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Myriad and BioMarin Expand Collaboration to Evaluate myChoice HRD(TM) as a Companion Diagnostic for Talazoparib

On March 17, 2015 Myriad reported an expansion of the Company’s collaboration with BioMarin Pharmaceutical Inc. Under the expanded collaboration, BioMarin will use Myriad’s myChoice HRD companion diagnostic test to prospectively identify patients with metastatic breast, ovarian and potentially other tumor types that may be sensitive to talazoparib(Press release, Myriad Genetics, MAR 17, 2015, View Source [SID:1234502301]). Financial terms were not disclosed.

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Talazoparib is an investigational poly-ADP ribose polymerase (PARP) inhibitor being developed by BioMarin. In the expanded relationship, the companies also will collaborate under FDA regulations and guidelines for the development and potential regulatory approval requirements for both talazoparib and myChoice HRD.

"Myriad is a pioneer in personalized medicine. Our companion diagnostics are providing clinicians with valuable biological data to accelerate and improve healthcare for their patients," said Mark Capone, president of Myriad Genetic Laboratories. "With cancer treatments, there is no one-size-fits-all approach for patients. We are excited to be working with BioMarin to help identify the patients who are most likely to benefit from talazoparib based on their own genetic makeup and biology."

The expansion adds to an ongoing collaboration that began in September 2013, when BioMarin began using Myriad’s BRACAnalysis CDx companion diagnostic test in its pivotal Phase 3 EMBRACA and Phase 2 ABRAZO clinical studies of talazoparib for advanced or metastatic breast cancer patients carrying BRCA mutations.

Kite Pharma Strengthens Its T Cell Receptor (TCR) Cancer Gene Therapy Platform Through Acquisition of T-Cell Factory B.V. (TCF(TM))

On March 17, 2015 Kite Pharma reported that it has further strengthened its TCR product platform and established a European presence through the acquisition of T-Cell Factory B.V. (TCF), a privately held Dutch company, which has been renamed Kite Pharma EU (Press release, Kite Pharma, MAR 17, 2015, View Source [SID:1234502299]). Founded by preeminent scientists, including Professor Dr. Ton N. M. Schumacher, Ph.D., of the Netherlands Cancer Institute (NKI) and Professor Dr. Dirk H. Busch, M.D., of the Technische Universität München (TUM), TCF has the ability to discover and develop tumor-specific TCRs for broad application in cancer treatment based on its proprietary TCR-GENErator platform. Professor Schumacher will assume the role of Chief Scientific Officer of Kite Pharma EU, and maintain his position as Deputy Director of the NKI. Through this acquisition, Kite Pharma has obtained license agreements with IBA GmbH, Sanquin Blood Supply Foundation, and the NKI that include rights to certain new intellectual property in the TCR space developed by Professor Schumacher at the NKI. In addition, the acquisition provides access to European clinical manufacturing facilities, launching a base for Kite to build its global presence and initiate clinical programs in the EU.

The acquisition of TCF follows the announcement earlier this month of Kite’s expanded Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop new TCR candidates, including against tumor neo-antigens, truly tumor-specific antigens generated as tumors accumulate genetic mutations. TCRs broaden the approach to cancer treatment by allowing targeting of tumor antigens found inside cancer cells, as well as surface antigens.

"The acquisition of TCF and its novel discovery and development platform provides Kite with a strong position in TCR gene therapy for cancer. In addition, with our strategic plans for expanding clinical operations to ex-US sites, Kite’s relationship with NKI, an internationally renowned research and clinical institution, provides an important operational platform and potential access to investigators, clinical sites and manufacturing facilities in Amsterdam," said Arie Belldegrun, M.D., FACS, Kite’s President and Chief Executive Officer. "Kite plans to leverage its access to intellectual property, know-how, and a network of collaborators across the continent to build a robust pipeline of TCR gene therapies."

"Through the tight link between our research institute and dedicated cancer hospital, we are in a unique position to discover, develop and manufacture cellular gene therapies for cancer," said Professor René Medema, Director of NKI. "NKI’s goal is to become the leader in T cell gene therapy in Europe, and we are expanding our clinical and manufacturing capacities. We are excited about partnering with Kite and potential future R&D collaborations with the company. We will continue to support Professor Schumacher in his new role with Kite Pharma EU in addition to his ongoing relationship with NKI."

"T cell based gene therapy products will have a profound role in treating currently intractable diseases. We believe the combination of TCF’s leading technology platform, the translational and development capabilities at the Netherlands Cancer Institute, and Kite’s expertise in advancing immune-oncology products, will rapidly bring important TCR-based gene therapies to patients," stated Professor Schumacher.

David Chang, M.D., Ph.D., Kite Pharma’s Executive Vice President, Research and Development, and Chief Medical Officer, commented, "In addition to expanding our capabilities in TCR, this acquisition is an important first step in our goal of global clinical expansion outside the US, applying our leadership and in-house clinical expertise in both CAR and TCR therapies. We are pleased with the accelerating momentum of our programs and look forward to additional clinical, operational, and manufacturing progress and accomplishments this year."

Financial terms of Kite’s acquisition of TCF include an upfront payment of up to €20.0M (approximately $21.0M USD) to TCF shareholders, licensors and employees, of which €3.8M (approximately $4.0M USD) will be paid in Kite stock. Kite is obligated to make certain milestone payments upon the achievement of clinical, regulatory and sales milestones relating to TCR-based product candidates.

Celldex Therapeutics Announces Clinical Trial Collaboration with Roche to Evaluate the Combination of Varlilumab and MPDL3280A

On March 17, 2015 Celldex Therapeutics reported that it has entered into a clinical trial collaboration with Roche to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex’s CD27 targeting investigational antibody, and MPDL3280A (anti-PDL1), Roche’s investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma (Press release, Celldex Therapeutics, MAR 17, 2015, View Source [SID:1234502298]).

Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body’s own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex’s Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response (11.0+ months) that has continued to decrease in tumor volume over time and prolonged stable disease (4 patients with a range of 5.3 to 30.7+ months).

"This collaboration with Roche furthers our ongoing initiative to investigate varlilumab’s potential in combination with a broad range of mechanisms and across multiple tumor types," said Thomas Davis, MD, Executive Vice President and Chief Medical Officer of Celldex Therapeutics. "Varlilumab is currently being studied in two Phase 1/2 combination studies and we expect it will enter at least another four combination studies this year. This latest trial is supported by promising signs of single-agent activity observed in our Phase 1 study in patients with renal cell carcinoma. We believe combining an immune activator with a checkpoint inhibitor in this disease setting may augment this activity and the synergy demonstrated in our preclinical varlilumab/anti-PDL1 combination models provide further support for this approach."

Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.

About Varlilumab

Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes. CD27 can be effectively manipulated with activating antibodies to induce potent anti-tumor responses and may result in fewer toxicities due to its restricted expression and regulation. Varlilumab is a potent anti-CD27 agonist that induces activation and proliferation of human T cells when combined with T cell receptor stimulation. In lymphoid malignancies that express CD27 at high levels, varlilumab may have an additional mechanism of action through a direct anti-tumor effect. Varlilumab has completed a Phase 1 dose-escalation study, demonstrating potent immunologic activity consistent with its mechanism of action and anti-tumor activity in patients with advanced, refractory disease. No maximum tolerated dose was reached and minimal toxicities were observed. Celldex has initiated a broad development program for varlilumab to explore its role as an immune activator in combination with a number of complementary investigational and approved oncology drugs. Varlilumab is currently being studied in two Phase 1/2 combination studies and several additional combination studies will be initiated in 2015.

About MPDL3280A (anti-PDL1)

MPDL3280A (also known as anti-PDL1 and RG7446) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. MPDL3280A is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Stemline Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Stemline Therapeutics, MAR 16, 2015, View Source [SID1234502384]).

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Rosetta Genomics has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Rosetta Genomics, MAR 16, 2015, View Source [SID1234502376]).