View this email in your browser

MedNess: bite-size biopharma and medtech news

Onco-this-Week
9th July, 2019
Subscribe here
MedNess This Week

HIGHLIGHTS
Drug Approvals
Selinexor earns accelerated approval based on results from Ph IIb STORM trial in RRMM patients who received at least 4 prior therapies (refractory to at least 2 PIs, at least 2 IMiDs, and a CD38 inhibitor); Ph III BOSTON trial to serve as confirmatory trial
“With today’s accelerated approval of XPOVIO by the FDA, patients with heavily pretreated multiple myeloma will now have a new therapeutic option to treat their disease,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “Discovering, developing and securing FDA approval for XPOVIO with its novel mechanism of action over the past decade required the dedication of many people, including the patients, caregivers and physicians involved in our clinical trials, along with the many employees at Karyopharm.  We are tremendously grateful for everyone’s contributions to this important milestone, and we look forward to the next stage in our pursuit of improving the lives of patients with cancer.”
EU approves Cemiplimab in advanced CSCC based on data from the registrational EMPOWER-CSCC-1 trial
“With no other medical treatments approved for advanced CSCC in the EU, Libtayo represents an important new option for patients affected with this advanced skin cancer who cannot be cured by surgery or radiation,” said Axel Hauschild, M.D., Ph.D., an investigator in the pivotal CSCC clinical program and Professor and Head of the Interdisciplinary Skin Cancer Center at the University Hospital Schleswig-Holstein in Kiel, Germany. “Results from the Libtayo pivotal trial are very encouraging and demonstrated substantial and durable responses following Libtayo treatment, including in the elderly and regardless of PD-L1 expression levels.”
Regulatory News
Unum Therapeutics' shares slide as FDA puts Ph I ATTCK-20-2 trial of ACTR087 on clinical hold
Hold was imposed after a patient experienced serious side effects (Gr 3 neurotoxicity and CMV infection, and Gr 4 respiratory distress). ACTR087 trial in question is running in CD20+ve R/R NHL patients. ACTR087 was at front of Unum’s pipeline; was however deprioritized last year. Drug seems to have historical safety issues as per some market analysts - latest reprioritization was a strong indication.
Ph III CanStem111P trial of napabucasin (plus weekly nab-paclitaxel with gemcitabine) versus weekly nab-paclitaxel with gemcitabine in mPDAC patients to be discontinued due to futility
“Pancreatic cancer is an area of high unmet need and our hope was to develop a new therapeutic option for patients. We are disappointed with the results of this interim analysis and would like to express gratitude to the trial participants, their families, investigators and staff for their efforts and contributions to this study,” said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. “Boston Biomedical and our parent company, Sumitomo Dainippon Pharma Co., Ltd., remain committed to CanStem303C, a phase 3 trial of napabucasin in metastatic colorectal cancer, and to oncology as a key priority for the organizations.”
Click Here for more Regulatory News
Onco-Trial Results
Interim analysis results from Ph III BEACON CRC trial announced; BRAFTOVI triplet inches closer to approval in approval in 2L-3L advanced BRAFV600E-mutant mCRC patients
"It's exciting to see the interim analysis results from the potentially practice-changing BEACON CRC trial, which demonstrated a significant improvement in outcomes compared to available standard of care options for patients with BRAFV600E-mutant metastatic colorectal cancer," said Scott Kopetz, M.D., Ph.D., FACP, Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. "These data add to the body of evidence supporting the BRAFTOVI Triplet as a potential new standard of care regimen for this patient population, who currently have limited treatment options available."
ESMO GI 2019: Puma Biotechnology presented interim results from the Biliary Tract cohort of Ph II SUMMIT basket trial of Neratinib
“Somatic HER2 mutations represent a distinct class of oncogenic driver mutations that appear to be clinically actionable for a subset of metastatic biliary tract cancers. A subset of cholangiocarcinoma and gallbladder cancer patients had tumor shrinkage or extended disease control suggesting anti-tumor activity in this rare population. These early findings in targeting HER2 in advanced bile duct cancers warrant further clinical and translational investigation.” said Dr. Harding.
Click Here for more Trial Results
Onco-Trial Status/Progress
Ph I/II trial of Telaglenastat initiated in combination with CDK4/6 inhibitor Palbociclib
“Preclinical data suggest that telaglenastat and palbociclib have synergistic activity in KRAS-mutated tumors, and may offer a new approach to the challenges associated with treating KRAS-mutated cancers,” said Susan Molineaux, Ph.D., president and chief executive officer of Calithera. “We are excited to launch this second clinical trial with Pfizer and are hopeful that the telaglenastat-palbociclib combination could fill a significant treatment gap for patients and medical professionals.”
Celyad presents update on autologous & allogeneic NKG2D-based CAR-T therapies in solid tumors
“We are encouraged by these initial results showing increased levels of cell engraftment of the non-gene edited allogeneic CAR-T candidate CYAD-101, and that following treatment with CYAD-101 we did not observe any evidence of graft versus host disease, our foremost concern with the  allogeneic therapy” commented Professor Dr. Eric Van Cutsem, Gastrointestinal Oncologist at the University Hospital of Leuven. “In addition, anti-tumor activity has been observed with both the autologous CYAD-01 and allogeneic CYAD-101 candidates, in heavily pre-treated metastatic colorectal cancer patients who have received prior FOLFOX chemotherapy, providing confidence into this potential combination approach of CAR-T therapy with standard-of-care chemotherapy.”
Click Here for more Progress/status of ongoing trials
Diagnostic Assays
Foundation Medicine expands indication for FoundationOne®CDx as a companion diagnostic for Olaparib
“Foundation Medicine is proud to receive FDA approval for another important companion diagnostic on FoundationOne CDx, our broad companion diagnostic test that is clinically and analytically validated for all solid tumors,” stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. “It is imperative that women with advanced ovarian cancer receive rigorous testing for BRCA1/2 mutations such as  FoundationOne CDx, which includes both germline and somatic mutations, to determine if they are a candidate for PARP inhibitors.”
MedNess Business
BioPharma and MedTech
Boehringer Ingelheim and Yuhan Corporation collaborate for next generation NASH treatment
Boehringer Ingelheim (BI) and Yuhan Corporation have signed an agreement for development and commercialization of Yuhan's first-in-class GLP1R/FGF21R dual agonist for the treatment of Nonalcoholic Steatohepatitis (NASH). According to the agreement, BI will pay upfront fees of $40M and the rest on success-based development and commercial milestones. The dual agonist has demonstrated high efficacy in preclinical trials and is expected to reduce liver cell injury and hepatic inflammation.  

About Boehringer Ingelheim:
Business: pharmaceuticals, biotechnology
Headquarter: Ingelheim, Germany
Founded 1885
Chairman of Board of Managing Directors: Hubertus von Baumbach
Net Sales (2018): €15.9B
Number of employees (2018): ~50,000
Job openings at BI
 
About Yunha Corporation
Business: pharmaceuticals, chemical
Headquarter: Seoul, South Korea
Founded 1926
CEO: Jung Hee Lee

Health management startup Livongo Health sets eye for $100M IPO
Livongo Health that started as diabetes management startup and diversified into other chronic diseases including hypertension, has filed for an IPO in a bid to raise up to $100M. Livongo had raised its $105M series E financing to develop its disease management platform and data science capabilities. Livongo along with five other companies had teamed up with Amazon to enable its voice assistant, Alexa, to develop a program to book doctors’ appointments. The funds raised are planned to use for “general corporate purposes, including working capital, operating expenses and capital expenditures”. 

About Livongo Health
Business: Digital Health
Headquarter: San Francisco Bay Area, USA
Founded 2014
CEO: Zane Burke
Job openings at Livongo
Amicus enters into strategic partnership with Thermo Fisher and Catalent to develop and manufacture its gene therapy
Amicus Therapeutics has entered into a strategic partnership with Brammer Bio, recently acquired by Thermo Fisher, and Paragon Gene Therapy, a unit of Catalent Biologics, for development and manufacturing of its gene therapy products. The partnership with Thermo Fisher will focus on clinical supply and commercial manufacturing of gene therapy for intrathecal adeno-associated virus (AAV) Batten disease program. The Paragon Gene Therapy collaboration will focus on AAV manufacturing and preclinical Pompe disease gene therapy program.
 
About Amicus Therapeutics:
Business: biotechnology
Headquarter: Cranbury, NJ, USA
Founded 2002
CEO: John Crowley
Net Sales (2018): $91.245M
Number of employees (2018): 508
Job openings at Amicus
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
Share Share
Tweet Tweet
Forward Forward
Subscribe
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.
Copyright © 2019 MedNess , All rights reserved.
You are receiving this MedNess Newsletter as a subscriber on the list.

Cover Image : Pixabay
Images : Twitter
Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
Our mailing address is:
MedNess
2160 Matthews Avenue 
Bronx 10462, NY 
NY

Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.