Weekly in Asia｜Oct-3

20191020-1026 Weekly in Asia

Takeda Licences Celiac Disease Therapy From COUR

Celiac disease is a serious autoimmune disorder that occurs in genetically predisposed individuals. The ingestion of gluten leads to small intestinal mucosal damage, leading to symptoms such as abdominal pain, diarrhea, nausea, and vomiting. It is estimated to affect 1 in 100 people worldwide.

Takeda Pharmaceutical Company Limited announced on October 22th that the Company has acquired an exclusive global license from COUR Pharmaceutical to develop and commercialize the investigational medicine CNP-101/TAK-101, a potential first-in-class treatment targeting the aberrant immune response in celiac disease.

Takeda is now planning to initiate a dose-ranging study to further explore the potential of TAK-101 in the treatment of patients with celiac disease on a gluten free diet to inform future registrational trials. COUR is eligible to receive up to $420 million in future payments, and royalties on sales of any commercialized products resulting from the license.

About COUR Pharmaceuticals

Founded in 2012 at Northbrook, Illinois, U.S., COUR Pharmaceuticals develops first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR’s platform of immune-modifying nanoparticles treats the root cause of immune disease unlike traditional approaches, which only minimize symptoms using toxic immune suppression.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan that focuses its R&D efforts on four therapeutic areas: oncology, gastroenterology, rare diseases and neuroscience.

New Horizon Health and Prenetics Co-Launches Non-Invasive DNA Test Tool

Colon Cancer is one of the most common cancers worldwide. It is highly preventable with early detection, however, it is often diagnosed at a late stage.

New Horizon Health Limited, China’s colon cancer screening biotech company, announced on October 22 that it had come up an agreement with Prenetics Limited, a genetic and digital health company to launch ColoClear™, a non-invasive multi-target stool DNA test for colorectal cancer. ColoClear™ is specifically developed for Asian individuals.

Under the terms of the agreement, New Horizon will provide a technical transfer to Prenetics for ColoClear™. Prenetics will set up a dedicated facility to begin commercialization services for Hong Kong in early 2020 and for Southeast Asia later in the year.

About Prenetics

Prenetics is a Hong Kong-based technology driven life sciences company specializing in precision medicine and digital health.

About New Horizon Health

Founded in 2013, New Horizon Health is a biotechnology company focused on the development of innovative products for the early detection of cancer with emphasis on GI and lung cancer.

NeuClone Announces First Human Dose of Stelara® (Ustekinumab) Biosimilar Candidate in Phase I Clinical Trial

Stelara® (Ustekinumab), a human interleukin-12 and -23 antagonist, was approved by the FDA to treat plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Following the extensive pre-clinical testing, Australia-based NeuClone on October 17 announced that the company has commenced dosing of Stelara® (ustekinumab) biosimilar candidate, NeuLara, in a single-dose, double-blind, randomized, 3-arm, multicenter Phase I clinical trial conducted across Australia in over 200 healthy volunteers. The objective is to demonstrate equivalent pharmacokinetics (PK) and to demonstrate equivalent safety of NeuLara to US- and EU-sourced Stelara®.

NeuLara was developed in partnership with Serum Institute of India and has become the second biosimilar from NeuClone’s pipeline to enter clinical development.

About NeuClone

Australia-based clinical-stage biosimilar company NeuClone focuses exclusively on the development of biosimilar monoclonal antibodies. Six biosimilar products have been disclosed, including Herceptin®, Stelara®, Synagis®, Prolia®/XGEVA®, Perjeta® and Humira®.

Biogen, Eisai Revive Plans for Alzheimer’s Drug Aducanumab

In 2007, Biogen and the Swiss biotech firm Neurimmune formed a pact to develop antibodies against aggregated amyloid-β together with researchers at the University of Zurich. Aducanumab was one of the investigational human monoclonal antibodies studied. Biogen later licensed aducanumab from Neurimmune under a collaborative development and license agreement. However, the low point of Alzheimer’s disease (AD)’s therapies in 2012 affected this promising treatment, some critics declared the amyloid hypothesis dead.

Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. Recently, Biogen Inc. revived plans to seek the U.S. Food and Drug Administration (FDA) approval for aducanumab.

Biogen and Eisai, Co., Ltd. announced on October 22 that, after consulting with the U.S. FDA, Biogen plans to pursue regulatory approval for aducanumab. Based on discussions with the FDA, Biogen plans to file a Biologics License Application (BLA) in early 2020 and will continue dialogue with regulatory authorities in international markets including Europe and Japan.

About Biogen

Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide.

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. The company positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer.

TCM Biotech and GGA Corp. Teams Up to Create a Global Exclusive Liver Cancer Recurrence Detection Platform

As the “Regulations Governing the Application of Specific Medical Examination Techniques and Medical Devices” and the Laboratory Developed Tests (LDTs) are scheduled to be launched at the end of this year, Taiwanese biotechnology companies are preparing for the battle.

On October 24th, TCM Biotech and GGA Corp. announced that the two companies signed a collaboration agreement to jointly build a post-recurrence tracking and detection platform for liver cancer. TCM Biotech obtained the exclusive authorization of this technology through the National Taiwan University Center of Industry – Academia Collaboration back in 2015. After the transfer of technology, the two parties worked closely to establish product standardization.

TCM Biotech and GGA Corp. will work together to integrate the exclusive technology and laboratory resources of both parties, actively develop the testing platform, and conduct clinical trials in conjunction with four medical centers, National Taiwan University Hospital, the Tri-Service General Hospital, Taipei Veterans General Hospital and Linkou Chang Gung Memorial Hospital to build a post-operative network for liver cancer detection in Taiwan. This approach aims for post-operative liver cancer recurrence detection network to comply with regulatory service systems, and to follow the policy to reach out the global industry for genetic detection.

About TCM Biotech International Crop.

Founded in 1998, TCM Biotech International Crop., the second approved biotechnology corporate by the Taiwan government, is a profitable property focus on therapeutic development with strong market network and channel, and has emerged in Taiwan stock market since 2012.

References

1. https://www.takeda.com/newsroom/newsreleases/2019/takeda-acquires-license-for-first-in-class-celiac-disease-therapy-from–cour-pharmaceuticals-following-positive-phase-2a-proof-of-concept-study/
2. https://neuclone.com/wp-content/uploads/2019/10/NeuClone-Announces-First-Human-Dose-of-NeuLara-17.10.2019-1.pdf
3. http://investors.biogen.com/news-releases/news-release-details/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease

Author

GeneOnline