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MedNess: bite-size biopharma and medtech news

10th September, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals
European Commission approved atezolizumab + chemotherapy (carboplatin and nab-paclitaxel) combination in 1L EGFR/ALK WT NSCLC patients based on Ph III IMpower130 trial data
“Today’s approval marks another advance for people living with non-squamous non-small cell lung cancer, providing a new treatment option for those affected in Europe,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This Tecentriq-based combination expands treatment options and offers flexibility to physicians when making treatment choices combining immunotherapy with chemotherapy – which is important, given the complexity of lung cancer.”
European Commission approved atezolizumab + chemotherapy (carboplatin and etoposide) combination in 1L ES-SCLC patients based on Ph III IMpower133 study results
“This approval makes Tecentriq the first cancer immunotherapy available in Europe for the initial treatment of extensive-stage small cell lung cancer, marking an important step forward for patients,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The combination of Tecentriq and chemotherapy has been shown to improve survival compared to the current standard-of-care – an advance that, until now, has been difficult to achieve due to the refractory nature of this disease.”
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Regulatory News
FDA granted Breakthrough Therapy Designation to capmatinib (INC280) in 1L mNSCLC patients with MET exon14 skipping-mutation
"We are pleased to announce that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC),” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.
Fast Track Designation granted for Magrolimab (5F9) for the treatment of AML and MDS based on preliminary data from Ph Ib trial
“We are pleased to receive Fast Track Designation for magrolimab in both MDS and AML, emphasizing the unmet need among these patients, and further equipping us to execute on our goal of delivering magrolimab as a promising new option to treating physicians,” said Mark Chao, M.D., Ph.D., Founder and VP Clinical Development of Forty Seven, Inc. “We were encouraged by the initial data from our Phase 1b clinical trial, which showed a 100% overall response rate (ORR) in untreated higher-risk MDS patients and a 64% ORR in untreated AML patients, along with a rapid time to response. We look forward to continuing our productive dialogue with the FDA as we advance magrolimab through the clinic and finalize the design of our pivotal program in MDS.”
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Onco-Trial Results
Durvalumab shows both significant survival benefit and improved, durable responses in ED SCLC patients in Ph III CASPAIN trial
José Baselga, Executive Vice President, Oncology R&D said: “We are encouraged to see more than a third of small cell lung cancer patients treated with Imfinzi plus chemotherapy alive at the 18-month landmark, which is remarkable given the aggressive nature of the disease. It is also noteworthy that these results may enable physicians to choose Imfinzi in combination with either cisplatin or carboplatin chemotherapy backbones. We look forward to working with regulatory authorities to bring Imfinzi to patients with small cell lung cancer around the world as soon as possible.”
Selpercatinib (LOXO-292) demonstrates 68% ORR and sustained durability in heavily pretreated RET fusion-positive NSCLC patients in Ph I/II LIBRETTO-001 trial
"In this large cohort, selpercatinib's response rate, durability, robust CNS activity, and safety show promise. Furthermore, this continues to confirm that RET fusions are clinically targetable alterations, placing them in the company of activating EGFR/ALK/ROS1 alterations. We are encouraged by these data as there is currently an unmet need to provide genomically-tailored therapy to patients with RET fusion-positive NSCLCs," said Alexander Drilon, M.D., lead investigator, Memorial Sloan Kettering Cancer Center in New York City.
Click Here for more Trial-results as well as Trial Status/Progress
MedNess Plus
FDA approves Nourianz (istradefylline) tablets as add-on treatments for the off-episodes in adults with Parkinson’s disease
FDA recently approved an add-on treatment to levodopa/carbidopa for the off-episodes in adult patients with Parkinson’s disease (PD). The approval for Nourianz (istradefylline) tablets was given to Kyowa Kirin, Inc.
"Parkinson’s disease is a debilitating condition that profoundly impacts patients' lives," said Eric Bastings, M.D., acting director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. "We are committed to helping make additional treatments for Parkinson’s disease available to patients."
FDA approves Ofev (nintedanib) capsules to treat adult patients with a rare lung disease
FDA recently approved Ofev capsules to treat and lower the decline in pulmonary functions in adult with interstitial lung disease associated with scleroderma (SSc-ILD). It is the first to be approved for this rare lung condition.
“Patients suffering from scleroderma need effective therapies, and the FDA supports the efforts of drug companies that are designing and conducting the clinical trials necessary to bring treatment options to scleroderma patients,” said Nikolay Nikolov, M.D., associate director for Rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Nintedanib is now a treatment option to slow the rate of decline in pulmonary function in patients who have interstitial lung disease from scleroderma.”
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MedNess Business
Onco-News

Idera Pharmaceuticals and AbbVie collaborate over immune-oncology clinical research

Idera and AbbVie entered into an immune-oncology clinical research collaboration agreement. Under the agreement, the companies will evaluate the anti-tumor responses by stimulating the immune system with OX40 agonist (ABBV-368), TLR-agonist (tilsotolimod), chemotherapeutic agent (nab-paclitaxel) and/or programmed cell death PD-1 inhibitor (ABBV-181). Idera will supply tilsotolimod for clinical trials and AbbVie will conduct the study.
Jobs at AbbVie
Jobs at Idera

Nkarta raises $114 million in series B to fight cancer using cell therapy

Nkarta Therapeutics has raised $114 million in series B financing round to develop engineered natural killer (NK) cells to fight cancer. The current financing will support two clinical programs: NKX101 program with allogenic NK cells designed to target NKG2D in patients with hematologic malignancies or solid tumors, and CAR-NK program targeting CD19 in B-cell malignancies. Nkarta is also setting up its GMP manufacturing facility in South San Francisco, which is expected to produce investigational products for early-stage clinical trials. The investment round was led by Samsara BioCapital in partnership with existing investors including NEA, Novo Holdings A/S and SR One, and new investors including Amgen Ventures, Deerfield Management, Life Science Partners, Logos Capital and RA Capital Management.  
Jobs at Nkarta

BioPharma and MedTech

Strategic alliance between Sumitomo Dainippon Pharma and Roivant Sciences to deliver new medicines to patients

Sumitomo Dainippon Pharma and Roivant Sciences have agreed to creation of an alliance to enable transfer of five “Vants”, biopharmaceutical companies under Roivant, with options to acquire up to six other Vants and access to Roivant’s proprietary technology platforms. Sumitomo Dainippon will further take an equity of over 10% shares of Roivant. In return, Roivant will receive an upfront payment of up to $3 billion. Roivant currently has over 25 clinical programs running through its 11 Vants with multiple potential product launches between 2020 and 2022. The deal could provide Sumitomo Dainippon a pipeline of potential launches as the bipolar depression drug Latuda® patent expiry nears.
Jobs at Roivant

Passage Bio raise $110 million in series B for gene therapy of rare brain disorders

Passage Bio has raised $110 million in series B financing round for developing AAV-delivered gene therapies for the treatment of various rare monogenic brain disorders. This round of financing comes only seven months after the series A round. The company intends to start three clinical trials in 2020 targeting GM1 gangliosidosis and frontotemporal dementia programs in the first half and Krabbe disease in the second half. The investment round was led by Access Biotechnology in partnership with existing investors including OrbiMed, Frazier Health Partners, Versant Ventures, Lily Asia Ventures, New Leaf Venture Partners and Vivo Capital, and new investors including Boxer Capital, Highline Capital Management, Logos Capital and Sphera Funds Management.
Jobs at Passage Bio
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 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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