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MedNess: bite-size biopharma and medtech news

18th September, 2019
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MedNess This Week

HIGHLIGHTS
I-Cube with Visikol Inc. 

(L-R) – Dr. Michael Johnson, Nick Crider, Dr. Tom Villani, Dr. Graeme Gardner, Dr. Erin Edwards, and Alex Magsam)

In conversation with Tom Villani, the Chief Scientific Officer of Visikol Inc.

In our very first edition of I-Cube we are pleased to feature Visikol Inc., a New Jersey based company that specialises in imaging and image analysis technologies. Starting out as a product-based company offering unique tissue clearing reagents to expanding capabilities to become a contract research organization offering several in-vitro assay and imaging services, the journey of Visikol has been both interesting and extremely innovative.
Read on to learn more about this interesting journey...

Visikol HISTO Owl Brain Imaging

Whole brain connectomics can be executed through the use of tissue clearing combined with immunofluorescent labeling using 
Regulatory News
 FDA grants Breakthrough Therapy Designation to Tepotinib in mNSCLC patients with METex14 skipping alterations

**The information contained is not intended for distribution in the USA, Canada or the UK and non-accessibility to MedNess readers within these geographical areas is not intentional**

“Tepotinib was associated with robust objective responses with durability that has not previously been seen in patients with metastatic NSCLC harboring MET exon 14 skipping alterations, selected by either tissue or liquid biopsy approaches,” said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. “This breakthrough therapy designation further underscores the potential of tepotinib, and we aim to advance this program and deliver this medicine as quickly as possible to NSCLC patients who may benefit.”
sNDA for neratinib + capecitabine combination in 3L HER2+ve breast cancer patients accepted by FDA; action date: Apr 2020
“The FDA’s acceptance of our sNDA marks another important regulatory milestone for my team,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “We look forward to working with the FDA during its review of this submission, which targets patients with HER2-positive metastatic breast cancer who have progressed on two or more prior treatments and who need additional treatment options.”
Trial Results
FAILED TRIAL: Toca 5 trial of Toca 511 + Toca FC failed to meet primary and secondary endpoints in relapsed high grade glioma (HGG) patients
"Recurrent brain cancer represents a very high unmet medical need and patients with this disease have very few treatment options," said Marty Duvall, chief executive officer of Tocagen. "While the Toca 5 trial results are disappointing, we will be conducting a thorough analysis of the data including molecular analyses and pre-planned subgroups. In addition, we will be conducting an operational review. We sincerely appreciate the exceptional support from patients and their families as well as patient advocates, physicians and our employees who have been committed to the rigorous study of Toca 511 & Toca FC in the Toca 5 trial."
Ph III CANDOR trial of KYPROLIS (carfilzomib) and DARZALEX (daratumumab) met primary endpoint of PFS improvement
"The potential to combine KYPROLIS with DARZALEX, two powerful targeted agents, represents an additional therapeutic approach for patients with relapsed or refractory multiple myeloma," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The results from the CANDOR study confirm the potential for KYPROLIS to be used in combination with an anti-CD38 monoclonal antibody."
Click Here for more Trial Results and Status/Progress
MedNess Business
Onco-News
KAHR Medical collaborates with Roche for clinical trial for patients with advanced lung cancer
KAHR Medical, an Israel-based biopharmaceutical company, announced a clinical collaboration with Roche to develop its lead program DSP107 targeting patients with Non-Small Cell Lung Carcinoma (NSCLC). The program explores a combination therapy of DSP107, a SIRPα-41BBL Dual Signaling Protein, in combination with Roche’s PD-L1 blocking checkpoint inhibitor atezolizumab (Tecentriq). The IND filing with FDA is expected in H1/2020 for Phase I/II clinical study with DSP107 as monotherapy or in combination with atezolizumab.
Jobs at Roche

VBI Vaccines and GSK collaborate for clinical study for recurrent glioblastoma patients
VBI vaccines and GSK have announced a collaboration to conduct Phase 2a clinical study for recurrent glioblastoma (GBM). The study will evaluate combination of VBI-1901, VBI’s cancer vaccine, with GSK’s AS01B adjuvant system focusing on recurrent GBM patients. This combinatorial study will be carried out as additional study arm for VBI’s ongoing Phase 1/2a clinical study of VBI-1901. GBM is a cytomegalovirus (CMV)-associated brain tumor with 12,000 new cases diagnosed every year is USA alone.
Jobs at VBI
Jobs at GSK
BioPharma and MedTech

Lundbeck acquires Alder BioPharmaceuticals for $1.95 billion to tackle migraine
Lundbeck has announced the acquisition of Alder BioPharma for $1.95 billion to expand their brain disease portfolio with Adler’s eptinezumab, an intravenous therapy for migraine prevention. Eptinezumab is an investigational monoclonal antibody that targets calcitonin gene related peptide (CGRP). According to the agreement, Lundbeck will make an upfront payment of $18 per share in cash, with an additional $2 per share upon approval of eptinezumab by EMA. If approved by FDA in February 2020, eptinezumab will become the first intravenous CGRP drug into the market. Lundbeck intends to use its effective organization across 56 countries to launch eptinezumab worldwide.
Jobs at Lundbeck

Insilico Medicine raises $37 million in series B for AI-based drug discovery
Insilico Medicine, an AI-based drug design company, has raised $37 million in series B financing round focusing on shortening the time for drug discovery. The company was able to conceptualize 30,000 novel small molecule inhibitor against discoidin domain receptor (DDR1), a kinase target implicated in fibrosis in 21 days. Over the next 25 days, six lead compounds were synthesized and validated in vitro and one compound was tested in mouse model with favorable activity.  The study published in Nature Biotechnology demonstrated the use of machine learning in shortening the time from hit-to-lead during the drug development process. Qiming Venture Partners led the investment with participation from Eight Roads, Lily Asia Ventures, BOLD Capital Partners, F-Prime Capital, Sinovation Ventures, Baidu Ventures, Pavilion Capital and Juvenescence.
Jobs at Insilico
Click Here for more collaborations, acquisitions, mergers and licensing...
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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Disclaimer
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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