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Foundation Medicine And Mirati Therapeutics Collaborate To Develop A Companion Diagnostic For Glesatinib (MGCD265) In Non-Small Cell Lung Cancer (NSCLC)

On December 21, 2015 Foundation Medicine, Inc. (NASDAQ: FMI) and Mirati Therapeutics, Inc. ("Mirati") (NASDAQ: MRTX), a targeted oncology company focusing on genetic and epigenetic drivers of cancer, reported that they have entered into a collaboration for the development of a companion diagnostic test for glesatinib (Press release, Foundation Medicine, DEC 21, 2015, View Source [SID:1234508622]). The test, designed for use by physicians, will be used to identify NSCLC patients most likely to respond to Mirati’s kinase inhibitor, glesatinib.

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The companion diagnostic is part of a coordinated regulatory strategy and is being developed in parallel with the clinical development of glesatinib. The coordinated regulatory strategy is expected to facilitate a submission to the U.S. Food and Drug Administration (FDA) of a Premarket Approval (PMA) for the companion diagnostic, concurrent with the New Drug Application (NDA) for glesatinib. Patients with MET gene amplification and MET mutations are currently being enrolled in a Phase 2 trial of glesatinib. FoundationOne, Foundation Medicine’s comprehensive genomic profiling assay for solid tumors, is being used in the trial to identify those patients most likely to benefit from glesatinib based on patient genomic profiles, which will enable targeted recruitment of patient populations.

"We’re pleased to work with Mirati as they advance glesatinib through the clinic, and to contribute to Mirati’s efforts to advance patient care through precision medicine," said Steven Kafka, Ph.D., president and COO, Foundation Medicine. "Our collaboration with Mirati is an example of the growing demand for companion diagnostics that rely upon comprehensive genomic profiling. Importantly, this collaboration also represents significant progress in advancing Foundation Medicine’s development of a universal companion diagnostic, a validated assay that streamlines and simplifies clinical decisions by providing all the necessary genomic information to help physicians target relevant cancer therapeutics with a single assay."

"Mirati treats cancer as a genetic disease. Often referred to as targeted oncology, this approach means we must find the genetic alterations responsible for driving cancer growth, like MET and Axl alterations, and block the activity of those targets. An effective patient selection strategy is a critical part of this process," said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. "In collaboration with Foundation Medicine, we expect to develop a companion diagnostic based upon their comprehensive genomic profiling assay that will detect all the relevant mutations in a single assay from a single biopsy, and provide patients with data to make the best treatment decisions. Identifying and treating the more than 15,000 non-small cell lung cancer patients in the U.S. who are most likely to respond to glesatinib may result in significantly improved patient outcomes."

About Glesatinib (MGCD265)
Glesatinib (MGCD265) is a tyrosine kinase inhibitor that is expected to potently and selectively target tumors in patients with driver alterations in MET (mutations and gene amplification) and Axl (rearrangements) that occur in approximately 8% of patients with non-small cell lung cancer (NSCLC). Glesatinib is being evaluated in a Phase 1b study in patients with solid tumors that have genetic alterations in MET or AXL genes. The Phase 2 trial in NSCLC patients with MET genetic alterations is underway to confirm and extend the data that supports the clinical benefit of glesatinib in patients with driver mutations in MET. Genetic alterations in these targets have been implicated as drivers of tumor growth and disease progression in NSCLC, gastroesophageal cancer and other solid tumors. MET and Axl are also implicated as drivers of tumor progression in patients whose tumors have become resistant to EGFR inhibitors. Therefore, Mirati believes that the combination of glesatinib with an EGFR inhibitor could potentially treat patients who have become resistant to agents targeting EGFR. Mirati retains worldwide rights to glesatinib.

Momenta Resumes Patient Enrollment in the Necuparanib (MOM-M402-103) Phase 2 Study

On December 21, 2015 Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) reported that it has resumed patient enrollment in its ongoing Phase 2 portion of the trial "A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer (Press release, Momenta Pharmaceuticals, DEC 21, 2015, View Source [SID:1234508621]).

" Study enrollment was paused last month following Momenta’s acceptance of recommendations from its Data Safety Monitoring Board (DSMB) to develop guidelines for diagnosing and managing thrombocytopenia, based on a limited number of specific toxicities observed in the study.

"We are pleased that following their review of the protocol amendment, the DSMB is supportive of resuming patient enrollment in our necuparanib study," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. "Given the projected timelines to obtain Institutional Review Board approval of the protocol amendment across study sites, we now anticipate that the top-line data should be available in the second half of 2017."

About Necuparanib
Necuparanib (M402) is a novel oncology drug candidate engineered to have a broad range of effects on tumor cells. The use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity; however, the dose of these products has been limited by their anticoagulant activity. Leveraging its experience in deciphering the structure-function relationships of complex therapeutics, Momenta engineered necuparanib from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins. A Phase 2 randomized, double-blind, controlled study to evaluate the antitumor activity of necuparanib in combination with nab-paclitaxel (Abraxane) plus gemcitabine, versus nab-paclitaxel plus gemcitabine alone in pancreatic cancer is currently underway. Necuparanib has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

Medivation Initiates Pivotal Clinical Trial of MDV9300 in Diffuse Large B-Cell Lymphoma

On December 21, 2015 Medivation, Inc. (NASDAQ: MDVN) reported the initiation of an international Phase 2 clinical trial that will evaluate the safety and efficacy of MDV9300 (pidilizumab) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Medivation, DEC 21, 2015, View Source [SID:1234508620]).

In light of the unmet medical need in this area, a positive outcome in this trial has the potential to support registration for this indication in the U.S. and European Union utilizing available expedited pathways.

"Despite overall improvement in outcomes following the incorporation of rituximab into standard initial chemoimmunotherapy, curative treatment options do not exist for an appreciable number of patients with relapsed disease," said Jason Westin, M.D., leader, DLBCL clinical research, The University of Texas MD Anderson Cancer Center. "Patients with DLBCL who have residual disease following autologous stem cell transplant or salvage chemotherapy have few effective therapies available, none of which are approved or proven to be capable of deepening and prolonging their response. It is my hope that this trial will demonstrate that MDV9300 is an efficacious and well tolerated treatment option for these patients."

"Our data indicate that administration of MDV9300 is associated with enhanced maturation and survival of T lymphocytes, which may improve adaptive immunity, as well as activation of natural killer cells, which may improve innate immunity," said David Hung, M.D., president and chief executive officer of Medivation. "Such broad effects on both sides of the immune response are not widely reported with checkpoint inhibitors and may differentiate pidilizumab from other agents in the complex immuno-oncology landscape."

About the Phase 2 Trial
The international, open-label, Phase 2 trial of MDV9300 is expected to enroll approximately 180 patients with an incomplete response following salvage therapy or autologous stem cell transplantation for relapsed or refractory CD20+ diffuse large B-cell lymphoma, transformed indolent lymphoma or primary mediastinal B-cell lymphoma. The patients will be assessed in two parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have received an autologous stem cell transplant, and the second cohort will enroll patients who have received salvage chemotherapy, but are transplant-ineligible. MDV9300 will be administered at a dose of 200 mg by IV infusion. The primary endpoint of the trial is best overall response rate.

Genmab Announces Completion of Agreement to Transfer Remaining Ofatumumab Rights

On December 21, 2015 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the agreement under which GlaxoSmithKline (GSK) grants Novartis Pharma AG (Novartis) the remaining rights to ofatumumab, including rights in autoimmune diseases, is now effective (Press release, Genmab, DEC 21, 2015, View Source [SID:1234508619]).

The agreement was announced in August 2015 and was subject to certain closing conditions, which have now been met. Novartis will be responsible for the development and commercialization of ofatumumab for all indications going forward.

"We are pleased with our existing collaboration with Novartis within the cancer field, and are looking forward to working with Novartis on ofatumumab for all remaining indications, including autoimmune diseases. We are looking forward to the initiation of clinical studies evaluating the subcutaneous formulation of ofatumumab as a potential therapy for patients with various autoimmune disorders," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).

Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

AVEO and EUSA Pharma Announce Exclusive Licensing Agreement for Tivozanib in Europe

On December 21, 2015 AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma, a newly-established specialty pharmaceutical business with global reach, reported an exclusive license agreement in which AVEO has granted EUSA Pharma European rights to tivozanib for the treatment of advanced renal cell carcinoma ("RCC") (Press release, AVEO, DEC 21, 2015, View Source [SID:1234508617]).

The agreement also includes a number of additional territories outside North America, including South America and South Africa, and additional potential indications.

Under the terms of the agreement, EUSA Pharma will pay AVEO an upfront research and development funding payment of $2.5 million, and up to $394 million in potential payments and milestones, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. A percentage of milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

EUSA Pharma plans to submit a Marketing Authorization Application for tivozanib as a first line treatment for advanced RCC to the European Medicines Agency in the first quarter of 2016. Under the terms of the agreement, EUSA Pharma will undertake and fund future regulatory and commercial activities to bring tivozanib to market and commercialize the product within the agreement’s territories.

"Tivozanib has the potential to become an important new first line treatment for advanced renal cell carcinoma in Europe, and we look forward to submitting a Marketing Authorization Application in the coming months," said Lee Morley, chief executive officer of EUSA Pharma. "As a recently established specialty pharma company, we have ambitious growth plans, and tivozanib is a strong strategic fit with our portfolio of marketed specialty products, as we increase our focus on oncology."

"Our agreement with EUSA Pharma marks a critical step in the execution of our company strategy. Between our partnership with EUSA and our previous agreements with Ophthotech and Pharmstandard, we have a solid foundation to potentially generate near-term capital and long-term value for this important asset while retaining commercial rights to tivozanib in oncology in North America," said Michael Bailey, president and chief executive officer of AVEO. "These tivozanib partnerships collectively amount to over $35 million in potential payments over the next 18 months in addition to potential payments from our other licensed pipeline assets, which could provide substantial additional funding to support our tivozanib development strategy for North America. We look forward to working with the experienced commercial and regulatory team at EUSA Pharma as they seek to successfully commercialize tivozanib in Europe."

Today’s Conference Call Information

AVEO will host a conference call today, December 21, at 9:00 am (ET). The call can be accessed by dialing (866) 428-2694 (domestic) or (704) 908-0403 (international) five minutes prior to the start time and providing the conference ID 13985653. A live webcast of the conference call can be accessed by visiting the investors section of the AVEO website at www.aveooncology.com. A replay of the webcast will be archived on the AVEO website for two weeks following the call.

About Tivozanib

Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been evaluated in several tumors types, including renal cell, colorectal and breast cancers.

About EUSA Pharma

Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company. The company has commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world. Currently, EUSA has a portfolio of five approved and several named-patient specialty hospital products, and the company has ambitious plans to expand this through acquisition and in-licensing. EUSA is led by an experienced management team with a strong record of building successful specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor Essex Woodlands.

EUSA Pharma’s products include: Caphosol for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy; Collatamp, a gentamicin-collagen implant licensed either in haemostasis or for the prevention and treatment of surgical site infection; Custodiol solution for use in the preservation of organs for transplantation; Fomepizole for the treatment of ethylene glycol poisoning; and Xenazine for the treatment of movement disorders associated with Huntington’s chorea.

For more information please visit www.eusapharma.com.