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MedNess: bite-size biopharma and medtech news

Onco-this-Week
13th July, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals
FDA approves Pexidartinib for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery
“The FDA approval of TURALIO represents a paradigm shift in the treatment of carefully selected TGCT patients who face significant disease morbidity and for whom surgery is not an option,” said William D. Tap, MD, Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center, New York, and lead investigator for the pivotal phase 3 ENLIVEN study. “We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size.”
Regulatory News
CMS expands coverage of CAR T-cell Therapy for Medicare beneficiaries
Medicare to now cover FDA-approved CAR T-cell therapies nationwide for certain patients with cancer, in addition to cover CAR T-cell therapy for off-label use that are recommended by CMS-approved compendia.
“We’re taking action to make sure we’re modernizing the program to provide access to the latest therapies,” CMS Administrator Seema Verma said in a conference call with reporters.
NDA accepted for Avapritinib in PDGFRA exon 18 mutant GIST and 4L GIST patients
"Patients with PDGFRA Exon 18 mutant GIST and fourth-line GIST are in need of new treatment options that address the underlying drivers of the disease," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "The FDA's acceptance of our application for Priority Review brings us closer to our goal of delivering avapritinib to patients with GIST, and we look forward to working closely with the FDA during the review process."
Click Here for more Regulatory News
Onco-Trial Results
Osimertinib significantly improves OS in 1L EGFR-mutated NSCLC patients in Ph III FLAURA trial
José Baselga, Executive Vice President, Oncology R&D said: “Today’s positive results show that Tagrisso provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming Tagrisso as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer.”
Ph III IMvigor130 study of atezolizumab plus platinum-based chemotherapy met co-primary endpoint of PFS improvement in 1L mUC patients
“IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer, an aggressive disease with high unmet need,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “These results support our broad clinical development programme for Tecentriq in bladder cancer, as well as our approach of combining immunotherapy with chemotherapy or other medicines to improve patient outcomes, and we look forward to discussing them with health authorities.”
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Onco-Trial Status/Progress
Data locked for first interim analysis in Ph III OPTIMA trial of ThermoDox® in HCC patients
Michael Tardugno, Celsion’s chairman, president and chief executive officer, said, “We look forward to receiving the iDMC’s recommendation from this first interim analysis of the OPTIMA Study. In accordance with the statistical plan, this initial interim analysis has a target of 118 events, or 60% of the total number required for the final analysis. At the time of the data cutoff, the Company received reports of 128 events. The hazard ratio for success at 128 events is approximately 0.63 and is consistent with the 0.65 hazard ratio that was observed in the prospective Heat Study subgroup, which demonstrated a 2-year overall survival advantage and a median time to death of more than 7 ½ years.”
 
AB Science aborts masitinib clinical program in stage III or IV melanoma patients
Post a portfolio prioritization, where AB Science announced updates on masitinib program in several other indications, the non-resectable or metastatic stage 3 or stage 4 melanoma program would be aborted and will not feature as strategic priorities of masitinib’s clinical program. AB Science cites indication’s relatively small clinical market size and requirement of an additional Ph III study for marketing authorization.
Click Here for more Progress/status of ongoing trials
Diagnostic Assays
sPMA filing planned to authorize BRACAnalysis CDx as a companion diagnostic test for Olaparib in gBRCA mutated mCRPC patients
“The PROfound trial confirmed the potential benefits of using biomarkers to help guide care for men with metastatic castration-resistant prostate cancer,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics.  “This study is another example of Myriad’s commitment to help our pharmaceutical partners achieve and deliver precision medicine for people with cancer.”
MedNess Plus
FDA approves new indications for the marketing of four previously cleared tests to help in the diagnosis of Lyme disease
“Lyme disease can have a devastating impact on patients. With today’s action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Regeneron releases positive results for the Phase 3 trial of Dupixent in children between 6 and 11 years of age with atopic dermatitis
"The results from this trial, the first to assess a biologic medicine in children under 12 with atopic dermatitis, are very important because of the significant unmet needs in this patient population. Children in the trial had suffered from severe atopic dermatitis for most of their lives," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "The trial showed that Dupixent significantly improved outcomes and quality of life, with no new safety signals." "In this trial, children with severe atopic dermatitis had uncontrolled disease covering, on average, nearly 60% of their skin. The unrelenting symptoms of this disease, which impact not just the child but the whole family, include widespread rashes, intense and persistent itching, and skin lesions," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Symptoms of severe atopic dermatitis can take a toll on children both physically and emotionally. We are encouraged by these results, which demonstrate that Dupixent improved skin lesions, reduced itching, cleared the skin and importantly, improved health-related quality of life measures for these young patients." 
 
FDA releases a statement in the wake of recent data accuracy issues regarding an approved gene therapy
In our late May article, we had written about the approval of a gene therapy product, Zolgensma, indicated to treat spinal muscular atrophy (SMA) in children less than two years of age. A month later, FDA was informed by the manufacturer about a data manipulation issue. In the recent statement released by the FDA, they have reiterated the importance of developing safe and effective medical products and have mentioned the importance of the manufacturer’s responsibility to submit accurate and complete information of all the products in line for approval. While the FDA continues to look into the matter, we shall keep an eye out for further developments in this case in the near future. 
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MedNess Business
Onco-News

ORIC Pharmaceuticals closes $55 million series D financing round for cancer therapy
ORIC Pharmaceuticals, a clinical stage oncology company, has raised $55 million in series D financing, bringing its total capital to over $175 million. The funds will be used to support the Phase 1b trial of ORIC’s lead candidate ORIC-101, a potent and selective glucocorticoid receptor antagonist. The planned Phase 1b studies combine ORIC-101 with Abraxane (nab-paclitaxel) or checkpoint inhibitor for solid tumors and ORIC-101 with androgen receptor modulator for prostate cancer. Additionally, the funds will support the CD73 program, currently in lead optimization stage, for developing oral small molecules targeting adenosine pathway.
Jobs at ORIC
Aquinox Pharmaceuticals acquires Neoleukin Therapeutics to develop novel immunotherapeutics
Aquinox Pharmaceuticals and Neoleukin Therapuetics have undergone a merger agreement where Aquinox will acquire Neoleukin, a biopharmaceutical company using sophisticated computational platform to design de novo protein therapeutics in immuno-oncology, inflammation and autoimmunity. Aquinox also gains access to Neoleukin's lead program NL-201, a potent IL-2/IL-15 agonist that activates T-cells and NK-cells to fight cancer.
Jobs at Aquinox
BioPharma and MedTech

Siemens Healthineers acquires Corindus Vascular Robotics for $1.1 billion
Corindus Vascular Robotics, a technology company specializing in robotic-assisted vascular interventions, has entered into a merger agreement with Siemens Healthineers. Under this agreement, Siemens will acquire the Corindus shares at $4.28 per share with a total purchase price of $1.1 billion and the deal is expected to close in the fourth quarter of 2019. Besides an FDA approval in March 2018 for the automated surgery software for its CorPath platform, Corindus also received regulatory approval for CorPath GRX platform for neurovascular intervention in New Zealand and Australia.
Jobs at Siemens Healthineers
Bayer buys BlueRock Therapeutics for $240 million for expansion into cellular therapies
Bayer and BlueRock Therapeutics have entered a complete buyout agreement under which Bayer will acquire BlueRock for $240 million in cash and additional $360 million in pre-defined development milestones. BlueRock was developed as a joint venture between Bayer and Versant Ventures with Bayer holding a 40.8% stake in the company. Under the agreement, BlueRock corresponds to a total value of $1 billion. With this acquisition, Bayer gains access to BlueRock's portfolio of cell therapy in neurology, cardiology and immunology along with a lead program in Parkinson's disease expected to enter the clinic by the end of 2019.
Jobs at Bayer
Click Here for more collaborations, acquisitions, mergers and licensing...
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Mayur Vadhvani, PhD
Business News
Abhi Dey
Consulting Editor
Arundithi Ananthanarayanan
I-cube
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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The sponsors do not have any influence on the nature or kind of the news/analysis reported in Onco-this-Week. 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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