1stOncology™: Cancer Intelligence Service – Page 16345 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

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

Bio-Path Holdings 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, Bio-Path Holdings, MAR 16, 2015, View Source [SID1234502296]).

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!

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

Agenus 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, Agenus, MAR 16, 2015, View Source [SID1234502295]).

8-K – Current report

On March 16, 2015 NantWorks and Sorrento Therapeutics reported that they have entered into a binding term sheet to initiate a global collaboration to discover and develop novel anti-cancer immunotherapies derived from Sorrento’s proprietary G-MAB library against neoepitopes of tumor-specific antigens discovered using NantWorks’ proprietary genomics-based, personalized medicine approach (Filing, 8-K, Sorrento Therapeutics, MAR 16, 2015, View Source [SID:1234502379]). Under the terms of the agreement, Sorrento will exclusively license to NantCell, LLC, a NantWorks company, certain antibodies and CAR-TNK products in exchange for $10 Million in cash and $100 million in NantCell’s equity. In addition to the equity and cash payments, Sorrento will retain a share of all future profits resulting from the collaboration.

In December 2014, Sorrento and NantWorks entered into a binding term sheet to form a joint venture known as "Nantibody, LLC". Under the terms of that agreement, Nantibody committed to develop a Phase III antibody from NantCell as well as a portfolio of pre-clinical immune-modulating, immuno-oncology, bispecific antibodies, and antibody-drug conjugates (ADCs) from Sorrento. Nantibody is to be funded with $100 Million with 60/40 ownership by NantWorks and Sorrento, respectively.

"We are excited to be working with NantWorks again", said Dr. Henry Ji, President and CEO of Sorrento. "Through these strategic alliances, we are accelerating the development of our diverse portfolio of fully human monoclonal antibodies into the clinic. In addition, we will be spearheading the discovery and development of immunotherapies against neoepitopes of tumor-specific antigens."

"We are pleased to expand our working relationship with Sorrento. Our innovative collaborations will unite Sorrento’s capability to develop immunotherapies with NantCell’s proprietary genomic and personalized medicine technologies," said physician scientist, biotechnology entrepreneur and NantWorks founder Dr. Patrick Soon-Shiong. "We are committing significant resources to the development of truly novel cancer immunotherapies, an area of significant unmet need."

Tokai Pharmaceuticals Announces Expansion to Collaboration with Qiagen on the Development of an AR-V7 Companion Diagnostic

On March 16, 2015 Tokai Pharmaceuticals reported an expansion of the agreement with Qiagen for the development and commercialization of an AR-V7 companion diagnostic for use with galeterone (Press release, Tokai Pharmaceuticals, MAR 16, 2015, View Source [SID:1234502294]).

Under the expanded agreement, Tokai will receive the exclusive right from Qiagen to its newly acquired circulating tumor cell (CTC) enrichment technology for use with galeterone, which will be incorporated into the companion diagnostic already under development by Qiagen.

"We are pleased to be expanding our partnership with Qiagen with exclusive access to their newly acquired CTC enrichment technology for use with the AR-V7 companion diagnostic for galeterone," stated Jodie Morrison, president and chief executive officer of Tokai Pharmaceuticals. "This access adds further support to our growing IP portfolio for galeterone for AR-V7 positive castration-resistant prostate cancer (CRPC). Qiagen is a global leader in liquid biopsy-based solutions for precision medicine and has the expertise to commercialize the companion diagnostic around the world. This global capability will be critical as we work to bring galeterone to prostate cancer patients who test positive for AR-V7, which has been linked to non-responsiveness to commonly used oral therapies. It is our belief that future availability of this companion diagnostic for AR-V7 will allow prostate cancer patients and their physicians to make more informed decisions regarding their care."

Development of an AR-V7 companion diagnostic for use with galeterone has been underway since October 2014. Qiagen’s newly acquired CTC technology was utilized in the AR-V7 assay methods developed by the Johns Hopkins University licensed by Tokai in January. Tokai and Qiagen expect that development of the AR-V7 clinical trial assay will be completed in the first half of 2015 prior to the start of the ARMOR3-SV AR-V7 metastatic CRPC registration clinical trial.

AR-V7 positive prostate tumors express a truncated form of the androgen receptor (AR). These truncated ARs are missing the C-terminal end of the receptor that contains the ligand binding domain. In 2014, the Johns Hopkins University, in a prospective study using the Qiagen technology to isolate and enrich CTCs and an assay to determine AR-V7 status, demonstrated poor responsiveness to Zytiga (abiraterone acetate) and Xtandi (enzalutamide), two commonly used oral therapies for metastatic CRPC. The Company believes that galeterone has the potential to treat patients with AR-V7 based on data from preclinical studies and retrospective data in patients with C-terminal loss, the most common form of which is AR-V7, from the Company’s Phase 2 ARMOR2 trial of galeterone.

"Our partnership with Tokai Pharmaceuticals, one of the collaborations which we are pursuing with pharma in this area, is expected to result in a liquid biopsy, CTC-based test for the AR-V7 splice variant in the first half of this year, with the potential to enhance outcomes for prostate cancer patients," said Peer M. Schatz, chief executive officer of Qiagen. "Following the success of the first-ever regulated companion diagnostic for solid tumors based on molecular biomarkers from a liquid biopsy in Europe, we are expanding our portfolio of highly accurate tests that analyze samples of body fluids that are non-invasive and more accessible than traditional tissue biopsies. Our liquid biopsy portfolio holds potential to create valuable insights and improve outcomes for patients."

Phase 3 Study with IMBRUVICA® (ibrutinib) Combination Demonstrates Significant Delay in Disease Progression

On March 16, 2015 Janssen Research & Development, LLC (Janssen) reported that a pre-planned interim analysis of the Phase 3 HELIOS (CLL3001) study investigating the combination of IMBRUVICA (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), showed the trial has met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) (Press release, Johnson & Johnson, MAR 16, 2015, View Source [SID:1234502293]). An Independent Data Monitoring Committee (IDMC) recommends that the study be unblinded and patients receiving placebo plus BR should be offered the option to receive IMBRUVICA as their next treatment. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics, Inc.

"This is the second randomized, controlled study in patients with previously treated CLL or SLL to show a significant improvement in progression-free survival, further underscoring the potential of IMBRUVICA," said Sen Zhuang, M.D., Ph.D., Vice President, Oncology Clinical Research, Janssen. "The data from the Phase 3 RESONATE trial demonstrated that IMBRUVICA as a single agent significantly improved both progression-free and overall survival compared to ofatumumab. Now, the interim data from HELIOS demonstrate that IMBRUVICA may be incorporated into a regimen with bendamustine and rituximab to improve outcomes for patients."

HELIOS is a Janssen-sponsored, randomized, double-blind, placebo-controlled, international, multicenter Phase 3 study conducted in 21 countries, which evaluated the safety and efficacy of IMBRUVICA in combination with BR in 578 patients with relapsed or refractory CLL/SLL who had received at least one prior therapy. Patients were randomized to receive either the combination of 420 mg IMBRUVICA orally once daily and six cycles of BR, or a matching regimen of placebo orally once daily and six cycles of BR, with IMBRUVICA or placebo continued until disease progression or unacceptable toxicity.

The primary endpoint of the HELIOS study is PFS, with secondary endpoints including safety (adverse events), overall response rate (ORR), overall survival (OS), rate of minimal residual disease (MRD)-negative responses and other improvements in hematologic values, disease-related symptoms and patient-reported outcome scores.

These topline results are planned to be submitted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, as well as for publication in a peer-reviewed journal. A full study report is being prepared and planned to be submitted to health authorities for future labeling considerations.