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Onco-This-Week
21st May , 2019
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Drug Approvals
“As we look to continue to improve outcomes for people with advanced RCC, new treatment approaches have the potential to benefit patients,” said Robert J. Motzer, M.D., Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center, New York, US, and principal investigator for JAVELIN Renal 101. “With today’s FDA approval of avelumab in combination with axitinib, we can now offer patients with advanced RCC a first-line treatment option that combines a PD-L1 immunotherapy with a well-known VEGFR TKI to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib.”
"Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard-of-care," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "Today's approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukaemia."
“The approval of these combination therapies marks a significant milestone for patients with multiple myeloma in Europe,” said Nadim Ahmed, President of Hematology/Oncology for Celgene. “With these new triplet regimens we hope to improve outcomes for both newly diagnosed patients as well as those who have relapsed or become refractory to first-line therapy. IMiD agents have brought significant benefit to multiple myeloma patients and we are committed to advancing our pipeline of novel myeloma treatments in order to ensure physicians and patients continue to have new treatment options available to fight this disease.”
Regulatory News
“While we are disappointed by the outcome of today’s ODAC vote, we will work closely with the FDA as it completes the review of our submission,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “Patients with relapsed/refractory FLT3-ITD AML are facing a very aggressive disease with poor prognosis, and we continue to believe that quizartinib could offer an important additional treatment option that specifically targets FLT3-ITD, a driver mutation in AML.”
FDA recommends initiating a new Ph IIIr trial of mirvetuximab soravtansine in high FRα-positive, platinum-resistant ovarian cancer patients post failure of FORWARD-1 study; Immunogen’s shares plunge
“Our meeting with FDA enabled us to clarify a regulatory path forward for mirvetuximab and we are evaluating all avenues to bring this promising therapy to ovarian cancer patients,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “The mirvetuximab combination cohorts continue to advance and, with approximately $270 million on the balance sheet as of the end of Q1, we remain focused on developing innovative ADC therapeutics and delivering more good days to people with cancer.”
Click here for more regulatory news ....
Onco-Trial Results
Failed Trial : Phase 3 KEYNOTE-119 study of  KEYTRUDA fails to meet primary endpoint of  OS in TNBC 
“Metastatic triple-negative breast cancer is an aggressive and challenging disease to treat, especially after progression on initial standard-of-care treatment,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “While we are disappointed by the outcome of this monotherapy trial, we are continuing to study KEYTRUDA in earlier stages of the disease and in combination with chemotherapy to address the unmet medical need of patients with triple negative breast cancer.”
PRINCIPIA presents Phase1 data of PRN1371 in patients with metastatic bladder cancer
The Phase 1, open-label dose escalation portion of the PRN1371 trial in adult patients with advanced solid tumors has been completed in 36 patients. PRN1371 was well tolerated and two patients continued on study. “As with other FGFR inhibitors, in a non-selected patient population, we did not see partial or complete responses (PRs/CRs).  However, we are encouraged by the observed duration of stable disease, by the remaining two patients on study, and by the established tolerability profile of our molecule,” said Martin Babler, president and CEO of Principia Biopharma.
“With no FDA-approved therapies after progression on trastuzumab, pertuzumab, and ado-trastuzumab emtansine, patients with HER2-positive metastatic breast cancer continue to need new treatment options. If approved, based on SOPHIA data, I believe that margetuximab could become a valuable treatment option for these patients,” said Hope S. Rugo, M.D., Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Comprehensive Cancer Center. “I look forward to presenting results from SOPHIA at ASCO.”
Trial Status/Progress
“We believe the clinical potential for BION-1301 is rooted in scientific rationale and we will pursue the development of BION-1301 in the IgAN indication, where we believe there is significant opportunity to address unmet patient need. We are pleased to initiate this study as a first step in evaluating BION-1301’s ability to reduce the autoimmune deposition of immune complexes affecting kidney function, and its potential to become a meaningful treatment option for this progressive kidney disease,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro.  “However, with the emergence of transformative therapeutic options for multiple myeloma, we have determined not to continue the current Phase 1/2 study as designed in this setting. Although no objective responses were observed, we believe there is potential for investigator-sponsored trials of BION-1301 in combination with other approved agents, given the excellent tolerability profile and PK-PD data.”
Click for more Trial results and Progress/status of ongoing trials
Companion Diagnostics
“LabCorp is committed to bringing precision testing to patients as quickly as possible,” said Marcia Eisenberg, PhD, chief scientific officer, LabCorp Diagnostics. “Our work on studies supporting regulatory approval of the therascreen® FGFR mutation analysis companion diagnostic for BALVERSA, and our commitment to make the test available to physicians and patients as soon as possible after approval, aligns with our mission to improve health and improve lives. LabCorp offers end-to-end support for diagnostic development and accelerated commercialization, distinctly positioning us at the intersection of research and patient care.”
MedNess Business
Onco-News
CD47 inhibitor 5F9 + Rituximab + Acalabrutinib combination to be tested in DLBCL patients
“We are looking forward to evaluating this novel triple combination of 5F9 and rituximab with acalabrutinib. With acalabrutinib, we have a compound that optimally targets Bruton tyrosine kinase (BTK),” said Andrew Mortlock, Chief Scientific Officer at Acerta Pharma. “We established the PRISM platform study in 2018 with the explicit goal of exploring novel combinations and are pleased to be able to collaborate with Forty Seven to include 5F9 in this platform and bring this innovative combination of therapies to patients.”
Onconova Therapeutics gives license to HanX Biopharmaceuticals to develop and commercialize Rigosertib in Greater China
“We are excited about our expanded collaboration with HanX, which now includes our lead investigational drug candidate, rigosertib, currently being studied in higher-risk MDS patients,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer. “We have now partnered with HanX for the development of rigosertib in Greater China, in addition to our continued collaboration on the development of ON 123300, our novel CDK4/6 and ARK5 inhibitor. We plan for patients from China to be included in Onconova’s INSPIRE trial, and this additional source will support the goal of completing accrual to INSPIRE in the second half of 2019. In addition, we expect this agreement will broaden the exploration of additional indications for rigosertib, such as lung cancer. We look forward to presenting our data on rigosertib for the first time in China at the Acute Leukemia Forum being held in Shanghai on May 31, 2019.”
Bio-Pharma and MedTech

ElevateBio raises $150M in Series A for bench-to-bedside solutions for cell and gene therapies
ElevateBio, a Boston based biotechnology company, tackles the bottleneck of limited manufacturing capabilities of early stage companies for cell and gene therapy products. With $150M series A financing, ElevateBio’s BaseCamp will provide a single R&D, process development and cGMP manufacturing capabilities on a 100,000 square feet area to support the portfolio companies and strategic partners that will be announced in coming weeks. The business model is structured to build single- and multiple-cell and gene therapy companies to empower scientific founders with bench-to-bedside capabilities including scientific support, manufacturing platform, drug development and commercialization expertise. The investments are co-led by UBS Oncology Impact Fund managed by MPM Capital and F2 Ventures, EcoR1 Capital, Redmile Group and Samsara BioCapital. 
Jobs: Multiple positions

Genentech and Parvus Therapeutics enter into $800M collaboration to develop therapies for immune disorders
Genentech has announced the partnership with Parvus Therapeutics amounting to $800M for upfront and milestone based payments, for development, manufacture and commercialization of novel treatments for autoimmune diseases based on Parvus’s NavacimTM precision medicine platform. The platform is based on presenting a peptide-major histocompatibility complex (pMHC) at supra-physiological concentration targeting T cell receptors (TCRs) on disease relevant T cells. This results in prolonged assembly of receptor microclusters and persistent signaling leading to disease-specific T regulatory cell differentiation and expansion that further reverses the autoimmune attack on self-tissue. In 2017, Parvus signed its first partnership deal with Novartis for treating type 1 diabetes using the same platform.
Jobs: Multiple positions
Click Here for more on  deals – M&A – Fund raising – Investments and more..
Onco-Conference Coverage
ASCO 2019
  1. Bristol-Myers Squibb to present new data from trials including CheckMate-040, -067, -069, -204, -205, -214, -238, -275, -436, -744, -920 and other assets
  2. Incyte announces abstracts accepted for presentation including FIGHT-202, Ph II GEOMETRY and REALISE trials
  3. Nektar Therapeutics announces five accepted abstracts from IO portfolio, including ones in sarcoma, melanoma and RCC
  4. Jazz Pharmaceuticals to present data from CPX-351 (liposomal daunorubicin and cytarabine) program
  5. Epizyme announces new Tazemetostat clinical data to be presented
  6. Biothera Pharmaceuticals to present clinical data from Ph II TNBC trial of Imprime PGG + Pembrolizumab
  7. Genentech to present new data including Entrectinib and Venetoclax + Obinutuzumab programs among other updates
  8. Merck to present research from broad oncology clinical development program including Ph III POLO, POLO-3, KEYNOTE-189, -062, -426, -048, 240 and Ph Ib KEYNOTE-001
  9. Forty Seven, Inc. to present initial safety and efficacy data from Ph Ib trial of CD47 inhibitor 5F9 in AML and MDS patients
  10. AstraZeneca to present results and updates from several programs including Ph III POLO, SOLO-1, -3, PACIFIC, DESTINY-Breast04 and Ph II TOPARP-B, GeparOLA, FAKTION trials
  11. ImmunoGen to present mature data from FORWARD II expansion cohort of Mirvetuximab Soravtansine + Bevacizumab in ovarian cancer patients
  12. Amgen to showcase data and clinical updates from programs including KRASG12C Inhibitor AMG 510, PSMA-targeting BiTE Pasotuxizumab, BCMA-targeting BiTE AMG 420, and AMG 757, AMG 119 and AMG 596
  13. Medicenna to present data from recently completed Ph IIb MDNA55 trial and preclinical updates from MDNA109 program
  14. Y-mAbs to present clinical updates from omburtamab and naxitamab programs
  15. Interim update of data for CPI-0610 in Myelofibrosis patients to be presented
  16. Abstracts from pivotal stage Oraxol (Oral paclitaxel and HM30181A) program and preliminary results from Oratecan (Oral irinotecan and HM30181A) Ph I trial to be presented
  17. TLR9 agonist SD-101 data to be presented
  18. Bria-IMT data from Ph I/IIa trial in advanced breast cancer patients to be presented
  19. NSCLC and AML clinical updates from AXL inhibitor Bemcentinib program to be presented
  20. Pembrolizumab monotherapy meets primary endpoint of non-inferior OS vs chemo in PD-L1+ve pts; Pembrolizumab + chemotherapy found not superior in OS vs chemo in Ph III KEYNOTE-062 trial in 1L GEJ/Gastric cancer pts
  21. TLR9 agonist SD-101 + Pembrolizumab data from Ph Ib/II trial in PD-(L)1 naive or ref melanoma, SCCHN patients to be presented
  22. Top studies to be presented at ASCO (including 5-yr survival data of Pembro in mNSCLC patients in KEYNOTE-001 trial)
  23. Updates from STING agonist ADU-S100 and anti-APRIL antibody BION-1301 to be presented
  24. Updates from CASSIOPEIA, MAIA, COLUMBA, CASTOR, POLLUX, CEPHEUS, SGNTV-001, innovaTV 208, COMPLEMENT 1 and PERSEUS trials to be presented
  25. PV10 updates from Ph I and Ib trials in mNET and cutaneous melanoma patients to be presented
  26. Novartis to present clinical updates from programs including Ph III MONALEESA-7, CompLEEment-1, and SOLAR-1, NATALEE, MONALEESA-2, COMBI-i, GEOMETRY, CANOPY, CANOPY-A, NETTER-1 etc.
  27. Genocea to present positive interim immunogenicity data from GEN-009 neoantigen vaccine Ph I/IIa trial
  28. Ph II updates from Umbralisib trial in R/R MZL patients to be presented
  29. Design and current status of Ph I/II trial of RP1 +/- nivolumab in four solid tumor types to be presented
  30. G1 Therapeutics to present additional Trilaciclib Ph II SCLC data
Click Here for more on conference updates...
Editors' Desk
Content Editors 
Concept and Design Team
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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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Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
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