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8-K – Current report

On January 12, 2015 Tokai Pharmaceuticals reported that it has entered into an agreement with the Johns Hopkins University related to the development of a companion diagnostic to determine the AR-V7 status of patients with castration-resistant prostate cancer (CRPC) for use with the Company’s lead product, galeterone, which is in development for the treatment of AR-V7 positive metastatic CRPC (Filing 8-K , Tokai Pharmaceuticals, JAN 15, 2015, View Source [SID:1234501348]).

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Under the agreement, the Company has obtained an exclusive, worldwide license from the Johns Hopkins University to patent applications and know-how covering an assay that has been used to determine the AR-V7 status of prostate cancer patients.

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, which is known as C-terminal loss. The AR splice variant AR-V7 is the most prevalent of the splice variants that cause C-terminal loss.

Clinical data from a prospective trial at the Johns Hopkins University as well as retrospective analyses of studies at MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center have shown that AR-V7 specifically and C-terminal loss generally is associated with 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 from the Company’s Phase 2 ARMOR2 trial of galeterone.

"We are pleased to have formalized the agreement with the Johns Hopkins University to support our ongoing AR-V7 companion diagnostic program. This license adds to the intellectual property around galeterone and is a critical milestone in the development of the companion diagnostic that will be used in our 148 patient Phase 3 ARMOR3-SV trial scheduled to begin in the first half of this year," stated Jodie Morrison, president and chief executive officer of Tokai Pharmaceuticals. "It is our hope that future availability of a companion diagnostic will allow prostate cancer patients and their physicians to make more informed decisions regarding their care."

In addition, the Company announced that it has entered into an agreement with Qiagen N.V. under which Qiagen will develop a non-invasive companion diagnostic utilizing an array of novel technologies for use with galeterone. The agreement formalizes an existing collaboration under which work has been ongoing.

Amgen Presents New Data Supporting First-Line Use Of Vectibix® (Panitumumab) In Combination With FOLFOX In Patients With Wild-Type RAS Metastatic Colorectal Cancer

On January 15, 2015 Amgen reported on new data from the Phase 2 PEAK and Phase 3 PRIME studies that support the first-line use of Vectibix (panitumumab) in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, in patients with wild-type RAS (absence of exons 2, 3, or 4 KRAS or NRAS mutations) metastatic colorectal cancer (mCRC) (Press release Amgen, JAN 15, 2015, View Source;p=RssLanding&cat=news&id=2008116 [SID:1234501347]). The data will be presented during a poster session at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place in San Francisco from January 15 to 17.

In an exploratory analysis from the PEAK study (abstract #660), treatment with Vectibix compared to bevacizumab (Avastin) resulted in a significantly higher proportion of patients with earlier tumor shrinkage at week eight (64 percent vs. 45 percent, respectively; 95 percent CI, p=0.0232), and among responding patients, a significantly longer duration of response (11.4 vs. 8.5 months, respectively; 95 percent CI, p=0.0142) and greater depth of response (65 percent vs. 46 percent, respectively; p=0.0007). Overall response rates (ORR) appeared to be similar between Vectibix and bevacizumab. This is consistent with observed overall survival (OS) and progression-free survival (PFS) rates, and with data previously reported. The safety profile of Vectibix was consistent with previously reported studies.

"These analyses help deepen our understanding of how Vectibix works when added to a standard first-line chemotherapy for the treatment of wild-type RAS metastatic colorectal cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Our Vectibix clinical trial program continues to yield new insights regarding biomarkers and drug sequencing."

While the primary analysis from PEAK showed similar ORR between the Vectibix- and bevacizumab-based regimens, this exploratory analysis demonstrates that Vectibix produces early, sustained anti-tumor activity, which may in part explain the OS and PFS benefits seen with Vectibix versus bevacizumab in this trial.

A separate analysis from the Phase 3 PRIME study (abstract #537), demonstrated that there were no significant differences in quality of life among patients treated with Vectibix plus FOLFOX versus FOLFOX alone despite the incidence of adverse events associated with each treatment regimen. The quality of life analysis included a scale that assessed mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Colorectal cancer is the third most common cancer found in both men and women in the U.S. and is the second leading cause of cancer deaths. Approximately 1.2 million cases of colorectal cancer are expected to occur globally each year.

3SBio Signs Exclusive Patent License Agreement for DIG-KT, a Bi-Specific mAb targeting VEGFR2 and Tie-2 with PharmAbcine

On January 15, 2015 3SBio reported it has entered into an exclusive licensing deal with PharmAbcine Inc (Press release 3SBio, JAN 15, 2015, View Source [SID:1234501344]). (“PharmAbcine”) for the development, manufacturing and marketing of DIG-KT, a bi-specific monoclonal antibody (“mAb”) targeting both VEGFR2/KDR and Tie-2 pathways for cancer in the territory of Greater China (including mainland China, Taiwan, Hong Kong and Macau) and Korea. The deal included undisclosed upfront, milestone and royalty payments.

Angiogenesis is correlated with disease progression and poor prognosis in many tumor types, such as colon, lung, breast and pancreatic cancers. Two key pathways, VEGF / VEGFR2 (KDR), as well as angiopoietin (ANG) / Tie-2, act cooperatively to induce tumor angiogenesis and metastasis. It has been found that combined blockade of VEGF/VEGFR2 and ANG/Tie-2 pathways results in additive effects on vascular regression and anti-tumor efficacy. Researchers from PharmAbcine have developed DIG-KT, a bi-specific mAb to treat solid tumors. DIG-KT binds VEGFR2/KDR and Tie-2 simultaneously, and blocks binding of VEGFR2 ligands, including VEGF-A, VEGF-C and VEGF-D, as well as Tie-2 ligands, including Ang1, Ang2, Ang3 and Ang4. Consequently, DIG-KT inhibits ligand-stimulated activations of both VEGFR2/KDR and Tie-2, therefore inhibits ligand-induced angiogenesis, proliferation, and migration of human endothelial cells.

Current anti-VEGF drugs such as bevacizumab, sorafenib and aflibercept are efficacious. Still, over time cancer cells develop resistance via induction of ANG/Tie-2 pathway, an alternate route to angiogenesis. Drugs targeting the Tie-2 pathway alone may have similar limitations. DIG-KT, by concurrent dual receptor inhibition of VEGFR2/KDR and Tie-2, is expected to be more efficacious in both bevacizumab-naïve patients and those failing VEGF therapy due to development of resistance. Preclinical proof-of-concept, including in vitro binding assays and in vivo efficacy in animal models, has demonstrated superiority of DIG-KT over current drugs in bevacizumab-resistant murine models of glioblastoma and pancreatic cancer.

“This is our second collaboration with PharmAbcine,” Dr. Jing Lou, Chairman and CEO of 3SBio, commented. “We are impressed by PharmaAbcine’s high scientific standards and look forward to working with them as we seek regulatory approvals to move DIG-KT into clinical trials in China and notably Korea, in line with our strategy to develop 3SBio’s development capabilities in key international markets. 3SBio continues to seek opportunities to expand its biologics pipeline. Novel mAb candidates, especially bi-specific mAbs, shed light on the treatment for refractory or metastatic cancers, such as pancreatic and breast cancers, which is consistent with 3SBio’s core therapeutic areas of oncology and nephrology.”

“We are very pleased to expand our partnership with 3SBio,” Dr. Jin-San Yoo, President and CEO of PharmAbcine, commented. “3SBio is a well-established industry leader with long-term vision in the innovative biological field in China, which makes them an ideal partner for strategic collaborations in the long term. DIG-KT is a novel bi-specific mAb with great potential to treat refractory tumors. We are looking forward to working with them to develop this mAb in China and Korea, so that tens of thousands of patients suffering for cancers and other severe diseases can benefit from this drug candidate.”

This is the second licensing agreement between 3SBio and PharmAbcine in less than two months. On November 18, 2014, 3SBio announced it had signed an exclusive patent license agreement for Tanibirumab, an anti-VEGFR2/KDR mAb.

NANTWORKS ANNOUNCES LAUNCH OF AN IMMUNO-ONCOLOGY COMPANY, NANTCELL, AND LICENSING AGREEMENT WITH AMGEN FOR AN ONCOLOGY ANTIBODY

On January 14, 2015 NantCell, LLC, a subsidiary of NantWorks, LLC, focusing on the discovery and development of immunology based innovative treatments for diseases through cell-based treatments at the molecular level, reported that it has entered into a licensing agreement with Amgen Inc. for AMG 479 (ganitumab), previously in Phase 3 development (Press release, NantWorks, JAN 14, 2015, View Source [SID:1234511990]). Under the agreement, NantCell acquired the exclusive rights to develop and commercialize worldwide, excluding Japan, AMG 479, a fully human monoclonal antibody that targets Type 1 insulin-like growth factor receptor (IGF-1R), a promising target for cancer therapy. Financial terms were not disclosed.

"We are pleased to enter into this agreement with Amgen," said Dr. Patrick Soon-Shiong, founder and chief executive officer of NantCell. "We acquired an immuno-oncology compound in late-stage development, with the potential to address a number of cancers affecting significant patient populations. This month marks the 10 year anniversary of the FDA approval of Abraxane, the first protein-based chemotherapy delivery vehicle now approved in multiple countries worldwide for breast, lung and pancreatic cancer. It is our belief that the future of cancer care will involve combination therapy with low dose, metronomic use of multiple chemotherapeutic agents, but combined also with immuno-oncology molecules, or with engineered killer cells targeted at the proteomic profile of the specific tumor, regardless of the anatomical type. The development of antibody molecules such as IGF-1R will require next generation sequencing at the proteomic level with a deep level of molecular interrogation to establish the appropriate combination with other drugs."

Patients entering clinical trials conducted by NantCell would be identified after a comprehensive "omic" analysis from DNA, RNA and protein, and treated on the resulting molecular profile to maximize clinical outcome and minimize side effects.

"We are pleased to collaborate with NantCell and NantWorks in their mission to establish a new level of quantitative predictability of patient selection," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Their integrated suite of technologies may help to improve patient selection and further clinical development of AMG 479."

Scientific and medical research suggest that IGF-1R plays a role in the development and progression of many cancers, possibly due to its anti-apoptotic properties, which allow cancerous cells to resist the cytotoxic properties of chemotherapeutic drugs or radiation therapy. The novel IGF-1R antibody inhibits cancer cell proliferation through disruption of the P13K/Akt and MAPK pathways. Signaling through IGF-1R plays an important role in the regulation of cell growth and survival, and has been shown to be a critical promoter of anchorage independent growth, a well-recognized mechanism for malignancy.

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About NantCell

NantCell, a wholly-owned subsidiary of NantWorks, LLC, is an immuno-oncology company focused on the discovery of innovative antibody, T cell and NK cell based treatments by developing molecularly targeted therapeutics, based on the proteomic profile of the patient’s tumor, independent of the cancer’s anatomical type. Dr. Patrick Soon-Shiong, the creator of Abraxane and the founder of the nab technology platform established NantCell to develop a pipeline of human antibodies and inhibitors of proteins which drive tumor growth and pursue Chimeric Receptor Antigen platforms in both T and NK cells. NantCell’s mission is to make obsolete the standard method of clinical trial design of "trial and error" and replace it with a level of quantitative predictability based on both the genomic and proteomic profile performed a priori. The Company will tap into comprehensive "omic" analytic tools and "big data" generated from supercomputing to develop molecularly designed drugs in this era of genomics and proteomics and identify patients and their tumor signature at the most granular cellular, DNA and protein levels. Patients entering clinical trials would be identified after a comprehensive "omic" analysis from tissue to cell to DNA to RNA to protein to peptide to drug, and tested based on this molecular profile to maximize clinical outcome and minimize side effects. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter@solvehealthcare.

About NantWorks

NantWorks, LLC, founded by renowned physician scientist and inventor of the first human nanoparticle chemotherapeutic agent Abraxane, Dr. Patrick Soon-Shiong, is the umbrella organization for the following entities: NantHealth, NantMobile, NantMedia, NantOmics, NantBioScience, NantCell, NantPharma, NantCapital and NantCloud. Fact-based and solution-driven, each of NantWorks’ division entities operates at the nexus of innovation and infrastructure.

The core mission of NantWorks is convergence: to develop and deliver a diverse range of
technologies that accelerates innovation, broaden the scope of scientific discovery, enhance
groundbreaking research, and improve healthcare treatment for those in need. NantWorks is building an integrated fact-based, genomically-informed, personalized approach to the delivery of care and the development of next generation diagnostics and therapeutics.

Roche licenses additional EGFR pathway-related intellectual property to QIAGEN

On January 14, 2015 Roche licenses additional EGFR pathway-related intellectual property to QIAGEN(Press release Hoffmann-La Roche, JAN 14, 2015, View Source [SID:1234501342]).

Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the company has entered into an agreement with QIAGEN that includes a provision of non-exclusive licenses to recently granted Roche patents pertaining to the detection of mutations in the EGFR pathway (including in the KRAS gene). Financial details were not disclosed.

The licenses apply to testing products which detect these mutations using molecular techniques including PCR, next generation sequencing (NGS) and other applications to aid in identification of cancer patients eligible for treatment with certain tyrosine kinase inhibitors. The licenses can be applied to existing and future products.

"As a leader in molecular assay development, we are pleased to provide licenses to the applicable patents so that existing and new tests can support patient treatment decisions," said Paul Brown, Head of Roche Molecular Diagnostics. "Ensuring that assays that utilize Roche proprietary information are fully licensed is a key business strategy for us."

"We are pleased with the agreement, which expands our existing intellectual property portfolio covering more than 35 biomarkers and our deep intellectual property estate in EGFR-related testing, including KRAS- testing", said Dr. Achim Ribbe, Vice President Corporate Business Development Licensing. "As a global leader in personalized healthcare, QIAGEN is working with numerous pharmaceutical companies to develop and market molecular companion diagnostics that can help improve patient outcomes and better utilize healthcare resources."