Accenture Puts Data Science to Work for Pediatric Leukemia Research

On September 23, 2020 Accenture (NYSE: ACN) reported that it has built a data and analytics approach to manage and derive insights from pediatric acute myeloid leukemia (AML) genomic data (Press release, Accenture, SEP 23, 2020, View Source [SID1234567721]). Working in collaboration with researchers and clinicians from Fred Hutchinson Cancer Research Center (Fred Hutch), and the Target Pediatric AML (TpAML) computational working group, a large-scale research project which supplied the data, this new approach aims to enable pediatric oncology physicians and researchers — specifically those focused on pediatric AML — to better analyze patient clinical trial and genetic data, with the potential to improve precision medicine.

In collaboration with the TpAML investigators, led by Dr. Soheil Meshinchi at Fred Hutch, Accenture data scientists aggregated and standardized anonymized genomic and clinical data from over 2,000 children with AML, treated in clinical trials. RNA data alone, one of the most critical indicators of treatment outcomes in precision medicine, amounts to over 48,000 columns per patient if managed in a standard table format. Combined with other relevant data points — such as patient demographics, clinical treatment arm, and prognosis — the sheer volume and variety of combinations presents a significant hurdle to comparing patient profiles and outcomes at scale.

"The Accenture data scientists who worked with the TpAML team had the clinical and genomic background knowledge to hit the ground running. We model this type of collaboration in all of our engagements so that we’re able to anticipate challenges and navigate them with speed," said Joe Depa, a managing director for Accenture Applied Intelligence. "In this case particularly, I am pleased that we were able to leverage the power of data and analytics to make this information more accessible to researchers, potentially advancing precision medicine and helping improve people’s lives."

Through this engagement, TpAML investigators provided access to the sequencing data and guidance on key data points — including genetic markers, clinical trial treatment details, and clinical outcomes — that can define a patient’s response to a particular treatment at the time of diagnosis (prior to the start of chemotherapy). These insights could help inform the recommended course of treatment, giving patients and physicians a more robust view of likely clinical success and side effects with standard therapy, based on an individual patient’s genetic makeup and medical history. This approach may provide a more informed pathway to more effective precision medicine for pediatric AML, where therapy might be modified based on patients’ predicted response to standard therapy – i.e., high-risk patients may be allocated to bone marrow transplantation or targeted therapies.

"Integration of genomic and clinical data and getting it into a usable, accessible format is a significant challenge in precision medicine," said Dr. Meshinchi. "This collaborative effort between TpAML investigators and Accenture data scientists provides a mechanism to more informed analysis of clinical and genomic data, and could help identify patients at high risk of failure with conventional treatments. Validation of these findings can help modify patients’ treatments based on their relapse risk."

By applying data science and engineering tools, such as Alteryx and Python, and machine learning libraries like scikit-learn, to this corpus of information, Accenture was able to create a code base that clinicians are using to model, understand and potentially predict how patients may respond to specific treatments. Data was made further accessible and consumable using Unity 3D visualization, offering a more interactive way to view the data in a game-space environment, laying a foundation for advanced, dynamic visualizations and VR experiences which could help clinicians potentially identify anomalies, or which they could use as an interface to present findings.

"For years, patients diagnosed with a disease often received the same treatment. And for some people, that treatment worked. However, for others, it did not work – or did so only marginally, or with serious side effects. With genome mapping, in combination with new analytical, scientific and technological advances, it is possible to develop targeted, more precise, personalized treatments for individuals or similar patient populations," explained Stuart Henderson, global Life Sciences lead for Accenture. "Precision oncology is delivering on the promise of better patient care and health outcomes in remarkable ways and we look forward to seeing more projects like this TpAML investigation."

This project builds on Accenture research underscoring the importance of data management and sharing to drive precision oncology, and the role of data and genomics in biopharmaceutical development.

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China’s Viva Biotech snaps up Hong Kong CRO SYNthesis to boost preclinical offering

On September 23, 2020 Viva Biotech reported that it is putting down $80 million to buy preclinical contract research organization SYNthesis and boost its outsourcing business (Press release, Vivia Biotech, SEP 23, 2020, View Source [SID1234565573]).

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Hong Kong-based SYNthesis is a preclinical small-molecule drug discovery service contract organization selling pharmaceutical chemistry and synthetic chemistry services to its clients.

Headquartered in Hong Kong, it also has service platforms in Suzhou in Shanghai and Australia as well as offices in the U.K. and the U.S.; a part of its plan is to broaden its geographic reach.

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It will now fall under the umbrella of Shanghai-based Viva Biotech, an integrated drug discovery platform focused on preclinical-stage innovative drug development, covering the full spectrum of our customers’ needs for early-stage drug discovery.

"We are very delighted to achieve the strategic acquisition agreement with SYNthesis. We believe that SYNthesis’s technical platform and international team in the field of pharmaceutical chemistry and synthetic chemistry will quickly strengthen the capabilities of Viva Biotech from early drug discovery service to drug R & D downstream business, as well as boost The Company’s downstream integration to CMC and CDMO fields," said Cheney Mao, Ph.D., chairman and CEO of Viva.

"I am thrilled and delighted to have my team at SYNthesis join forces with the Viva team," added Xian Bu, Ph.D., managing director of SYNthesis. "Our preclinical small molecule pharmaceutical chemistry platform will be organically combined with the structure-based drug discovery and bioassay platforms of Viva Biotech, to provide a comprehensive preclinical R&D services for more customers. Together we will become a force to be reckoned with in the high-end medicinal chemistry space."

Genor Bio Conducting $370 Million IPO in Hong Kong

On September 23, 2020 Genor Biopharma, a Shanghai company, reported that it is conducting a Hong Kong IPO that could raise up to $370 million (Press release, Genor Biopharma, SEP 23, 2020, View Source [SID1234565542]). The company is developing a clinical-stage portfolio of 14 mAbs and recombinant fusion proteins, a combination of novel drugs and biosimilars that target indications in cancer, metabolic and autoimmune diseases. Its PD-1 molecule is currently in four pivotal Phase II trials. In June, Genor completed a $160 million Series B financing led by Beijing’s Hillhouse Capital Group.

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BD Submits Pre-Market Approval Supplement to FDA to Enable ThinPrep® Pap Test™ PreservCyt® Solution to be Used with the BD Onclarity™ HPV Assay

On September 23, 2020 BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, reported that it has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the use of the ThinPrep Pap Test PreservCyt Solution vial as an approved sample type for its BD Onclarity HPV Assay (Press release, BD Pharmaceutical Systems, SEP 23, 2020, View Source [SID1234565541]).

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The BD Onclarity Assay PMA supplement was submitted to the FDA to expand sample claims and platform usage. Pictured BD Onclarity HPV Assay reagent plates.
The BD Onclarity Assay PMA supplement was submitted to the FDA to expand sample claims and platform usage. Pictured BD Onclarity HPV Assay reagent plates.
The PMA supplement would expand the sample claims that can be used in addition to the BD SurePath vial for the detection of human papillomavirus (HPV) using the BD Onclarity HPV Assay. The submission includes performance data for the BD Viper LT and the BD COR Systems. An additional supplement was submitted in January 2020 to seek approval for the BD Onclarity HPV assay on the BD COR System and the BD SurePath Liquid Based Cytology vial.

BD recently announced the FDA approval of a PMA supplement that included the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 making the BD Onclarity HPV Assay the only FDA-approved assay to individually identify and report these genotype results.

"This PMA supplement to the FDA signifies BD’s commitment to expanding the availability of the BD Onclarity HPV Assay in the U.S. to support better patient management by providing clinicians more data to inform treatment decisions across multiple collection devices," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "BD is dedicated to providing comprehensive screening solutions that are accessible globally in the fight to eliminate cervical cancer."

About BD Onclarity HPV Assay
The BD Onclarity HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath Collection Vial and in the Hologic PreservCyt Solution (not approved in the United States). The assay is for use in accordance with clinical guidelines and within the scope of local regulatory authorizations as part of a comprehensive approach to cervical cancer screening. The BD Onclarity HPV Assay has FDA approval for clinical use in cytology-based screening with ASC-US triage, in co-testing paradigm, and in primary HPV screening. BD Onclarity HPV Assay has FDA approval for use in vaccinated women. As the previously vaccinated subpopulation ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18, increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women.7

Lung Cancer Research Awards funded by ALK Positive Patient Group in Second Collaboration with LUNGevity Foundation

On September 23, 2020 Patient group ALK Positive and LUNGevity Foundation reported the three 2020 recipients of the ALK-positive Lung Cancer Research Awards (Press release, LUNGevity Foundation, SEP 23, 2020, View Source [SID1234565540]). This award, driven by ALK Positive—a group that has grown to 2,000+ ALK-positive lung cancer patients and their caregivers in 50+ countries—supports high-impact research that seeks to quickly improve outcomes for the approximately 5% of non-small cell lung cancer patients who have tested positive for a mutation in the anaplastic lymphoma kinase (ALK) gene and that has the potential to transform ALK-positive lung cancer from an inevitably fatal condition into a chronic, or even curable, condition.

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The 2020 ALK-Positive Lung Cancer Research Award Program represents the second collaboration between LUNGevity Foundation, the premier private funder of lung cancer research in the U.S., and ALK Positive. The two organizations are working together to change outcomes for people diagnosed with ALK-positive lung cancer. ALK Positive is the foremost group of ALK-positive patients and is directly influencing the direction of research that will, one day, save their lives. These awards total $1,600,000 with monies raised by ALK Positive.

The three awards selected are:

Phase 1 first-in-human clinical trial with a therapeutic ALK vaccine in patients with ALK+ NSCLC: Mark Awad, MD, PhD, Dana-Farber Cancer Institute
Overcoming bypass signaling to enhance clinical responses in ALK-positive lung cancer: Ibiayi Dagogo-Jack, MD, Massachusetts General Hospital
Overcoming ALK resistance with covalent cysteine-reactive inhibitors: A. John Iafrate, MD, PhD, Massachusetts General Hospital
Two of the selected projects are clinical trials. The first is to test a therapeutic ALK vaccine and builds on Dr. Mark Awad’s 2018 grant aimed at understanding the antibody response against the ALK protein and to determine which parts of the ALK protein trigger an immune response. If successful, this would be the first vaccine for ALK-positive patients. The second clinical trial is to determine how to improve clinical response in ALK-positive patients by using combination therapies to combat acquired resistance to ALK tyrosine kinase inhibitors. The third translational research project is to determine a way to overcome resistance to ALK medications using a novel approach that targets the ALK protein for degradation.

"We are thrilled to be driving the grant selection and award process, and to fund such cutting-edge research that we hope will lead to new treatment options that can help fulfill the mission of ALK Positive to improve the life expectancy and quality of life of patients with ALK-positive cancer worldwide. These three projects, including the first-ever lung cancer clinical trials funded by a patient-driven organization, represent the direction in which we want to go. Our ALK Positive ‘family’ raised the $1.6M to fund this research that will impact the lives of patients worldwide," explains Colin Barton, Chair of the ALK Positive Medical Committee. "LUNGevity has an exceptional reputation and is a major private funder of lung cancer research in the U.S. We are excited to partner with them on these important projects."

"LUNGevity is proud to be partnering with ALK Positive to identify and drive research projects that have the potential to quickly improve outcomes for ALK-positive patients," says Upal Basu Roy, Vice President of Research at LUNGevity Foundation. "We’re excited that these projects combine the patient voice with the scientific rigor demanded of such critical research, and we are hopeful that they will lead to saved lives."