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MedNess: bite-size biopharma and medtech news

12th May, 2020
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MedNess This Week
HIGHLIGHTS
Our Sponsors
COVID Special
FDA issues an emergency use authorization for the investigational drug remdesivir for the treatment of COVID19
FDA recently issued an emergency use authorization (EUA) for the use of the investigational antiviral drug remdesivir for the treatment of patients with COVID-19. It will be used to treat adults and children with suspected and laboratory-confirmed COVID-19, hospitalized for severe disease.
“From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, M.D. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.”
FDA approves emergency use authorization for the new antibody test from Roche
FDA recently issued an emergency use authorization (EUA) for Roche’s Elecsys®, an antibody test (anti-SARS-CoV-2). The test will help to determine if a person was exposed to the SARS-CoV-2 virus, since upon exposure to the virus, our body develops antibodies.
“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO Roche Group. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
Moderna announces worldwide strategic collaboration with Lonza to manufacture the former’s coronavirus candidate vaccine mRNA-1273
Moderna Inc. and Lonza Ltd have recently announced a 10-year strategic collaboration agreement to increase the manufacture of Moderna’s mRNA vaccine (mRNA-1273) in the treatment of SARS-CoV-2 along with future Moderna products. The agreement will ensure large scale manufacture of these vaccines now and in the future.
“Moderna’s technology represents a significant opportunity to change the way we protect people against disease,” said Albert M. Baehny, Lonza’s Chairman and CEO ad interim. “The current pandemic illustrates the need to combine the best science with resilient supply chains that can scale. We are fully committed to leveraging our global network and experience in manufacturing technologies to support Moderna’s manufacture of mRNA-1273 as well as collaborating on future Moderna products.”
Click Here for more details and updates on COVID19
Collated by : Esha Sehanobish, PhD
Drug Approvals
FDA approves Retevmo™ (selpercatinib) for RET fusion +ve mNSCLC, RET-mutant mMTC & radioactive iodine-refractory RET-fusion +ve thyroid cancer patients
"In the clinical trial, we observed that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib, including responses in difficult-to-treat brain metastases," said Alexander Drilon, M.D., acting chief of early drug development at Memorial Sloan Kettering Cancer Center and lead investigator for LIBRETTO-001. "The approval of selpercatinib marks an important milestone in the treatment of NSCLC, making RET-driven cancers now specifically targetable in the same manner as cancers with activating EGFR and ALK alterations, across all lines of therapy. I am pleased that patients with these RET-driven cancers have this newly approved option."
FDA approves LYNPARZA® (olaparib) as 1L Maintenance Treatment with Bevacizumab for HRD+ve Advanced Ovarian Cancer
Dave Frederickson, executive vice president, head of the oncology business unit, AstraZeneca, said, “This approval represents another milestone for LYNPARZA in patients with ovarian cancer. The median progression-free survival of more than three years offers new hope for women to delay relapse in this difficult-to-treat disease. These results further establish that HRD-positive is a distinct subset of ovarian cancer and HRD testing is now a critical component of diagnosis and tailoring of treatment for women with advanced ovarian cancer.”
FDA approves MET inhibitor Tabrecta™ for mNSCLC with METex14 based on Ph 2 GEOMETRY trial data
“Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth,” said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne and lead investigator of the GEOMETRY study. “MET exon 14 skipping is a known oncogenic driver. With today’s decision by the FDA, we can now test for and treat this challenging form of lung cancer with a targeted therapy, offering new hope for patients with NSCLC harboring this type of mutation.”
Regulatory News
FDA granted Enhertu Breakthrough Therapy Designation for HER2+ve metastatic gastric cancer
José Baselga, Executive Vice President, R&D Oncology, said: “Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines. We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease.”
FDA grants Regenerative Medicine Advanced Therapy (RMAT) Designation to Ilixadencel in RCC
“We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to treat disease. As a designation similar to the FDA’s Breakthrough Therapy Designation, we will now also have the opportunity to receive direct guidance from the FDA which will inform key development decisions and ultimately bring us closer to delivering ilixadencel to patients in need,” commented Alex Karlsson-Parra, CEO of Immunicum.
sNDA submitted to MHLW for trastuzumab deruxtecan (DS-8201) in HER2 positive metastatic gastric cancer patients
"Today’s submission by Daiichi Sankyo brings us closer to bringing trastuzumab deruxtecan to a population of patients with unmet medical need in Japan,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “If approved, trastuzumab deruxtecan has the potential to meaningfully advance the treatment of patients with HER2 positive metastatic gastric cancer as the first ever antibody drug conjugate approved to treat this type of cancer.”
FDA extends PDUFA date for BLA for lisocabtagene maraleucel (liso-cel) in (R/R) large B-cell lymphoma by 3 months
  • Asset: lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy
  • Target population: adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.
  • New PDUFA action date: November 16, 2020.
  • Reason: Subsequent to the submission and acceptance of the BLA and upon FDA request, additional information was submitted to the FDA, deemed a major amendment to the application, requiring additional time for FDA review
Trial Results
Libtayo® (cemiplimab) shows clinically meaningful and durable responses in 2L advanced basal cell carcinoma
“While PD-1 inhibitors have transformed the outlook for many patients with melanoma, progress for patients with non-melanoma skin cancers has not been as rapid,” said Peter C. Adamson, M.D, Global Head of Oncology Development at Sanofi. “We are continuing to address this unmet need by first bringing Libtayo to patients with advanced cutaneous squamous cell carcinoma, and now, with this second trial, as a potential therapy for patients with advanced basal cell carcinoma. These important new results further demonstrate Libtayo’s potential in patients with difficult-to-treat, non-melanoma skin cancers.”
Positive Topline Results Announced from Ph 3 UNITY-CLL trial of Umbralisib + Ublituximab (U2) in CLL Patients
John Gribben, MD, DSc, FRCP, FRCPath, FMed Sci, Professor of Medical Oncology, Barts Cancer Institute, London, UK, and Global Study Chair for the UNITY-CLL study stated, "It’s extremely gratifying to see positive results for this important trial exploring the combination of umbralisib and ublituximab in patients with both front-line and relapsed/refractory CLL. Today’s outcome marks the first successful Phase 3 trial of a PI3K delta-based regimen in a CLL patient population that included previously untreated patients.” Dr. Gribben continued, “CLL remains incurable and new treatment options are still very much needed, particularly those that provide a differentiated mechanism and safety profile from our currently available treatment options.”
Click Here for more Trial Results
Trial/Program Status
First Patient Dosed in Ph 1/2 Trial of RTX-240 in Solid Tumors
“We are excited to advance our first-ever oncology Red Cell Therapeutic, RTX-240, into clinical development and to increase our understanding of its potential to help cancer patients,” said Christina Coughlin, M.D., Ph.D., chief medical officer of Rubius Therapeutics. “We are leveraging virtual capabilities to initiate clinical trial sites and concentrating on oncology-focused centers to enroll patients, while ensuring that patient and clinician safety is our top priority. By working with these oncology-focused sites, we believe we will have the greatest opportunity to enroll the trial in order to serve as many patients as possible.”
Enrollment Update provided in Ph 2 Trial of VAL-083 for Adjuvant Treatment of Brain Tumors; Trial 90% enrolled
  • 22 patients in the adjuvant arm of the ongoing Ph 2 trial of adjuvant treatment (pre-TMZ -- maintenance therapy) of MGMT-unmethylated GBM with VAL-083.
  • The adjuvant arm of the Ph 2 trial of VAL-083 being conducted at the MD Anderson Cancer Center (MDACC) plans to enroll up to 24 1L patients with surgery + TMZ-based CRT to receive VAL-083 instead of TMZ SOC.
  • In rGBM arm of the study72 patients out of a planned 83 patients have now been enrolled.
Click Here for more Trial/Program Status
Conference Coverage - ASCO 2020
  1. Karyopharm to present Data from Ph 3 BOSTON Study
  2. BeiGene to present data from Tislelizumab and Zanubrutinib trials
  3. AVEO Oncology to Present Final OS Analysis from Ph 3 TIVO-3 Trial of Tivozanib in RCC
  4. Genmab to present Epcoritamab, Tisotumab Vedotin and Daratumumab results
  5. Calithera Biosciences to present Telaglenastat Ph 2 KEAPSAKE Trial data
  6. Celyad to Present Update from CYAD-101 for Advanced CRC and Next-Gen shRNA Platform
  7. Iovance Biotherapeutics to Present Updated melanoma Data from C-144-01 trial
  8. Allogene Therapeutics & Servier to present data from dose escalation Phase 1 ALPHA study of ALLO-501 in R/R NHL patients
  9. Merck to present 25 abstracts to Showcase Significant Clinical Advances in Cancer Care
  10. Roche to present new data from clinical trials of 19 approved and investigational medicines across 21 cancer types
  11. bluebird bio to Present Updated Results From Pivotal Phase 2 KarMMa Study of Ide-cel in RRMM patients
Collated by : Richa Tewari, PhD
Medness Plus
FDA approves Farxiga oral tablets for the treatment of adults with heart failure
“Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.”
Click Here for more on MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News

Antengene Announces Expansion of Partnership with Karyopharm in Asia Pacific Markets
“We are delighted to have the opportunity to expand our very productive, efficient and results-driven collaboration with Antengene which began two years ago,” said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. “The exemplary partnership between the two companies enables Karyopharm to fulfill its mission to develop and deliver novel drug candidates to patients around the world.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech

ADC therapeutics announces $100 million IPO in COVID affected market
ADC Therapeutics (ADC, CH), announced an IPO for 7,355,000 common shares at a price offering between $16- $18 per share on 11th May 2020. ADC is an antibody-adjuvant therapy company that has developed pyrrolobenzodiazepines-conjugated antibodies for cancer therapy.
Pyrrolobenzodiazepines bind to DNA grooves after being targeted to the tumor, preventing cell division and ultimately killing cancer cells. Two of the company’s antibody conjugates- ADCT-402 (for diffuse large B cell lymphoma) and ADCT-301 (for Hodgkins lymphoma) have seen promising clinical trials and are close to FDA approvals.
ADC had previously raised $530 million in private sector funding since 2011. It had backed out of a $200 million IPO around October 2019 citing adverse market conditions but has now returned with an IPO offering of $100 million riding on the advancement of its portfolio drugs.
Illumina spin off GRAIL gets massive $390 million in series D funding for early cancer detection technology
Illumina spin off GRAIL, Inc. (GRAIL, CA) announced securing $390 million in series D funding on May 6th 2020. The investment backing comes from Illumina, Inc. as well as public sector investors such as Pension Investment Board (PSP Investments) and Canada Pension Plan Investment Board (CPP Investments). GRAIL has proprietary deep sequencing technology and artificial intelligence platforms for early detection of up to 50 cancer types in a single blood draw.
The technology relies on detection of methylation patterns in tumor-derived cell free nucleic acids, the release of which is an early cancer event. High intensity sequencing of methylation patterns not only reveals the type of cancer but also tissue of origin with GRAIL’s platform that has low risk of false positives and background biological noise.
The new investment will help fund GRAIL’s efforts at further development and commercialization of its technology. Interestingly, GRAIL is conducting 2 clinical trials- PATHFINDER; a prospective study that is currently enrolling towards a 6,200 patient cohort for early detection of cancer and SUMMIT; a longitudinal prospective study that aims to detect cancer in 50,000 asymptomatic individuals (aged 50-77) with a significant history of smoking.
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
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 
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