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MedNess: bite-size biopharma and medtech news

11th August, 2020
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Onco I-Analyse
Roche’s Tecentriq, in combination with paclitaxel, flunks in 1L, PD-L1+ TNBC study
On 7th August, Roche announced that Tecentriq, in combination with paclitaxel, failed to meet primary endpoint of PFS in the phase III IMpasssion131 study. The trial evaluated the combination in comparison with paclitaxel in patients with previously untreated, locally advanced, or metastatic TNBC whose tumors express PD-L1. The data for secondary endpoint of OS also showed a negative trend, although the study was not powered to show significance of OS and the data was immature at the time of the analysis. Results are being discussed with global health authorities and will be presented at a future medical meeting.
Results come as a surprise as in March last year, Tecentriq was granted accelerated approval in combination with a different chemotherapy backbone, nab-paclitaxel for frontline, PD-L1+ (≥1% TIC) locally advanced or metastatic TNBC. The combination demonstrated a statistically significant PFS benefit and clinically meaningful improvements in OS. Tecentriq in combination with nab-paclitaxel is approved in over 70 countries in this patient segment and is the current standard of care in PD-L1+ TNBC.
Until now, Roche had remained the market leader in 1L TNBC after securing the first immunotherapy approval and the company estimates the indication could be worth up to $1bn in additional revenues for the Tecentriq. However, In May 2020, Merck’s Keytruda hit the mark with investigator’s choice chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin) in similar settings with KEYNOTE-355 study (PD-L1+ (≥10% CPS)).
FDA has granted priority review to Merck’s sBLA for KEYNOTE-355 with PDUFA date set for November 28, 2020. This will give Keytruda a competitive advantage by offering physicians a greater flexibility for the chemotherapy choice, making Keytruda a major competitor for Tecentriq. Considering that Keytruda is the top-selling PD-1/PD-L1 inhibitor, the recent events will impact Roche’s ambitions in TNBC. However, since OS is the gold standard in cancer care, it remains to be seen how much market share can Keytruda capture among those prescribers who prefer nab-paclitaxel.
Until now, both Keytruda and Tecentriq were moving head-to-head in TNBC. FDA has also granted priority review to Keytruda as neoadjuvant and adjuvant treatment in TNBC (PDUFA: March 29, 2021); Roche is also prepping up for regulatory filing in earlier settings.
TNBC has remained an aggressive and immune inert tumor with chemotherapy as the backbone therapy. High unmet need exists Results from IMpassion131 and Keytruda’s past trials continue to stress the need to better understand the disease biology and tumor microenvironment of immune inert tumors, like TNBC
“Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens” - Levi Garraway, Roche’s CMO
Collated by :Shilpa Rawal, PhD
COVID19 Special

New preclinical data from Johnson and Johnson’s vaccine candidate study shows positive results in generating a robust protection against COVID-19
Johnson and Johnson recently published results in Nature from its preclinical studies that show positive results in generating a robust protection of its candidate vaccine against COVID-19 causing virus SARS-CoV-2. Their investigational vaccine is an adenovirus serotype 26 (AD26) vector based one.
“We are excited to see these pre-clinical data because they show our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose. The findings give us confidence as we progress our vaccine development and upscale manufacturing in parallel, having initiated a Phase 1/2a trial in July with the intention to move into a Phase 3 trial in September,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “As we collectively battle this pandemic, we remain deeply committed to our goal of providing a safe and effective vaccine to the world. Our pre-clinical results give us reason to be optimistic as we initiate our first-in-human clinical trial, and we are excited to enter the next stage in our research and development toward a COVID-19 vaccine. We know that, if successful, this vaccine can be rapidly developed, produced on a large scale and delivered around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC, Johnson & Johnson.

Moderna announces the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19
Moderna announced the beginning of the Phase 3 study for its mRNA vaccine, mRNA-1273 against COVID-19, in collaboration with the NIAID and BARDA.
“We are pleased to have started the Phase 3 COVE study,” said Stephane Bancel, CEO at Moderna. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
Pfizer and Gilead enter into an agreement to manufacture Remdesivir for the treatment of COVID-19
Pfizer recently announced that they have entered into a multi-year agreement with Gilead Sciences to manufacture and supply Remdesivir for the treatment of COVID-19.
“From the beginning it was clear no one company or innovation would be able to bring an end to the COVID-19 crisis. Pfizer’s agreement with Gilead is an excellent example example of members of the innovation ecosystem working together to deliver medical solutions,” said Albert Bouria, Chairman and Chief Executive Officer. “Together, we are more powerful than alone. As one of the largest manufacturers of vaccines, biologics and sterile injectables, it is a privilege to offer our expertise and infrastructure to help fight this pandemic. In that spirit, we are pleased that Gilead is using our manufacturing capacity to help facilitate supply of this medicine to patients as quickly as possible.”
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Collated by :  Esha Sehanobish, PhD
Drug Approvals
FDA approves BLENREP (belantamab mafodotin-blmf) for the treatment of RRMM patients based on DREAMM-2 trial results
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease. BLENREP is the first approved anti-BCMA therapy and has the potential to transform the treatment of patients with relapsed or refractory myeloma who have limited treatment options today.’’
Regulatory News
FDA awards Rare Pediatric Disease Designation (RPDD) to paxalisib for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG)
Kazia CEO, Dr James Garner, commented, “although glioblastoma remains our primary focus for paxalisib, we have been devoting increasing energy to developing the drug in childhood brain cancer as well. For patients diagnosed with DIPG, there are currently no FDA-approved drug treatments, and the average survival from diagnosis is around 9.5 months. The granting of RPDD by the FDA recognises our efforts and achievements so far and leaves us well placed to move paxalisib forward as a potential therapy for DIPG. We continue to be inspired by the dedication of our collaborators in this field and are committed to understanding whether paxalisib may be able to help in this enormously challenging paediatric disease.”
FDA grants Fast Track Designation to BST-236 for the Treatment of AML Patients
“Receiving Fast Track designation from the FDA is an important recognition of the potential of BST-236 to address the significant unmet need in the population of AML patients who are medically unfit to receive intensive chemotherapy, and to improve the outcomes for these patients” said Dr. Ruth Ben Yakar, Chief Executive Officer of Biosight. “The compelling safety and efficacy data from both a completed Phase 1/2a and ongoing Phase 2b studies of BST-236, may establish it as a new intensive therapy backbone of AML and may, for the first time, allow older adults deemed unfit for standard chemotherapy, to benefit from an intensive treatment.”
Omburtamab BLA submitted to FDA for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma
“I am excited to see the completion of Y-mAbs’ second BLA submission this year in neuroblastoma. As children treated for high-risk systemic neuroblastoma potentially experience longer systemic remissions, we expect more patients eventually relapsing with brain metastasis and there is currently no standard therapy available for these patients. We believe this is a key milestone for families facing CNS/leptomeningeal metastasis from neuroblastoma and for Y-mAbs. As the father of a long-term high-risk neuroblastoma survivor with CNS/Leptomeningeal metastasis, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma,” stated Thomas Gad, Founder, Chairman and President.
Trial Results
Positive results from Ph 2 ELARA trial of Kymriah® (tisagenlecleucel) in R/R FL patients announced: study met primary endpoint of CRR improvement
“We are pleased that Kymriah is showing meaningful results and may provide a potentially definitive treatment option for patients with relapsed and refractory follicular lymphoma,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “These results further support our efforts to reimagine medicine in this incurable malignancy and reach this underserved patient population, who are historically burdened with several years of various treatments.”
Ph 3 CS1001-302 trial of CS1001 + platinum-based chemotherapy met pre-specified primary endpoint in 1L squamous and non-squamous mNSCLC patients
Professor Caicun Zhou, Principal Investigator of the CS1001-302 Study and Director of the Department of Oncology, Shanghai Pulmonary Hospital, said, “We are gratified to see that the CS1001-302 study met its pre-specified primary endpoint at the interim analysis. CS1001 in combination with chemotherapy significantly improved PFS in patients with squamous and non-squamous NSCLC and was well tolerated. This study is the first anti-PD-L1 mAb to demonstrate overwhelming efficacy as 1L treatment of Stage IV NSCLC in a randomized, double-blind phase III trial.”
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Trial/Program Status
HCC Patients to be Followed for Overall Survival in Ph 3 OPTIMA Study of ThermoDox® + RFA
“Last month’s DMC recommendation to consider discontinuation of the OPTIMA Study based on the 2nd interim data was never anticipated, nor was it supported by the science, independent clinical evaluation of the HEAT Study subgroup or prospective preclinical research conducted by Celsion and our consultants to support the OPTIMA Study. We believe, therefore, that Celsion is obligated to undertake this rigorous evaluation of the data and the trial’s recruitment trends,” stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. “While the trial outcome as predicted by the second interim analysis may not change, and as unlikely as it may be, in the event we see substantial clinical benefit while continuing to monitor patients, we will carefully review our options with the 14 regulatory agencies that have allowed the OPTIMA Study to be conducted. We appreciate the ongoing support and confidence from our research Investigators and clinical advisors.”
First Patient Enrolled in Ph 2 Portion of LIO-1 Trial of Lucitanib + Opdivo In Gynecologic Cancers
“The Phase 2 part of the LIO-1 trial will advance our scientific understanding of the potential for an inhibitor of multiple tyrosine kinases, including VEGF, such as lucitanib, to be combined with a PD-1 inhibitor for the treatment of gynecologic cancers,” said Dr. Erika Hamilton, Director of the Breast and Gynecologic Research Program, Sarah Cannon Research Institute at Tennessee Oncology. “It is estimated that nearly 100,000 women will be diagnosed with a gynecologic cancer in the U.S. this year alone, and it is vital that we identify new treatment options, in particular new combinations, for these women.”
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
Complement System May Play a Major Role in Severe COVID-19 Complications
In a new study, researchers at Columbia University Irving Medical Center reported that one of the immune system’s oldest branches called complement may be influencing the severity of COVID-19 for some patients.
The study, published in Nature Medicine, reported that people with age-related macular degeneration were at higher risk of developing severe complication for COVID-19. Age-related macular degeneration is a disease caused by an overactive complement system. They study also found that clotting activity is linked to COVID severity and that mutations in certain complement and coagulation genes are associated with severity of the symptoms.
The idea to investigate the role of coagulation and complement in COVID began with a sweeping survey of viral mimicry across all viruses on earth -- over 7,000 in all.
The survey found that coronaviruses are masters of mimicry, particularly with proteins involved in coagulation and proteins that make up a complement. Complement proteins work a bit like antibodies and help eliminate pathogens by sticking to viruses and bacteria and marking them for destruction. Complement can also increase coagulation and inflammation in the body. The researchers hypothesized that the novel coronavirus by mimicking the complement and coagulation proteins might drive the immune system into a hyperactive state and people with conditions linked to a hyperactive complement or coagulation disorders may be more susceptible to the virus.
They found that out of 11,000 COVID patients who came to Columbia University Irving Medical Center with suspected COVID-19, the researchers found that over 25% of those with age-related macular degeneration died, compared to the average mortality rate of 8.5%, and roughly 20% required intubation. The greater mortality and intubation rates could not be explained by differences in the age or sex of the patients.
AstraZeneca Partners with Digital Stethoscope Maker Eko to Support it Heart Failure Research
AstraZeneca has partnered with Eko – a maker of artificial intelligence-powered digital stethoscopes, to build new digital tools to help screen for early signs of heart disease on a global scale.
The collaboration will also focus on further developing Eko’s algorithms while implementing Eko’s technology into AstraZeneca’s cardiovascular clinical studies.
The collaboration follows the recent clearance of Eko’s digital stethoscope AI by the FDA. The AI detects heart murmurs and cases of atrial fibrillation during a routine physical. Held on the chest, the company’s Duo device captures heart sounds as well as a single-lead ECG, to help spot conditions that typically show no symptoms and may require the specially trained ear of a cardiologist. 
Before that, Eko bagged a breakthrough designation for an algorithm currently in development to identify weaknesses in the heart muscle’s ability to pump blood to the rest of the body, known as reduced left ventricular ejection fraction.
That software, which analyzes 12-lead ECG scans, received an emergency authorization from the FDA in May for use against COVID-19, to help screen patients for serious heart complications.
Collated by :  Debarati Banik
MedNess Reviews
Big data-centric collaboration of HHS, DOE & VA to use the fastest computer of US for a COVID-cure
The collaboration of Department of Energy (DOE), the Department of Health and Human Services (HHS), and the Department of Veterans Affairs will now see a new data analytics initiative aimed to coordinate and share COVID-19 information. The COVID-19 Insights Partnership will provide a framework to channelize the power of DOE’s world-leading high-performance computing (HPC) and artificial intelligence resources to conduct COVID-19 research. This will provide a scaffold of reliable analytic resources to the HHS and VA which will analyze health data in an unprecedented manner. The COVID-19 Insights Partnership will focus on better understanding of COVID-19 in terms of vaccine and therapeutic development, outcomes, virology, and other critical scientific topics. HHS and VA will also provide additional updates and information on research projects. A key instrumental role will be played by the fastest supercomputer of the US, Summit, which is located at DOE’s Oak Ridge National Laboratory. It is capable of large-scale, complex analyses on massive integrated datasets and, also to generate AI-powered insights helping researchers identify and advance potential treatments and enhance outcomes for COVID-19 patients with extraordinary speed.
Chronic illness burden risk identified in HIV-patients
Data-collection from the world’s largest study of cardiovascular disease prevention in people with HIV has revealed a significant risk within the population towards a chronic disease burden. This data is the result of an NIH-funded study, Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE), which was conducted between 2015 to 2019 and enrolled 7,770 participants. It spanned across 100+ clinical research sites spread out within 12 countries and five continents. The study was designed to confer an advanced look at the disproportionate risk of comorbidities in people with HIV from all regions of the world. The comorbidities included in the study included some of the prominent chronic conditions, both cardiovascular and non-cardiovascular. Examples included: cardiovascular disease, chronic liver and kidney disease, physical function impairment and frailty, premature reproductive aging, cancer, and obesity. The clinical coordinator center for the REPRIEVE study has been assigned to Massachusetts General Hospital (MGH) also coordinating data collection with the Harvard T.H. Chan School of Public Health. In the dataset, which is particularly important for healthcare providers, it is revealed that physical function impairment and pre-frailty are common features among middle-aged people with HIV. Moreover, body-mass index (BMI) and physical activity are key modifiable risk factors that may prevent further decline in function with aging among this population. This insight will open avenues for designing preventive strategies in this vulnerable aging populations
Medness Plus
FDA approves Olinvyk for the management of moderate to severe pain in adults
FDA recently approved an opioid, Olinvyl (oliceridine) for the treatment of moderate to severe pain in adult patients. The opioid treatment will only be used if the pain is severe enough to require its intravenous administration and in cases when other treatments are not enough to treat the pain.
“Addressing the opioid crisis remains a top priority for the FDA. We will continue to do everything we can to reduce the number of Americans who are addicted to opioids and cut the rate of new addiction through a number of cross-agency initiatives,” said Douglas Throckmorton M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “Importantly, the FDA will only approve new drug applications, including those for opioid medications, following a rigorous review to evaluate the risks and benefits and ultimate determination that the data support safety and effectiveness. Of note, this particular medication is only indicated for use in a controlled clinical setting, meaning under medical supervision and not for use in a take-home prescription.”
FDA approves SPRAVATO® for the treatment of depressive symptoms in adults with major depressive disorder
FDA recently approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray for the treatment of depressive symptoms in patients with major depressive disorder (MDD). It is supposed to be taken with an oral antidepressant.
"People living with major depression need more options to meet their most critical needs, and we’re proud to help redefine how we treat ongoing and acutely worsening depressive symptoms,” said Bill Martin, Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. “SPRAVATO can now help patients with challenging to treat depression find significant and swift relief from debilitating depressive symptoms, offering those living with this serious mental health condition the possibility of a better future.” “Many people who live with depression know all too well the feeling of desperation. If that major depression progresses to active suicidal thoughts, it’s crushing, and they need options to help change the trajectory of their acute depressive episode,” said Theresa Nguyen, Chief Program Officer, Mental Health America. “Traditional oral antidepressants need weeks or more to take effect, so the availability of a medicine that can begin providing relief within a day is potentially life changing.”
Click here for more MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News

Daiichi Sankyo and AstraZeneca to Evaluate Patritumab Deruxtecan (U3-1402) + TAGRISSO in EGFR-Mutated NSCLC Patients
“The majority of patients with activating mutations of EGFR, or EGFR-mutated NSCLC, overexpress the HER3 protein in the cancer cells, and there is evidence that HER3 expression is a passenger marker of resistance to TKIs. Clinical and preclinical data, as well as biomarker expression and resistance mechanism research, support the further evaluation of patritumab deruxtecan and TAGRISSO as a treatment combination for patients with EGFR-mutated NSCLC who have progressed after treatment with a TKI, typically TAGRISSO,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “This clinical trial collaboration supports our goal to optimize development of patritumab deruxtecan in patients with EGFR-mutated metastatic NSCLC to further improve current standards of care. Daiichi Sankyo is pleased to begin this focused collaboration with AstraZeneca on this important aspect of patritumab deruxtecan development.”
Seattle Genetics Achieves Milestone Payment Under ADC Collaboration with GSK Triggered by BLENREP (belantamab mafodotin-blmf) FDA Approval
“BLENREP is the first BCMA-targeted treatment to be approved by FDA, becoming another first-in-class medicine utilizing our ADC technology for the treatment of patients with cancer,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Notably, this ADC uses our novel mafodotin cell-killing payload. There are now multiple drugs approved by FDA using our ADC technology, and each addresses an important unmet medical need.”
Click here for more mergers , acquisitions and business news
Collated by : Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Tanmoy Samaddar
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Divyaanka Iyer
MedNess Reviews
Debarati Banik
HealthIT
Abhi Dey
Consulting Editor
Shilpa Rawal, PhD
Onco I-Analyse
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
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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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