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MedNess: bite-size biopharma and medtech news

8th October, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals

Pembrolizumab receives NMPA approval as monotherapy in China for 1L PD-L1+ve NSCLC patients
“New treatment options that can help improve survival outcomes are desperately needed in China, as lung cancer remains the leading cause of cancer deaths in this country,” said Professor Yi-Long Wu, honorary director of the Guangdong Lung Cancer Research Institute, and tenured professor of Guangdong Provincial People’s Hospital. “In KEYNOTE-042, KEYTRUDA monotherapy demonstrated a survival benefit, compared with chemotherapy alone, across histologies in patients with either locally advanced or metastatic non-small cell lung cancer whose tumors expressed PD-L1 in at least 1% of tumor cells.”
Regulatory News
Niraparib receives Breakthrough Therapy Designation in previously treated mCRPC patients
  • Designation granted on the basis of Ph II GALAHAD trial results (recently presented in ESMO - 2019 meeting)
  • With this designation, Niraparib seems to have an edge over other PARP inhibitors in the race
  • Niraparib also being tested in 1L mCRPC patients in combination with abiraterone and prednisone in Ph III MAGNITUDE trial
  • Other PARP inhibitors in race are: Olaparib (in combination with Pembrolizumab in Ph Ib/II KEYNOTE-365 trial), Rucaparib in TRITON-2 trial (and with a BTD in BRCA1/2-mutated mCRPC patients, too) and Talazoparib in Ph II TALAPRO-1 trial
  • PROfound and TRITON-3 trials, on the other hand, are exploring the efficacy of PARP inhibitors in pre-chemo settings
“Receiving orphan drug designation for T-Cell Lymphoma, in addition to the previously-granted Fast Track status, for Peripheral T-Cell lymphoma, marks another important regulatory milestone to bring COPIKTRA to patients who are faced with this aggressive type of disease with limited therapeutic options,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “We look forward to sharing the results of our Phase 2 PRIMO study and efficiently advancing our development program in this indication.”
Fast Track Designation granted to Imetelstat for Relapsed/Refractory Myelofibrosis
  • FTD granted to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment, or R/R MF
  • FTD includes patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera
  • End of Phase 2 meeting with the FDA planned by the end of the first quarter of 2020 to determine if there is a regulatory path forward for imetelstat in R/R MF
Trial Results
Rivoceranib (apatinib) fails to meet primary endpoint of OS improvement in Ph III ANGEL trial in 3L+ gastric or GEJ patients
“This study demonstrates the potential of rivoceranib to treat patients with late-stage gastric cancer,” said Dr. Steven Norton, Elevar Therapeutics’ Vice President of Clinical Development, “this is the first multinational phase 3 study after rivoceranib’s approval in China. We look forward to further analyzing the data and believe that it will support our planned regulatory submissions.”
Encouraging OS results and safety profile announced in Ph II TYME-88-Panc trial of SM-88 (racemetyrosine) monotherapy in advanced pancreatic cancer patients
“Given that there are no effective options to treat this poor prognostic patient population, we recently launched our SM-88 pivotal trial for patients with third-line pancreatic cancer. We are increasingly encouraged that SM-88 has the efficacy, safety and quality of life potential to be a new treatment approach for late-stage pancreatic patients,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. “Assessing the potential of emerging biomarkers, such as the evaluation of circulating tumor cells for predicting the outcome and the response to specific investigational medicines, such as SM-88, is an important next step to improve the prognosis of patients with metastatic cancers.”
Click Here for more Trial Results
Trial Status/Progress
Ph I/Ib trial of Syk inhibitor HMPL-523 initiated in patients with relapsed or refractory lymphoma
  • First patient dosed on September 26, 2019 in the U.S.
  • Multi-center, open-label, two-stage study, including dose escalation and expansion, investigating the effects of HMPL-523 administered orally to patients with relapsed or refractory lymphoma
  • Primary outcome measures: safety and tolerability
  • Secondary outcomes: pharmacokinetic (PK) measurements and preliminary efficacy such as objective response rate (ORR)
First patient dosed in Ph Ib/II trial of BAVENCIO (avelumab) in multi-drug combinations with CMP-001 in SCCHN patients as part of the JAVELIN Medley study
“The dosing of patients in this trial represents an important milestone for Checkmate as we seek to build upon promising data we have generated to date with CMP-001, particularly in PD-1-refractory advanced melanoma. Based upon the preclinical and clinical work conducted to date, we believe CMP-001 can effectively convert cold tumors to hot and thereby improve response to PD-1/L1-based immunotherapy in a variety of solid tumors. We look forward to the results of this clinical trial,” commented Barry Labinger, President and CEO of Checkmate Pharmaceuticals.
 
Click Here for more Trial Status/Progress
MedNess Plus
FDA approves Jynneos, the first live, non-replicating vaccine for the prevention of monkeypox and small pox
FDA recently announced the approval of a live, non-replicating vaccine for the treatment of smallpox and monkeypox. 
“Following the global Smallpox Eradication Program, the World Health Organization certified the eradication of naturally occurring smallpox disease in 1980. Routine vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Therefore, although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect. Today’s approval reflects the U.S. government’s commitment to preparedness through support for the development of safe and effective vaccines, therapeutics, and other medical countermeasures.”
FDA approves Descovy, a second HIV drug to reduce the risk of HIV-1 infection
FDA recently approved Descovy for the treatment of adults and adolescents for HIV-1 pre-exposure prophylaxis (PrEP) in an effort to reduce the risk of HIV-1 infection mainly from sex.
“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” said Jeffrey Murray, M.D., M.P.H., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”
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MedNess Business
Onco-News

Takeda and Prometheus Biosciences enter into partnership to develop therapies for inflammatory bowel disease
Prometheus Biosciences has entered into a strategic collaboration with Takeda where it will use its bioinformatics discovery platform to identify and validate three targets for inflammatory bowel disease. Once validated, Takeda will follow up with the candidates for drug discovery, development and commercialization. According to the agreement, Prometheus will receive an undisclosed amount as upfront payment and up to $420 million in milestone based payments from Takeda. 

Tokyo-based AI Medical Service raise $43 million in series B for endoscopy image analysis
AI Medical Service has raised $43 million in series B to support the clinical trial of its software that analyzes endoscopy images in real time using artificial intelligence for detection of gastric cancer. The investors for current funding include Globis Capital Partners, World Innovation Lan and the Sony Innovation Fund by Innovation Growth Ventures. With multiple Japanese medical institutions, AI Medical Services is set to build a large dataset of endoscopic images.
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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