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MedNess: bite-size biopharma and medtech news

22nd January, 2020
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MedNess This Week
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Drug Approvals
FDA approves AYVAKIT™ (avapritinib) for adults with unresectable or metastatic PDGFRA exon 18 mutant GIST patients
"Today's approval of AYVAKIT brings forward a new standard of care for patients with PDGFRA exon 18 mutant GIST, a genomically defined population that previously had very limited treatment options. For the first time, we can offer these patients a highly effective treatment that targets the underlying genetic cause of their disease," said Michael Heinrich, M.D., Professor of Medicine at Oregon Health & Science University and an investigator on the NAVIGATOR trial. "Building on our growing understanding of the molecular basis of GIST, this milestone ushers in a new era of precision medicine in this disease. The FDA approval represents a call to action to conduct mutational testing in all patients with GIST before initiating kinase inhibitor therapy, as recommended by clinical guidelines, so appropriate patients may realize the benefits of this promising new medicine."
FDA Approves KEYTRUDA® (pembrolizumab) in BCG-unresponsive, high-risk, NMIBC patients
“Today’s approval of KEYTRUDA reinforces our company’s commitment to expanding existing treatment options for certain patients with high-risk, non-muscle invasive bladder cancer,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “As the first anti-PD-1 therapy approved in this setting, KEYTRUDA will be a new clinical option for a patient population that previously had limited FDA-approved therapies available.”
Regulatory News
Application filed with the FDA for Breakthrough Therapy Designation for the use of Leronlimab for the treatment of mTNBC
“This strong data confirms the power of leronlimab as a CCR5 inhibitor for patients living with mTNBC, and is clearly replicating early animal study results that demonstrated 98% elimination of metastases,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner of CytoDyn, and an advisor to CytoDyn. “Our collective team of key opinion leaders believes that all patients with similar cancers in regards to CCR5 expression may also benefit from the use of leronlimab, including melanoma, brain, throat, lung, stomach, breast, ovarian, uterine, pancreatic, bladder, and thyroid cancer patients. We also believe the mechanism of action for leronlimab may have potential indications in autoimmune diseases such as multiple sclerosis, polymyolitis, Crohn’s disease, inflammatory bowel syndrome and psoriasis.”
Fast Track Designation granted to Infigratinib in 1L advanced or metastatic Cholangiocarcinoma and Orphan Drug Designation in Cholangiocarcinoma
“We believe that Fast Track and Orphan Drug Designations for infigratinib for the treatment of cholangiocarcinoma underscores the need for new, targeted treatments for genetically-driven subsets of this cancer, particularly for adults with first-line advanced or metastatic cholangiocarcinoma,” said Susan Moran, MD, MSCE, chief medical officer for QED. “Fast Track designation will enhance our interaction with the FDA on our first-line advanced or metastatic cholangiocarcinoma program and may help us get this medicine to patients more quickly.”
Click Here for more Regulatory News
Trial Results
Failed trial: KEYTRUDA® (pembrolizumab) + chemotherapy combination significantly improved PFS in 1L ED SCLC patients but did not meet co-primary endpoint of OS improvement
“Results of KEYNOTE-604 demonstrated the potential of KEYTRUDA, in combination with chemotherapy, to improve outcomes for patients newly diagnosed with extensive stage small cell lung cancer, a highly aggressive malignancy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We sincerely thank the patients and investigators for their participation in this study and are committed to helping patients who face difficult-to-treat types of lung cancer.”
Tyvyt (Sintilimab Injection) + ALIMTA (Pemetrexed) and Platinum met predefined primary endpoint in Ph 3 ORIENT-11 trial as 1L therapy in nonsquamous NSCLC
Professor Li Zhang, Head of the Department of Internal Medicine, Sun Yat-sen University Cancer Center, stated: "In 2019, the National Cancer Center published Chinese data on lung cancer from 2015, showing an incidence of 20 percent and a mortality rate of about 27 percent, ranking it first among all cancer types. Patients who have nsqNSCLC without sensitive EGFR mutation or ALK rearrangement need more treatment options. Treatment with an anti-PD-1 monoclonal antibody in combination with chemotherapy may bring a greater survival benefit to this patient population. We are glad to see that these findings from this trial of sintilimab met the predefined primary endpoint in the interim analysis."
Click Here for more Trial Results
Trial Status/Progress
Ph 3 LIBRETTO-531 trial opens in RET-Mutant Medullary Thyroid Cancer
"Approximately 60 percent of people with medullary thyroid cancer have an activating RET point mutation, yet the current therapeutic options are not ideal for many patients," said Lori Wirth, MD, medical director of the Center for Head and Neck Cancer, Massachusetts General Hospital Cancer Center. "This Phase 3 trial of selpercatinib in patients with advanced or metastatic RET-mutant MTC seeks to confirm a new standard of care that we hope will provide a more effective treatment option for this patient population."
  • TELLOMAK Phase II trial evaluating the efficacy and safety of lacutamab (IPH4102) in patients with advanced T-cell lymphomas
  • Decision came after discussions with regulatory authorities regarding Good Manufacturing Practice (GMP) deficiencies at the Company’s manufacturing subcontractor site that manages the fill and finish operations of the lacutamab clinical vials
  • FDA has placed the TELLOMAK trial on partial clinical hold; however, MHRA has agreed for the trial to continue as planned with current available supply.
Click Here for more Status/Progress of more trials
Collated by : Richa Tewari, PhD
Medness @ Health-IT
Your Physician’s Little Helper is coming to town
What if technology became human enough to sense burnouts and could do something about it? The well-known American supplier of health information technology solutions, services, devices, and hardware, Cerner corporation has taken up the AI-innovation to launch a new assistant to physicians: a voice-enabled documentation system which would significantly cut down the screen-time for physicians to enter data, not to mention ensuring more engaging interaction with the patient and more time-efficient care. As described by Tanuj Gupta, MD, vice president and physician executive of Cerner Intelligence, this technology will not only “set the pace of advancement in the industry” but also will make “care delivery easier for clinicians and simpler for patients”.
Click here to know the Whys and Hows ...
FDA gives a thumbs up to quality and cybersecurity improvement in the medical devices’ realm
Medical Device Innovation Consortium (MDIC) has received an award of 2.8 million from the FDA to support a program for medical devices quality and to improve cybersecurity for the devices. As Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health (CDRH) stated in the press release, MDIC is an essential partner for the Case for Quality and the expansion of this program is aimed to further collaborate with MDIC “to enhance the success of CfQ VIP while promoting high-quality devices and increasing patient safety.”
Will this work?? Click here to know more...
Collated by : Debarati Banik
Medness Business
Onco-News
MedNess Reviews

New immune components as predictors of favourable outcomes for CIT
Last week three independent groups published in Nature their work on new signatures that predict success in cancer immunotherapy (CIT). They showed that patients who have B Cells associated with tumour lymphoid structures respond better to CIT. 

The key findings are:

  1. TLS has a synergistic effect with killer T cells that can attack tumours
  2. Tumour sites can have mature TLS that were thought to have an absence of immune cells.
  3. Increased B cell diversity in TLS among patients who were positive responders suggests that B cells from responding patients have a better capability to identify a diverse range of tumour antigens.
Click here to know more...
Bicycle Therapeutics and Cancer Research UK to develop New Bicycle® Immuno-oncology Candidate, BT7401
“The modular nature of the Bicycle platform enables a number of opportunities to generate new therapeutics that could address unmet need in oncology and other serious diseases,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle. “This new collaboration marks yet another initiative designed to help us bring a potentially important Bicycle-based therapy to patients more efficiently. We are excited to extend our relationship with Cancer Research UK by collaborating with them on BT7401. Cancer Research UK is a partner of choice, with a broad network of collaborators and extensive expertise in cancer treatment. Through our collaboration, we believe we will be able to characterize the biologic and therapeutic profile of BT7401, which we’re pleased to add to our growing portfolio of novel immuno-oncology assets.”
Nektar and BMS expand the active clinical development program for bempeg + nivolumab in adjuvant melanoma and MIBC
“Bristol-Myers Squibb and Nektar view bempeg as an important asset and IL-2 as an important target,” said Fouad Namouni, M.D., head of oncology development, Bristol-Myers Squibb. “We look forward to expanding the registrational program currently underway for bempeg and are committed to the development of potential new combination therapies to address the unmet needs of patients living with cancer.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech
Lilly Announces Agreement to Acquire Dermira
Lilly announced its agreement to acquire Dermira, a biopharmaceutical company that is focussed on finding treatment for chronic skin conditions. The all-cash transaction of 1.1 Billion dollars will see Lilly Buying Dermira for 18.75 dollars/share. It will allow Lilly to expand its immunology pipeline by adding Dermira's lebrikizumab, a novel, investigational, monoclonal antibody that is engineered to bind IL-13. The drug is being evaluated in Phase 3 clinical trial for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, ages 12 years and older
Biogen Acquires Alzheimer's and Parkinson's Asset from Pfizer
Biogen announced that it would acquire PF-05251749, a clinical-stage circadian rhythm regulator that can have implications for Alzheimers and Parkinson's patients. PF-05251749 is a novel casein kinase inhibitor that penetrates the blood-brain barrier. Biogen will pay 75 million dollars up front, with 635 million dollars in milestone payments for the asset. 
Borisy's new company, EQRx takes aim at drug prices
Venture capitalist Alexis Borisy and his team launched a new company called EQRx with 200 M dollars series A, aiming to reduce the drug pricing. He said they have the plan to bring ten drugs in the next ten years to the market. As we enter the election, drug pricing remains the top trending News, and it looks like it's not going to be replaced very soon. 
Click Here for more business news
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
I-cube
Debarati Banik
HealthIT
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting Editor
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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