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MedNess: bite-size biopharma and medtech news

7th April, 2020
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HIGHLIGHTS
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Regulatory News
FDA Grants Fast Track Designation to ME-401 For the Treatment of Adult R/R Follicular Lymphoma Patients
"We are pleased to report that we have received Fast Track designation for ME-401. This designation holds several important advantages to expedite the development and regulatory review of ME-401 as we work diligently to deliver it as a new potential treatment option for patients and their physicians," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We remain very encouraged by the maturing body of ME-401 clinical data, and we are excited to continue expanding the opportunity that ME-401 holds to provide a meaningful impact in the treatment of B-cell malignances.
NDA submitted to FDA for Tivozanib in R/R RCC Patients
“NDA submission is a distinguishing milestone for any development stage biotechnology company, and our tivozanib NDA is an important step in our goal of providing an effective and more tolerable therapeutic option to patients with relapsed or refractory RCC,” said Michael Bailey, president and chief executive officer. “The TIVO-3 study provides valuable insight into the potential sequencing of therapy following earlier TKI and immunotherapy treatment, an area of significant need for kidney cancer patients whose disease has relapsed or become refractory to multiple lines of therapy. All of us at AVEO offer our continued gratitude to the patients, caregivers, and investigators who participated in our clinical trials. We look forward to working closely with the FDA during their review process and remain hopeful that the study’s overall survival (OS) hazard ratio (HR) will continue to favor tivozanib at the time of the final readout, expected by June 2020.”
Click Here for more Regulatory News
Trial Results
Primary endpoint of significant improvement in 12-month survival rate observed in Step-1 of Ph 3 ‘Atalante 1’ trial in NSCLC Patients
Alexis Peyroles, CEO of OSE Immunotherapeutics, said: “We are very pleased with these positive results for Tedopi in Step-1 and with a 10% absolute difference in 12-month survival rate versus chemotherapy in NSCLC patients after failure of checkpoint inhibitor treated in Atalante 1 Step-1 trial. This outcome confirms the therapeutic value of our neoepitope product in a patient population for whom there are no registered product today and who needs new therapeutic options. Based on these positive results, we are now eager to engage in discussions with regulatory authorities to evaluate Tedopi’s current clinical results and agree upon the best options for further development to maximize on the product’s positive data in terms of benefit/risk ratio. In parallel, given the significant value added by positive Step-1 results, we continue exploring potential partnership opportunities for Tedopi.”
KEYTRUDA® (pembrolizumab) Significantly Improved PFS as 1L Treatment for Advanced MSI-H or dMMR CRC Patients in Ph 3 KEYNOTE-177 Trial
“These head-to-head data with KEYTRUDA are the first time a single-agent, anti-cancer therapy, and particularly an anti-PD-1 monotherapy, achieved a statistically significant improvement in progression-free survival over chemotherapy, including the current standard of care regimen of mFOLFOX6 plus bevacizumab, in patients with MSI-H colorectal cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These data in the first-line treatment setting provide further evidence of the benefits of KEYTRUDA monotherapy in patients whose tumors are MSI-H or dMMR. We look forward to sharing these data as quickly as possible with the medical community and regulatory authorities.”
Click Here for more Trial Results
Trial/Program Status
Ph 2 CyFi-2 Study of Ficlatuzumab in Relapsed and Refractory AML Discontinued
“While this is a difficult decision, as we remain optimistic about the potential of ficlatuzumab in AML, we believe it is necessary in light of the COVID-19 pandemic and its effect on the states where the CyFi-2 study was to take place,” said Michael Bailey, president and chief executive officer of AVEO. “Our investigators have been informed of the closure, and we greatly appreciate their enthusiasm for the study. We remain committed to the practice of scientific discovery and will focus our resources and efforts on our ongoing initiatives.”
 
Ph 2 Trial of HMPL-453 Initiated in Advanced Malignant Mesothelioma Patients in China
  • Chi-Med initiated a Phase 2 trial of FGFR inhibitor HMPL-453 in patients with advanced malignant mesothelioma.
  • The trial NCT04290325 is a single-arm, multi-center, open-label study, evaluating the efficacy, safety and PK of HMPL-453 advanced malignant mesothelioma patients who failed at least one line of systemic therapy.
  • Primary outcome measure: ORR
  • Secondary outcome measures: DCR, TTR, DoR, PFS), and OS
Click Here for more Trial/Program Status
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
New telemedicine and mHealth platforms to deliver remote care during quarantine period
The American Telemedicine Association (ATA) and Consumer Technology Association (CTS) have been proactive in launching an online database for providers and consumers offering telehealth and mHealth solutions in the face of Coronavirus pandemic. According to ATA CEO Ann Mond Johnson, telehealth is a critical tool in “facilitating the timely diagnosis and treatment of individuals, while limiting the risk of person-to-person spread of the virus. Telehealth solutions can be critical, not only during a pandemic situation, but also to facilitate our day to day well-being as succinctly phrased by the ATA CEO. CTS and AWS are going to be the working partner with ATA in this venture. This initiative was prompted by the US Chief Technology Officer Michael Kratsios, calling the digital health products, tools and services as one of the priorities of the Trump administration.
Promotion of a telehealth bill to cover Medicare reimbursement
Congressional leaders have agreed to a coronavirus response bill that will allow Medicare reimbursement for care providers using telehealth to treat seniors at home. Both the House and Senate agreed on waiving Medicare’s geographical restrictions on telehealth during a public health emergency, which is meant to enable providers to use telehealth in urban and rural areas as well as in the patient’s home - all defined within the scope of an “emergency area.”. The restrictions on the use of a telephone to deliver care is also loosened, as long as that phone has audio-visual capabilities. According to the house speaker Nancy Pelosi, “To protect public health, the bill will allow Medicare providers to extend telemedicine services to seniors regardless of where they live, at an estimated cost of $500 million.” According to the report published in Politico, the spending bill allocates about $6.5 billion to the US Department of Health and Human Services, including $2.2 billion for the Centers for Disease Control and Prevention to address state and local preparedness. Some of that money will likely be used by healthcare providers to extend telehealth and mHealth platforms to reduce crowding in hospitals, treat isolated patients and facilitate remote patient monitoring programs.
Collated by : Debarati Banik
MedNess Reviews
COVID Special

Cellex’s Antibody Blood Test for COVID-19 Receives Emergency Authorization from FDA 
A rapid antibody blood test for COVID-19 developed by Cellex has received emergency FDA authorization. This is the first antibody test for COVID-19 to receive emergency authorization from the FDA.
The test resembles and is a combination of a blood glucose test and a home pregnancy test. It uses a fingerprick of blood and a small strip to detect two different types of antibodies produced by the body to fight off the infection.Available by prescription, this test is distinctly different from other COVID-19 tests authorized by FDA, that focus on sequencing the genetic material of the virus to detect active infections.
However, this rapid test, that delivers a reading within 15-20 min, may not work in the first few days of infection because enough antibodies may not be produced by the body.
But given the lower sophistication of serological tests, the FDA has instructed all serological test developers to include instructions stating that the tests must not be used as a sole method for testing. Currently, there is a public list of nearly 50 other serological test manufacturers maintained by the FDA. The majority are based in China, have notified the agency of their plans to distribute their products in the U.S. without seeking an Emergency Use Authorization.

Can the BCG Vaccine Help Reduce the Severity of COVID-19?
A recent epidemiological study that found a correlation between universal BCG vaccination policy and reduced morbidity and mortality for COVID-19, has sparked the scientific community’s interest on the probable effectiveness of the BCG vaccine against COVID-19.BCG- the vaccine against Tuberculosis is administered widely to children in some developing countries as a part of their universal vaccination policy.
Although the study has been undermined by several experts in the medical community for various reasons, the protective effects of the vaccine against some common respiratory infections (other than Tuberculosis) has been observed at a population level, particularly in children.
With no vaccine currently available against COVID-19, the BCG vaccine, if found effective could possibly offer some hope in reducing morbidity and mortality for COVID-19.
In an effort to test the protective effects of the BCG vaccine, researchers in four countries have started or will soon be starting clinical trials. It is important here to note that experts believe that the vaccine may be only effective is reducing the severity of the disease in infected individuals.
A team from Netherlands and researchers at Children’s Research Institute in Australia have set up a study for randomized clinicals in 1000 and 4000 healthcare workers respectively.
Research teams in University of Athens, Greece and the Max Plank Institute for Infection Biology in Germany have also been engaged in efforts to set up a study in the elderly.
Following the lead of these four countries and in the effort to mitigate the severity of the disease, many teams in developed countries across the globe are currently seeking funding for similar clinical trials.
A gene hunt for understanding COVID-19 susceptibility
The COVID-19 Host Genetics Initiative, is a concerted endeavor of large biobanks that analyze data from thousands of volunteers to find links between their DNA and health. About 12 biobanks, such as the UK biobank, deCODE genetics (Iceland), FinnGen (Helsinki) and the Harvard personal genome project are now coming together to gather and analyze genetic data from COVID-19 patients to understand the spectrum of symptoms shown upon infection. Currently the spectrum ranges from asymptomatic to mild symptoms to critically ill patients. The idea is to compare patients exhibiting serious cases of COVID-19 without the underlying conditions of advanced age, diabetes, heart or lung conditions, to asymptomatic carriers or those with mild disease. Some of the objectives include assessing polymorphic associations of angiotensin-converting enzyme 2 (ACE2, which marks the viral entry point) and human leukocyte antigen genes (that influence immunity to pathogens). The consortium will also be revalidating recent reports, without peer review, on SARS-Cov2 susceptibility- such as the study which associates viral immunity to blood group type. The project is in the initial stages of roll out and is expected to yield results in a span of few months.
Onco-Reviews
Targeting the DNA structure of myeloid derived suppressor cells prevents metastasis
Secondary tumour formation (tumour metastasis) is commonly observed after the primary tumour is resected (or surgically removed) despite follow up radio/chemotherapy. A research group has now found a way to circumvent this problem. A study published in Nature, shows that the resection of 3 types of mouse tumour models with known aggressive pulmonary metastasis (subcutaneous Lewis lung carcinoma (LLC), subcutaneous HNM007 oesophageal squamous cell line and 4T1 mammary cancer) followed by low dose treatment with “epigenetic drugs” 5-azacytidine (DNA methyl transferase inhibitor) and entinostat (histone deacetylase inhibitor) led to reduced lung metastasis. This was due to hampered recruitment of myeloid derived suppressor cells (MDSCs) to the secondary site (lungs).
MDSCs are tumour educated, aberrant immune cell populations that interact with tumour secreted factors and get recruited to the site of the secondary organ; creating a pre-metastatic niche with by aiding changes such as increased blood vasculature and decreased anti-tumour activity of T cells.
In the Nature study, treatment with low doses of 5-azacytidine (0.5 mg/kg body weight) and entinostat (5 mg/kg body weight) after tumour resection, downregulated the non-canonical NF-kB pathway in monocyte and neutrophil derived MDSCs residing in the bone marrow. This lowered levels of CCR2 (receptor for the tumor secreted cytokine CCL2) in monocytes and CXCR2 (receptor for tumor secreted chemokine CXCL1) in neutrophils, hampering both their mobilisation to and colonization in the lungs after tumour resection. This outcome coincided with significantly reduced lung metastasis in all 3 tumour models. Both CCL2 and CXCL1 promote trafficking of MDSCs from the bone marrow to the tumour microenvironment. Moreover, this epigenetic rewiring resulted in the differentiation of monocytic MDSCs into interstitial macrophages that are not known to be associated with metastatic functions.
The low dose of the epigenetic drugs ensures systemic tolerance and elicits a synergistic effect on MDSCs rewiring. This study opens up a new paradigm for adjuvant treatments of tumors such as Non-small-cell lung carcinoma (NSCLCs), that have a high metastasis rate post resection. 
Medness Business
Onco-News

Kite Licenses Antibodies and Establishes Collaboration With Teneobio in Multiple Myeloma
“Kite is committed to pursuing novel CAR T therapies that have the potential to be meaningfully differentiated treatment options for people living with multiple myeloma,” said Peter Emtage, PhD, Senior Vice President of Research at Kite. “Based on encouraging early clinical signals and unique attributes of the binding domain from Teneobio, this exciting collaboration will be central to our strategy of developing next-generation CAR T therapies with the potential to overcome the tumor microenvironment.”
Fate Therapeutics and Janssen to Develop Novel iPSC-derived Cell-based Cancer Immunotherapies
“We are delighted to enter this strategic collaboration, which brings together Janssen’s scientific and global commercialization leadership, deep domain expertise in oncology and proprietary technologies for targeting and binding certain tumors and our industry-leading iPSC product platform to develop novel off-the-shelf CAR NK and T-cell cancer immunotherapies,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “The collaboration strengthens our financial and operating position through a focused effort of developing cell-based cancer immunotherapies utilizing Janssen’s proprietary antigen binding domains, while enabling us to continue to exploit our deep pipeline of wholly-owned product candidates and further develop our off-the-shelf, iPSC-derived cell-based immunotherapies.”
First AI-powered FOLFOX predictor, MI FOLFOXai, to guide 1L metastatic colorectal cancer treatment launched; Improving OS by 50%
“FOLFOX is part of an NCCN Guidelines® recommended first-line treatment regimen for the roughly 35,000 patients in the U.S. newly diagnosed with metastatic colorectal cancer each year, and initiating the most appropriate therapy at this stage can be critical to successfully altering the course of disease,” said W. Michael Korn, M.D., Chief Medical Officer of Caris. “Clinical outcomes from MI FOLFOXai validations represent a mean overall survival of nearly 50%, making it imperative to get this information to patients and their physicians as soon as possible.”
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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