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Onco-this-Week
27th August, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals
MHLW approves Daratumumab combination in 1L ASCT-ineligible multiple myeloma patients
“Multiple myeloma remains one of the most common forms of blood cancer in Japan and as such, we are encouraged that patients in Japan newly diagnosed with this disease now have the option to receive a DARZALEX containing regimen,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
MHLW approves LONSURF in unresectable advanced or recurrent gastric cancer patients based on Ph III TAGS data
Ph III TAGS trial was evaluating LONSURF (trifluridine/tipiracil) versus placebo in patients with metastatic gastric cancer refractory to standard treatments, a patient segment characterized with high unmet need. Trifluridine/tipiracil met primary endpoint of significant improvement in overall survival compared to a placebo, leading to the approval.
MHLW approves atezolizumab – chemotherapy combination in ED SCLC patients based on Ph III I/III IMpower133 trial
“Tecentriq is the first cancer immunotherapy for the treatment of aggressive and difficult-to-treat extensive-stage small cell lung cancer,” said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. “We are very pleased that we can deliver Tecentriq as a potential new standard of care for the treatment of extensive-stage small cell lung cancer which has had limited therapeutic options for a long period of time.”
Regulatory News
Priority review granted; sNDA accepted for enzalutamide in mCSPC patients based on results from the Ph III ARCHES trial
“We are pleased to receive the Priority Review designation, which reflects the need for more treatment options for men living with metastatic hormone-sensitive prostate cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “The submission is supported by a strong data package, including two Phase 3 trials investigating XTANDI in men living with this form of prostate cancer.”
PharmaMar to submit NDA for Lurbinectedin under accelerated approval in SCLC in the USA
FDA agreed with PharmaMar’s proposal to file for accelerated approval its New Drug Application for lurbinectedin monotherapy for the treatment of 2L SCLC. NDA filing to take place in the Q4 2019.
Priority review granted; NDA accepted for Zanubrutinib in R/R MCL patients based on results from the Ph I and Ph I/II trials; PDUFA: Feb 2020
“Zanubrutinib, a potent and selective BTK inhibitor designed to maximize BTK occupancy and minimize off-target effects, has shown promise as a potential treatment for a number of B-cell malignancies,” said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. “We are proud to have submitted our first NDA in the U.S., which has now been accepted and designated for Priority Review by the FDA for the treatment of patients with relapsed/refractory mantle cell lymphoma, an aggressive form of lymphoma. We are conducting a broad global clinical development program for zanubrutinib that currently consists of eight Phase 3 or potentially registration-enabling trials, including two head-to-head comparative trials, with approximately 1,500 patients treated across all programs.”
Onco-Trial Results
Durvalumab + Tremelimumab combination fails to meet primary endpoint of OS improvement in Ph III NEPTUNE trial in 1L high-TMB mNSCLC patients
  • Durvalumab may have a stronger foothold in maintenance settings but 1L NSCLC is a category dominated by Pembrolizumab, hence AstraZeneca had targeted high TMB population in 1L; however TMB is still far from being a reliable and routinely biomarker (recalling the controversial hype generated with Nivolumab in 1L high TMB patients after failure in all comers and withdrawn sBLA)
  • NEPTUNE's protocol was tweaked to emphasize high-TMB population
  • Addition of Tremelimumab was also debated specially after the failure of this combination in SCCHN (EAGLE trial)
Single-agent Palbociclib fails to show efficacy in patients with CDKN2A mutated or deleted advanced PDAC and cholangiocarcinoma patients in TAPUR trial
Palbociclib monotherapy fails to show any clinical activity in TAPUR trial in patients with CDKN2A mutated or deleted advanced pancreatic adenocarcimona and cholangiocarcinoma (billiary cancer), as per results published in JCO.
Results of Ph IIb STORM trial of Selinexor in triple class refractory multiple myeloma patients published in NEJM
Sundar Jagannath, MD, Tisch Cancer Institute at Mount Sinai School of Medicine, principal investigator of the STORM study and co-lead author of the manuscript, said, “The data from the STORM study demonstrate that oral selinexor, a first-in-class XPO1 inhibitor, combined with dexamethasone twice weekly, resulted in a response rate of 26% in heavily pretreated patients.  The characteristics of the patients in the STORM study, including being heavily pretreated, yet still experiencing rapidly progressing disease, are consistent with the growing population of patients who have exhausted available myeloma therapies, but still desire to continue therapy.  Of particular significance, for the 39% of patients who had a minimal response (MR) or better, overall survival (OS) was 15.6 months, compared to 1.7 months in patients whose disease progressed or where response was not evaluable.”
Positive results from Ph II DREAMM-2 trial of Belantamab Mafodotin in RRMM patients announced
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said: “I am pleased with the results of the DREAMM-2 study and excited about what these data could mean for patients with multiple myeloma who have exhausted other lines of treatment. We are on track to file belantamab mafodotin later this year and continue to investigate how it could help even more patients with this disease.”
Onco-Trial Status/Progress
Ph I expansion part of XMT-1536 initiated in platinum-resistant Ovarian Cancer and NSCLC patients
“The initiation of the expansion cohorts is an important milestone for Mersana. We have chosen a dose that continues to show a promising efficacy and tolerability profile in heavily pretreated patients without selecting for NaPi2b expression,” said Anna Protopapas, President and CEO of Mersana Therapeutics. “The advancement of XMT-1536 brings us one step closer to proof of concept and our goal of significantly improving outcomes for people living with cancer.”
Patient enrollment suspended in Ph III ACELARATE trial of Acelarin in pancreatic cancer patients
Post interim review of data by independent committee, patient enrollment in Ph III trial of Acelarin was suspended, leading to the company’s shares tumbling.
MedNess Plus
FDA approves Pretomanid for the treatment of a highly treatment-resistant tuberculosis affecting the lungs
FDA recently approved a combination of linezolid and bedaquiline (Pretomanid tablets) for the treatment of highly “treatment-resistant” tuberculosis affecting the lungs. 
“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it. Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options. New treatments are important to meet patient national and global health needs. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections. This approval also marks the second time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, a pathway, advanced by Congress, to spur development of drugs targeting infections that lack effective therapies. We hope we continue to see more development of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs.”
FDA approves Barostim Neo System to improve the symptoms of patients with advanced heart failure
FDA recently approved Barostim Neo System to help improve the symptoms of advanced heart failure in patients who cannot use other heart failure devices such as cardiac resynchronization therapy. 
“Patients with advanced heart failure have limitations of physical activity, experiencing fatigue, palpitation or shortness of breath with activity and may not benefit from standard treatments, including currently marketed drugs and devices. This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.
FDA approves EYLEA injection prefilled syringe indicated to treat four retinal conditions
FDA recently announced the approval of the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA (aflibercept) injection prefilled syringe. 
"With eight pivotal Phase 3 trials and millions of injections used around the world, EYLEA sets a high bar for visual acuity and safety across multiple retinal diseases, including wet age-related macular degeneration and diabetic eye diseases," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "This approval may help doctors more conveniently and efficiently deliver EYLEA to appropriate patients."
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MedNess Business
Onco-News
Inex Innovations Exchange and Nova Satra merge to tackle women’s health in Asia
Singapore-based molecular diagnostics companies,Inex Innovations Exchange and Nova Satra, merge over a $72 million deal combining their laboratory space, R&D and distribution arms as well as patents and trademarks to form Inex Innovate. The new company aims to broaden its commercial reach across the Asia-Pacific region for its reproductive health, prenatal exam and cancer testing by 2020, and it’s pipeline currently includes three tests. OvaCis is a point-of-care diagnostic that can quickly distinguish between benign and malignant tumor, Zena is the blood test for ovarian cancer and NovoTect BC is an epigenetics test for early detection of breast cancer. The merger is financially supported by Asian conglomerate Genting Berhad, Enterprise Singapore and SNS Holdings
BioPharma and MedTech

Finch Therapeutics raises $53 million for microbiome-based therapies
Finch Therapeutics has raised $53 million in series C financing round for furthering its microbiome-based therapies for recurrent C.difficileinfections and autism. The series C funds will be used to accelerate the development of two programs: CP101, a Full-Spectrum Microbiota® (FSM®) therapy designed to restore the microbiome through an oral capsule to prevent C.difficileinfections, and another FSM therapy for autism where the behavioral alterations are often accompanied by gastrointestinal symptoms. Finch is enrolling patients for its C.difficile PRISM 3 clinical study and for its Phase II investigator-initiated clinical study to evaluate the safety and efficacy of FSM therapy in adults with ASD. The financing includes existing investors including Avenir Growth Capital, Morgan Noble, Shumway Capital and Willette Advisors, as well as new investors including OCV Partners, Susquehanna International Group, Symbiosis LLC and Trans-Pacific Technology Fund.
 Jobs at Finch
Themis Bioscience and MSD collaborate to develop vaccine candidates 
Themis Bioscience has announced exclusive license agreement and research collaboration with MSD (Merck & Co., Inc.) to develop vaccine candidates using Themis’ measles virus vector-based platform, initially developed at the Pasteur Institute. According to the agreement, MSD will provide research funding and equity investment for Themis to develop vaccine candidates against undisclosed disease targets. In addition, Themis will be eligible to receive development and sales milestone payments of up to $200 million, as well as royalties on approved products. 
Chinook Therapeutics raises $65 million in series A to advance precision medicine for kidney diseases
Vancouver-based Chinook Therapeutics has raised $65 million in series A financing to discover and develop precision medicines for rare and severe kidney diseases. The funds will be used for the advancement of its various kidney disease programs into clinical trials by 2021 using their proprietary platform which leverages single cell RNA sequencing, human-derived organoids and new translational methods. The investors for series A include Versant Ventures, Apple Tree Partners and Samsara BioCapital.
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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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