View this email in your browser

MedNess: bite-size biopharma and medtech news

29th December, 2021
Subscribe here
MedNess This Week
HIGHLIGHTS
 
Drug Approval
KEYTRUDA + LENVIMA Approved in Japan for Patients With Unresectable, Advanced or Recurrent Endometrial Carcinoma That Progressed After Chemotherapy
“Rates of endometrial carcinoma have been steadily increasing in Japan each year, and there are limited options for patients who are diagnosed at an advanced stage or find their disease has returned,” said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck Research Laboratories. “With today’s approval, patients in Japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy.”
Regulatory News

Patritumab Deruxtecan Granted U.S. FDA Breakthrough Therapy Designation in Patients with EGFR-Mutated mNSCLC
“The Breakthrough Therapy Designation for patritumab deruxtecan acknowledges the need for new treatment approaches to overcome resistance and improve survival in patients with metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We are proud that the FDA has once again recognized our innovative science and technology and we look forward to bringing this potential first-in-class HER3 directed antibody drug conjugate to patients with this specific type of lung cancer as quickly as possible.”
New Drug Application (NDA) Submitted to the U.S. FDA for Dovitinib for Third-Line Treatment of RCC
Allarity’s CEO Steve Carchedi noted, “This NDA submission for dovitinib, in connection with the Dovitinib-DRP® companion diagnostic, is a historic milestone for our Company and an important step for late-stage renal cell carcinoma patients awaiting new treatment options.  Over the past decade, we have worked diligently to advance our novel oncology therapeutics pipeline together with our unique DRP® diagnostic technology to realize the promise of personalized cancer care for patients.  We greatly look forward to the approval of dovitinib and to introducing the clinical value of DRP® companion diagnostics to oncologists and their patients.”
Click here for more Regulatory News
Trial Results
Preliminary Results for Ongoing Ph 2 Expansion Study of CX-2029 Announced
“We are pleased to report these first results from the ongoing Phase 2 expansion study of CX-2029, a novel ADC developed with the CytomX Probody Therapeutic platform. We are encouraged that the response rate in heavily-pretreated and unselected sqNSCLC patients at this recent data cut off is trending with our stated target of 20% and enrollment in this tumor type continues towards our goal of 25 efficacy-evaluable patients. No new safety signals were observed and we are also encouraged by the low discontinuation rate due to adverse events. These preliminary results corroborate our previous Phase 1 observations and open a potential sqNSCLC commercial opportunity in the growing post-checkpoint inhibitor setting where there are limited treatment options,” said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. “We continue to work closely with our partner, AbbVie, and look forward to completing the expansion phase of the CX-2029 development program and providing further data updates in 2022.”
 
Trial/Program Status
DESTINY-Lung04 Ph 3 Trial of ENHERTU® Initiated in Patients with Previously Untreated HER2 Mutant mNSCLC
“The results seen in the DESTINY-Lung01 trial showed a robust and durable tumor response in previouslytreated patients with HER2 mutant metastatic non-small cell lung cancer,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “Based on these promising findings, we are conducting DESTINY-Lung04 to evaluate the potential of ENHERTU as an earlier line of therapy in this patient population.”
Click here for more Trial Statuses
Collated by: Richa Tewari, PhD 
  
  MedNess HealthIT
New informatics study to help Alzheimer’s patients
The University of Pennsylvania’s School of Nursing, the Perelman School of Medicine, in collaboration with other divisions within the institute, is working towards building Penn Artificial Intelligence and Technology Collaboratory for Healthy Aging (PennAITech); a program to use AI to improve in-home care for older adults with Alzheimer’s disease with the help of consumer informatics and aging data. The lead investigators in this study are George Demiris, PhD, FACMI; Jason Karlawish, MD; and Jason Moore, PhD, FACMI who designed the program to monitor, collect and analyze data from aged patients under homecare, combine them with EHR and clinical studies, and come up with patterns through AI model at point of care for decision support. According to the press release by the institute, “Funded pilot projects will be supported through cores focused on administration, stakeholder engagement, technology identification and training, clinical translation and validation, networking, and ethical and policy issues. Pilot projects will be solicited from academia, industry, and health systems.” A funding of $20 million over 5 years is expected from the National Institute on Aging to support this research.
Pulmonary embolism detection made easier through AI
Researchers at Icahn School of Medicine at Mount Sinai have come up with a novel solution to detect pulmonary embolism by combining electrocardiograms (EKG) and EHR data to improve screening methods. Current state of diagnosis heavily relies on CTPA or computed tomography pulmonary angiograms, which are time consuming, uses harmful radiation exposure, and can be offered in only a handful of hospital facilities. A pilot study by the group suggests that their machine learning algorithm used for prediction analysis is more efficient than current screening practices in determining if moderate-to high-risk patients have pulmonary embolisms. Pulmonary embolisms stem from deep vein blood clots breaking away and clog lung arteries and can be lethal or chronic in their outcome. The symptoms, however, are not always specific to indicate the condition, and therefore difficult to diagnose. The team used data from 21,183 Mount Sinai Health System patients who indicated moderate to highly suspicious signs of pulmonary embolism. According to the press release, “While some algorithms were designed to use EKG data to screen for pulmonary embolisms, others were designed to use EHR data. In each situation, the algorithm learned to identify a pulmonary embolism case by comparing either EKG or EHR data with corresponding results from CTPAs.”
Collated by: Debarati Banik
MedNess Business
  Onco-News
 
Novartis strengthens immunotherapy pipeline with option, collaboration and license agreement with BeiGene for TIGIT inhibitor ociperlimab
“This agreement adds a potentially transformative new therapy to our expanding immunotherapy platform and is part of the broad Novartis Oncology effort to drive the next wave of innovation in cancer treatments,” said Susanne Schaffert, PhD, President, Novartis Oncology. “Ociperlimab is a promising late-stage compound in non-small cell lung cancer, with potential in a wide range of solid tumors. We believe it is a strong candidate for potentially synergistic combination with the PD-1 inhibitor tislelizumab. We’re proud of the strong and innovative partnership we’ve established with BeiGene, as it builds on our previous collaboration with tislelizumab and will continue to help us reimagine medicine for people living with cancer.”
 
Sanofi To Acquire Amunix Immuno-Oncology Pipeline With Next Generation Conditionally Activated Biologics
“This acquisition demonstrates our ongoing commitment to investing in promising research and discovery platforms,” said John Reed, M.D., Ph.D., Global Head of Research & Development, Sanofi. “The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues, thus bringing the promise of more effective and safer treatment options for cancer patients. We are excited to rapidly advance Amunix’s promising pipeline and to combine their innovative candidate medicines with complementary molecules in Sanofi’s immuno-oncology portfolio.”
Click here for more Business News
Collated by: Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Shilpa Rawal, PhD
Onco I-Analyse
Arundithi Ananthanarayanan
MedNess Reviews
Debarati Banik
HealthIT
Darpan Chakraborty
Social Media Manager
IP & BioPharma News
 
Nisha Peter, PhD
Consulting Editor

 
Rinki Saha
BioPharma News
Managing Editor
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Share Share
Tweet Tweet
Forward Forward
Subscribe
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.
Copyright © 2019 MedNess , All rights reserved.
You are receiving this MedNess Newsletter as a subscriber on the list.

Cover Image : iStock
Images : Twitter , Unsplash.com
Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
Our mailing address is:
MedNess
1150 First Ave. King of Prussia,, PA 19406

Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.