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MedNess: bite-size biopharma and medtech news

15th October, 2019
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MedNess This Week

HIGHLIGHTS
Regulatory News
FDA Fast Track Designation granted to Navicixizumab for the treatment of heavily pretreated ovarian cancer
“We are pleased that the FDA continues to recognize the potential of navicixizumab to become a viable new treatment option for patients with platinum-resistant ovarian cancer who failed multiple other therapies,” said Jill Henrich, Senior Vice President of Regulatory Affairs at Mereo BioPharma. “This designation follows our successful Type B End of Phase 1 meeting with the FDA held in July 2019 regarding a potential pathway for accelerated approval for navicixizumab where the FDA agreed in principle on an outline for a Phase 2 clinical trial that could potentially support accelerated approval of navicixizumab in patients with ovarian cancer who have become resistant to prior therapies.”
NICE recommends access to rucaparib for women with relapsed ovarian cancer in England through the Cancer Drugs Fund (CDF)
"Ovacome welcomes the availability of rucaparib via the CDF as an option for maintenance treatment of platinum-sensitive relapsed high grade serous epithelial ovarian cancer regardless of BRCA status or line of treatment in the relapsed maintenance setting,” said Victoria Clare, CEO of Ovacome, a United Kingdom ovarian cancer charity focused on providing support to anyone affected by ovarian cancer. “It is vital that the expansion of available maintenance options continues as maintenance treatments extend the time between chemotherapies. Many women with relapsed ovarian cancer know that they are facing a future of managing their disease as a chronic illness.”
Trial Results
Updated prolonged survival data announced in Ph I/II ADXS-PSA trial
“We are excited to report these updated data which show a meaningful increase in median overall survival for patients in the combination arm of the KEYNOTE-046 study,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “We believe that ADXS-PSA in combination with KEYTRUDA ® has the potential to be an important new treatment option for patients with advanced metastatic, castration-resistant prostate cancer, which based on these data, warrants further evaluation. We are currently assessing next steps for a potential new study for ADXS-PSA in combination with KEYTRUDA ® in mCRPC and we look forward to providing additional details about the program’s path forward.”
Encouraging Ph Ib study data of AN0025 (an oral EP4 antagonist) for locally advanced rectal cancer announced
“There is a tremendous need for new treatment strategies in rectal cancer, especially in patients with high-risk of relapse enrolled in this study. With nearly 40% of patients not requiring surgery or achieving a complete pathological response in the post-surgical specimen in this study, AN0025 in combination with the standard pre-operative treatment warrants further development. The excellent toxicity profile of this novel immunotherapy and potential combination with both conventionally fractionated radiochemotherapy or short course irradiation with consolidating chemotherapy make this strategy feasible worldwide.” said lead author Dr. Lucjan Wyrwicz, MD, PhD, Department of Oncology and Radiotherapy, M. Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland.
CYRAMZA® (ramucirumab) Ph III data in 1L EGFR-mutated NSCLC published in The Lancet Oncology
"The findings from RELAY show the utility of targeting the VEGFR and EGFR pathways together in this setting, and validate previous non-clinical and clinical studies which demonstrated interactions between EGFR and VEGFR2 signaling in the setting of EGFR mutations," said Kazuhiko Nakagawa, M.D., Department of Medical Oncology, Kindai University Faculty of Medicine, and global lead principal investigator of the RELAY trial.
Trial Status/Progress
Milestone of 100-patient enrollment reached in pivotal Ph III trial (AVENGER 500) of CPI-613®️ (devimistat) for metastatic pancreatic cancer patients
“Enrolling 100 patients in our pancreatic cancer clinical trial is an important milestone for Rafael,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “Pancreatic cancer is one of the deadliest cancers in the world and patients with metastatic pancreatic cancer, specifically, have a very low five-year survival rate of 3%. Reaching this milestone reflects our mission of improving the odds for patients with unmet medical needs, and is a major step towards the ultimate goal of enrolling 500 patients to the trial. We would like to extend our sincere gratitude to all the patients and doctors who have participated in the trail so far.”
 
First patient enrolled in Ph II trial of Defibrotide for the prevention of CAR-T associated neurotoxicity
"The introduction of CAR-T therapies to the oncology treatment landscape is groundbreaking but can be associated with serious complications such as neurotoxicity," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "At Jazz, we strive to improve outcomes for patients, and we are committed through our development program to explore the potential of defibrotide, including as a preventative treatment for neurotoxicity in patients receiving CAR-T therapy."
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MedNess Business
Onco-News

Innovent and Chi-Med to evaluate the combination of Sintilimab and Surufatinib in solid tumors
"Sintilimab, co-developed by Innovent and Eli Lilly and Company, has gained broad recognition by the market, due to its profiles in safety and efficacy. Through partnership with other companies, we are exploring more sintilimab-based combination therapies. We already saw some promising results out of such combinations," said Dr. Michael Yu, Chairman and Chief Executive Officer of Innovent. "We are excited to further collaborate with Chi-Med to develop the combination therapy of sintilimab and surufatinib, hoping more patients will benefit from this potential therapy globally."
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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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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