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MedNess: bite-size biopharma and medtech news

21st April, 2020
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MedNess This Week
HIGHLIGHTS
Our Sponsors
Drug Approvals
FDA Approves TUKYSA™ (tucatinib) for Advanced Unresectable or Metastatic HER2-Positive Breast Cancer Patients based on Ph 3 HER2CLIMB trial data
“With highly significant and clinically important results for overall and progression-free survival, the addition of TUKYSA to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,” said Eric P. Winer, MD, Chief of the Division of Breast Oncology, Susan F. Smith Center for Women's Cancers at Dana-Farber. “Cancer spreads to the brain in up to half of patients with HER2-positive metastatic breast cancer; and this approval is based on a unique clinical trial that included patients with active brain metastases, either untreated or progressing. TUKYSA is well tolerated by patients and is a valuable addition to the agents we have for HER2-positive metastatic breast cancer.”
FDA Approves Jelmyto™ for Patients with Low-Grade Upper Tract Urothelial Cancer
“UroGen was founded on the vision to improve lives by challenging the current standard of care. Jelmyto, which leverages our innovative technology and expertise in specialty cancers and urologic diseases, is just the beginning as we build a company focused on bringing novel solutions to patients,” said Liz Barrett, President and Chief Executive Officer, UroGen. “We thank the patients and researchers involved in our OLYMPUS trial for helping us advance a transformative treatment in a disease space that has been historically ignored. We are tremendously proud to have pioneered this first-in-class therapy that improves patient care in a difficult-to-treat cancer.”
Regulatory News
Surufatinib Granted U.S. FDA Fast Track Designations for the Treatment of Both Pancreatic and Non-Pancreatic Neuroendocrine Tumors
  • FDA granted two Fast Track Designations for the development of surufatinib, for the treatment of both advanced and progressive pancreatic neuroendocrine tumors (“NET”) and extra-pancreatic (non-pancreatic) NET in patients who are not amenable for surgery.
  • Surufatinib is a novel, oral angio-immuno kinase VEGFR, FGFR and CSF-1R inhibitor.
  • Surufatinib was granted Orphan Drug Designation for pancreatic NET in November 2019.
NDA for XOSPATA® (gilteritinib) Accepted for Regulatory Review in China by the National Medical Products Administration in FLT3+ R/R AML Patients
  • NDA for XOSPATA® (gilteritinib) accepted by NMPA
  • XOSPATA is oral once-daily therapy
  • Proposed for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+)
  • Already approved in the U.S. and Japan (2018), Europe and Canada (2019), and Korea, Brazil and Australia (2020)
NMPA Grants Priority Review to the sNDA for ZEJULA (Niraparib) for 1L Ovarian Cancer Maintenance Treatment
“China NMPA’s decision to grant priority review to our sNDA for ZEJULA underscores both the urgency of the medical need and the potential of ZEJULA as an innovative therapeutic option in the first-line setting for ovarian cancer patients,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “Ovarian cancer remains a devasting disease in China and we are excited that many more patients may soon have access to ZEJULA earlier in the course of their treatment. We thank the agency for their commitment and continued support to patients in need and look forward to working closely with them to move this important indication for ZEJULA toward approval.”
Trial Results
Ph 3 Trial of Tislelizumab + Chemotherapy in 1L Non-Squamous NSCLC Patients Met the Primary Endpoint of PFS Improvement at Interim Analysis
“We are excited to announce the positive outcome in the interim analysis of this Phase 3 study of tislelizumab in first-line non-squamous NSCLC, following the positive interim analysis in first-line squamous NSCLC earlier this year,” said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “These results add to our growing body of evidence demonstrating the efficacy and safety of tislelizumab for the treatment of advanced cancers. We look forward to continuing to evaluate tislelizumab in more than 25 studies, including 15 potentially registration-enabling trials.”
Potent Antitumor Activity of Repotrectinib Reported in 1L and Solvent-Front Mutation Ros1-Positive NSCLC Patients
“Our findings provide encouraging support for repotrectinib as a potential first-line treatment in ROS1-positive non-small cell lung cancer, and later-line use after progression from a prior ROS1 TKI,” said Dr. Byoung Chul Cho, Division of Medical Oncology, Yonsei Cancer Center at Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea and corresponding author of the paper. “In addition, these preclinical data as presented initially at the annual AACR conference in 2019 and now expanded upon in the publication suggest repotrectinib may prevent or delay the emergence of the G2032R solvent-front mutation and subsequent compound mutations, potentially improving clinical outcomes.”
Trial/Program Status
Ph 2 KEAPSAKE NSCLC trial, Ph 1/2 telaglenast + Ibrance combination trial in KRAS mutated CRC and NSCLC patients and CB-280 arginase inhibitor program temporarily paused
“Our first priority during the COVID-19 pandemic is the health of our employees, as well as patients and medical professionals involved in our clinical programs. We are continuing all clinical operations, with additional COVID-19 related safety measures in place. Given the fluid nature of the current situation, and the impact of the pandemic on clinical sites globally, we are delaying the start of enrollment of patients in our two new clinical trials, while we work towards accelerating the opening of sites,” said Susan Molineaux, president and chief executive officer of Calithera. “We believe we are on track to announce top-line CANTATA results this year, and we are narrowing the timeframe to the fourth quarter of 2020.”
Click Here for more Trial/Program Status
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
DoD is using AI to trace Coronavirus hotspots
The Department of Defense is utilizing artificial intelligence, machine learning, and data visualization tools to look for patterns or identify potential hotspots during the coronavirus pandemic and will continue to use these tools in future outbreaks. The Department is spearheading a team at the Pentagon and a crisis management team at the Joint Staff’s facility in Suffolk in Virginia, which will receive the same information and conclusions as the Pentagon team, only to step in for the Pentagon team if necessary. According to Marine Corps Lt. Gen. Daniel O'Donohue, “We're learning from them, as militaries go through the same crisis. This crisis, as tragic as it so profoundly is, is exercising us in ways that are relevant, to include cross-learning across allies and partners,” recognizing the importance of partnerships and alliances across the globe and learning from each other. “The management of relationships, the coordination and complex activity, the whole-of-government approach, decision and information tools, all will be things we need in any fight,” he added. “The focus is relevance now, and how do we learn and get better and exercise those things in the future that have relevance that endures beyond this crisis.” 
NIH continues with its commitment to study Adolescent Cognitive Development through big data
NIH is renewing its funding to continue the Adolescent Brain Cognitive Development (ABCD) study for an additional seven years, which will help the researchers to expand big data resources on brain development and child health. The ABCD study, which was launched in 2015, is the largest long-term study of the adolescent brain ever conducted in the US currently following 11,750 children, for at least ten years starting at ages 9 or 10. The study aims to answer long-held questions about the development of the teenage brain through adolescence and beyond, in addition to the effect of stimulus, such as, drug-exposure (nicotine, marijuana, and alcohol), screen time activities, sleep patterns, engagement in sports and arts, and other variables that may impact brain development, cognitive skills, and mental health. The new funding estimates to an amount of $290 million which will support research institutions and children assessment sites across the country with NIH supporting the study’s Coordinating Center and Data Analysis Informatics & Resource Center at UC San Diego.
Collated by :  Debarati Banik
Medness Business
Onco-News

Intensity Therapeutics and Bristol Myers Squibb to Conduct Ph 2 Trial of INT230-6 and Yervoy® (ipilimumab) in Advanced Solid Tumors
“We are excited to have entered into this clinical collaboration with Bristol Myers Squibb, a global leader and pioneer in immuno-oncology,” said Lewis H. Bender, President and CEO of Intensity Therapeutics. “This new collaboration builds upon our other partnerships to evaluate the potential of INT230-6 in combination with immunotherapy. A joint publication with the National Cancer Institute last year, showed remarkable synergy with the combination of INT230-6 and CTLA-4 antibodies in nonclinical in vivo models. The ability to combine our drug in the clinic with Yervoy, may benefit patients with cancers that have high unmet medical need. Results from this collaboration could accelerate the timeline for clinical development and approval of our drug.”
MEI Pharma and Kyowa Kirin Announce Global License, Development and Commercialization Agreement for ME-401
"This global partnership with Kyowa Kirin is a key step to achieving our goal of broadly developing and commercializing ME-401, optimizing the opportunity to benefit patients across multiple B-cell malignancies inside and outside the U.S., and also building value for our shareholders," said David M. Urso, J.D., chief operating officer & general counsel of MEI Pharma. "The decision to expand our alliance with Kyowa Kirin is based on the successful relationship we've built working together to date under our 2018 Japan license agreement, and the respect we have for Kyowa Kirin and their ability to jointly execute our shared vision of ME-401 in the U.S. and around the world."
TScan and Novartis to Discover and Develop of Novel T Cell Receptor Therapies for the Treatment of Solid Tumors
“As one of the only companies able to efficiently discover novel cancer antigens that can be targeted with TCR-based therapies, we are delighted to be collaborating with Novartis to develop important TCR treatments,” said David P. Southwell, President and Chief Executive Officer, TScan. “We see expansive potential for our platform and this collaboration gives us the opportunity to work with Novartis to develop novel TCR therapies, while at the same time preserving our ability to develop our own proprietary pipeline in both liquid and solid tumors.”
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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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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