Weekly in Asia 20190616-0622

Japan Approves Roche’s Personalized Cancer Drug Rozlytrek

Tyrosine receptor kinase (TRK) A/B/C and ROS1 proteins activates fusions that drive proliferation in certain types of solid tumor, including pancreatic, thyroid, salivary gland, breast, colorectal and lung.

Roche’s Rozlytrek® (entrectinib) is an oral medication that can block ROS1 and neurotrophic tyrosine receptor kinase (NTRK) kinase activity and may result in the death of cancer cells with ROS1 or NTRK gene fusions. Roche announced on June 18th that its personalized medicine Rozlytrek® has become the first tumor-agnostic medicine approved in Japan by the Ministry of Health, Labour and Welfare (MHLW) for adult and pediatric patients with NTRK fusion-positive advanced recurrent solid tumors.

About Roche

Roche engages in the diagnostics and prescription pharmaceuticals businesses internationally. It also offers gene expression, gene sequencing, and real time PCR systems for researchers. The company licenses its products or technologies to third parties. The company was founded in 1896 and is headquartered in Basel, Switzerland.

China Medical University Hospital Opens Cell Therapy Center

The Translational Cell Therapy Center of China Medical University Hospital (CMUH) was officially opened on the 18th of June. Long-Bin Jeng, chief executive of the Cell Therapy Center, pointed out that CMUH was approved by the Ministry of Health and Welfare in May this year for the ” phase IV cancer dendritic cell immunotherapy“. Patients with stage 4 cancer, including brain metastases, epithelial ovarian cancer, pancreatic cancer, prostate cancer, head and neck cancer, liver cancer, breast cancer, and colorectal cancer, will be able to receive this therapy at the center. Other cell therapy applications developed by the center and the services provided include cell storage, new cell drug development and clinical trials.

About China Medical University Hospital

Located in Taichung, Taiwan, China Medical University Hospital (CMUH) is an affiliated hospital of China Medical University that offers outstanding medical services, clinical instruction and research development.

Terns Pharmaceuticals Initiates Phase 1 Clinical Trial of TERN-101 for the Treatment of NASH

Non-alcoholic steatohepatitis (NASH) is chronic liver inflammation and damage caused by the accumulation of excess fat in the liver. It leads to fibrosis, cirrhosis, and eventually liver cancer or liver failure. The global rate of NASH is increasing dramatically. However, there is currently no approved medication or treatment.

On June 13th, Terns Pharmaceuticals announced the launch of Phase 1 clinical trial of TERN-101, an farnesoid X receptor (FXR) agonist, to evaluate safety, pharmacokinetics, and plasma biomarkers of FXR pathway activation in participants receiving placebo or TERN-101 at various dose levels for 7 days. In addition to the Phase 1 trial now ongoing in the US, Terns also plans to conduct clinical trials in China.

About Terns Pharmaceuticals

Based in China and the United States, Terns Pharmaceuticals is a clinical-stage biopharmaceutical company that focuses on the discovery and development of molecularly targeted, oral, small-molecule drugs to treat cancer and liver diseases.

China NMPA Approves Sinovant’s Clinical Trial Application for Lefamulin

The crisis of antibiotic resistance is increasing at an alarming rate, particularly among the pathogens responsible for pneumonia, tuberculosis, gonorrhoea, and salmonellosis. Among which, community-acquired bacterial pneumonia (CABP) is a life-threatening illness that is associated with a substantial economic burden to healthcare systems around the globe.

Sinovant Sciences’ Lefamulin, a novel semi-synthetic antibiotic of the pleuromutilin class being developed as a potential treatment for CABP, has been accepted by the Center for Drug Evaluation at the China National Medical Products Administration (NMPA). Lefamulin works by selectively inhibiting translation of bacterial protein synthesis. In pre-clinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that most commonly cause CABP, including multi-drug resistant strains. The initiation of registrational clinical trials for patients with CABP is arranged in the second half of 2019.

About Sinovant
Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D in China to meet the needs of patients in Greater China and around the world.

Lumosa to Initiate Phase 2 Human Clinical Trial for LT3001 to Treat Acute Ischemic Stroke

Brain stroke is one of several diseases that the medical community is trying urgently to resolve. Each year, there are about 15 to 17 million people in the world suffering stroke; among which, 80% of the patients are ischemic. Lumosa Therapeutics, on 13 June 2019, announced that the company is set to commence the Phase 2 proof of concept (PoC) study for LT3001, a novel small molecule for the treatment of acute ischemic stroke (AIS). Animal studies well demonstrated LT3001’s multiple functions in restoring cerebral blood flow and reducing ischemic/reperfusion injury. The safety, tolerability and pharmacokinetic properties of LT3001 has been evaluated via the Phase 1 trial involving 16 healthy volunteers. The US FDA has no objections during the 30-day reviewing period on the company’s Investigational New Drug (IND) application. Lumosa is now actively seeking global partners for co-development for this project.

About Lumosa Therapeutics

Based in Taipei, Taiwan, Lumosa Therapeutics is dedicated to the development of innovative new drugs for the treatment of unmet medical needs in the fields of neurological and inflammatory diseases.

References:

1. https://www.reuters.com/article/us-roche-cancer/roche-wins-japan-approval-for-personalized-cancer-drug-rozlytrek-idUSKCN1TJ0H4
2. https://udn.com/news/story/11322/3879593
3. http://www.cmuh.cmu.edu.tw/en/dep_about.php?depid=99928
4. https://www.ternspharma.com/6-13-19-terns-pharmaceuticals-initiates-a-phase-1-clinical-trial-of-tern-101
5. https://www.sinovant.com/d100
6. https://www.lumosa.com.tw/en/News/Press+Release/Lumosa-AIS-new+drug-US+Phase+II+Clinical+Trial-initiated++

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