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Onco-This-Week
18th June , 2019
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MedNess This Week
Highlights
Drug Approvals
“This approval is a very exciting milestone in the treatment of head and neck cancer and has the potential to transform the way we treat patients with this debilitating disease by offering important new therapeutic options,” said Dr. Barbara Burtness, professor of medicine, Yale School of Medicine and co-director, Development Therapeutics Research Program, Yale Cancer Center. “Metastatic or recurrent head and neck cancer has been an area of significant unmet need, so it is encouraging to have immunotherapy regimens available for patients in the first-line setting.”
FDA approves lenalidomide + rituximab combination for the treatment of previously treated FL or MZL patients based on Ph III AUGMENT study results
“Nearly 15 years following the initial FDA approval, REVLIMID continues to demonstrate benefits for new patient populations,” said Jay Backstrom, M.D., M.P.H., Chief Medical Officer for Celgene. “REVLIMID in combination with rituximab (R2) leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously treated follicular lymphoma and marginal zone lymphoma delay disease progression.”
CD79-targeting ADC Polatuzumab vedotin (+BR) gets accelerated approval in 3L+ patients based on results from the Ph Ib/II GO29365 trial, registering 40% complete response
“Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.”
Regulatory News
FDA accepts Luspatercept BLA in MDS patients based on data from the pivotal Ph III MEDALIST trial; PDUFA: Dec 2019
“The ongoing U.S. and European regulatory reviews of the luspatercept filings in MDS and beta-thalassemia strongly support our primary goal, which has always been to bring a potentially transformative new treatment to these patients with unmet clinical need as quickly as possible,” said Habib Dable, President and Chief Executive Officer of Acceleron. “At the same time, we continue to explore the ability of luspatercept to address anemia in additional settings, including patients with treatment-naïve MDS, non-transfusion-dependent beta-thalassemia, and myelofibrosis.”
NDA submitted to FDA for KIT and PDGFRA inhibitor Avapritinib for the treatment of PDGFRA Exon 18 mutant GIST and 4L GIST patients
"There is an important need for new treatment options that offer durable responses for PDGFRA Exon 18 mutant and fourth-line GIST patients," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "By targeting the underlying molecular drivers of GIST, avapritinib has the potential to help these patients realize the benefits of precision therapy. We plan to work closely with the FDA to bring avapritinib to appropriate GIST patients as quickly as possible."
Onco-Trial Results
Ph III ASCERTAIN study of Cedazuridine and decitabine (as fixed-dose combination ASTX727), met the primary endpoint of decitabine exposure equivalence in MDS and CMML patients; NDA filing planned by 2019 end
“We are delighted with the outcome of the ASCERTAIN trial, and the demonstration that the fixed dose combination of cedazuridine with decitabine enables successful oral delivery of decitabine, alleviating the significant burden of five days of monthly IV infusions for patients who may continue to benefit from the drug for several months or even years,” said Mohammad Azab, Astex Pharmaceuticals’ president and chief medical officer.
FAILED TRIAL: Ph III TOURMALINE-AL1 trial of ixazomib + dexamethasone in R/R AL amyloidosis patients did not meet the first of two primary endpoints; trial to discontinue
“While we are disappointed with this outcome, we aim to maximize our learnings from this trial and share findings with the community in hopes of helping to improve care for patients living with this devastating disease,” said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. “This has been one of the largest studies ever conducted in systemic light-chain AL amyloidosis and we are proud to have led it. This study demonstrated our dedication to this rare and traditionally difficult-to-enroll patient population and we thank the patients and investigators for their engagement and participation. We remain optimistic about NINLARO and continue to investigate NINLARO in patient populations across the continuum of multiple myeloma care.”
Click Here for more Onco-Trial Results 
Onco-Trail Status/Progress
Ph III CanStem303C trial of napabucasin + FOLFIRI +/- bevacizumab to continue in advanced mCRC patients as per independent DSMB recommendation
Following a pre-specified interim analysis of 50% of the total planned events, independent DSMB recommended to continue Ph III CanStem303C study without modification.
Ph III ELEVATE-TN trial of acalabrutinib in 1L CLL patients met primary endpoint of PFS improvement; to be stopped early
José Baselga, Executive Vice President, Oncology R&D said: “These findings confirm the superiority of Calquence as a monotherapy and also in combination over standard-of-care treatments for chronic lymphocytic leukaemia. The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year.”
Click Here for more Progress/status of ongoing trials
MedNess Business
Onco-News
Merck to acquire Tilos Therapeutics to add TGFβ-modulating investigational antibodies to its portfolio
Merck is set to acquire Tilos Therapeutics, a privately owned biopharmaceutical company for treatment of cancer, fibrosis and autoimmune diseases by targeting TGFbeta complex. Merck, through its subsidiaries, will acquire Tilos for up to $773M with part upfront payment and rest through milestone payments.
“We are proud that the Tilos team has advanced the discoveries of our scientific founders by developing a portfolio of anti-LAP antibodies designed to realize the full potential of TGFβ-modulating therapeutics,” said Dr. Barbara Fox, CEO, Tilos. “This agreement with Merck, an industry leader in biopharmaceutical research and development, provides meaningful validation for our therapeutic approach and best positions our pipeline for broad clinical and commercial success.”
BeiGene to take back global rights to its PD-1 inhibitor tislelizumab from Celgene following Celgene's merger with Bristol-Myers Squibb
“Our collaboration with Celgene was instrumental for the late-stage clinical development of tislelizumab and has provided us with significant resources to continue our broad clinical program,” said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. “As we have been leading most of the ongoing Phase 3 or potentially registration-enabling trials with a global development organization of over 800 people, we believe that we are well-positioned to continue the development of tislelizumab. I am proud of the work that we have accomplished in collaboration with Celgene and am excited by the tremendous opportunity that we have ahead now that we’ve regained full global rights to tislelizumab.” 
BioPharma and MedTech

Pfizer acquires Array BioPharma for $11.4B

Pfizer is set to acquire Array BioPharma, a biopharmaceutical focused on discovery, development and commercialization of small molecules targeted against cancer and other diseases. The deal amounts to $11.4B with $48 per share in cash. The acquisition strengthens Pfizer’s leadership in oncology with addition of breakthrough combination of BRAF/MEK inhibitors under investigation for a potential therapy for patients with BRAF-mutant metastatic colorectal cancer.
“Today’s announcement reinforces our commitment to deploy our capital to bring breakthroughs that change patients’ lives while creating shareholder value,” said Albert Bourla, chief executive officer of Pfizer. “The proposed acquisition of Array strengthens our innovative biopharmaceutical business, is expected to enhance its long-term growth trajectory, and sets the stage to create a potentially industry-leading franchise for colorectal cancer alongside Pfizer’s existing expertise in breast and prostate cancers.”
Gene therapy developed by Bluebird Bio for beta-thalassemia to cost over €1.5M
Bluebird Bio has put a price tag of €1.575M for its gene therapy product Zyntelgo for treatment of transfusion dependent beta-thalassemia. The disease is caused by mutation in the beta-globin gene that results in decreased or absent haemoglobin in the red blood cells. With the ‘pay-as-you-go’ model, the patients initially pay €315,000 and the rest in subsequent annual installments only if they continue to respond to the therapy. The price tag makes it the second most expensive gene therapy product after Novartis’ $2.125M Zolgensma for spinal muscular atrophy.
 
Click Here for more on  deals – M&A – Fund raising – Investments and more..
Conference Coverage
EHA 2019
  1. ArQule presented preliminary clinical proof-of-concept data from ongoing Ph I trial of reversible BTK Inhibitor, ARQ 531, in patients with relapsed/refractory hematologic malignancies
  2. Regeneron Pharmaceuticals announced positive early-stage data for REGN1979 in R/R B-NHL patients, including R/R DLBCL patients who had progressed after CAR-T therapy
  3. Kura Oncology announced updated interim data from the ongoing Ph II trial of tipifarnib in R/R PTCL patients
  4. BMS presented updated data from Ph II ELOQUENT-3 trial of elotuzumab plus pomalidomide and dexamethasone (EPd) versus pomalidomide and dexamethasone (Pd) alone in RRMM patients
  5. BerGenBio ASA presented data showing significant efficacy in a Ph II BGBC003 trial of oral AXL inhibitor bemcentinib + low-dose cytarabine (LDAC) in unfit AML patients
  6. Oryzon Genomics presented preliminary data from Part I (dose finding) of the Ph II ALICE trial of iadademstat + azacitidine in elderly AML patients
  7. Karyopharm Therapeutics announced new and updated data from the Ph Ib/II STOMP trial of selinexor + dexamethasone + SoC in RRMM patients
  8. AstraZeneca announced detailed results from the interim analysis of the Ph III ASCEND trial of acalabrutinib in R/R CLL patients
  9. Sunesis Pharmaceuticals presented results from the Ph Ib/II trial of BTK inhibitor vecabrutinib in adults with R/R CLL and other B-cell malignancies
  10. Forty Seven, Inc. announced updated data from ongoing Ph Ib/II trial of 5F9 + rituximab in R/R NHL patients, including DLBCL and indolent lymphoma
  11. BeiGene announced updated results from a pivotal Ph II trial of Tislelizumab in Chinese patients with R/R classical Hodgkin Lymphoma
  12. Stemline Therapeutics announces results from ongoing Ph I/II trial of Tagraxofusp (SL-401) in R/R CMML patients and patients with intermediate, or high risk, R/R Myelofibrosis
  13. Amgen announced the 5-year OS analysis from Ph II BLAST trial of blinatumomab in MRD-positive ALL patients
  14. Verastem Oncology announced clinical data for duvelisib in R/R CLL/SLL patients in Ph III DUO trial
  15. Oncopeptides AB announced updated interim efficacy and safety data from the ongoing, pivotal Ph II HORIZON trial in RRMM patients
  16. Tolero Pharmaceuticals presented data from the ongoing Ph I Zella 101 trial of CDK9 inhibitor alvocidib + cytarabine and daunorubicin in 1L AML patients
  17. Imago BioSciences announced positive safety and early efficacy clinical data from ongoing Ph I/IIa IMG-7289-CTP-102 trial of IMG-7289 in high or intermediate-2 risk myelofibrosis patients resistant to or intolerant of approved therapy
  18. Sutro Biopharma announced encouraging interim safety data from ongoing Ph I dose escalation trial of CD74-targeting ADC STRO-001 in patients with B-cell malignancies
  19. Geron Corporation announced clinical data and analyses of telomerase inhibitor imetelstat in ESAs-refractory heavily transfused non-del(5q) lower risk R/R MDS (LR-MDS) patients and R/R MF patients
Click for a detailed list of ASCO abstracts
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Mayur Vadhvani, PhD
Business News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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Disclaimer
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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