTech will manufacture and supply the antibody to Medivation over the next 3 years for clinical development purposes. In addition, the arrangement contemplates a guaranty agreement between Medivation and CureTech’s largest (53%) shareholder — Clal Biotechnology Industries Ltd. (CBI) — with respect to certain obligations of CureTech. The guaranty is subject to approval by CBI shareholders. If approval of the guaranty agreement is not obtained, Medivation has the option to terminate both the license agreement and the manufacturing and supply agreement or proceed with such agreements on reduced economic terms (i.e. a reduction of $2 million in the upfront payment and 1% from each tier of royalties). The shareholder vote on the guaranty and Medivation’s exercise of its option to continue to maintain the license are expected to occur in December 2014.

Under the terms of the license agreement, and depending on whether the guaranty from CBI is obtained, CureTech would receive an upfront payment of up to $5.0 million from Medivation and would also be entitled to payments upon the attainment of certain development and regulatory milestones totaling $85 million. In addition, CureTech would be eligible to receive sales based milestone payments totaling up to $245 million, upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 4%-11% based on annual worldwide net sales.