View this email in your browser

MedNess: bite-size biopharma and medtech news

23rd June, 2020
Subscribe here
MedNess This Week
HIGHLIGHTS
Our Sponsors
COVID Special
FDA revokes the emergency use authorization for the use of chloroquine phosphate and hydroxychloroquine in Covid-19
FDA recently revoked the EUA (Emergency Use Authorization) for the use of hydroxychloroquine sulfate and chloroquine phosphate that was donated to the Strategic National Stockpile.
“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate. This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation. “We remain committed to using every tool at our disposal in collaboration with innovators and researchers to provide sick patients timely access to appropriate new therapies. Our decisions will always be based on objective and rigorous evaluation of the scientific data. This will never change.”
FDA issues an Emergency Use Authorization for the first Covid-19 diagnostic test using next generation sequence technology
FDA recently issued an Emergency Use Authorization (EUA) for the first ever Covid-19 diagnostic test that uses next generation sequence technology. The EUA was granted to Illumina Inc.
“Throughout the COVID-19 pandemic, we have seen the ingenuity that results from the FDA working in partnership with the private sector. Having a next generation sequencing diagnostic tool available will continue to expand our testing capabilities. Additionally, genetic sequencing information will help us monitor if and how the virus mutates, which will be crucial to our efforts to continue to learn and fight this virus,” said FDA Commissioner Dr. Stephen Hahn, M.D. “COVIDSeq leverages the performance of NGS to help address the global need for diagnostic testing to fight the COVID-19 pandemic,” said Francis deSouza, Chief Executive Officer of Illumina. “Beyond diagnostic testing, Illumina and a number of our customers are exploring NGS-based workflows to enable high-volume screening to support a return to work and school.”
Click Here for more details and updates on COVID19
Collated by : Esha Sehanobish, PhD
Drug Approvals
FDA Grants Accelerated Approval to Zepzelca™ (lurbinectedin) in mSCLC Patients
"Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients whose metastatic SCLC has progressed on or after platinum-based therapy," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Jazz congratulates PharmaMar on the successful development of Zepzelca and we are proud to partner with them to bring this new therapy to the U.S. market, expanding our presence in oncology."
FDA approves KEYTRUDA monotherapy in adult/pediatric TMB-H patients based on KEYNOTE-158 trial results
“For the second time, KEYTRUDA monotherapy is now approved based on a biomarker rather than the location in the body where the tumor originated,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “TMB-H, defined as 10 mutations per megabase or more, can help identify patients most likely to benefit from KEYTRUDA. We’re pleased that our collaborative efforts to advance biomarker research have resulted in our ability to provide a new treatment option that addresses a high unmet medical need for these patients with cancer.”
Click Here for more on Drug Approvals
Regulatory News
Fruquintinib Granted U.S. FDA Fast Track Designation for mCRC
  • FDA granted Fast Track Designation for fruquintinib in mCRC patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS WT, an anti-EGFR therapy
  • Ph 3 registration FRESCO-2 study is initiated in refractory mCRC in the U.S., Europe and Japan.
  • FRESCO-2 is expected to start patient enrollment in mid-2020
  • U.S. FDA acknowledged that the totality of the fruquintinib clinical data (including FRESCO-2 results, if positive; the prior positive Ph 3 FRESCO results showing OS improvement; and additional completed and ongoing supporting mCRC trial results; could support an NDA for 3L patients
  • Adequacy of the data will be assessed during the review of NDA.
FDA grants Fast Track designation to liposomal irinotecan (ONIVYDE®) in 1L metastatic pancreatic cancer patients
“Since the initial approval of ONIVYDE® in metastatic pancreatic cancer, we have continued to dedicate our research efforts to better understand the needs of pancreatic cancer patients. Through ongoing clinical investigations and exploratory real-world analyses, we have sought to determine whether patients who receive active treatment early have an improvement in survival,” said Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen. “As we continue to enroll additional patients in the ongoing Phase 3 NAPOLI-3 clinical study, we look forward to working closely with the FDA to potentially bring ONIVYDE® to more pancreatic cancer patients earlier in the disease.”
Click Here for more on Regulatory News
Trial Results
Ph 3 IPATential150 trial of ipatasertib + abiraterone and prednisone/prednisolone met co-primary endpoint of rPFS improvement
“Prostate cancer remains a leading cause of death in men worldwide and patients with metastatic castration-resistant prostate cancer can be difficult to treat,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The early results of the IPATential150 study are encouraging in our ongoing mission to develop new treatment options for people with advanced prostate cancer.”
Ph 3 IMpassion031 trial of Tecentriq® (atezolizumab) + chemo met primary endpoint of pCR improvement in early TNBC patients, regardless of PD-L1 expression
“Triple-negative breast cancer remains an aggressive disease with high rates of recurrence,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our goal in treating TNBC at its earliest stages is to provide people with the best chance for a future cure. Adding Tecentriq to chemotherapy now has the potential to help women with TNBC at multiple different stages of the disease.”
Click Here for more on Trial Results
Trial/Program Status
Two Ph 1 Clinical Trials for Novel Antibody-Based Drug Candidates SEA-TGT and SGN-B6A Initiated
“We believe that anti-TIGIT antibodies may have an important therapeutic role in the evolving immuno-oncology landscape,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “SEA-TGT utilizes our novel SEA technology, which in preclinical research has demonstrated enhanced effector function that potentially differentiates it from other TIGIT antibodies in the clinic. The initiation of clinical trials for both SEA-TGT and the ADC, SGN-B6A, underscore our commitment to advancing novel drug candidates from our pipeline into clinical testing.”
Update Announced on Ph 1 Trial of CUE-101 in Recurrent/Metastatic Head and Neck Cancer
“Based on the preliminary safety, tolerability, biomarker metrics and clinical activity observed to date, we are highly encouraged that CUE-101 appears to have an attractive therapeutic window. We are looking forward to launching our combination trial with Merck’s Keytruda® (pembrolizumab) as well as a neo-adjuvant trial later this year to generate clinical data sets pertaining to tumor-infiltrating lymphocytes, or TILs, from the targeted T cell population,” said Ken Pienta, M.D., acting chief medical officer. “Moreover, based on our collective data to date, we are now well-positioned to further exploit the flexibility of our trial design which allows us to expand any given dose level up to nine patients, further enhancing the supporting data evaluating the drug’s safety and therapeutic window. This will enable us to select the optimal dose to be advanced into Part B of the Phase 1 trial.”
EHA 2020: Updates Announced on Ph 2 MANIFEST Study for CPI-0610 and EZH2 Franchise
“I’m encouraged that the initial signals of activity with CPI-0610, such as spleen and symptom responses, that were presented last December at ASH continue to be observed in a larger dataset presented in these EHA posters,” said Claire Harrison, D.M. (Oxon.), Professor of Haematology and a MANIFEST investigator. “In addition, we continue to see signals of disease modification, such as increases in hemoglobin, conversions of transfusion-dependent patients to transfusion independence, and bone marrow fibrosis improvements. If corroborated in further testing, these data suggest that CPI-0610 could potentially change the treatment paradigm in MF.”Top of Form
Collated by : Richa Tewari, PhD
MedNess Reviews
FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening
Crysvita (burosumab-twza), from Ultragenyx Pharmaceutical Inc., was given the go-ahead by the U.S. Food and Drug Administration (FDA)to treat patients with tumor-induced osteomalacia (TIO), a rare disease characterized by the development of tumors causing weakened bone and fragile.
 The tumors associated with TIO were found to lower blood phosphate level by releasing a peptide-hormone like substance known as fibroblast growth factor 23 (FGF23). FGF23 regulates phosphate levels in the blood, which is a macronutrient responsible for bone maintenance, cellular energy homeostasis, and neural functioning. Treatment of TIO usually focuses on removing the tumor, but when that is not possible, Crysvita, an FGF23-blocking antibody, can help increase the blood phosphate levels and alleviate the weakening of bones (also known as osteomalacia).
 In two separate studies with a total of 27 adults with TIO, Crysvita could elevate blood phosphate levels in 50% and 69% percent of patients through week 24 and could maintain near-normal levels of blood phosphate through week 144 and week 88, respectively. Bone scans of the first cohort of patients also indicated signs of bone lesion healing post-treatment with Crysvita.
The most common side-effects included muscle spasms, rash and hives, abscess, dizziness, constipation, and injection site reaction.
 Crysvita was previously approved in April 2018, by the FDA for the treatment of X-linked hypophosphatemia, that is known to cause low levels of phosphate in the blood and leads to impaired bone development in children and teenagers.
Collated by : Tanmoy Samaddar
Medness Plus
FDA approves HIV-1 infection treatment for pediatric patients
FDA recently approved Tivicay (dolutegravir) and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 in pediatric patients.
“For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults,” said Debra Birnkrant, M.D., director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research. “While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV. Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen. Today’s approval gives our youngest HIV patients more options, helping them live longer, healthier lives.”
FDA approves the marketing of the first game-based digital therapeutic device to improve attention function in children with ADHD
FDA recently approved the EndeavorRx device, the first game-based digital therapeutic device to help improve the attention function of children with attention deficit hyperactivity disorder (ADHD).
“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”
Click Here for more on MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News

IDEAYA and GSK Announce a Broad Partnership in Synthetic Lethality
“GSK is the ideal strategic partner for IDEAYA, as this partnership enables compelling potential combinations and the opportunity to build the industry leading Synthetic Lethality pipeline that targets molecularly defined populations in several major solid tumors, including potentially lung, prostate, breast, colorectal, and ovarian cancer,” said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences.
ISA Pharmaceuticals Strengthens Strategic Immuno-Oncology Collaboration with Regeneron
“This agreement will accelerate the development and commercialization of our lead asset, ISA101b, to treat two important cancers with high unmet medical needs.” commented Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals. “We are extremely pleased to be working with Regeneron and for their continued support of both ISA Pharmaceuticals and our clinical studies in both indications.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech
Surrozen raises $50 million in series C financing to advance its Wnt modulating antibodies into clinical trials for liver and inflammatory bowel disease
Surrozen Inc. (Surrozen, San Francisco, CA) is biotechnology company engaged in developing regenerative/reparative antibodies to a broad spectrum of diseases. It has two Wnt- based proprietary platforms, SWEETS (Surrozen Wnt signal enhancers engineered for tissue specificity) and SWAP (Surrozen Wnt signal activating proteins).
On June 19th 2020, Surrozen announced raising $50 million in series C financing from The Column Group, Hartford Healthcare Trust, and Horizons Ventures along with Euclidean Capital. The money will be used to advance the 2 INDs into clinical trials.
Alpine Immune Sciences cuts $865 million licensing deal with Abbvie for its first in class dual CD28/ICOS costimulation antagonist against SLE
Alpine Immune Sciences (Alpine; Seattle & North Chicago), announced a licensing deal with Abbvie on June 18th 2020. Specializing in innovative treatments for autoimmune/ inflammatory diseases, Alpine has developed a first in class dual action molecule, ALPN-101, which is a CD28/ICOS costimulation antagonist. ALP-101 has proved efficacious in preclinical studies with well characterized pharmacokinetics and safety data from adult healthy volunteers. Abbvie has claimed exclusive licensing of the molecule and has paid $60 million in upfront cash, with a potential aggregate payment of $805 million upon completion of success-based development, regulatory and commercial milestones. Additionally, Alpine will received tiered royalties on net sales of ALP-101.
“AbbVie’s expertise in Immunology has led to remarkable breakthroughs in the treatment of autoimmune diseases…ALPN-101’s dual mechanism of action has compelling potential as a next-generation treatment in systemic lupus erythematosus and other autoimmune diseases. We are excited to partner with the team at Alpine on the development of this novel therapeutic.”- Tom Hudson, M.D., Senior Vice President and Chief Scientific Officer, AbbVie.
Click Here for more news and details on mergers, acquisitions and business updates
Collated by : Divyaanka Iyer
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Tanmoy Samaddar
MedNess Reviews
Divyaanka Iyer
BioPharma News
Debarati Banik
HealthIT
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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 
Content Editors: Richa Tewari , Esha Sehanobish , Divyaanka Iyer, Arundithi Ananthanarayanan, Debarati Banik, Tanmoy Samaddar, 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.