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Onco-This-Week
14th May , 2019
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Regulatory News
Can-Fite prepares for end-of-phase II meeting with FDA to start Ph III trial of Namodenoson in HCC patients
“We look forward to our upcoming meeting with the FDA regarding our Phase III study design. We are hopeful that based on efficacy data in the largest subgroup of the patient population from our Phase II study, we can move forward into a pivotal Phase III trial for marketing approval with the guidance of the FDA,” stated Can-Fite CEO Pnina Fishman.”
IND application of IDE196 cleared for metastatic uveal melanoma and other solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations and PKC fusions
“Patients with metastatic UM generally have a poor prognosis, with historic clinical response rates generally ranging from 0% to 10% and median overall survival of 10 months. In light of this significant patient need and the promising activity seen in the initial IDE196 clinical study, we are excited for continued development of IDE196 to further evaluate its clinical potential,” said Dr. Matteo Carlino, Medical Oncologist, Blacktown and Westmead Hospitals, Clinical Associate Professor, University of Sydney, and IDE196 clinical investigator.
“This is an important acknowledgement of the potentially paradigm-shifting therapy option in metastatic triple-negative breast cancer,” stated Dr. Richard Pestell, M.D., Ph.D, Vice Chairman and Chief Medical Officer of CytoDyn.  “Currently, there are no enduring treatment options for mTNBC patients and, we thank the FDA for recognizing the potential of leronlimab for mTNBC patients,” continued Dr. Pestell.
Onco-Trial Results

Ph I trial of mRNA-based mesothelin-targeting cell therapy MCY-M11 progresses

“Successfully completing patient dosing in our first cohort and initiating dosing in a second higher-dose cohort are important milestones for MaxCyte, representing tangible progress for our lead CAR therapeutic and our proprietary CARMA autologous cell therapy platform,” said Claudio Dansky Ullmann, MD, Chief Medical Officer. “We are very excited about the potential of MCY-M11 as a new, effective therapeutic in solid tumors where the majority of patients still have very limited treatment options.”
FAILED TRIAL: Ph III CheckMate-498 trial did not meet primary endpoint of OS improvement with Nivolumab + RT in 1L MGMT-unmethylated GBM patients
“While we are disappointed the CheckMate -498 trial did not meet its primary endpoint, GBM is a notoriously aggressive cancer,” said Fouad Namouni, M.D., head, oncology development, Bristol-Myers Squibb. “We are grateful to all those who participated in this trial and remain committed to researching the potential of immunotherapy to address the important unmet medical need of patients who suffer from this devastating disease.”
Ph III ASCEND trial of BTK inhibitor Acalabrutinib meets primary endpoint of PFS improvement at interim analysis in R/R CLL patients; trial to stop early
José Baselga, Executive Vice President, R&D Oncology said: “Calquence is the first BTK inhibitor to show benefit in a Phase III trial as a monotherapy compared to current standard-of-care combinations used in relapsed or refractory chronic lymphocytic leukaemia. We look forward to presenting detailed results at a forthcoming medical meeting.”
Credits : Medical Xpress
José Baselga, Executive Vice President, R&D Oncology, said: “We are encouraged to see positive data from trastuzumab deruxtecan, with the DESTINY-Breast01 trial now reinforcing what earlier data have shown. We believe this antibody drug conjugate has the potential to redefine the treatment of patients with HER2-expressing cancers, and we are eager to bring it as quickly as possible to patients with refractory HER2-positive breast cancer who continue to have high unmet medical need.”
Click for more Trial results and Progress/status of ongoing trials
COMPANION DIAGNOSTICS
"This Breakthrough Device designation is a significant step forward in our commercial strategy, helping to clear the path for Natera to participate in registrational drug trials that use Signatera for patient selection and study enrichment," said Solomon Moshkevich, Natera's General Manager, Oncology and Transplant Businesses. "This milestone directly supports our stated goal of achieving $40 to $50 million in cumulative pharma contracts by the end of 2019."
"We are pleased to achieve this important milestone with our partner Almac, moving us closer to the start of our pivotal study for repotrectinib in the second half of 2019," said Athena Countouriotis, M.D., president and chief executive officer. "With a clear unmet medical need for therapies that target genomic alterations in different cancers, the diagnostic assay will provide clinical investigators with timely information to confirm the presence of the oncogenic drivers we continue to study in patients with advanced solid tumors."
MedNess Plus
FDA approves the first vaccine for the prevention of dengue
Dengvaxia, a product of Sanofi, is the first vaccine for the prevention of dengue disease, to be approved recently by the FDA. “The FDA is committed to working proactively with our partners at the U.S. Centers for Disease Control and Prevention, as well as international partners, including the World Health Organization, to combat public health threats, including through facilitating the development and availability of medical products to address emerging infectious diseases. While there is no cure for dengue disease, today’s approval is an important step toward helping to reduce the impact of this virus in endemic regions of the United States."said Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs.
Psychogenics Inc. and Sunovian Pharmaceuticals recently received an FDA Breakthrough therapy designation for their product SEP-363856, to treat patients with schizophrenia.“Schizophrenia is a major public health challenge associated with persistent abnormalities in thinking, perception and behavior, as well as impairments in quality of life and functional skills, that affects approximately 2.4 million people in the U.S.,” said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. “Breakthrough Therapy Designation underscores the potential of SEP-363856 as a novel treatment for patients with schizophrenia, for whom few major advances in treatment have occurred since the advent of antipsychotic pharmacotherapy in the 1950s. Investigational studies to further evaluate the clinical benefit of SEP-363856 are in progress, and we look forward to working closely with the FDA on this important potential new therapy."
Moderna Inc, announces the Phase 1 data for mRNA vaccines against the H10N8 and H7N9 influenza strains
Moderna Inc. recently announced the publication of the Phase 1 data from two clinical trials of mRNA vaccines against the H10N8 and H7N9 influenza virus.“Both seasonal and pandemic influenzas are serious public health problems, and there is a clear need for effective vaccines that can be quickly developed and deployed. Production of current flu vaccines takes significant time and requires virus or antigen production in cell-culture or eggs and in dedicated facilities,” said Mike Watson, senior vice president of vaccine partnerships and health impact at Moderna and a study co-author. “These Phase 1 data highlight the potential of Moderna’s mRNA platform to demonstrate similar or better immunogenicity than existing vaccines, which can be rapidly produced in a multi-use facility.”
FoldRx, a subsidiary of Pfizer receives approval for treatment of cardiomyopathy caused by transthyretin mediated amyloidosis
“Transthyretin-mediated amyloidosis is a rare, debilitating and often fatal disease,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis.”
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MedNess Business
BioNTech acquires MVT-5873 and other antibody assets from MabVax Therapeutics to expand portfolio
“BioNTech’s vision is to identify and provide the best therapeutic options for each individual cancer patient. To make this possible, we are developing and integrating complementary technologies and drug modalities into our overall portfolio of treatment approaches,” said Prof. Dr. Ugur Sahin, CEO of BioNTech. “MabVax Therapeutics has developed an antibody with a novel mode of action in a disease indication that complements our pipeline expansion plans. This clinical-stage antibody together with the other pre-clinical assets that we have acquired from MabVax Therapeutics enhance our antibody portfolio, which also benefits from our ongoing collaboration with Genmab and the acquisition of MAB Discovery earlier this year.”
Boston Scientific acquires spine-spacer developer Vertiflex in $465M deal
Boston Scientific expand their pain management portfolio by acquiring Vertiflex, maker of minimally invasive vertebrate spacer for treating lumbar stenosis using FDA approved Superion® Indirect Compression System. The deal includes $465M upfront payment including an additional commercial milestone payment over next three years. With as many as 6 million people in USA suffering from lumbar stenosis, Vertiflex expects to reach at least $60M in sales this year.
Job : Multiple positions
Twentyeight-Seven Therapeutics receives series A extension to $82M+ for cancer treatment
Launched in September 2018 with $65M series A fund, Twentyeight-Seven (28-7) Therapeutics has received additional $17.75M as series A extension fund for cancer treatment. The company’s lead oncology program focuses on modulation of non-coding RNA (ncRNA) by targeting RNA modulating protein (RMP) using small molecule drug candidates. The RMP Lin28 binds to precursor of Let-7 and prevents its maturation to functional tumor suppressing miRNA. The current focus is on designing small molecule candidates that reduces the interaction of Lin28 with Let-7 thereby increasing the level of this important tumor suppressor. 
Job : Scientist /Senior Scientist
Bayer spurs biotech innovation in Berkeley – Invests $150M to build Cell Culture Technology Center
Bayer announced investment of $150M to build up new Cell Culture Technology Center on Bayer’s existing Berkeley campus in California. The center will be state-of-art bio-manufacturing facility based on disposable technology and will focus on development of biological therapies with main emphasis on cardiology and oncology. The new 40,000 square foot facility, expected to be complete by late 2021, will combine automation, digital capabilities and single-use bioprocessing. The center will be developed in partnership with Fluor and GE Healthcare.
Click Here for more on  deals – M&A – Fund raising – Investments and more..
Q1-2019 Financial Results 
  1. Infinity Pharmaceuticals announce Q1 2019 financial results and provide updates on IPI-549 program
  2. Genmab provides updates on Daratumumab program as part of Q1 2019 financial results
  3. Clovis Oncology shares clinical development plans for Rucaparib and Lucitanib along with Q1 2019 results
  4. Trovagene provides updates on Onvansertib program as a part of Q1 2019 financial results
  5. Jounce Therapeutics announces Q1 2019 results and provides updates on Vopratelimab (JTX-2011), JTX-4014 and JTX-8064 program
  6. Regeneron reports Q1 financial results; also discusses two deaths from bispecific antibody RGN1979
  7. Karyopharm presents Q1 2019 results and Selinexor program updates
  8. Syndax announces Q1 2019 results; provides updates on Entinostat and SNDX-5613 programs
  9. Cellectar reports Q1 2019 financial results and provides CLR131 update
  10. CTI Biopharma presents Pacritinib updates along with Q1 2019 financial results
  11. Erytech Pharma provides updates on TRYbeCA1 and TRYbeCA2 trials along with Q1 results
  12. Amgen to present data on KRAS G12C inh AMG 510, BCMA-targeting BiTE AMG 420 and PSMA-targeting BiTE as announced in Q1 2019 results
  13. Halozyme reports Q1 2019 results and provides updates on ENHANZE and PEGPH20 programs
  14. Pfizer reports Q1 2019 financial results and clinical programs updates
  15. Merck reports Q1 2019 financial results and clinical programs updates
  16. Incyte reports Q1 2019 financial results and clinical programs updates
  17. Lilly Oncology announces Q1 2019 results; shelves Prexasertib and LY3023414
  18. MacroGenics shares Q1 2019 results and updates from Margetuximab, B7-H3, PD-1 franchise and Flotetuzumab programs
  19. Mirati Therapeutics presents Q1 2019 results; intial clinical update on MRTX849 expected in H2 2019
  20. Arcus Bioscience announces Q1 2019 results and pipeline updates
  21. Idera Pharmaceutical reports Q1 results and provides updates on Tilsotolimod program
  22. CRISPR Therapeutics provides financial results for Q1 2019 and updates on CTX110 program
  23. AbbVie reports Q1 2019 financial results and 2018 events
  24. AstraZeneca announces Q1 2019 results
  25. BMS announces Q1 2019 results; Ph II CheckMate-714 trial fails to meet its primary endpoints
  26. Daiichi Sankyo announced consolidated financial results for year ended March 31, 2019 (Fiscal 2018)
  27. Seattle Genetics reports Q12019 financial results
Conference Coverage
MDS 2019
  1. Clinical updates from RAS-mimetic Rigosertib program to be presented
ASCO 2019
  1. 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
  2.  TLR9 agonist SD-101 data to be presented
  3. Bria-IMT data from Ph I/IIa trial in advanced breast cancer patients to be presented
  4. NSCLC and AML clinical updates from AXL inhibitor Bemcentinib program to be presented
  5. 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
  6. TLR9 agonist SD-101 + Pembrolizumab data from Ph Ib/II trial in PD-(L)1 naive or ref melanoma, SCCHN patients to be presented
  7. Top studies to be presented at ASCO (including 5-yr survival data of Pembro in mNSCLC patients in KEYNOTE-001 trial)
  8. Updates from STING agonist ADU-S100 and anti-APRIL antibody BION-1301 to be presented
  9. Updates from CASSIOPEIA, MAIA, COLUMBA, CASTOR, POLLUX, CEPHEUS, SGNTV-001, innovaTV 208, COMPLEMENT 1 and PERSEUS trials to be presented
  10. PV10 updates from Ph I and Ib trials in mNET and cutaneous melanoma patients to be presented 
ELCC 2019
  1. mOS NR at 20-month follow-up with Atezolizumab with Bev and Chemo in 1L non-sq and 2L EGFR/ALK+ mNSCLC in Ph III IMpower150 trial
  2. Updated Entrectinib data in overall and CNS positive cohorts from Ph I ALKA-372-001, STARTRK-1 and Ph II STARTRK-2 trials presented
  3. 77% ORR with Osimertinib in 1L EGFR+ NSCLC patients in Ph I AURA trial; supports Ph III FLAURA trial results and approval
ESMO GI 2019
  1. Update on allogeneic and autologous NKG2D-based CAR-T candidates in refractory mCRC patients to be presented
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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Cover Image : Pixabay
Images : Medical Xpress , Twitter
Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
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