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MedNess: bite-size biopharma and medtech news

20th May, 2020

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MedNess This Week

HIGHLIGHTS

Covid special : Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
FDA Grants Full Approval to QINLOCK™ (ripretinib) in 4L GIST based on Ph 3 INVICTUS trial data
Enhertu granted BTD in the US for HER2-mutant mNSCLC based on Ph 2 DESTINY-Lung01 data
Long-term Follow-up Results from L-MIND Study of Tafasitamab announced in R/R DLBCL patients
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
HealthIT : Quantum machine learning in COVID-19 drug discovery and disparity in telehealth usage is apparent in COVID-19 era
Reviews: Concerns over false negatives from Abbott's portable coronavirus test and hope from T-cells in COVID19 patients
Conference Coverage - ASCO 2020
Boehringer Ingelheim Acquires Northern Biologics’ Preclinical Cancer Antibody Pipeline

Our Sponsors

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 meeting, we 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.

Collated by : Arundithi Ananthanarayanan

Conference Coverage - ASCO 2020

ABSTRACTS

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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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.

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Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey
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