View this email in your browser

MedNess: bite-size biopharma and medtech news

9th September, 2020
Subscribe here
MedNess This Week
HIGHLIGHTS
Our Sponsors
Onco I-Analyse
Blueprint Medicines’ Gavreto (Pralsetinib) receives FDA accelerated approval for RET-fusion positive metastatic NSCLC
On September 04, Blueprint Medicines announced that the FDA has granted accelerated approval to its once-daily oral pralsetinib for RET fusion positive mNSCLC as detected by an FDA approved test. The approval was based on phase I/II ARROW basket trial, which showed encouraging response rates, durable clinical responses and tolerable safety profile irrespective of number of prior therapies, RET-fusion partner or CNS metastases. The EU marketing application is also under review by the EMA.
The study demonstrated an ORR of 57% (CR: 5.7%) and 70% (CR: 11%) in patients previously treated with platinum-based chemotherapy and treatment-naïve patients, respectively. Median response duration was not reached and 9.0 months in the above two sub-groups. Pralsetinib had earlier received Breakthrough therapy designation by the FDA.
The current approval is contingent upon the continued clinical benefit shown by pralsetinib in a phase III AcceleRET trial. The trial is currently recruiting patients and will evaluate pralsetinib vs. platinum chemotherapy ± Pembrolizumab.
Blueprint Medicines will jointly commercialize pralsetinib with Genentech in the US and the product in expected to be available in the coming week. Both companies will work towards eligible patient identification and improving access including financial assistance through YourBlueprint™.
This collaboration includes an upfront payment of $775 million to Blueprint Medicines, with a possibility of up to $927 million in milestone payments. Genentech will also acquire pralsetinib’s commercialization rights outside the U.S., excluding Greater China where CStone Pharmaceuticals has all development and commercialisation rights.
Additionally, the FDA has accepted pralsetinib’s NDA for RET-mutant MTC and RET fusion-positive thyroid cancer. The application has been granted a priority review and will be evaluated under the FDA’s RTOR (Real-Time Oncology Review) pilot program. The PDUFA date is February 28, 2021.
RET alterations affect nearly 1-2% of NSCLC patients. This approval is another step forward towards personalized treatment for NSCLC patients. Earlier in May, FDA had granted approval to Lilly’s selpercatinib (Retevmo) for the treatment of RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer MTC and RET fusion-positive thyroid cancer.
Collated by :Shilpa Rawal, PhD
COVID19 Special
Sanofi’s Kevzara® did not meet the primary and key secondary endpoints in Phase 3 trial associated with COVID-19
Sanofi earlier this week announced that 200 and 400 mg of Kevzara® (sarilumab) administered intravenously in severely or critically ill, hospitalized COVID-19 patients, did not meet the primary and key secondary endpoint. This data was based on the Phase 3 trial and the results for investigational drug was compared to placebo added to the usual standard of hospital care. Detailed results of this study will be submitted later in the year to a peer-reviewed publication. No further clinical studies will be conducted for Kevzara for the treatment of COVID-19.
“Although this trial did not yield the results we hoped for, we are proud of the work that was achieved by the team to further our understanding of the potential use of Kevzara for the treatment of COVID-19,” said John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi. “In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making.  At Sanofi, we are committed to help combat the global COVID-19 pandemic, including developing vaccine candidates that can be manufactured at large-scale.”
Click Here for more COVID19 special
Collated by :  Esha Sehanobish, PhD
Drug Approvals
Imfinzi approved in the EU for the treatment of ES-SCLC based on Ph 3 CASPIAN trial
Luis Paz-Ares MD, Ph.D., Chair, Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain and principal investigator in the Phase III CASPIAN trial said: “For the first time, patients with extensive-stage small cell lung cancer in Europe will have the option of an immunotherapy combination with cisplatin, a preferred chemotherapy for many European physicians in this setting. Today’s approval of Imfinzi provides physicians with an important new 1st-line treatment option that provides significant overall survival benefit with a well-tolerated treatment.”
FDA Approves Onureg® (azacitidine tablets) for AML patients in First Remission based on Ph 3 QUAZAR AML-001 trial data
“Continued treatment with Onureg demonstrated an overall survival benefit in adults with AML who had achieved first complete remission in the QUAZAR® AML-001 study and, notably, it has the potential to do this in a convenient manner, given its once daily oral formulation,”1 said Andrew Wei, MBBS, Ph.D., QUAZAR® AML-001 lead investigator, Alfred Hospital and Monash University, Melbourne, Australia. “This approval should help establish continued treatment with Onureg as a standard component of AML therapy for adults who achieved first complete remission following chemotherapy and who cannot proceed to intensive curative therapy, like hematopoietic stem cell transplant.”
Regulatory News
sBLA submitted to FDA for Yescarta® in R/R iNHL patients
“People living with indolent NHL often experience a disease that starts out slowly but becomes more aggressive over time with each subsequent relapse,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “The efficacy observed in ZUMA-5 may provide a potentially transformative treatment option for higher-risk patients with certain types of indolent NHL. We look forward to working closely with the FDA to progress this application with the goal of bringing Yescarta to patients with indolent NHL as soon as possible.”
FDA grants orphan drug designation for Rhenium NanoLiposomes (RNL™) for the treatment of rGBM patients
“Receiving FDA orphan drug designation and approval to advance the trial into Cohort 6 are key milestones in our development of this treatment for recurrent glioblastoma,” said Dr. Marc Hedrick, President and Chief Executive Officer of Plus Therapeutics. “We believe RNL has the potential to prolong survival for patients with malignant brain tumors and that of other difficult to treat radiosensitive tumors.”
Click here for more Regulatory News
Trial Results
Data from Ph 2 GEOMETRY mono-1 published in NEJM show treatment with Tabrecta™ (capmatinib, formerly INC280) resulted in positive ORR in mNSCLC patients with MET exon 14 mutation
"The pivotal data published today not only confirm the positive results we’ve seen previously with Tabrecta treatment in non-small cell lung cancer, but  also underscore the value of early and broad molecular testing of patients’ tumors to guide treatment decisions for both first-line and previously treated patients, " said Jeff Legos, Senior Vice President, Head of Oncology Drug Development, Novartis Oncology. “We know patients with this particularly aggressive form of lung cancer have a poor prognosis; they are often older and more medically fragile. We are committed to continuing to work with global health authorities to bring Tabrecta to patients as quickly as possible."
Positive biomarker data from mitazalimab Ph 1 trial announced demonstrating proof of mechanism
“The presented biomarker data confirm the proof of mechanism and strengthen our belief in mitazalimab as a powerful therapeutic agent. The observed induction of PD-L1-genes supports that mitazalimab has a potential to make tumors more responsive to PD-1 therapy. This is a very important factor and provides an opportunity for a clear path to the market and for adding benefit to patients,” commented Per Norlén, CEO at Alligator Bioscience.
Trial/Program Status
Global Ph 3 FRESCO-2 Trial of Fruquintinib Initiated in mCRC patients
  • Hutchison China MediTech Limited (“Chi-Med”) initiated, a Phase 3 registration FRESCO-2 study of fruquintinib for the treatment of mCRC patients in the U.S., Europe and Japan. 
  • First patient dosed on Sep 3, 2020, in the U.S.
  • Ph 3 FRESCO-2 is a randomized, double-blind, placebo-controlled, multicenter trial would evaluate overall survival in mCRC patients and will enrol patients in approximately 130 sites in 10 countries.
  • Clinicaltrials.gov identifier: NCT04322539.
  • FDA granted Fast Track Designation to fruquintinib in mCRC patients in June 2020. 
  • Clinical data from this study and completed Ph 3 FRESCO study in Chinese patients would support a future NDA for the treatment of 3L+ mCRC patients.
  • In addition to FDA, Ph 3 FRESCO-2 trial design was also reviewed and endorsed by PMDA & EMA
Extended enrollment for the Ph 3 OCEAN study in RRMM patients completed
“This is very exciting news. Thanks to the dedicated participation from patients, investigators and study teams around the world, we have managed to reach our extended enrollment target faster than anticipated, despite these challenging times”, says Marty J Duvall, CEO of Oncopeptides AB. “I am really impressed by the journey that Oncopeptides has made ever since the study start in 2017, from being a small Stockholm based R&D company, to becoming a fully- fledged, integrated, global biopharma company, preparing the first commercial launch”.
Click here for more Trial Progress
Collated by : Richa Tewari, PhD
Medness Plus
FDA approves two additional doses of Eli Lilly and Company’s Trulicity® for the treatment of type 2 diabetes
FDA earlier this week approved two additional doses of Trulicity® (dulaglutide) for the treatment of patients with type 2 diabetes. Trulicity® is a prescription medication that is used to improve blood glucose and reduce the risk of cardiovascular events. It is injected subcutaneously in the stomach, thigh or upper arm. The two new doses that have been approved are once-weekly Trulicity® to include 3 and 4.5 mg. The results from the clinical trial showed that these doses were able to further reduce A1C levels and the body weight in comparison to the 1.5 mg dose that is normally used.
"People find the Trulicity pen simple and easy-to-use," said Leonard Glass, M.D., F.A.C.E, vice president of Medical Affairs, Lilly. "Now, with the 3.0 and 4.5 doses available, people with type 2 diabetes who use Trulicity can benefit from additional A1C and weight loss as their condition progresses." "The FDA's decision to approve the additional doses of Trulicity is a positive step forward for people living with type 2 diabetes and their care teams," said Juan Pablo Frias, M.D., Medical Director and Principal Investigator, National Research Institute. "This progressive condition can require different treatment approaches over time, and findings from AWARD-11 showed the additional doses of Trulicity can lead to further A1C and weight reductions for people with type 2 diabetes whose current treatment may no longer be meeting their needs."
FDA approves an automated insulin delivery and monitoring system for pediatric patients
FDA issued an approval for a hybrid closed loop diabetes management device called MiniMed 770G System, for patients 2 to 6 years old with type 1 diabetes. This device intends to monitor glucose level and provide appropriate basal insulin doses with minimal input from the user or their caregivers. It is the first of its kind that can provide insulin doses based on continuous glucose monitoring in patients 2 to 6 years of age. It has not been approved for those younger than 2 years of age and those who need less than eight units of insulin in a day. The glucose level will have to be monitored throughout the day and insulin will be injected using a syringe, pen or pump to ensure adequate levels of glucose. The approval was granted to Medtronics.
“Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition—which can particularly impact children—is safe and effective.”
Click here for more MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News

AbbVie and I-Mab Enter In to Global Strategic Partnership for lemzoparlimab (TJC4)
"Cancer is the second-leading cause of death globally and the need for novel cancer therapies has never been more acute. The addition of I-Mab's novel CD47 programs complements our global clinical strategy in hematology and immuno-oncology," said Thomas J. Hudson, M.D., senior vice president of R&D and chief scientific officer, AbbVie. "We have been impressed with what I-Mab has been able to accomplish in research and clinical development and we look forward to working together to make a meaningful difference in the lives of millions of patients globally."
Gilead Sciences and Jounce Therapeutics Announce Exclusive License Agreement for JTX-1811 Program
“Gilead’s investment in Jounce and, specifically, JTX-1811 reinforces the value of our Translational Science Platform and differentiated and sustainable approach to novel immuno-oncology programs, focused on patients with cancer who have yet to benefit from immunotherapy. We look forward to seeing JTX-1811 progress to the clinic,” said Richard Murray, PhD, Chief Executive Officer and President of Jounce Therapeutics. “Our mission to deliver the right immunotherapy to the right patient population for meaningful and long-lasting benefit remains at the core of our discovery and clinical development work. Our JTX-1811 program is a prime example of these efforts.”
Collated by : Richa Tewari, PhD
Click here for mergers , aquisitions and more business news
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
MedNess Reviews
Shilpa Rawal, PhD
Onco I-Analyse
Debarati Banik
HealthIT
Abhi Dey
Consulting Editor
Nisha Peter, PhD
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 : Pixabay
Images : Twitter , Unsplash.com
Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
Our mailing address is:
MedNess
2160 Matthews Avenue 
Bronx 10462, NY 
NY

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