On August 4, 2020 HUYA Bioscience International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported it has exclusively licensed worldwide rights, outside of China, to the SHP2 inhibitor, HBI-2376, from Suzhou GenHouse (Press release, HUYA Bioscience, AUG 4, 2020, View Source [SID1234562851]).

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SHP2 is an important component of RAS signaling pathway leading to activation of ERK/MAPK pathways in a variety of cancer cells. Additionally, SHP2 interaction with PD-L1 (an immune checkpoint molecule) results in the inhibition of T cell activity in the tumor microenvironment. The possibility of SHP2 inhibition to enhance T-cell immunity is of enormous potential relative to the success of PD-L1 checkpoint inhibitors in oncology. As a result, SHP2 multi-functions in tumor progression, cancer cell growth and suppression of anti-tumor immunity, further demonstrating development of SHP2 inhibitors for unmet clinical need.

"SHP2 is an exciting target and inhibitors of this enzyme have excellent potential to combine broadly with checkpoint inhibitors as well as other targeted anti-tumor agents, especially those targeting the RAS pathway," said Dr. Dan Von Hoff, a leader in oncology drug development and long-time advisor to HUYABIO who serves as Director of Translational Research at the Translational Genomics Research Institute as well as Professor of Medicine at the University of Arizona and the Mayo Clinic.

Dr. Mireille Gillings, CEO and Executive Chair of HUYABIO said, "There is a large unmet medical need for safer and more effective cancer treatments. We believe that HBI-2376 is a promising novel compound that has the potential to treat cancer patients across many tumor types. Our lead program HBI-8000 continues to exceed expectations as regards efficacy and breadth of immune oncology effects across a wide variety of solid and liquid tumors. The addition of HBI-2376 expands our pipeline and our current momentum in developing new standards of care in oncology."

About HBI-2376
HBI-2376 is an oral small molecule inhibitor of SHP2 for multiple tumor types whose cellular growth is dependent on the activity of receptor tyrosine kinases in the mitogen-activated protein kinase or MAPK pathway. Extensive biochemical characterization has shown that HBI-2376 is a highly potent and selective inhibitor of SHP2 phosphatase. Furthermore, preclinical investigations showed significant efficacy for HBI-2376 as a single agent or in combination with other small molecule inhibitors or checkpoint inhibitors in multiple tumor models. HUYABIO is planning to conduct the necessary studies to advance HBI-2376 to IND filing in the USA in the near future.

On August 4, 2020 PPD, Inc. (Nasdaq: PPD ), a leading global contract research organization, reported it has signed a new three-year agreement with Pfizer Inc. to provide drug development services to advance Pfizer’s portfolio (Press release, Pfizer, AUG 4, 2020, View Source [SID1234562850]). Under the terms of the agreement, Pfizer has the right to extend the term for additional two-year periods. Financial details of the agreement were not disclosed.

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The agreement builds on the companies’ existing relationship, in which PPD provides wide-ranging expertise in global clinical development and laboratory services to support Pfizer’s drug development initiatives across multiple therapeutic areas.

"United in purpose, we are committed to building on our long-standing relationship with Pfizer with innovative solutions, quality execution and the dedication of our talented teams to help Pfizer deliver exciting new therapies," said David Simmons, PPD’s chairman and CEO. "PPD is strategically positioned to continue supporting Pfizer in its pursuit of breakthroughs that change patients’ lives. We are privileged to take the next steps together and contribute to Pfizer’s initiatives to achieve a healthier world."

On August 4, 2020 Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, reported that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Ripretinib targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST (Press release, Zai Laboratory, AUG 4, 2020, View Source [SID1234562848]).

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"The grant of this priority review for ripretinib NDA underscores the potential of ripretinib to alter the treatment landscape for GIST patients, especially for those who are refractory to prior therapies," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "The magnitude of the unmet need for GIST patients in China is significant, with over 30,000 Chinese patients diagnosed each year. We thank the agency for their commitment and continued support to patients in need and look forward to working closely with them to advance this important therapy toward approval."

Priority review was established in China to encourage the new drug development and accelerate the market access of drugs with significant clinical value and urgent clinical need. It is implemented under the Drug Registration Rules (Bureau Order 27) and the Working Procedure for Priority Review and Approval of Drug Marketing Authorization (Tentative, NMPA 2020 No. 82) effective on July 1, 2020 and July 7, 2020, respectively. According to these guidelines, the regulatory authority will prioritize the review process and evaluation resources for applications under priority review, which should expect reduced review and approval timelines.

About Ripretinib

Ripretinib is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a unique dual mechanism of action that regulates the kinase switch pocket and activation loop. Ripretinib inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary exon 17 D816V mutation involved in systemic mastocytosis, or SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

Ripretinib is approved by the U.S. FDA under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Ripretinib is also approved by Health Canada under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Deciphera Pharmaceuticals is developing ripretinib for the treatment of KIT and/or PDGFRα-driven cancers, including GIST, SM, and other cancers.

Zai Lab has an exclusive license agreement with Deciphera for the development and commercialization of ripretinib in Greater China (Mainland China, Hong Kong, Macau and Taiwan).

On August 4, 2020 bioAffinity Technologies, a privately held biotech company, reported a poster explaining the Company’s use of flow cytometry for diagnosis of lung disease, including cancer, at the International Society for Advancement of Cytometry CYTO 2020 (Press release, BioAffinity Technologies, AUG 4, 2020, View Source [SID1234562844]). The CYTO 2020 conference runs today and tomorrow in a virtual format due to COVID-19.

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"We are pleased to have the opportunity to share our cutting-edge use of flow cytometry for accurate, non-invasive lung cancer diagnosis. Our platform not only advances early lung cancer testing, but also can be developed to detect other diseases of the lung," bioAffinity President and Chief Executive Officer Maria Zannes said.

The Company’s first product, CyPath Lung, is a flow-cytometric test to aid in the diagnosis of lung cancer. Flow cytometry allows for quantitative analysis of cells and cell systems. In the CyPath Lung process, individual cells are suspended and then analyzed by flow cytometry one at a time through a focus of exciting light, which is scattered in patterns characteristic to the cells and their components. Cells are labeled with fluorescent markers so that light is first absorbed and then emitted at altered frequencies. A sensor in the flow cytometer detects the scattered or emitted light and measures the size and molecular characteristics of individual cells. This allows for cellular profiles of sputum samples that can used to distinguish cancerous from cancer-free lungs.

"Data acquisition and our automated analysis is very fast," Ms. Zannes said. "CyPath Lung can analyze an average sputum sample of about 21 million cells in less than 20 minutes."

CyPath Lung allows patients to collect sputum samples non-invasively at home and ship them overnight to the laboratory for processing. Sample data is acquired by flow cytometry. Using automated analysis of pre-set parameters, CyPath Lung profiles the lung environment, including the presence of cancer cells. Data acquisition and physician reports can be generated in minutes.

A test validation trial comparing people at high risk for lung cancer to patients with the disease resulted in CyPath Lung specificity of 88% and sensitivity of 82%, similar to far more invasive procedures and surgery currently used to diagnose lung cancer. CyPath Lung is a well-balanced, highly accurate test.

CyPath Lung has been licensed by Precision Pathology Services, a CAP/CLIA laboratory in San Antonio, Texas. Precision Pathology Services anticipates certification and sale of CyPath Lung in 2020 as a Laboratory Developed Test (LDT). Following its certification as an LDT, physicians will order CyPath Lung for their patients who are smokers and former smokers at high risk for lung cancer and who receive a positive screening result or otherwise are suspected of having the disease.

People who have smoked the equivalent of one pack of cigarettes a day for 30 years or more, have not quit smoking in the past 15 years and are 55-80 years of age are recommended for annual screening by low dose computed tomography (LDCT). Screening by LDCT has been proven to detect lung cancer at earlier stages when it can be successfully treated, but screening has a low Positive Predictive Value (PPV) that can lead to unnecessary and risky procedures.

Using CyPath Lung after a positive LDCT screen can improve the PPV by 5.6-fold compared to LDCT alone. Early diagnosis of lung cancer followed by treatment has been shown to increase the 10-year survival rate of the disease to 88% from the present 5-year survival rate of 21.7%.

On August 4, 2020 BostonGene Corporation (BostonGene), a biomedical software company focused on defining optimal precision medicine-based therapies for cancer patients, reported its collaboration with The Weinstock Laboratory, a translational research program focused on novel therapeutics for lymphoid malignancies, at Dana-Farber Cancer Institute, Inc (Press release, BostonGene, AUG 4, 2020, View Source [SID1234562843]). The collaboration aims to define predictors of response to PI3 kinase inhibition in relapsed/refractory T-cell lymphomas.

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The Weinstock Laboratory is leading the research efforts to reveal mechanisms of response and resistance, and possible cause of adverse effects to Duvelisib (PI3K delta & gamma inhibitor) in patients with T-cell lymphomas (TCLs). Their work is supported by the Leukemia and Lymphoma Society and by Verastem, the makers of Duvelisib. In this collaboration, BostonGene provides advanced computational analytics of genomic, transcriptomic, proteomic and multiplex imaging data sets to predict drug response and identify new biomarkers. BostonGene’s software uses a set of unique deconvolution algorithms that reveal cellular content of a tumor and surrounding microenvironment using transcriptome next generation sequencing (NGS) data, and image analysis algorithms to elucidate spatial parameters of tumor microenvironment distribution using immunofluorescence (IF) imaging data.

"We are excited to collaborate with BostonGene," said David Weinstock, MD, at Dana-Farber Cancer Institute, Inc. "Improving patient outcomes is our top priority and by partnering with BostonGene we hope to accurately predict which patients will benefit from treatment by identifying new biomarkers that could be useful for other patients with cancer. The results have the potential to bring significant advantages to physicians as they make individual treatment decisions."

"BostonGene is thrilled to collaborate with the Weinstock Laboratory at Dana-Farber Cancer Institute, Inc." said Andrew Feinberg, President and CEO of BostonGene. "Our sophisticated analysis of RNAseq and exome sequencing will identify genomic and transcriptional alterations that could serve as predictive biomarkers of response and resistance to PI3 kinase inhibition that could ultimately improve patient outcomes. "