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MedNess: bite-size biopharma and medtech news

24th March, 2020

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HIGHLIGHTS
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Regulatory News
sNDA Submission of ZEJULA® (Niraparib) accepted for 1L Maintenance Treatment of Ovarian Cancer in China by the NMPA
“We believe ZEJULA is a potential best-in-class PARP inhibitor due to its compelling efficacy, once-daily dosing and superior pharmacokinetic properties including its ability to cross the blood brain barrier,” said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. “The NMPA’s acceptance of our sNDA submission for ZEJULA as a first-line monotherapy treatment after surgery and platinum-based chemotherapy has the potential to both fundamentally change how women with ovarian cancer are treated in China and significantly expand ZEJULA’s market opportunity. Zai Lab remains committed to make a meaningful impact on the way cancer is treated in China and globally, and we plan to continue to develop and bring many new and innovative treatment options to patients in need.”
FDA provides feedback from pre-NDA meeting regarding a potential path to approval for Dovitinib
Steve Carchedi, CEO of Oncology Venture, stated “We are excited to move towards U.S. submission of our first oncology portfolio asset and appreciate FDA guidance in the filing process.  Mr. Carchedi further noted that “Renal Cell cancer continues to have a high unmet need and we hope that Dovitinib, alone or together with a DRP® companion diagnostic that we are validating for the drug, will provide patients with a more effective treatment.”
Click Here for more Regulatory results
Trial Results
FAILED TRIAL: Imfinzi confirmed sustained OS benefit in final analysis of the Ph 3 CASPIAN trial in 1L ES-SCLC but Tremelimumab arm didn’t meet co-primary endpoint of OS improvement
José Baselga, Executive Vice President, Oncology R&D, said: “We are pleased to see the sustained and meaningful survival benefit of Imfinzi for patients with small cell lung cancer after more than two years median follow up. We have already received the first global regulatory approval for Imfinzi with etoposide plus either carboplatin or cisplatin and remain on track for more approvals soon as we provide patients an important new 1st-line treatment option.”
Positive top-line results announced for pivotal Ph 3 FLASH trial of SGX301 in Cutaneous T-Cell Lymphoma patients
"This is an important outcome for patients suffering from CTCL. SGX301 has successfully demonstrated efficacy in this challenging chronic cancer, with no safety concerns, making it a potentially preferred first-line option for the treatment of early stage CTCL, which is the large majority of patients suffering from this disease," stated Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study. "The treatment showed a statistically significant improvement after just 6 weeks of treatment. This successfully proves that the drug has biologic activity in combating this disease in a relatively short time window, with preliminary data suggesting that the improvement continues to increase with extended treatment. In addition to the efficacy demonstrated, SGX301 was well-tolerated and its mechanism of action is not associated with DNA damage like other currently available therapies."
Click Here for more Trial Results
Trial/Program Status
Protocol of INTR@PID Lung 037 study of bintrafusp alfa versus pembrolizumab amended
  • Merck and GSK are jointly developing and commercializing bintrafusp alfa
  • Trial to be changed to adaptive design based on pre-specified rules to determine whether to expand to Phase 3 or continue as Phase 2
  • Study endpoints changed from ORR/PFS to PFS/OS to support the trial as a study
New patients’ enrollment and first treatment procedure in Ph 2 NMIBC trial (“Study II”) temporarily placed on hold pending resolution of COVID-19 global pandemic
Shawn Shirazi, Ph.D., CEO of Theralase stated, “Theralase is pleased that we have enrolled and successfully treated 12 patients in Study II and look forward to analyzing and reporting out on the clinical data, when clinically relevant. The Company’s immediate goal is to successfully enroll and treat 20 to 25 patients, who have received two treatment procedures, to provide clinical evidence to Health Canada and the FDA on the primary, secondary and tertiary clinical outcome objectives; which may then be used to support Breakthrough Therapy Designation (“BTD”) approval from the FDA. The Company is strategically targeting clinical sites across Canada and the US (subject to IND approval) that serve large urban populations to maximize enrollment in Study II.”
Click Here for more Trial/Program Status
Collated by : Richa Tewari, PhD
Medness @ HealthIT
Updates and advancements on COVID-19
Tracking hospital-bed availability through data platform during COVID-19 outbreak
Definitive Healthcare has partnered with Esri, an international supplier of geographic information system software, web GIS and geodatabase management applications. This partnership is aimed to develop an interactive data platform to analyze and monitor US hospital bed capacity, as well as potential geographic areas of risk, during the COVID-19 outbreak. The application provides a plethora of information, such as, the location and number of licensed beds, staffed beds, ICU beds, and total bed utilization rates in the US. The GIS hub of the platform provides an overlay of US Census data to compare the surrounding US population with the total number of available hospital beds. It also accurately showing where in the US, and at which hospitals, additional beds could be accommodated. The developers hope that these resources will provide researchers, public health authorities, and the public with user-friendly information to help identify geographic areas of risk, or places with a low capacity to accommodate sick patients. Read the full story here. Experience the scope of the data platform here
Amazon Web Services (AWS) has launched the AWS Diagnostic Development Initiative with an initial investment of $20 million aimed to accelerate COVID-19 research and testing. The nature of funding will be through AWS in-kind credits and technical support to assist research teams in leveraging the full potential of the cloud to develop innovative solutions. This way, AWS hopes to support customers to bring better and more accurate diagnostic solutions to market faster, and promote collaborations across organizations working on similar issues. According to HealthIT Analytics, the program will be accessible to accredited research organizations and private entities who utilize AWS to support research-oriented workloads for the development of diagnostics at the point of care. Initially, efforts will focus on solutions for COVID-19, but the initiative will also consider other infectious disease diagnostic projects in future. Read it on Amazon updates.
Updates on Cardiovascular risk-detection
Cardiovascular disease remains the leading cause of death among men and women in the US surpassing cancer and infectious diseases. Wouldn’t it be useful to predict or detect cardiovascular risk factors through genomic methods in a large or vulnerable population? A team from Baylor College of Medicine’s Human Genome Sequencing Center is using advanced precision medicine tools and genetic testing to identify genes that influence risk for cardiovascular disease and related conditions as part of their HeartCare study. What are the risk-signs and downstream procedures? The study is screening for genetic risk of aortic aneurysms, cardiomyopathies, arrhythmias, high cholesterol, medication sensitivity, and other conditions. Researchers will work with the providers, who review the findings and develop a care plan if needed. Genetic counseling services are available for participants who test positive for a risk gene. Find the full story here.
Collated by :  Debarati Banik
Medness Reviews
WHO announces SOLIDARITY, a global scale clinical trial for drugs against COVID-19
The World Health Organisation (WHO) has announced a multi-national megatrial called SOLIDARITY, which will test 4 potential treatments for SARS-CoV-2 on thousands of subjects enlisted in participant countries. 10 countries have signed up for the trial, including Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand.
SOLIDARITY will evaluate the efficacy of the repurposed drugs Remdesivir (Gilead Sciences, antiviral, failed ebola drug), anti-malarial Chloroquine-hydroxychloroquine combination, anti-HIV Kaletra (AbbVie Inc., Ritonavir-Lopinavir combination) and Kaletra in combination with interferon-beta. These drugs are documented to be well tolerated, have government approvals, can be supplied to the scale of the pandemic and importantly negate the need for novel drugs- a time saving advantage in this pandemic. The trial will evaluate a common ‘master protocol’ for head-on comparison of the drugs for their potential to kill or slow down the virus and also for prophylactic potential and use in vulnerable sectors such as health care workers. "Multiple small trials with different methodologies may not give us the clear, strong evidence we need about which treatments help to save lives,"- WHO director-general Tedros Adhanom Ghebreyesus
The SOLIDARITY Response Fund has raised US$43 million as of 18th March 2020. The WHO Director general’s opening remarks for the trial can be accessed
here.
Another cross-borders European trial called
DISCOVERY, independently testing the same 4 potential drug treatments for COVID-19, will have 3200 subjects participating from Belgium, France, Germany, Luxembourg, the Netherlands, Spain, Sweden and the United Kingdom. The large, multi-ethnic dataset generated from the trials should provide definitive evidence for COVID-19 treatment.
Newly Devised Methylation Catalyst Could Help Enhance Potency of some Drugs
Replacing hydrogen atoms with methyl groups on some drug molecules has been known to boost drug potency up to 2000-fold. However, chemists have struggled to streamline this ‘magic methylation’ process due to the complexity of carrying out the reaction.
Now, a team of chemists from the University of Illinois, Urbana-Champaign
report a newly devised a catalyst that catalyzes this reaction in a single step on a wide variety of druglike molecules. an advance that could lead to novel treatments for everything from cancer to infectious diseases.
What is more interesting is that this method is compatible with late-stage functionalization of drug scaffolds and natural products, making this method a suitable and cheap approach for inserting methyl groups in lead drug candidates.
The development of this new catalyst is a result of consistent efforts from the group for more than a decade. Initially starting out with an iron-based catalyst-
a snowflake-shaped compound with an iron atom at its center  that could add oxygen atoms to desired spots in drug-like molecules the group were able to create a similar manganese-based catalyst that can now effectively catalyze the ‘magic methylation’ on many druglike compounds.
This new method for ‘magic methylation’ shows significant promise in drug discovery and improving efficacy of known drugs for the treatment of cancer and infectious diseases.

Researchers Turn to Systems Pharmacology Approach to Suggest Potential Drug Combinations to Tackle the Novel Coronavirus
With the mounting number of COVID-19 cases, drug repurposing is the approach currently being used by various pharmaceutical companies and research groups to identify an effective treatment for the disease.
Adding to the drug repurposing efforts, a team of Cleveland Clinic researchers have identified combinations of previously known drugs that may be effective against the novel coronavirus.
The team implemented a systems pharmacology-based network medicine platform, quantifying the interplay between the Human Coronavirus (HCoV)–host interactome and drug targets in the human protein–protein interaction network. The idea behind this approach is the protein targeted by some drugs might also work as antivirals because of common protein–protein interactions and “functional pathways” that occur when viruses interact with their hosts.

Using network proximity analyses of drug targets and HCoV–host interactions in the human interactome they were able to identify three potential combinations of existing drugs: melatonin plus chemotherapy drug mercaptopurine; sirolimus, most commonly used to prevent organ-transplant rejection, combined with another chemotherapy drug, dactinomycin; and breast cancer drug toremifene plus emodin, a chemical found in plants like rhubarb, that may be able to target cellular factors that allow the viruses to replicate.
However, the researchers caution that
study limited as it does not predict the potential side effects or interactions of these drug combinations. Therefore, preclinical validation would have to be conducted before testing the combinations in clinical studies.

Medness Business
Onco-News
IDEAYA and Pfizer to evaluate IDE196 + Binimetinib in solid tumors with GNAQ or GNA11 hotspot mutations
"The prevalence of GNAQ or GNA11 hotspot mutations in MUM, Cutaneous Melanoma, CRC, and other solid tumors represents approximately 6,000 patients in the U.S. and the five major European countries, and there are no approved targeted therapies for MUM or GNAQ/GNA11 hotspot mutation solid tumors," said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences. "We look forward to testing the clinical potential of binimetinib in combination with IDE196 in this genetically distinct patient population."   
Novocure announces Optune Lua™ as the brand name for the NovoTTF-100L™ system
“The Optune brand emphasizes the unique product offerings of Novocure’s Tumor Treating Fields delivery systems and suggests the prospect of hope and optimized care,” said Pritesh Shah, Novocure’s Chief Commercial Officer. “Optune Lua is easy to pronounce and remember, and should help patients, caregivers and providers ask for the treatment by name.”
Collated by : Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Debarati Banik
HealthIT
Divyaanka Iyer
MedNess Reviews
Nisha Peter, PhD
Managing Editor
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting Editor
Ananda Ghosh, PhD
Founder
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Disclaimer
The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
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