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Astellas to Present at J.P. Morgan Healthcare Conference (pdf 178KB)

On December 20, 2017 Astellas Pharma Inc. reported that the company’s President and CEO Yoshihiko Hatanaka will present at the 36 th Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2018 in San Francisco, Calif (Press release, Astellas, DEC 20, 2017, View Source [SID1234522702]). The presentation will take place at The Westin St. Francis at 9:30 a.m., with a
question and answer session occurring from 10:00 a.m. – 10:25 a.m. PST.

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›At 2:30 a.m., January 10, 2018 with a question and answer session occurring from
3:00 a.m. – 3:25 a.m. in Japan time

To access a live webcast of the presentation, visit JP Morgan Web site at
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Also, the materials will be available at our website after the presentation.
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TX16 Completed PK Study

ON December 19, 2017 Tanvex rported that its recently completed pharmacokinetics (PK) study of the company’s biosimilar product candidate, TX16, showed favorable results supporting PK similarity of TX16 and the reference product, US-licensed Avastin (Press release, Tanvex BioPharma, DEC 19, 2017, View Source [SID1234524595]). In a prospective, single dose, double blinded, parallel group study conducted in 69 healthy adult male subjects, the test to reference ratio of geometric least squares (LS) mean and corresponding 90% confidence interval (CI) for the primary endpoint, AUC 0-∝, were within the acceptance range of 80.00 to 125.00%. In addition the test to reference ratios of geometric LS means and corresponding 90% CIs of the other PK endpoints, AUC 0-t and C max, were also within the acceptance range of 80.00% to 125.00% demonstrating similar peak concentrations and extent of exposure between TX16 and Avastin.

Overall, both TX16 and Avastin were generally safe and well tolerated by the study subjects, with mild to moderate treatment-emergent adverse events and no severe or serious adverse events reported.

Avastin (bevacizumab) is a vascular endothelial growth factor-specific angiogenesis inhibitor approved in the US for the treatment of multiple indications in combination with other agents, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

According to IMS data, US sales of Avastin were US$3.1 billion in 2016.

Onconova Therapeutics Announces License and Collaborative Development Agreement with HanX Biopharmaceuticals for ON 123300, a Dual Inhibitor of CDK4/6 + ARK5

On December 19, 2017 Onconova Therapeutics, Inc. (Nasdaq:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing small molecule drug candidates to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported the signing of a license and collaboration agreement with HanX Biopharmaceuticals, Inc., a company focused on development of novel oncology products, for the further development, registration and commercialization of ON 123300 in China (Press release, Onconova, DEC 19, 2017, View Source [SID1234522713]). ON 123300 is a first-in-class dual inhibitor of CDK4/6 + ARK5, which is currently in advanced pre-clinical development. This compound has the potential to overcome the limitations of current generation CDK 4/6 inhibitors.

Under the terms of the agreement, Onconova will receive an upfront payment, regulatory and commercial milestone payments, as well as royalties on Chinese sales. The key feature of the collaboration is that HanX will provide all funding required for Chinese IND enabling studies performed for Chinese Food and Drug Administration IND approval. The Companies also intend for these studies to comply with US Food and Drug Administration (FDA) standards. Accordingly, such studies may be used by Onconova for an IND filing with the FDA. Both Companies will oversee the IND enabling studies. Onconova will maintain global rights outside of China.

"This collaboration provides an innovative way forward for our promising pipeline molecule. We are excited to advance ON 123300 towards a US IND as we seek to create a new standard of care with the potential to overcome the limitations of current generation compounds that require a combination treatment for therapeutic use. We believe that ON 123300 also has the potential to act as a single agent, due to the unique targeting of ARK 5, as well as CDK 4 and 6, making it potentially suitable for indications that may not be responsive to the current generation of CDK4/6 inhibitors, such as Palbociclib," commented Ramesh Kumar, President and CEO of Onconova. "CDK inhibitors have emerged as one of the most promising and targeted large market cancer therapies. We remain focused on our later stage rigosertib clinical development programs in MDS with near term milestones, and look forward to a close collaboration with HanX as we leverage their strong expertise in drug development and commercialization."

Faming Zhang, Ph.D., founder and Chief Executive Officer of HanX, commented, "HanX is a specialty pharmaceutical company focused on oncology, with an emerging pipeline of targeted agents including a proprietary PD-1 checkpoint antibody soon entering Phase 1 trials. We are pleased to be working with Onconova, which shares our commitment to developing innovative therapeutics in oncology. We look forward to working together to accelerate the development of ON 123300 for patients suffering from many types of cancer, including breast cancer, in both China and globally. As we launch our internally developed programs, such as a novel PD-1 program and other kinase inhibitors, we are excited by the potential synergies between our pipeline of checkpoint product candidates and CDK inhibitors."

Onconova recently presented promising pre-clinical data on in vitro metabolism and bioavailability for ON 123300 at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition. The data showed improved understanding of the metabolism of ON 123300 and the identification of metabolites, as well as a two to three-fold increase in bioavailability as a result of the Company’s formulation development efforts.

Atreca Reports on Tumor-Fighting Responses in B Cells from Patients with Non-Progressing Metastatic Cancers

On December 19, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported publication of noteworthy results in preclinical cancer research enabled by Atreca’s Immune Repertoire Capture (IRC) technology (Press release, Atreca, DEC 19, 2017, View Source [SID1234522717]). As reported in Clinical Immunology (DOI: 10.1016/j.clim.2017.10.002), Atreca scientists, collaborating with researchers at Stanford University and California Pacific Medical Center, demonstrated that patients with non-progressing, metastatic cancer generate antibodies directed against public tumor antigens (epitopes present in tumors of more than one patient) in a manner having the hallmarks of a typical antigen-driven humoral immune response. In preclinical in vivo models, certain of these antibodies also induce tumor regression and durable anti-tumor immunity. The research involved the sequencing and analysis of native antibodies accessed from single B cells in the active, ongoing anti-tumor immune responses of non-progressing patients with metastatic melanoma, lung adenocarcinoma, or renal cell carcinoma.

"This published research further confirms our ability to use IRC technology to validate B cell responses as a vital window for understanding effective patient immune responses in cancer, including the discovery of patient antibodies serving as the foundation for therapeutic discovery," commented William H. Robinson, M.D., Ph.D., Atreca board member, Co-Founder, and Associate Professor of Medicine in the Division of Immunology and Rheumatology of the Department of Medicine at Stanford University, as well as co-author on the published research. "By measuring key features of the immune response from non-progressing patients, including patient antibodies’ targeting of antigens expressed across multiple cancer types, we now have important new evidence of the role of B cells in mounting effective immune responses to cancer."

"We are proud of this seminal work, having discovered key features of patient immune responses to cancer. By examining single patient B cells, Atreca has a unique opportunity to understand productive anti-tumor responses and develop effective, next-generation cancer immunotherapies," said Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-Founder. "Based on these and other compelling research findings, Atreca is executing on its goals of both identifying the widest range of antibodies targeting public tumor antigens and advancing a robust therapeutic pipeline using that information."

Five Prime Therapeutics and Zai Lab Announce Exclusive License Agreement for FPA144 Anti-FGFR2b Antibody in Greater China and Global Strategic Development Collaboration

On December 19, 2017 Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, and Zai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, reported an exclusive license agreement for FPA144 in Greater China and global strategic development collaboration (Press release, Five Prime Therapeutics, DEC 19, 2017, View Source [SID1234522706]). Five Prime’s FPA144 is a first-in-class isoform-selective, humanized monoclonal antibody in clinical development as a targeted immuno-therapy for tumors that overexpress FGFR2b, including gastric and gastro-esophageal junction cancer. China has one of the highest incidence rates of gastric cancer in the world, with approximately 680,000 new cases annually.1,2 The randomized, controlled Phase 3 portion of the FIGHT trial evaluating FPA144 plus chemotherapy is expected to start in the second half of 2018 and would serve as a global registrational study for the treatment of front-line gastric and gastro-esophageal junction cancers. Zai Lab will manage the Phase 3 portion of the trial in China.

"We believe Zai Lab is the right partner for FPA144 in Greater China for this innovative product," said Aron Knickerbocker, Chief Operating Officer of Five Prime and incoming Chief Executive Officer (effective January 1, 2018). "China accounts for more than 40% of new gastric cancer cases globally2, so it is critical to align strategically with a strong collaborator with the infrastructure, relationships and resources to help us advance FPA144 global development expeditiously. Zai Lab is ideally positioned given their experienced leadership team, focus on innovative drugs, and established expertise and network within oncology. We look forward to working with Zai Lab to carry out our worldwide development program for FPA144 and accelerate enrollment in the global Phase 3 portion of the FIGHT trial."

"Five Prime has pioneered the development of some very exciting and highly-targeted antibodies, including FPA144, which we believe holds tremendous promise for cancer patients in Greater China. We are committed to working with Five Prime to accelerate the global development timelines for this important investigational therapy," stated Samantha Du, Chairman and CEO of Zai Lab. "This strategic collaboration highlights the strength of our team and business model as the partner of choice in China and in delivering innovative therapies to patients in China and beyond."

Under the terms of the agreement, Five Prime has granted Zai Lab an exclusive license to develop and commercialize FPA144 in the Greater China territory: China, Hong Kong, Macau, and Taiwan. Zai Lab will be responsible for conducting the Phase 3 FIGHT trial in Greater China, including screening, enrollment and treatment of patients, and for commercialization of FPA144 in the Greater China territory. Five Prime will manufacture and supply FPA144 for the study. A Joint Steering Committee will be formed between the companies to oversee development, regulatory and commercialization activities in greater China. Five Prime will receive a $5 million upfront payment and is eligible to receive up to $39 million in development and regulatory milestone payments. Five Prime is also eligible to receive from Zai Lab a royalty percentage on net sales of FPA144 in Greater China ranging from the high teens to the low twenties. Given the strategic importance of China to the development and commercialization of FPA144 and to align the interests of the two companies globally, Zai Lab is also eligible to receive a low single-digit royalty from Five Prime on net sales of FPA144 outside of Greater China.

"Gastric cancer is the fifth most common cancer in the world and the second most common in China. Patients whose tumors overexpress FGFR2b or have FGFR2 gene amplification have an especially poor prognosis," said Dr. Shukui Qin, the Executive Member of the Asian Clinical Oncology Society, Senior Vice President of Chinese Society of Clinical Oncology and the Director of Cancer Center of People’s Liberation Army. "I am encouraged that we may be able to identify those patients with companion diagnostics and potentially treat them more effectively with a highly targeted therapy like FPA144. There is a critical need for more effective and safe therapies for gastric cancer patients here, so I am pleased that I and my fellow oncologists throughout China can play an important role in the FIGHT trial."

About FPA144
FPA144 is an isoform-selective, humanized monoclonal antibody in clinical development as a targeted immuno-therapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. FPA144 has also been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells.

FPA144 is being evaluated as a potential treatment for gastric cancer and bladder cancer. In a Phase 1 trial, FPA144 demonstrated monotherapy activity in heavily pre-treated patients with FGFR2b-positive gastric cancer and did not exhibit certain toxicities that have been seen with less selective FGFR2 small molecule therapeutics. An estimated 10% of patients with gastric cancer have tumors that overexpress FGFR2b or have FGFR2 gene amplification, which is associated with poor prognosis.