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MedNess: bite-size biopharma and medtech news

24th September, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals

FDA approves ERLEADA (apalutamide) for mCSPC patients based on results from Ph III TITAN trial
"Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that androgen deprivation therapy (ADT) alone, is often not enough," said Dr. Kim Chi, Medical Oncologist at BC Cancer - Vancouver and principal investigator of the TITAN study. "Results from the TITAN study showed that, regardless of the extent of disease, patients with metastatic castration-sensitive prostate cancer have the potential to benefit from treatment with apalutamide in addition to ADT."
FDA approves KEYTRUDA (pembrolizumab) + LENVIMA (lenvatinib) combination for MSS or pMMR endometrial carcinoma patients based on Ph II KEYNOTE-146/Study 111 trial data
“Today’s approval of the KEYTRUDA plus LENVIMA combination for advanced endometrial carcinoma that has progressed following prior systemic therapy brings the first approved combination treatment to women with this type of cancer whose tumors are not MSI-H or dMMR and who are not candidates for curative surgery or radiation, and demonstrates the potential of our collaboration with Eisai,” said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories. “Merck is committed to developing this combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program, which is under active investigation.”
Regulatory News
Committee for Medicinal Products for Human Use (CHMP) recommends gilteritinib (in FLT3+ R/R AML) along with other drugs in recent meeting
CHMP recommends gilteritinib in FLT3+ R/R AML; arsenic trioxide in acute promyelocytic leukaemia (APL); bortezomib in MCL and MM; clofarabine in acute lymphoblastic leukaemia in paediatric patients; avelumab + axitinib in 1L RCC and docetaxel (Zentiva) + androgen-deprivation therapy (ADT), with or without prednisone or prednisolone for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) patients.
Trial Results
Phase III IMpower110 trial of Tecentriq (atezolizumab) + chemotherapy (cisplatin / carboplatin and pemetrexed / gemcitabine) in 1L PD-L1+ve ALK/EGFR WT NSCLC patients met primary endpoint of OS benefit
“We are encouraged that Tecentriq monotherapy has shown a significant survival benefit over chemotherapy as an initial treatment in people with squamous or non-squamous non-small cell lung cancer with high PD-L1 expression,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “These findings reinforce the potential of Tecentriq to play an important role in the treatment of multiple forms of lung cancer, and we look forward to discussing these data with health authorities.”
New DARZALEX (daratumumab) data from GRIFFIN trial shows high response rate and depth of response in 1L transplant-eligible multiple myeloma patients
"This primary analysis of the GRIFFIN study builds on the safety and efficacy data in the initial group of 16 patients presented at the 2018 American Society of Hematology Annual Meeting," said Andree Amelsberg, M.D., MBA, Vice President, Oncology Medical Affairs, Janssen Biotech, Inc. "It provides further support for evaluation of DARZALEX® in the transplant-eligible patient population, which is important as we continue our work to discover new therapeutic approaches to improve outcomes for patients."
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Trial Status/Progress
Ph Ib trial of Onvansertib in AML completed; patient enrollment initiated in Ph II
"Initiation of our Phase 2 trial in AML is a significant step forward in the development of onvansertib for the treatment of AML," said Thomas Adams, PhD, Chief Executive Officer and Chairman of Trovagene. "We are very pleased by the safety and clinical activity observed with onvansertib in combination with standard-of-care chemotherapy in patients with relapsed or refractory AML, where there remains a significant need for new effective treatment options. Our Phase 2 trial will focus on patients who are showing resistance to first-line treatment, including venetoclax. Our preclinical data showed anti-tumor activity of onvansertib in a venetoclax-resistant AML xenograft model, suggesting its potential to provide a new and effective treatment option for these patients." 
Click Here for more Trial Status/Progress
Conference Coverage
  1. AstraZeneca to present data from Ph III FLAURA, PAOLA-1, PROfound, CASPIAN, PACIFIC and ASTRIC trials
  2. 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
  3. Pfizer to present clinical updates from several trials including Ph III BEACON CRC, JAVELIN Renal 101 and POLARIS trials
  4. Amgen to present clinical updates from the trials of AMG 510, AMG 160, talimogene laherparepvec (T-VEC), denosumab and panitumumab
  5. Seattle Genetics to present updates from MOUNTAINEER trial and from trials of enfortumab vedotin and tisotumab vedotin
  6. Cellectar Biosciences to present updates from CLR 131 R/R DLBCL patients
MedNess Plus
FDA grants Breakthrough Therapy Designation for Gazvya (obinutuzumab) for the treatment of adults with lupus nephritis
FDA recently granted a Breakthrough Therapy Designation to Gazvya (obinutuzumab) for the treatment of lupus nephritis in adult patients.
“New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase III trial next year.”
FDA grants Priority Review and approves Biologics License Application (BLA) for an investigational vaccine for Ebola Zaire virus
FDA recently granted priority review and accepted the Biologics License Application (BLA) for an investigational Ebola vaccine (V920).
“Merck has worked with government partners and the global health community to accelerate development of our investigational V920 Ebola vaccine. FDA’s priority review designation to underscores our long-standing partnership with the U.S. government toward its development and licensure,” Dr. Paula Annunziato, VP, Merck Research Laboratories. “A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site, so that licensed supply can be produced over time to support global public health preparedness and health security objectives. We look forward to continuing to work with the FDA throughout the review process.” ” We continue to be proud and humbled to provide our investigational V920 Ebola vaccine as an additional tool in support of the comprehensive public health response efforts against the current Ebola outbreak. Merck appreciated and continues to work closely with our collaborators and is inspired by the relentless determination of everyone involved, especially frontiers responders, working to contain this unique and dangerous outbreak,” Dr. Annunziato added.
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MedNess Business
Onco-News

Boundless Bio raises $46 million in series A targeting extrachromosomal DNA for difficult-to-treat cancer

Boundless Bio has raised $46 million in series A financing round focusing on cancer treatment by targeting extrachromosomal DNA (ecDNA). ecDNA are circular DNA molecules located outside the chromosomes and are associated with high frequency in almost half of solid tumors. They are thought to be the key drivers of aggressive cancers. With excellent scientific founders, Boundless Bio is leveraging on their expertise to build technology for identifying and characterizing ecDNA-driven tumors, and developing targeted treatments for solid tumors. The financing round was co-led by ARCH Venture Partners and City Hill Ventures in partnership with Vertex Ventures, GT Healthcare Capital Partners, Boxer Capital of the Tavistock Group, Alexandria Venture Investments and more.
Jobs at Boundless Bio

OSE Immunotherapeutics receives €5.4 million from Bpifrance as milestone payment
OSE Immunotherapeutics received its first milestone payment of €5.4 million from Bpifrance for the development of SIRPα-antagonist mAb BI 765063 related to its collaborative EFFI-CLIN ‘Invest in the Future’ program. OSE was able to achieve multiple objectives including characterization of the SIRPα/CD47 axis and determination of preclinical efficacy, completion of regulatory preclinical toxicology studies, manufacturing of GMP complaint batches and development of tools for immune profile and biomarker assessment. The mAb BI 765063 therpay is being developed in partnership with Boehringer Ingelheim and is currently in clinical phase 1 for advanced solid tumors. 

Tonix Pharmaceuticals and Columbia University enter into a licensing agreement for development of TNX-1700 for gastric and pancreatic cancer

Tonix Pharmaceutics and Columbia University announced an exclusive licensing agreement for the development of recombinant Trefoil Family Factor 2 (rTFF2), or TNX-1700 targeted towards treatment of gastric and pancreatic cancers. TNX-1700 is currently in preclinical development stage, which was developed, in part, by Dr. Timothy C. Wang, Chief, Division of Digestive and Liver Diseases, and Director of the Gastrointestinal and Pancreas Cancer Program and Tumor Biology and Microenvironment (TBM) program in the Herbert Irving Cancer Center at Columbia University. Tonix is a clinical stage biopharmaceutical company with multiple clinical stage programs focusing on psychiatric disorders, pain and addiction, and preclinical stage programs to improve biodefense and prevent organ transplantation rejection.
BioPharma and MedTech

Ginkgo Bioworks raises $290 million in series E financing to expand its cell programming platform
Boston-based Ginkgo Bioworks has raised $290 million in series E financing round bringing the total amount of money raised to $719 million. The company uses organism biology to grow products instead of manufacturing them thereby bringing biotechnology into consumer goods market. Ginkgo intends to use the funds for expansion of its cell programming platform to use biology effectively for synthesis of scalable products.
Jobs at Ginkgo
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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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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