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MedNess: bite-size biopharma and medtech news

29th October, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals
European Commission approves XOSPATA™ (gilteritinib) monotherapy in R/R AML patients with a FLT3 mutation based on Ph III ADMIRAL trial results
“AML is a rare cancer and patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy,” said Giovanni Martinelli, M.D., Institute of Hematology, S.Orsola-Malpighi University Hospital, Bologna, Italy, an investigator in the ADMIRAL trial. “Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union.”
European Commission approves Opdivo (nivolumab) four-week dosing schedule for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
“The approval of Opdivo two and four-week flat dosing schedule in the adjuvant melanoma setting is an important milestone for patients across the European Union who now have additional treatment flexibility,” said Ralu Vlad, Pharm.D, development team lead, product design and delivery, Bristol-Myers Squibb. “Bristol Myers-Squibb is committed to empowering patients with cancer and their families to regain control of their lives through more flexible treatment options that fit their individual needs.”
FDA approves niraparib for HRD-positive advanced recurrent ovarian cancer based on Ph II QUADRA trial results
Axel Hoos, MD, PhD, SVP Oncology R&D, GSK, said: “This new indication reinforces our commitment to providing treatment options for more women impacted by ovarian cancer, especially those with high unmet needs. We look forward to continuing our clinical development program of Zejula and understanding its full potential as a treatment for people living with ovarian cancer.”
Regulatory News
FDA granted Fast Track Designation for bemcentinib in elderly AML patients whose disease has relapsed
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are thrilled that bemcentinib has been granted Fast Track Designation. Not only does this make us eligible for accelerated approval and priority review, but it serves as an important validation of bemcentinib in this significant unmet medical need we are trying to address. Currently, bemcentinib is in expanded Phase II trials in the U.S. and Europe for the treatment of AML and the Company has recently announced positive interim top line data.”
Trial Results
Ph III CheckMate -9LA of Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) meets primary endpoint of OS improvement compared to chemotherapy alone in 1L NSCLC patients
“We are excited by the CheckMate -9LA results, which demonstrate the potential of Opdivo plus low-dose Yervoy to provide a survival benefit to patients with non-small cell lung cancer in the first-line setting when administered concomitantly with a limited course of chemotherapy,” said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. “These results build on the benefit the combination of Opdivo plus Yervoy has previously shown in first-line melanoma, renal cell carcinoma and most recently lung cancer, and may provide a new therapeutic option for patients.”
  • Combination received FDA Breakthrough Therapy Designation last year based on Ph Ib trial results (ESMO 2018: n=73, ORR: 32%, mPFS: 14.9 mos, PFS6: 65%, mOS: NR)
  • In the combo, Bevacizumab inhibits VEGF-related immunosuppression and enhances Atezolizumab’s ability to restore anti-cancer immunity
  • The highly likely approval will also help Atezolizumab gain ground on Pembrolizumab and Nivolumab as HCC sales will add up to NSCLC (in addition to recent increasing sales from SCLC and TNBC). This should also offset last year's RCC setback in Europe
  • These results re-affirm synergistic potential of IO + targeted therapies vs lackluster monotherapy performances
  • Atezolizumab could very well become the first immunotherapy approved in 1L HCC, a strong contender against current two-phase targeted therapy regimen of Lenvatinib and Sorafenib (Nivolumab already failed in 1L, Pembrolizumab in Sorafenib-treated pts)
  • Other trials to look for: Ph III LEAP-002 (Pembrolizumab); Ph III HIMALAYA (Durvalumab + Tremelimumab); and Ph III Tislelizumab trial
Click Here for more Trial Results
Trial Status/Progress
First patient dosed in a Ph I trial of MB-108 (oncolytic virus C134) in recurrent glioblastoma multiforme
“Dosing the first participant in this trial represents an important step in evaluating MB-108’s potential to treat patients with glioblastoma,” Dr. Markert said. “We are pleased to have achieved this milestone and look forward to sharing more information as the trial progresses.”
Ph II/III MAHOGANY trial of Margetuximab initiated in patients with gastric or gastroesophageal junction cancer
“The MAHOGANY study for patients with gastric or gastroesophageal junction cancer is designed to support registration of margetuximab and is a part of our strategy to advance margetuximab in HER2-positive cancers,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “The combination of margetuximab and a checkpoint inhibitor could potentially provide a chemotherapy-free option as a first-line treatment for patients whose tumors are positive for both HER2 and PD-L1 or be used with chemotherapy in a broader HER2-positive population to improve the clinical activity of existing standard of care.”
Click Here for more Trial Status/Progress
MedNess Plus
FDA announces the approval for the marketing of a rapid diagnostic test to detect Ebola virus antigen
“Today’s marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the U.S. Government, especially as we work with our partners, including the World Health Organization, to help address the current Ebola outbreak in the Democratic Republic of Congo (DRC),” said Acting FDA Commissioner Ned Sharpless, M.D. “The current outbreak in the DRC has already killed thousands and the outbreaks in West Africa that began in 2014 tragically killed more than 11,000. Investigational vaccines and therapeutics have shown promising results, but one of the most important tools in stopping these outbreaks is quickly diagnosing patients and supporting safe and dignified burials. This marketing authorization may provide additional assurances to health care professionals seeking to use these types of rapid diagnostics. The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving. Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials.”
FDA approves Trikafta for the treatment of cystic fibrosis
“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, M.D. “In the past few years, we have seen remarkable breakthroughs in therapies to treat cystic fibrosis and improve patients’ quality of life, yet many subgroups of cystic fibrosis patients did not have approved treatment options. That’s why we used all available programs, including Priority Review, Fast Track, Breakthrough Therapy, and orphan drug designation, to help advance today’s approval in the most efficient manner possible, while also adhering to our high standards. The FDA remains committed to advancing 
Click Here for more MedNess Plus
MedNess Business
Onco-News

AstraZeneca's Q3 2019 Oncology portfolio review
OUT: 

·       Ph III SAVIOUR trial of MET inhibitor savolitinib in renal cell carcinoma patients

·       Ph III NEPTUNE trial of PD-L1 and CTLA-4 inhibitors, Durvalumab and Tremelimumab, in 1L NSCLC patients 

IN: 

·       Ph III CAPItello-290, POSEIDON, ADRIATIC, CAPSIAN, DANUBE, HIMALAYA, KESTREL, NILE, DUO-O, SPRINT, DESTINY-Breast02/-03/-04 and DESTINY-Gastric01 trials 

UNDER REVIEW: 

·       Ph III DESTINY-Breast01 trial 

UPCOMING KEY REGULATORY SUBMISSION ACCEPTANCES 

·       H2 2019: SPRINT, POSEIDON, CAPSIAN trials 

·       H1 2020: SPRINT (EU), DANUBE, KESTREL, PAOLA-1, PROFOUND trials 

·       H2 2020: SOLO-3 trial 

·       2021: HIMALAYA, NILE, GY004, DESTINY-Breast02, BR31, PACIFIC-2, EMERALD-1, OLYMPIA, PEARL trials 

ACCELERATED APPROVALS: 

·       Lynparza ovarian cancer SOLO-2; Tagrisso EGFRm T790M NSCLC; Imfinzi bladder cancer; Calquence MCL 

BTD: 

·       Tagrisso EGFRm T790M NSCLC; Lynparza prostate cancer PROFOUND; Imfinzi bladder cancer 1L; Calquence CLL, MCL; Imfinzi stage III NSCLC 1L PACIFIC; Tagrisso NSCLC 1L FLAURA; selumetinib NFI type 1 SPRINT; trastuzumab deruxtecan breast cancer 

SAKIGAKE: 

·       Trastuzumab deruxtecan gastric cancer
Advaxis announces business and pipeline update
Advaxis, a clinical stage biopharma company, has announced the updates of its immunotherapy clinical programs ADXS-HOT, ADXS-NEO, ADXS-PSA and ADXS-HPV designed to target various forms of cancers. The programs utilize Listeria monocytogenes (Lm) bacteria-based antigen delivery products that are bioengineered to secrete antigen/adjuvant fusion proteins.
Bio-Pharma and MedTech

Pliant Therapeutics and Novartis enter into an agreement to develop novel therapy for NASH and Fibrosis
Pliant Therapeutics and Novartis have agreed to a strategic collaboration to develop Pliant’s preclinical candidate, PLN-1474 and up to three additional candidates. PLN-1474 is a small molecule inhibitor of αVβ1 integrin that blocks activation of TGFβ to prevent growth of fibrotic tissue and is being developed for nonalcoholic steaohepatitis (NASH). Under the agreement, Pliant will receive $80 million for the development of PLN-1474 and additional targets through Phase 1 after which Novartis will be responsible for its future development, manufacturing and commercialization. Pliant is expected to submit an IND application by the end of 2019 to the US FDA.
Sartorius acquires Danaher’s life science platform for $750 million
Sartorius has further strengthened its position in the bioprocessing and bioanalytics sector by acquiring Danaher’s life science platform for $750 million in cash. The deal includes the acquisition of three large businesses: FortéBio that comprises of label-free biomolecular characterization business, the chromatography hardware and resins business, and the SoloHill that includes microcarrier and particle validation business. The contract is subject to closing of Danaher’s acquisition of GE Biopharma business and regulatory approvals.
Click Here for more mergers, acquisitions and job opportunities in the featured companies
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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