View this email in your browser

MedNess: bite-size biopharma and medtech news

28th April, 2020
Subscribe here
MedNess This Week
HIGHLIGHTS
Our Sponsors
COVID Special
Abbott launches its third COVID-19 lab-based antibody test for detection of the novel coronavirus infection
Abbott recently announced the launch of their third COVID-19 test. This is a serology-based lab test that will be used for the detection of antibodies, IgG to understand if a person has been infected with SARS-Cov-2.
"We continue to contribute in a significant and meaningful way by providing new solutions across our diagnostics testing platforms," said Robert B. Ford, president and chief executive officer, Abbott. "I'm extremely proud of the many Abbott people who are working around the clock to get as many tests as we can to healthcare workers and patients."
FDA authorizes the first diagnostic test for at-home patient sample collection
FDA recently announced the authorization of the first diagnostic test allowing the at-home collection of samples from patients for COVID-19. Using the LabCorp’s pixel by LabCorp COVID-19 test home collection kit, samples can be self-collected by patients at home.
“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers. Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
FDA issues a safety communication against the use of hydroxychloroquine for COVID-19 patients outside the hospital setting or a clinical trial
FDA recently issued a drug safety communication against the usage of hydroxychloroquine or chloroquine often in combination with azithromycin. Recent reports suggest that there has been serious heart rhythm issues (arrythmia) associated with the use of this combination of drugs for the treatment of COVID-19. Even though further investigations are still on-going, FDA has now issued a safety communication against the use of the drugs outside of the hospital or a clinical setting due to the risk of heart rhythm issues. The hydroxychloroquine/chloroquine that is being used is essentially from the Strategic National Stockpile, the national repository of the critical medical supplies to be used during medical health emergencies.
Click Here for more details and updates on COVID19
Drug Approvals
FDA approved Trodelvy™ (sacituzumab govitecan-hziy) in mTNBC patients who have received at least two prior therapies
“The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease,” stated Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and Assistant Professor of Medicine at Harvard Medical School. Dr. Bardia was the lead investigator of the Phase 2 study. “In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.”
FDA Approves Incyte’s Pemazyre™ (pemigatinib) in 2L Unresectable Locally Advanced or Metastatic Cholangiocarcinoma Patients
“Our research into FGFR2 fusions or rearrangements in cholangiocarcinoma and the development of Pemazyre as the first targeted treatment option demonstrates our commitment to translating scientific discovery into solutions that can positively impact patients’ lives,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “We’re proud to bring Pemazyre to patients and will make this new treatment available immediately.”
FDA Approves IMBRUVICA® (ibrutinib) + Rituximab for the Treatment of 1L CLL Patients
"FCR, a chemoimmunotherapy-based regimen, has been the standard of care for many previously untreated younger patients with CLL. With the introduction of this ibrutinib-rituximab combination, patients now have a more effective, non-chemoimmunotherapy option," said Brian Koffman, M.D., C.M. (retired), Co-Founder and Chief Medical Officer/Executive Vice President, CLL Society, a nonprofit organization focused on CLL patient education, support and research. "In the 14 years since I was first diagnosed with CLL, the treatment landscape has advanced dramatically for the better, with ibrutinib continuing to play a pioneering role in defining what it means to live with this disease."
Regulatory News
sNDA for Tislelizumab + Chemotherapy in 1L Advanced Squamous NSCLC Accepted in China
“This sNDA filing is another important milestone in tislelizumab’s development program, coming on the heels of its recent approval in urothelial carcinoma in China – our first approval in solid tumors and the announcement of the positive outcome of our second study in first-line NSCLC, in patients with non-squamous histology. Our team was able to submit the regulatory application only 20 months after trial initiation, illustrating how efficiently we can move to serve those in need,” commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. “We look forward to working closely with the CDE on this filing and hope to bring a new treatment option to the large population of patients with advanced squamous NSCLC in China who could benefit from immunotherapy.”
Kymriah® receives FDA Regenerative Medicine Advanced Therapy (RMAT) designation in FL
“This designation supports the advancement of Kymriah, which could potentially address an unmet need in certain patients with follicular lymphoma, as we strive to reimagine medicine at Novartis. These patients are often faced with the burden of several years of various treatments as their disease continues to progress.” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.
Click Here for more Regulatory News
Trial Results
Positive Topline Result Announced from Pivotal Ph 3 CheckMate -743 Trial of Opdivo® (nivolumab) + Yervoy® (ipilimumab) vs. Chemotherapy in 1L Malignant Pleural Mesothelioma
“Malignant pleural mesothelioma is a devastating disease that has seen limited treatment advances over the past decade,” said Sabine Maier, M.D., development lead, thoracic cancers, Bristol Myers Squibb. “These topline results from the CheckMate -743 trial demonstrate the potential of Opdivo plus Yervoy in previously untreated patients with malignant pleural mesothelioma, and is another example of the established efficacy and safety of the dual immunotherapy combination seen in multiple tumor types. We would like to thank the patients who participated in this trial, as well as the investigators and site personnel for their perseverance during the conduct of this study and in delivering this important result for patients in the midst of the COVID-19 pandemic. We look forward to working with investigators to present the results at a future medical meeting, and to discussing them with health authorities.”
Positive Topline Results Announced from Pivotal Ph 3 CheckMate-9ER Trial of Opdivo® (nivolumab) + CABOMETYX® (cabozantinib) in 1L RCC
“The results from the pivotal CheckMate -9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients,” said Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. “Preliminary assessment of the data shows the combination of a 40mg dose of cabozantinib plus nivolumab demonstrated a favorable safety profile. If approved, this combination may become an important new first-line option for patients with metastatic renal cell carcinoma. We look forward to presenting detailed results at an upcoming congress.”
Click Here for more Trial Results
Trial/Program Status
Combination Therapy Portion of Ph 2a Trial of Marrow-Infiltrating Lymphocytes (MILs™) in NSCLC Patients Opened
“We are excited to open the combination therapy portion of our trial for NSCLC patients who have relapsed on or are refractory to anti-PD-1 therapy,” said Don Hayden, chairman and chief executive officer of WindMIL. “Having the trial’s safety committee clear MILS for use in combination with nivolumab is an important milestone for our NSCLC program, and it further underscores the favorable safety profile observed with MILs in the treatment of more than 100 patients to date. We continue to see high physician and patient interest in our NSCLC study and WindMIL is doing all it can to support patients and physicians as they adapt to the challenging treatment environment COVID-19 has created. We remain committed to finding ways to leveraging our MILs technology platform to better address the unmet needs of patients living with cancer.”
Update provided on Ph 3 TRYBECA-1 trial of Eryaspase in 2L metastatic pancreatic cancer patients
“We are pleased that the TRYbeCA-1 trial has continued to progress well despite the challenges caused by the COVID-19 global pandemic,” said Gil Beyen, CEO of ERYTECH. “The third independent safety review has once again confirmed the favorable safety profile of our lead product candidate eryaspase, and the trial has now surpassed 75% of the planned target enrollment. While prioritizing the safety of patients, health care providers and our employees, we have successfully deployed measures to safeguard the integrity of the trial by ensuring patients’ continued access to treatment and appropriate follow-up. The enrollment of new patients is also continuing, but at a slower pace than over the past few weeks. We currently anticipate a limited delay in completing patient enrollment of 3 to 4 months from previous plans. In addition, and unrelated to COVID-19, the average time to events appears longer than originally expected. We now expect the interim superiority analysis around the end of this year and final results in the second half of 2021.”
Click Here for more Trial/Program Status
Collated by : Richa Tewari, PhD
Medness Reviews

Veracyte Gets Exclusive License to Yale genomic test for Idiopathic Pulmonary Fibrosis
Veracyte, the San Franscisco based genomic diagnostic company has entered into an exclusive licensing agreement with Yale University to advance the first-of-its-kind genomic blood test for predicting disease progression in patients with idiopathic pulmonary fibrosis (IPF).
The test developed by Yale researchers checks for a 52 gene signature in peripheral blood to gauge whether a patient diagnosed IPF could rapidly worsen from the disease. This genomic profile test was substantially more accurate at identifying patients with rapid progression of IPF as compared to a traditional assessment using clinical variables according to a study published in Science Translational Medicine. The findings were subsequently validated in an international multicenter study published in Lancet Respiratory Medicine.
The exclusive license agreement gives Veracyte the rights to use the 52 gene signature on its recently acquired nCounter FLEX Analysis System. Veracyte plans to use this test alongside its Envisia Genomic Classifier, which is used to differentiate IPF from other lung diseases.
Researchers Discover a Protein Target for Heart Muscle Regeneration
Researchers at the UT Southwestern Medical Center have recently discovered that a protein called calcineurin that plays a critical role in the ability of the mouse heart muscle to regenerate after the first week of life.
This study published in Nature comes almost a decade after the same team discovered that mouse hearts were able to regenerate when damaged in the first seven days of life. They had reasoned that if this regenerative capability was recreated later in life, it may offer new ways to treat heart damage. Earlier, the team had focused on the transcription factor Meis1, that prevents heart cells from dividing. When they deleted the gene for Meis1 in mice, they observed that the cardiomyocytes continued dividing after the first week of life. However, this effect was transient.
On further study, they discovered that another protein called Hoxb13 was responsible for shuttling Meis1 into cells and was also critical. Upon deletion of genes for both Hoxb13 and Meis1in adult mice, the researchers observed that the heart’s ability to pump blood returned to near normalcy after a heart attack. The mice hearts also looked closer to developing stages even when they were adults. On further investigation, the researchers discovered that calcineurin is responsible for regulating both Hoxb13 and Meis1 and by inhibiting calcineurin they were able to prolong the window of cardiomyocyte proliferation.
From a bench-to-bedside perspective, this study is significant as there are already drugs on the market that target calcineurin. Testing these drugs individually or in combination would possibly offer hopes for the treatment of heart damage.
Medness Business
Onco-News

Cue Biopharma and Merck to Evaluate CUE-101 + KEYTRUDA® (pembrolizumab) in 1L HPV+ Recurrent/Metastatic Head and Neck Cancer
“We are very pleased to collaborate in this important study with Merck, an established leader in cancer immunotherapy, with our first clinical asset, CUE-101, which represents our IL-2 variant CUE-100 Series,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Through the monotherapy and combination studies, we believe we will be able to demonstrate the mechanistic advantages of our approach and platform for modulating disease-relevant T cells directly in the patient’s body to safely enhance efficacy over current standards of care.”
Gilead, Kite and oNKo-innate Announce Research Collaboration to Discover Cancer Immunotherapies Focused on Natural Killer (NK) Cells
“Gilead is pleased to partner with oNKo-innate as a leader in this new and highly promising area of cancer immunotherapy,” said William A. Lee, PhD, Executive Vice President, Research, Gilead Sciences. “We have a strategic focus of growing both our expertise and pipeline in immuno-oncology and we believe this exciting collaboration will support each of these objectives as we work to discover and develop novel cancer therapies for patients.”
TRACON Pharmaceuticals Retains Global Rights to TRC253 Following Completion of Ph 1/2 Trial
“While TRC253 is as active as Xtandi in prostate cancer cell lines and in patient-derived xenograft models,  we determined during clinical development that the F877L androgen receptor mutation TRC253 was designed to treat was far less common than predicted, and the product candidate was not highly active in prostate cancer patients with acquired resistance to Xtandi or Erleada.  Given the preclinical data that suggest TRC253 may be as active as Xtandi in an earlier line setting, we believe TRC253 can be developed and commercialized successfully in China where many prostate cancer patients do not have widely available access to Xtandi or Erleada,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “As we have established three corporate partnerships in China over the past three years, we have developed significant relationships with Chinese pharmaceutical and biotechnology companies that we intend to leverage to identify a potential partner for TRC253 in this large oncology indication.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech

Moderna bags BARDA funding of $483 million for advancing its COVID-19 mRNA vaccine
Moderna Inc. (Moderna, Cambridge, MA) has secured a commitment from Biomedical Advanced Research and Development Authority (BARDA) of $483 million in accelerating the clinical trials of its mRNA vaccine, mRNA-1273, against SARS-CoV-2. The announcement was made on 16th April 2020.
Moderna has demonstrated its expertise with mRNA vaccines in diverse set of disease fields which include infectious diseases (CMV, EBV and Zika), respiratory infections (RSV, H7N9) and cancers (solid tumors and melanoma), many of which are in clinical trials.
Astellas acquires Nanna Therapeutics for $15 million, adding mitochondria-focussed drug discovery platform to its expanding portfolio
On 21st April 2020, Nana Therapeutics Limited (Nanna, Cambridge, MA) announced its acquisition by Astellas Pharma Inc. (Astellas, HQ: Japan) in a deal involving a little under $15 million for buying issued share capital of Nanna. It is now a wholly owned subsidiary of Astella, with the eligibility to receive future potential milestone payments of up to $71 million.
Nanna has been developing advanced and more diverse DNA encoded chemical libraries (DELs), which are compatible with phenotype-based screening and cell-based assays using patient derived cells, not possible on conventional DEL platforms.
In comparison with high throughput plate-based assays, Nanna’s CEO David Williams told endpoint news- “All of those technologies use a very miniaturized approach..So we use a microfluidic platform base where we can do essentially a lot of experiments in a very very small area — volume, and what that allows us the potential to do is to access diseased tissue or patient cells or very rare, difficult-to-obtain proteins to be able to do more functional assays on them.”
FoRx Therapeutics bags $11 million seed funding from big pharma VCs for damaging DNA across cancers
Forx Therapeutics (Basel, Switzerland) is a biotechnology company that develops cancer drugs intervening in DNA replication stress pathways. The company’s founder Thanos Halazonetis, has pioneered research in the field of break-induced replication (BIR), a mechanism found across cancers.
While the drug targets and lead molecules are as yet undisclosed, Novartis Venture Funds, Pfizer Ventures, Merck’s M Ventures and Omega Funds have entrusted Forx Therapeutics with $11 million funding in the seed round for its technology that is a potential treatment panning cancers. The announcement was made on 22nd April 2020. The BIR targets have shown potential in therapy and maintenance treatment in pre-clinical studies and present low risk of treatment resistance that is the eventually outcome of most treatment modalities. The company is hopeful of starting clinical trials in 3 years, targeting hard to treat cancers like colon cancer, first.
Click Here for more 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
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.