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.

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"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."

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.

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"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.

On March 16, 2015 Genmab reported it has decided not to exercise the co-development right for HuMax-TAC-ADC under its agreement with ADC Therapeutics Sarl. Genmab will retain 25% of the rights to the product (Press release, Genmab, MAR 16, 2015, View Source [SID:1234502292]). Under the terms of the companies’ agreement, Genmab had a 50% ownership stake with an option to maintain equal ownership of HuMax-TAC-ADC prior to the submission of an Investigational New Drug (IND) application and fund half of the development costs. Genmab has decided not to maintain its co-development right for HuMax-TAC-ADC, but will retain a 25% ownership stake in the product. ADC Therapeutics has indicated it intends to file an IND for HuMax-TAC-ADC in the first half of 2015.

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"While we have decided not to fund co-development of HuMax-TAC-ADC with ADC Therapeutics, we are pleased to still have 25% of the rights to the product, which has potential to become a first-in-class antibody-drug conjugate therapeutic in certain hematological cancer indications," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About HuMax-TAC-ADC
HuMax-TAC-ADC is an ADC combining Genmab’s HuMax-TAC antibody and ADC Therapeutics’ PBD-based warhead and linker technology. HuMax-TAC-ADC targets CD25, which is expressed on a variety of hematological tumors and shows limited expression on normal tissues, which makes it a very attractive target for antibody-payload approaches. HuMax-TAC-ADC has the potential to be a first-in-class antibody-drug conjugate for the treatment of CD25-expressing lymphomas and leukemias. HuMax-TAC-ADC is in development under an agreement between Genmab and ADC Therapeutics.

About PBD Warheads & Linkers
ADCs developed using ADC Therapeutics’ technology combine monoclonal antibodies specific to particular tumor targets with highly potent pyrrolobenzodiazepine (PBD) based warheads developed by ADC Therapeutic’s partner Spirogen Limited. These PBD warheads are joined to antibodies by linkers that release the PBD warhead in the targeted cancer cells. This technology has attracted the attention of other biotechnology companies such as Genentech and Seattle Genetics.