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MedNess: bite-size biopharma and medtech news

2nd June, 2020
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MedNess This Week
HIGHLIGHTS
Our Sponsors
COVID19 Special

First human trial of potential antibody treatment for COVID-19 begins
"We are grateful to collaborate with colleagues at AbCellera, NIAID, and the many academic institutions who have helped us reach this milestone in humanity's fight against COVID-19 — a disease first characterized only six months ago. We are privileged to help usher in this new era of drug development with the first potential new medicine specifically designed to attack the virus. Antibody therapies such as LY-CoV555 may have potential for both prevention and treatment of COVID-19 and may be particularly important for groups hardest hit by the disease such as the elderly and those with compromised immune systems," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories.
A New Visual-COVID-19 test Offers Hope for Rapid Testing
Borrowing principles from visual diagnostic tests, researchers from the University of Maryland have developed a simple diagnostic test for COVID-19. The work published in ACS Nano, describes a test that could provide a visual result within 10 minutes and does not require any laboratory equipment.
The test leverages the use of gold nanoparticles, that change color in the presence of the virus, that can be observed by the naked eye. Specifically, gold nanoparticles that are engineered to react in the presence of an RNA that is specific to the novel coronavirus. These nanoparticles are suspended in a liquid and have a purple color.
Upon introduction of the novel coronavirus RNA, extracted from a nasal swab or saliva sample, the nanoparticles begin to bind to the specific viral RNA and begin to cluster. This brings about a visible change in color of the solution from purple to blue. The researchers believe that this test may be able to detect RNA material from the virus as early as the first day of infection.
This innovative test has led to the creation of the company VitruVian Bio as the scientists plan to develop the test for widespread use and seek emergency use authorization by the FDA. However, additional studies are still needed to validate the assay.
As many countries plan to reopen, this test could be an inexpensive and ideal diagnostic suited for use in daycare centers, nursing homes, college campuses or the workplace settings.
**Watch this space for more updates**
Drug Approvals
FDA Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combined with Limited Chemotherapy in 1L mNSCLC patients based on Ph 3 CheckMate -9LA trial results
“We have come a long way in understanding the role of dual immunotherapy-based approaches in cancer and the potential impact on patients’ long-term outcomes,” said David P. Carbone, MD, PhD, CheckMate -9LA investigator and Director of the James Thoracic Oncology Center at The Ohio State University. “The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status. With today’s approval, more patients now have access to an Opdivo + Yervoy-based option and a chance at a longer life.”
FDA Approves ALUNBRIG® (brigatinib) as a First-Line Treatment Option for 1L ALK+ve mNSCLC patients
“We’re extremely proud of the positive results ALUNBRIG has shown for newly diagnosed ALK+ NSCLC patients, particularly those with brain metastases,” said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. “Through a robust clinical development program and ongoing investigations across the NSCLC treatment landscape, Takeda is committed to uncovering solutions for people living with devastating forms of lung cancer in need of new options. We believe this approval for ALUNBRIG is a substantial step in the right direction and represents significant progress for Takeda’s broader lung cancer portfolio.”
FDA approves CYRAMZA® (ramucirumab) for 1L EGFR-Mutated mNSCLC patients
"The approval of this new first-line metastatic EGFR-mutated non-small cell lung cancer regimen, which inhibits the VEGFR and EGFR pathways together, is an important milestone in the treatment of this disease. It is wonderful that patients now have multiple options for initial therapy capable of delaying disease progression for considerably longer than erlotinib, which has been our traditional standard approach," said Edward Garon, M.D., David Geffen School of Medicine, University of California, and North America lead investigator of the RELAY trial. "Ramucirumab, in combination with erlotinib, is a welcomed first-line option to offer our patients with metastatic EGFR-mutated non-small cell lung cancer."
Regulatory News
LYNPARZA® (olaparib) Receives CHMP recommendation for 1L Maintenance Treatment of Patients with gBRCA-Mutated Metastatic Pancreatic Cancer
Pancreatic CancerDr. José Baselga, executive vice president, oncology R&D, AstraZeneca, said, “Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to potentially bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU.”
FDA no longer plans to hold an ODAC meeting to discuss margetuximab BLA
"Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency’s questions as they arise," said Scott Koenig, M.D., President and CEO of MacroGenics. "We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer."
Click Here for more Regulatory News
Trial Results
FAILED TRIAL: iDMC concludes that Ph 3 PALLAS unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival (iDFS)
“We are disappointed in this outcome. Breast cancer is a leading cause of death around the world and delaying or preventing the development of metastatic disease is a significant unmet need. PALLAS is a large study with many subgroups and we are actively collaborating to determine if there are patients who may benefit from adjuvant treatment with the palbociclib combination," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “Since its initial approval in 2015, IBRANCE has helped change the treatment landscape for people with HR+, HER2- metastatic breast cancer. We are grateful to all patients, health care providers and our academic partners who have devoted so much to make this important study possible.”
Positive Topline Results announced from Ph 3 NORA trial of ZEJULA® as Maintenance Therapy for Chinese Patients with Platinum-sensitive, Recurrent Ovarian Cancer
“The NORA clinical data in Chinese patients confirmed the compelling clinical profile of ZEJULA and were consistent with the results seen in the global NOVA study,” said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer. “Importantly, the NORA study demonstrated an individualized starting dose regimen at 200 mg preserved the efficacy while improving safety profile in Chinese patients, particularly with regard to the hematological toxicities. Building on both the promising results of NOVA and Zai Lab’s PK study that demonstrated no ethnicity difference between Chinese and global subjects, the NORA study further underscores the promise of ZEJULA as a maintenance therapy for Chinese patients with platinum-sensitive recurrent ovarian cancer.”
Trial/Program Status
Compugen Doses First Patient in COM701 Phase 1 Monotherapy Expansion Cohort
Erika Hamilton, M.D., Director of Breast Cancer and Gynecologic Cancer Research Program at Sarah Cannon Research Institute and principal investigator in the COM701 Phase 1 study, said, “There is a significant need to develop novel treatments for patients with advanced cancer who are unresponsive to or relapse following treatment with the currently available standard of care immune checkpoint inhibitors. The preliminary signs of anti-tumor activity observed in the heavily pretreated, all-comer patient population included two confirmed partial responses in patients with microsatellite stable colon and platinum resistant primary peritoneal cancer which are tumor types typically unresponsive to immune checkpoint inhibitors. We are excited to advance to the monotherapy expansion stage of the study potentially offering patients a new effective cancer immunotherapy treatment.”
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
A ring of truth: Real-time system tracking symptoms to predict COVID-infection
Florida Atlantic University’s Schmidt College of Medicine is in the process of implementing a ring-shaped tracker of physiological changes indicative of COVID-19 infection. According to the original source, it is designed to identify ‘patterns of onset, detection, progression, and recovery from COVID-19 by observing body temperature, heart rate, breathing rate and related measures, as well as illness symptoms such as fever, cough, and fatigue’. FAU researchers are part of a global study called TemPredict, which is led by the University of California San Francisco (UCSF), and includes primarily two groups: frontline healthcare workers and the general population.
The functionality of the smart ring, named as Oura ring, depends on tracking the body’s heart rate, temperature, movement, and sleep to determine whether the collected physiological data, combined with responses to daily symptom surveys, can be indicative of illness symptoms. The ring itself resembles a wedding band, is worn around-the-clock to continuously provide data in real time, and presents a tremendous potential of identifying signs of illness during the asymptomatic phase before even getting sick, according to the researchers.
Machine learning to the rescue of detection of sepsis
According to a research published in Nature Communication by the group of Savas and Patel, sensitive and rapid quantification of bacterial load and cytokines from human biological samples can be used to generate predict sepsis outcomes with nearly 100 percent accuracy by using machine learning algorithms. Given the fact that more than 1.7 million Americans develop sepsis each year resulting in 270,000+ deaths per year, a more unified standard of care is required in detecting sepsis. The researcher group from University of Chicago developed a new, extremely sensitive method that can quantify an antibiotic resistant gene along with the bacteria, and immune molecule levels within sepsis patients more rapidly than current approaches.
The technique relies on a digital polymerase chain reaction (PCR) test that uses digital proximity ligation assays (PLA) to quantify the levels of particular proteins and genes in the blood. Use of a blood sample to test for gram-negative (GN) and gram-positive (GP) bacterial DNA would be sufficient, given the abundance of the bacterial-genetic material load within many septic patients. The team is in the process of developing a machine to quickly test samples on site at ICUs, proceeding with a clinical trial. They are also hopeful about extending the test to include more groups of bacteria beyond just the GN and GP levels, provide better practical understanding to reduce antibiotic resistance, as well as viral infections that promote cytokine overload, such as, COVID-19.
Collated by :  Debarati Banik
MedNess Reviews

FDA Approves First Radioactive Dye for Mapping Tau Tangles
The Tauvid injection, developed by Eli Lilly’s Avid radiopharmaceuticals subsidiary recently received approval from the FDA, the first radioactive dye for imaging tau pathology.
The injection contains a radioactive dye molecule that binds to the sites of the brain associated with Tau protein misfolding, making it visible under a PET scan. This helps clinicians estimate the density and scope of the neurofibrillary tangles that form within neurons and disrupt signaling, and provides a way to measure tau pathology. Tau pathology, along with amyloid pathology are the two key methods used for evaluating the brains of patients for Alzheimer’s.
Previously, the FDA had approved Lilly and Avid’s Amyvid radioactive agent for imaging amyloid plaque under a PET scan. In clinical studies, the outcome of the Tauvid brain scans were compared to post-mortem analyses of donated brain tissues of terminally ill patients. Evaluations of the images after Tauvid injection had high probabilities of correctly spotting tau pathology, though it was less accurate in completely ruling it out.
According to the FDA, Tauvid was assessed in patients with generally severe stages of dementia and its performance may be lower in earlier stages of cognitive decline. The availability of both imaging agents for amyloid plaques and tau tangles would help provide a more comprehensive evaluation of Alzheimer’s patients.

**Watch this space for more on MedNess Plus**
Conference Coverage - ASCO 2020
ABSTRACTS
  1. Medicenna Updates Efficacy Results from Phase 2b Recurrent GBM Trial
  2. Medicenna Presents Data on MDNA11, an IL-2 Superkine
  3. Tagrisso demonstrated unprecedented DFS in the adjuvant treatment of Stage IB-IIIA patients with EGFR-mutated lung cancer
  4. Roche’s Alecensa increases OS rate in ALK+ NSCLC
  5. KEYTRUDA® (pembrolizumab) + LENVIMA® (lenvatinib) Combination Demonstrated Clinically Meaningful Tumor Response Rates in Unresectable HCC and Advanced RCC patients
  6. KEYTRUDA® (pembrolizumab) shows Superiority to SOC Chemotherapy in MSI-H CRC patients
  7. Trillium Therapeutics announced data from ongoing Ph 1 dose escalation study of TTI-622 in with advanced R/R lymphoma patients
  8. New data show first-line triplet regimen of pembrolizumab, Herzuma® and chemotherapy are effective in treatment of HER2+ve advanced gastric cancer
  9. AVEO Oncology Announces Ph 1b/2 DEDUCTIVE trial of FOTIVDA® (tivozanib) + IMFINZI® (durvalumab) in 1L mHCC patients Advances to Ph 2
  10. Arvinas Releases Updated Dose Escalation Data from Ph 1/2 ARV-110 trial in mCRPC Patients
  11. Deciphera Pharmaceuticals Presents Preliminary Data from Ph 1b/2 Study of Rebastinib + Paclitaxel in Advanced Endometrial Cancer Patients
  12. ImmunoGen Presents Initial Data from FORWARD II trial of Mirvetuximab Soravtansine + Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status
  13. Takeda presents data from Ph 2 OPTIC Interim Analysis in Patients with Resistant / Intolerant Chronic-Phase CML
  14. AstraZeneca presents Ph II Study 22 trial data of tremelimumab + Imfinzi (durvalumab) combination in advanced HCC patients
  15. Deciphera Pharmaceuticals Announces Positive PRO Results from INVICTUS Pe 3 trial of QINLOCKTM (ripretinib) in 4L GIST Patients
  16. Trastuzumab Achieves Slight Reduction in Recurrence for Women with HER2+ve DCIS on NRG Oncology Trial NSABP B-43
  17. Imfinzi showed a sustained OS benefit in 1L ES-SCLC in the Ph 3 CASPIAN trial
  18. SPEAR T-cells Targeting MAGE-A4 Demonstrate New Responses in Esophagogastric Junction (EGJ), Lung, and Head and Neck Cancers
  19. Pfizer and Astellas present final OS results from Ph 3 PROSPER trial of XTANDI® (enzalutamide) + ADT in nmCRPC patients
  20. Taiho Oncology presented interim efficacy and safety results from Ph 2 FOENIX-CCA2 trial of futibatinib (TAS-120) in iCCA patients with harboring FGFR2 gene fusions or other rearrangements
  21. Enhertu significantly improved tumour response rate and OS in HER2+ve metastatic gastric cancer in Ph 2 DESTINY-Gastric01 trial
  22. Enhertu achieved a tumour response rate of 45.3% in patients with HER2+ mCRC patients in Ph 2 DESTINY-CRC01 trial
  23. Enhertu demonstrated meaningful clinical activity in patients with HER2-mutant NSCLC in interim analysis of Ph 2 DESTINY-Lung01 trial
  24. WindMIL Therapeutic’s presents Ph 2 study of MILs™ – NSCLC
  25. Iovance presented Pivotal Cohort 4 Data for Lifileucel from C-144-01 trial in advanced Melanoma
  26. Autolus Therapeutics presents additional data on AUTO3 in DLBCL
  27. Janssen presented data from Ph 1b/2 CARTITUDE-1 study in RRMM; ERLEADA® (apalutamide) OS data from Ph 3 SPARTAN in nmCRPC; and results from Ph 1 studies of amivantamab in NSCLC; and teclistamab in RRMM patients
  28. Blueprint Medicines presented Durable Clinical Activity and Safety data of Pralsetinib Across Broad Range of RET Fusion-Positive Tumors
  29. Amgen Presents New AMG 510 Clinical Data Across Multiple Solid tumors
  30. Allogene Therapeutics and Servier announced positive initial results from Ph 1 ALPHA study of ALLO-501 in R/R NHL patients
  31. Yescarta® (Axicabtagene Ciloleucel) Demonstrates High Rates of Response in R/R iNHL patients
  32. Takeda Announced Compelling Data from Ph 2 Trial of Pevonedistat + Azacitidine in Patients with Higher-Risk MDS
  33. Sanofi presents longer-term results and durable responses of Libtayo® (cemiplimab-rwlc) in advanced cutaneous squamous cell carcinoma
  34. BeiGene Presented Updated Head to Head Results from Ph 3 Trial of Zanubrutinib vs. Ibrutinib in Patients with Waldenström’s Macroglobulinemia
  35. Karyopharm Reports Positive Ph 3 BOSTON Data in multiple myeloma patients
  36. Myovant Sciences Announces Additional Positive Efficacy and Cardiovascular Safety Data from Ph 3 HERO Study of Once-Daily, Oral Relugolix in Advanced Prostate Cancer
  37. Seattle Genetics Announces Positive Results from Exploratory Analyses of HER2CLIMB for TUKYSA™ (tucatinib) in Brain Metastases Patients With HER2-Positive Breast Cancer
  38. Chi-Med presented new and updated analyses on the ongoing studies of savolitinib and surufatinib
  39. Mersana Therapeutics Reports Positive Interim Data from the Expansion Portion of the XMT-1536 Phase 1 Study
  40. GSK presented DREAMM-2 and DREAMM-6 data of belantamab mafodotin in RRMM patients
  41. Novartis presented long-term RFS benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery
  42. Novartis presented MONALEESA-7 (M7) and MONALEESA-3 (M3) subgroup analysis
  43.  Treatment with avelumab + best supportive care following chemotherapy shown to significantly extended OS in patients with advanced urothelial cancer in the JAVELIN Bladder 100 trial
  44. Adjuvant Osimertinib shown to Delay Disease Recurrence in Patients With Localized NSCLC
  45. Pembrolizumab doubles time to disease progression in MSI-H/dMMR mCRC patients
  46. TRACON Pharmaceuticals presented Updated Envafolimab Results In MSI-H/DMMR CRC And Results From Opdivo + Yervoy trial In Undifferentiated Pleomorphic Sarcoma
  47. BriaCell Presented preliminary efficacy & safety data
  48. Treos Bio presented positive final data from Ph I/II study of PolyPEPI1018 in MSS mCRC patients 
Medness Business
Onco-News

Chi-Med and BeiGene to Evaluate Combinations of Surufatinib and Fruquintinib with Tislelizumab
“By working together with a partner like Chi-Med, we hope to understand and develop innovative combination therapies that may bring meaningful treatments to cancer patients around the world. Through this collaboration we plan to further evaluate tislelizumab in combination with oral VEGFR inhibitors to target a variety of solid tumor cancers,” said Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operations & Biometrics and APAC Clinical Development, at BeiGene.
Gilead Sciences and Arcus Biosciences to Co-develop and Co-commercialize Next-generation Cancer Immunotherapies
“We are very pleased to build on Gilead’s growing presence in immuno-oncology with this important new strategic collaboration with Arcus,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “Gilead is committed to accessing the world’s best innovation in immuno-oncology and our agreement with Arcus further demonstrates that commitment. By gaining access to its broad, diverse pipeline and Arcus’s clear strengths in discovery and development, we believe that our partnership with Arcus will significantly accelerate our progress in developing transformative new therapies for cancer.”
Collated by : Richa Tewari, PhD
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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