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MedNess: bite-size biopharma and medtech news

1st October, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals

FDA approves DARZALEX® (daratumumab) + Bortezomib, Thalidomide and Dexamethasone in 1L Multiple Myeloma patients
“Today’s approval is an important step forward for patients with multiple myeloma. There are now three different treatment combinations that include DARZALEX for patients newly diagnosed with multiple myeloma, whether they are eligible for ASCT or not. We are grateful for the efforts of the IMF, HOVON and Janssen that led to the strong data from the CASSIOPEIA trial, which formed the basis of this new approval,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Regulatory News
Innate Pharma and AstraZeneca to advance monalizumab into Ph III trial of monalizumab + cetuximab in mSCCHN patients
HIGHLIGHT: Monalizumab to be advanced to Ph III trial in head and neck cancer patients
“This is an important scientific milestone as we continue to invest in innovation and advance our late-stage clinical development pipeline,” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “Together with AstraZeneca, we are working diligently to progress this potential novel treatment for head and neck cancer patients, a population with a high unmet medical need.” 
“This positive CHMP opinion for Opdivo two and four-week dosing reinforces our commitment to offering flexible dosing options for patients, caregivers and healthcare providers,” said Ralu Vlad, Pharm.D, development team lead, product design and delivery, Bristol-Myers Squibb. “We look forward to the European Commission’s decision and potentially bringing this new Opdivo dosing regimen to patients as quickly as possible.”
FDA grants Rare Pediatric Disease Designation for OT101/Trabedersen for the treatment of diffuse intrinsic pontine glioma (DIPG)
HIGHLIGHT:
“We are excited about this Rare Pediatric Disease designation for our lead anti-brain tumor drug candidate for pediatric DIPG patients who are in urgent need for therapeutic innovations,” said Dr. Vuong Trieu, Chief Executive Officer of Mateon. “We will continue to build on our pipeline of therapeutics for rare and orphan diseases, including cancers.”
Trial Results
Clinical data presented from Ph I/II PIVOT-02 trial of Bempegaldesleukin (NKTR-214) + Nivolumab in mTNBC patients
"Among all the breast cancer types, triple-negative breast cancer has the poorest prognosis and new treatment options are needed for our patients," said Sara M. Tolaney, M.D., MPH, Associate Director of the Susan F. Smith Center for Women's Cancers at Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School. "While checkpoint inhibitors in combination with taxanes have been shown to provide survival benefit to advanced TNBC patients whose tumors are positive for PD-L1, more effective treatment combinations are needed, particularly for those patients whose tumors are PD-L1 negative."
Topline data analysis complete from Ph II MERECA trial of ilixadencel
“The purpose of the MERECA trial was to gain the first set of comparative data on what effect ilixadencel has on patients when combined with a standard treatment. The results indicate that ilixadencel benefits patients by clearing tumors at a higher rate and for a longer time than sunitinib alone,” commented Carlos de Sousa, CEO of Immunicum. “The results support the continued clinical development of ilixadencel for the benefit of cancer patients, and we look forward to starting the preparations for the pivotal study in RCC.”
Click Here for more Trial Results
Trial Status/Progress
Pivotal stage of Ph II TYME-88-PANC trial launched to evaluate SM-88 in 3L metastatic pancreatic cancer patients
"We believe that targeting cancer’s metabolism by disrupting protein synthesis has advantages over existing treatment approaches for both efficacy and safety," said Giuseppe Del Priore, M.D., Chief Medical Officer at TYME. "In clinical studies to date, SM-88 had encouraging efficacy results and appears to be well-tolerated. The pancreatic phase II data demonstrated that new efficacy indicators, including achieving at least stable disease and decreasing circulating tumor cells following treatment with SM-88 correlate with greater overall survival in metastatic pancreatic cancer patients."
Dose-escalation milestones achieved in ongoing Ph I/II Ewing Sarcoma and Ph I advanced solid tumor clinical trials of Seclidemstat
HIGHLIGHT:
David Arthur, President and Chief Executive Officer of Salarius, stated, “Clearance from the Safety Review Committees to proceed to the higher dosing cohort is an important milestone in the ongoing clinical trials. Ultimately, our goal with these studies is to pinpoint the optimal dose of Seclidemstat, which, in addition to determining the safety parameters of the drug, will enable us to obtain key pharmacokinetic information and, potentially, initial efficacy data.  Based on current projections we are on track to reach maximum tolerated dose early next year and report early patient data from both studies in 2020.”
Click Here for more Trial Status/Progress
Conference Coverage
ESMO 2019 Abstracts
  1. AstraZeneca to present data from Ph III FLAURA, PAOLA-1, PROfound, CASPIAN, PACIFIC and ASTRIC trials
  2. AstraZeneca and Merck announced detailed mPFS improvement from Ph III PAOLA-1 trial of Lynparza (olaparib) in 1L maintenance in ovarian cancer patients
  3. AstraZeneca presented detailed OS results from Ph III FLAURA trial of Tagrisso (osimertinib) in 1L EGFR-mutated NSCLC patients
  4. BMS to present OS data from CheckMate-227; 5-year survival data from CheckMate-067 along with updates from CheckMate-238/-459/-358 and ATTRACTION-3 trials
  5. Pfizer to present clinical updates from several trials including Ph III BEACON CRC, JAVELIN Renal 101 and POLARIS trials
  6. Pfizer to present four IBRANCE® (palbociclib) real-world analyses in HR+ HER2neg metastatic breast cancer patients
  7. Amgen to present clinical updates from the trials of AMG 510, AMG 160, talimogene laherparepvec (T-VEC), denosumab and panitumumab
  8. Seattle Genetics to present updates from MOUNTAINEER trial and from trials of enfortumab vedotin and tisotumab vedotin
  9. Cellectar Biosciences to present updates from CLR 131 R/R DLBCL patients
  10. Immunomedics presents interim data from Ph II TROPHY-U-01 trial of Sacituzumab-Govitecan in metastatic urothelial cancer
Click Here for more on ESMO-2019 updates
MedNess Business
Onco-News

Clovis Oncology licences 3B Pharmaceuticals’ FAP-radiotherapy program for cancer treatment
Clovis has entered into an agreement to license 3BP’s imaging agent targeting fibroblast activation protein alpha (FAP) and to develop peptide-based radionuclide therapy. FAP is highly expressed in various tumors types including epithelial, lung, breast, pancreatic and colorectal cancers. According to the agreement, Clovis will pay $12 million upfront with additional milestone based payments, and will have the rights to conduct global clinical trials excluding Europe (inclusive of Russia, Turkey and Israel), where 3BP retains the right.
BioPharma and MedTech

Deerfield Management invests $635 million to create life science campus in New York City
Deerfield Management is set to invest in real estate dedicated for life science research at 345 Park Avenue in Manhattan. The total investment of $635 million is paced to create a 300,000 sq. ft. life science campus called NYCLifeSci to being together researchers, entrepreneurs and leading organizations to develop therapeutics for treating diseases. The campus that follows the league of Alexandria Center for Life Science, is being backed by the New York City Development Corporation and the Industrial Development Agency to create facilities to boost New York's Biotech scene. The campus is expected to create 1,400 jobs life science jobs.

Beam Therapeutics plans to raise $100 million in IPO
The gene-editing company Beam Therapeutics is set to raise $100 million through IPO. The funds raised are planned for executing IND-enabling studies along with pre-clinical and clinical trials of various programs. The base-editing approach uses a chemical reaction to create a precise base change at targeted DNA sequence. Beam is currently focusing on its lead optimization programs in cancer and blood disorders including acute myeloid leukemia, acute lymphoblastic leukemia, beta thalassemia and sickle cell anemia. Other less advanced programs of Beam include liver diseases, ocular and brain disorders.
Click Here for more business news and job openings in the featured companies
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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