View this email in your browser

MedNess: bite-size biopharma and medtech news

10th March, 2020
Subscribe here
MedNess This Week
HIGHLIGHTS
Our Sponsors
Regulatory News
BLA accepted; Priority Review granted for Tafasitamab and Lenalidomide for the Treatment of R/R DLBCL
"We are extremely pleased that the FDA has accepted filing of our application and granted priority review, as we believe that the combination of tafasitamab and lenalidomide may provide an additional treatment option for patients suffering from DLBCL, who have relapsed after or are refractory to the current standard of care," said Dr. Malte Peters, Chief Development Officer of MorphoSys. "We would like to thank all patients participating in our clinical studies and we will continue to work relentlessly towards making tafasitamab available to patients."
Fast Track Designation for Tipifarnib in T-Cell Lymphomas
“This important designation from the FDA comes just two months after tipifarnib was awarded Fast Track for the treatment of patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC),” said Bridget Martell, M.A., M.D., Acting Chief Medical Officer of Kura Oncology. “We believe that this designation reflects tipifarnib’s significant potential in these devastating disease settings, and we are now actively preparing to initiate a second registration-directed trial of tipifarnib in advanced nodal lymphomas of TFH phenotype, including AITL.”
Click Here for more Regulatory News
Trial Results
FAILED TRIAL:  Ph 3 DANUBE trial for Imfinzi (durvalumab) +/- tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoint of OS improvement in high PD-L1 expressing patients, or for Imfinzi + tremelimumab in all comer patients
José Baselga, Executive Vice President, Oncology R&D, said: “AstraZeneca remains committed to addressing unmet needs in bladder cancer and the potential for immunotherapy to improve outcomes for these patients. The results from this trial will inform our comprehensive Phase III development programme in bladder cancer. We look forward to the results of the Phase III NILE trial also in the 1st-line metastatic setting, and we continue to advance clinical trials for patients at earlier stages of the disease.”
Update OS data from Part A of Ph 1/2a Study of VBI-1901 Vaccine Responders in Recurrent GBM Patients announced
“We remain encouraged by the data from this ongoing Phase 1/2a study of VBI-1901 in the recurrent GBM setting, a setting in which it has historically been incredibly difficult to show any benefit, especially with a monotherapy,” said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. “The standard of care treatment in the recurrent GBM setting is not well defined, however, commonly-used regimens, including chemotherapy and VEGF-A inhibitors as monotherapy and in combination, have demonstrated 12-month OS rates below 50% with median OS around 8 to 12 months1. Moreover, these regimens often cause significant toxicity, poorly affecting quality of life for the individual. While the data generated for VBI-1901 is early, we continue to be optimistic as we work hard to provide any meaningful benefit to patients who currently have few treatment options.”
Brain Cancer Patient from Berubicin Phase 1 Trial Remains Cancer Free
"We are delighted to provide this update on Berubicin's potential capabilities given the unmet need for this aggressive disease," commented John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals.  "We are looking forward to initiating our Phase 2 clinical trial in the second half of this year with our partner, WPD Pharmaceuticals, Inc. In addition, we expect WPD Pharmaceuticals, Inc. to commence a first-ever Phase 1 trial in children later this year. As previously announced, the pediatric trial will be conducted at Children's Memorial Health Institute, the largest pediatric hospital in Poland." WPD Pharmaceuticals, Inc. was founded by Dr. Waldemar Priebe, the founder of the Company. 
Trial/Program Status
Over 50% Enrollment Reported in Ph 2 Trial of VAL-083 For Adjuvant Treatment of Brain Tumors
"The pace of enrollment for the adjuvant arm of the study has been very encouraging and we hope to see both that arm, and the recurrent arm continue to enroll patients steadily. We will continue to provide updates as they become available," commented Saiid Zarrabian, DelMar's Chief Executive Officer. "In the meantime, having completed enrollment of our first-line study, we continue to anticipate an initial data readout before the end of August 2020."
Ph I trial of Debio0123 in combination with carboplatin to treat refractory solid tumors initiated
“This clinical phase of Debio 0123 is highly anticipated in light of the therapeutic potential of the molecule. Pre-clinical research results suggest that this potent WEE-1 inhibitor has the potential to show activity in cancer patients, particularly in combination with DNA damaging treatments, such as chemo- and radiation-therapies.” – Angela Zubel, Chief Development Officer, Debiopharm.
Patient enrollment completed in Ph 3 ILLUMINATE-301 trial of tilsotolimod in combination with ipilimumab in patients with anti-PD-1 refractory advanced melanoma
“We are making outstanding progress in moving toward our goal of delivering tilsotolimod to the market in our lead indication for anti-PD-1 refractory advanced melanoma patients,” stated Vincent Milano, Idera’s Chief Executive Officer. “We achieved this critical milestone earlier than anticipated, which we believe is truly a testament to the high unmet need facing these patients.”
Collated by : Richa Tewari, PhD
Medness @ HealthIT

Color vs. Cancer: AI gets smarter
Genetic and racial disparity can be a major factor in determining the course and recurrence of cancer. However, AI algorithms, built on the data from majority of patient population may not be able to see the minute variations and therefore predict incorrectly for minority populations. Researchers at Case Western Reserve University investigating prostate cancer have previously identified specific cellular and stromal features in tumors that can be taught to the AI in order to predict patient-response to chemotherapy, immunotherapy, and potential cancer recurrence. Interestingly, minute cellular distinctions exist between black and white patients which could not be distinguished by the AI, since it is build from data from the majority of the group. The study that has been published in the esteemed journal Clinical Cancer Research, strives to rectify the program to include features of the minority population within the database used by the AI, so that it can become more efficient in predicting risk factors. In other words, feeding more specific information to the AI can make it go more generalized in accuracy. The full story can be found here.

Preventive Genomics: Not so futuristic anymore
A new initiative by Massachusetts General Hospital (MGH) is to launch a Preventive Genomics Clinic that will help advance precision medicine and preventive care by leveraging genetic information. The new clinic will work with the primary care practices at MGH to help patients better understand, prevent, and predict disease. Main reasons for referral to the clinic? It may range from requests for interpretation of an existing genetic test result to concern about family history of disease. Moreover, there is always an interest in learning about the risks and benefits of testing while still asymptomatic. The main process follows the sequence of: 1) Patients meeting with a genetic counselor and physician to gather personal and family history information, 2) If patients consent to proceed with genetic testing, the team reviews testing options, and lastly, 3) Team works with the patient’s health insurance to determine whether it would be covered, and subsequently builds a treatment plan based on test results. The full story can be found here.
Collated by :  Debarati Banik
Medness Business
Onco-News
MorphoSys and Incyte Announce Antitrust Clearance of Global Collaboration and License Agreement for Tafasitamab
  • MorphoSys AG and Incyte’s license agreement and joint collaboration regarding development and global commercialization of tafasitamab (MOR208) became effective by receiving antitrust clearance earlier this week.
  • This event triggers the $750 million upfront payment by Incyte to MorphoSys in addition to Incyte's equity investment into MorphoSys of $150 million in new American Depositary Shares (ADS) within the defined timelines.
Voluntis and Bristol-Myers Squibb to Co-Develop Digital Therapeutics For Oncology
Pierre Leurent, CEO of Voluntis: “Bristol-Myers Squibb is a leading innovator in oncology. We are delighted to join forces with their talented teams to work on digital therapeutics that could have a significant impact on the treatment experience for patients worldwide. This collaboration is a recognition of our unique know-how and technology, as well as an important opportunity to bring it to scale in oncology.” 
Collated by : Richa Tewari, PhD
BioPharma and MedTech

Merck shows robust performance in the Multiple Sclerosis market with its repurposed drug MAVENCLAD
“Most current MS treatments rely on continuous administration with continuous imunosuppression, which is linked to a number of risks and a high-monitoring burden. However, MAVENCLAD® does not continuously suppress the immune system. Rather it selectively affects the adaptive immune system, while having a minimal effect on innate immune function”, said Dr. Luciano Rosetti (Global Head of R&D at Merck KGaA) in an interview to Future Medicine

Abbvie-Allergan merger clears hurdles towards European Commission’s approval 
Since Abbvie’s announcement of acquiring Allergan in a $63 billion deal last year, the merger of the companies is pending approval with US regulatory authorities. However, as of March 2020, the merger has the European Commision’s approval after the company off-loaded 3 of Allergan’s drugs, clearing anti-trust laws. The main divesture is Allergan’s Brazikumab, an IL-23 inhibitor currently under testing for Crohn’s disease and ulcerative colitis. Brazikumab has significant overlap with Abbvie’s IL-23 inhibitor Skryzi, which has performed well in Phase 3 trial for psoriasis. Brazikumab is sold to AstraZeneca. The other 2 drugs, Zenpep and Viokace (pancreatic replacement enzymes) have been sold to Nestle. The amounts of the divestures are as yet undisclosed. This merger positions Abbvie as the 4th largest global drug manufacturer, with blockbusters like Skryizi (psoriasis, $216 million 2019 sales), Rinvoq (rheumatoid arthritis, $33 million 2019 sales), Botox (aesthetic medication, $271.8 million 2019 sales) and Vraylar (antipsychotic, $234.6 million 2019 sales) in its portfolio.
Click Here for more on acquisitions and mergers
Collated by :  Divyaanka Iyer
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Debarati Banik
HealthIT
Divyaanka Iyer
MedNess Reviews
Nisha Peter, PhD
Managing Editor
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting Editor
Ananda Ghosh, PhD
Founder
Share Share
Tweet Tweet
Forward Forward
Subscribe
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.
Copyright © 2019 MedNess , All rights reserved.
You are receiving this MedNess Newsletter as a subscriber on the list.

Cover Image : Pixabay
Images : Twitter , Unsplash.com
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.