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MedNess: bite-size biopharma and medtech news

20th May, 2020

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MedNess This Week
HIGHLIGHTS
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COVID19 Special
Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
Watch this space for more updates in the coming weeks 
Drug Approvals
FDA Grants Full Approval to QINLOCK™ (ripretinib) in 4L GIST based on Ph 3 INVICTUS trial data
"Today’s approval of QINLOCK establishes a new standard of care for patients who have received three prior therapies,” said Margaret von Mehren, MD, Chief of Sarcoma Oncology and Associate Director for Clinical Research, Fox Chase Cancer Center, Philadelphia, Pennsylvania. “GIST is a complex disease and the majority of patients who initially respond to traditional tyrosine kinase inhibitors eventually develop tumor progression due to secondary mutations. In the INVICTUS study, QINLOCK has demonstrated compelling clinical benefit in progression-free and overall survival. QINLOCK is well tolerated and is a crucial new therapy for these patients with a high unmet need.”
FDA approves Rubraca® (Rucaparib) in BRCA1/2-Mutant, mCRPC patients Treated With Androgen Receptor-Directed Therapy And A Taxane-Based Chemotherapy
“Standard treatment options for men with mCRPC have been limited to androgen receptor-targeting therapies, taxane chemotherapy, Radium-223 and sipuleucel-T,” said Wassim Abida, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center, and Principal Investigator for the TRITON2 study. “Rubraca is the first in a class of drugs to become newly available to patients with mCRPC who harbor a deleterious BRCA mutation. Given the level and duration of responses observed with Rubraca in men with mCRPC and these mutations, it represents an important and timely new treatment option for this patient population.”
FDA approves Pomalyst® (pomalidomide) for AIDS-Related and HIV-Negative Kaposi Sarcoma
“Patients with Kaposi sarcoma have had few options to manage their disease for two decades,” said Diane McDowell, M.D., vice president, Hematology Global Medical Affairs, Bristol Myers Squibb. “We’re excited that the additional research into Pomalyst in this rare disease area has resulted in our ability to provide a much-needed oral treatment option for patients.”
FDA Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) in 1L PD-L1≥1% mNSCLC based on Ph 3 CheckMate-227 trial data
“Patients with metastatic lung cancer remain in need of new treatment options that may provide durable responses,” said Matthew D. Hellmann, M.D., CheckMate -227 study investigator and medical oncologist at Memorial Sloan Kettering Cancer Center. “The results from the CheckMate -227 trial show that a dual immunotherapy approach offers a chance at long-term survival for appropriate patients with metastatic NSCLC.”
Regulatory News
Enhertu granted BTD in the US for HER2-mutant mNSCLC based on Ph 2 DESTINY-Lung01 data
Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: “We are encouraged by the promising evidence of activity seen with Enhertu in patients with advanced lung cancer and a HER2 mutation. We look forward to working closely with the FDA on the potential for Enhertu to become the first HER2-directed therapy approved for non-small cell lung cancer.”
Successful Type B Meeting With FDA For Pivotal Study Of Envafolimab In Sarcoma Announced
“We appreciate the valuable discussions and guidance from our Type B meeting discussion with the FDA and concurrence on the design for the pivotal trials of envafolimab in sarcoma,” said Charles Theuer, M.D., Ph.D., President and CEO. “Following the successful completion of the regulatory meetingwe are focused on advancing envafolimab as a single agent and in combination with Yervoy (ipilimumab) for the treatment of the sarcoma subtypes of UPS and MFS, both of which have been shown to be responsive to immune checkpoint inhibition treatment. We look forward to initiating ENVASARC later this year.”
Trial Results
Long-term Follow-up Results from L-MIND Study of Tafasitamab announced in R/R DLBCL patients
"We are extremely encouraged by the long-term data from our L-MIND study which confirms the previously reported results from the primary analysis," commented Dr. Malte Peters, Chief Research and Development Officer, MorphoSys. "Tafasitamab in combination with lenalidomide has the potential to address the significant medical need in patients suffering from r/r DLBCL, and we are working diligently towards our key priority of making tafasitamab available to eligible patients."
Trial/Program Status
Ph 2 trial planned to evaluate the efficacy and safety of t-haNK, N-803, and aldoxorubicin HCI plus standard of care in 1L/2L locally advanced or metastatic pancreatic cancer
“Our results from expanded access use of PD-L1 t-haNK in combination with N-803 offer proof-of-concept that, together with these agents, the immune system may play a role to activate robust and durable responses in metastatic cancer patients who have failed all standard-of-care therapies,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. “Based on these encouraging data, we are moving forward with a randomized Phase 2 program that will evaluate our immunotherapy combination on top of standard of care, compared to standard of care alone, in first- and second-line treatment settings. This unique approach to orchestrating the innate and adaptive immune systems to induce immunogenic cell death may be an important new approach for pancreatic cancer patients—these being among the most challenging to treat with poor prognoses.”
Ph 1 Dose Escalation Study of XMT-1592 initiated
“XMT-1592 has shown a differentiated preclinical profile, particularly in NSCLC where we saw a four-fold increase in efficacy over XMT-1536, consistent with increased exposure to the DolaLock payload in the tumor, and we look forward to working to validate the clinical differentiation of this candidate,” said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. “XMT-1592 also has the potential to further extend our leadership position in NaPi2b-expressing malignancies, and we are very pleased to have reached this important 2020 goal of advancing this promising ADC candidate into the clinic.”
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
Quantum machine learning in COVID-19 drug discovery
Researchers from Penn State College of Engineering are utilizing the platform of machine learning combined with quantum physics to search for drugs targeting COVID-19. As opposed to the 5-10 years of working through the conventional drug discovery process, the quantum machine learning approach could be faster and more economical to bring a drug to the market. According to Dr. Swaroop Ghosh, the Joseph R. and Janice M. Monkowski Career Development Assistant Professor of Electrical Engineering and Computer Science and Engineering, “High-performance computing such as supercomputers and artificial intelligence can help accelerate this process by screening billions of chemical compounds quickly to find relevant drug candidates.” Dr. Ghosh’s team have previously used quantum computing to develop a toolset for solving combinational optimization problems. Drug discovery belongs to the same type of problem, making it possible to utilize the same platform for developing COVID-19 drug. According to HealthITAnalytics newsletter, researchers across the healthcare continuum are using AI and other big data analytics tools to quickly find treatments for COVID-19. Read more on this here.
Disparity in telehealth usage is apparent in COVID-19 era
The recent advancement in telehealth facilities and the associated regulations and funding to promote its usage has been the focus of this column in last few issues of MedNess. This news, as featured in the Healthcare IT News from HIMSS brings out a further challenge showing an evidence-based disparity of utilizing these benefits, in fact within the most vulnerable populations. The study shows that old people and those with lower income less likely to use these facilities, according to the results of a Black Book and Sage Growth Partners survey of 591 U.S. healthcare consumers. Majority of respondents (78%) using telehealth were satisfied with their experience. However, a majority of consumers aged 55 to 64 (81%) and aged 65+ (84%), who have access to telehealth have not had a virtual or telemedicine visit: indicating a pattern of reluctance in the aged population towards these services. A disparity towards telehealth access became apparent with the income group. Only 36% of people >$25,000 have access to telehealth, whereas these numbers are: 55% for the bracket of $50,000 to $100,000, 70% of those earning $100,000 to $200,000 and 70% of those with an income of more than $200,000. According to Dan D’Orazio, CEO of Sage Growth Partners, "Failing to account for the distinct needs of patient populations may lead to lower access and utilization – which can further widen gaps in health status", as he still expresses optimism bring telehealth to specialty care, primary care, urgent care and chronic care management, along with its accepted use cases like tele-stroke and telepsychiatry.
Collated by :  Debarati Banik
MedNess Reviews

NYU study raises concerns over false negatives from Abbott's portable coronavirus test
Researchers at the NYU Langone Health found that the Abbott’s rapid, point-of-care coronavirus test could miss nearly half of the positive cases.
The
study that was pre-published on bioRxiv involved 101 patients receiving emergency COVID-19 care through the system’s Tisch Hospital is yet to be peer-reviewed.
The samples were collected twice from each patient at the same time –  once using a dry nasal swab, and once with a longer swab reaching deeper into the nose that was then submerged in viral transport media. The samples were tested using Abbott’s ID Now analyzer and Cepheid’s Xpert Xpress test within one or two hours of sample collection.
Both Abbotts’s and Cepheid’s test use small, countertop devices designed to produce results in minutes or less than an hour and are authorized by the FDA.
According the study, among the dry nasal swab samples, about 48% of the positive tests returned by Cepheid were falsely read as negative by Abbott’s ID NOW and across the dry and submerged sample collection and transport methods, the ID NOW test missed one-third of the samples detected positive by Xpert Xpress.
Abbott has published a statement in its website that
best method for getting accurate results from its test is to use the device as close as possible to the patient, and has told users to insert dry swabs directly into the machine with little delay after samples are taken. The company also emphasized that the use of viral transport media, could dilute the samples and affect the sensitivity of the test.
Previously Abbott had reported a 0.02% rate of false negatives, but the adverse reports on the ID NOW test has prompted the FDA to evaluate reports of inaccurate results.
Abbott has also agreed to conduct studies to evaluate the device in a variety of clinical settings.

T cells found in COVID-19 patients offer hope for long-term Immunity
In the recent efforts to uncover the immune mechanisms against the SARS-CoV-2 virus, a team of researchers have found T cells that target the virus in the blood of people who have recovered from the infection.
The study also found that some people who haven’t been exposed the the virus also had T cells that could recognize the virus, suggesting that previous infections with other coronaviruses could provide some level of protection against SARS-CoV-2.
T-cells usually recognize fragments of viruses or viral proteins. When the cells identify a viral protein, helper T cells release chemical signals that trigger other parts of the immune system to kick into gear. Others, called killer T cells, hunt down and kill infected cells.
The team predicted which viral proteins from SARS-CoV-2 might provoke powerful T cell responses. Then they exposed immune cells from 10 COVID-19 patients and 11 healthy people to these viral proteins.
They found that around 70 percent of the COVID-19 patients harbored the cell-killing T cells, and all carried helper T cells that recognized the SARS-CoV-2 spike protein. They also had helper T cells also recognized other viral proteins.
They also found that about half of the healthy people had helper T cells that recognized SARS-CoV-2 proteins, and about a third had the killer T cells. All of these people tested positive for antibodies against two coronaviruses that cause common colds.
Although the study does not clarify that infection with SARS-CoV-2 would provide long terms immunity, the findings provide insights for scientists to develop better vaccine against the disease.

Conference Coverage - ASCO 2020
ABSTRACTS
  1. G1 Therapeutics, Inc. to present data across three randomized, double-blind, placebo-controlled Phase 2 trials of trilaciclib in SCLC
  2. MacroGenics Announces Preliminary Clinical Results from MGD013 and MGC018 to be Presented 
  3. BeiGene Announces Clinical Data of BTK inhibitor BRUKINSA™ (zanubrutinib) and anti-PD-1 antibody tislelizumab to Be Presented
  4. Janssen Presents First Data from Phase 1 Study of BCMAxCD3 Bispecific Teclistamab in Patients with Heavily Pretreated RRMM patients
  5. First data from Allogene’s Phase 1 dose escalation ALPHA study of ALLO-501 in R/R NHL to be presented
  6. BMS and bluebird bio to Present Updated Positive Results from Pivotal KarMMa Study of Ide-cel in RRMM Patients
  7. BMS to present 3-yr follow-up OS results from Part 1 of the Ph 3 CheckMate -227 trial of Opdivo (nivolumab) + Yervoy (ipilimumab) in mNSCLC presented
  8. BMS announces the presentation of First results from CheckMate -9LA
  9. Merck to present PFS result from KEYTRUDA® (pembrolizumab) + Chemotherapy in Certain Patients with mTNBC
  10. Merck to present results from KEYTRUDA’s Ph 3 KEYNOTE-204 in R/R cHL patients
  11. Merck to present new combination data for KEYTRUDA® (pembrolizumab) in Stage III NSCLC and Reinforce Long-Term Survival in mNSCLC
  12. Merck to present ORR data from HIF-2α Inhibitor in Patients with von Hippel-Lindau (VHL) Disease-Associated ccRCC
  13. Janssen to present Final analysis of the Phase 3 SPARTAN study
  14. Janssen to present Longer-term follow-up data from Phase 1b/2 CARTITUDE-1 study
  15. Bayer to present data from the pre-specified final OS analysis of the Phase III ARAMIS trial
  16. Data from 23 studies across Eli Lilly and Company's (NYSE: LLY) oncology product portfolio will be presented
  17. AstraZeneca to present 98 abstracts, including 19 oral presentations with one plenary and 10 late-breakers
  18. Novartis to present Data from more than 110 abstracts, including Novartis-sponsored and investigator-initiated trials in ASCO and EHA conferences
  19. Regeneron Pharmaceuticals, Inc. to share updates from its diverse clinical oncology portfolio
  20. Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program
  21. Eisai to Present Latest Data from Oncology Pipeline including KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Investigational Combination Therapy and HALAVEN® (eribulin mesylate)
  22. Gilead and Kite Continue to Advance Next Generation Cancer Therapies 
  23. ImmunoGen Announces Initial Data from FORWARD II Study of Mirvetuximab Soravtansine + Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status
  24. Exelixis Announces Results From COSMIC-021 Trial of Cabozantinib + Atezolizumab in Multiple Advanced Solid Tumor Types
  25. Arvinas Announces Updated Ph 1 Data Demonstrating Clinical Activity of PROTAC® Protein Degrader ARV-110 in Patients with Refractory Prostate Cancer
  26. INOVIO's to present OS12 data from Ph 1/2 trial of INO-5401 + Libtayo® (cemiplimab) in 1L Glioblastoma Patients
  27. MorphoSys to Present Data from Tafasitamab program
  28. MEI Pharma and Kyowa Kirin Announce to announce Data from Ph 1b Study of ME-401 on an Intermittent Schedule in FL and Other B-cell Malignancies patients
  29. Helsinn and MEI Pharma to present Updated Clinical Data from Ph 2 Study of Pracinostat + Azacitidine in Patients with High/Very-high Risk Myelodysplastic Syndromes
  30. Janssen Announces Ph 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced NSCLC Harboring Exon 20 Insertion Mutations
  31. Progenics to Present Results from the Ph 3 CONDOR Trial of PyL™ (18F-DCFPyL) in Prostate Cancer
  32. Innovent Announces Key Results from a Number of Clinical Studies to Be Presented
  33. Pfizer to present new data from clinical trials of 18 approved and investigational medicines
  34. Roche to present first clinical data on novel anti-TIGIT cancer immunotherapy tiragolumab
  35. Karyopharm to present Data from Ph 3 BOSTON Study
  36. BeiGene to present data from Tislelizumab and Zanubrutinib trials
  37. AVEO Oncology to Present Final OS Analysis from Ph 3 TIVO-3 Trial of Tivozanib in RCC
  38. Genmab to present Epcoritamab, Tisotumab Vedotin and Daratumumab results
  39. Calithera Biosciences to present Telaglenastat Ph 2 KEAPSAKE Trial data
  40. Celyad to Present Update from CYAD-101 for Advanced CRC and Next-Gen shRNA Platform
  41. Iovance Biotherapeutics to Present Updated melanoma Data from C-144-01 trial
  42. Allogene Therapeutics & Servier to present data from dose escalation Phase 1 ALPHA study of ALLO-501 in R/R NHL patients
  43. Merck to present 25 abstracts to Showcase Significant Clinical Advances in Cancer Care
  44. Roche to present new data from clinical trials of 19 approved and investigational medicines across 21 cancer types
  45. bluebird bio to Present Updated Results From Pivotal Phase 2 KarMMa Study of Ide-cel in RRMM patients
 
Medness Business
Onco-News

Boehringer Ingelheim Acquires Northern Biologics’ Preclinical Cancer Antibody Pipeline, Expanding IO Portfolio 
“This acquisition provides Boehringer Ingelheim with two complementary assets to our existing cancer immunology portfolio and supports our strategy to target ‘cold’ tumors with synergistic combination approaches,” said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research, Boehringer Ingelheim. “Driving innovation in tumor stroma and myeloid cell biology is yet another example of how we are ‘Taking Cancer On’ by exploring first-in-class approaches to provide the best treatment options for cancer patients.”  

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 
Concept and Design: Ananda Ghosh and Nisha Peter
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