GeneOnline’s Weekly News Highlights: Nov 13-Nov 17

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GeneOnline’s editorial team has compiled a digest of top international biotechnology and healthcare news of the week to help readers keep abreast of global biomedical industry updates.

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Ajinomoto to Acquire Forge Biologics for $620 Million to Boost Gene Therapy Capabilities

On November 13, Ajinomoto Co., Inc. and Forge Biologics officially entered into a definitive agreement, marking a significant strategic move in the biotechnology sector. The Japanese firm is set to acquire the Ohio-based viral vector and plasmid CDMO in an all-cash deal valued at $620 million and the transaction is slated for completion by the end of Q4 2023. As a cGMP-compliant CDMO, Forge specializes in accelerating AAV gene therapy programs at any stage, from preclinical to clinical and commercial manufacturing, and is operating from its custom-designed facility spanning an impressive 200,000 square feet. Upon finalization of the deal, Forge Biologics will transition into a fully consolidated subsidiary of Ajinomoto.

Guardant Health Launches Innovative Blood-Based Colorectal Cancer Screening in South Korea

Headquartered in Palo Alto, California, precision oncology leader Guardant Health, Inc. has officially launched its blood-based colorectal cancer screening test, Shield™, in partnership with Samsung Medical Center in South Korea. Guardant’s test is a pioneering approach to colorectal cancer screening, utilizing circulating tumor DNA (ctDNA) analysis, detecting small genetic fragments shed into the bloodstream by tumors. In the pivotal ECLIPSE study involving over 20,000 patients, the Shield test demonstrated an impressive 83% sensitivity for detecting colorectal cancer in average-risk adults in the U.S., with a specificity of 90%. Early detection is crucial to reducing mortality rates, especially as colorectal cancer often lacks symptoms in its initial stages.

A Pioneering Partnership Between Africa CDC and China CDC Elevates Public Health Initiatives

The leadership of the Africa Centres for Disease Control and Prevention (Africa CDC) and the China Centres for Disease Control and Prevention (China CDC) have recently affirmed their commitment to bolster collaboration in advancing public health in Africa. Key areas of focus include disease diagnosis, infectious disease management, workforce development, outbreak response, surveillance, and early warning systems. As a part of the China-Africa collaboration, a cutting-edge Reference Laboratory named after Chinese Scientist Dr. Wu Lien-teh, a pioneer of modern medicine in China, was unveiled at the Africa CDC Office earlier this month, with the aim of bridging significant gaps in African laboratory systems. The facility is equipped with biosafety level (BSL) laboratories, including specialized BSL-II and high containment laboratories (BSL-III), addressing critical shortcomings in diagnostic capabilities in Africa.

Singapore’s NUS Medicine Launches Centre for Sustainable Medicine

The Yong Loo Lin School of Medicine at the National University of Singapore (NUS Medicine) has recently announced the launch of the Centre for Sustainable Medicine, aiming to lead the healthcare sector’s response to climate change, reducing carbon dioxide emissions from healthcare systems, and fostering climate-resilient health practices that accelerate the net zero transition. The Center outlines three early initiatives to support Singapore’s ambition to become a leader in sustainable medicine, including a Clinical Fellowship in Sustainable Medicine to transform medical education, a comprehensive assessment of the carbon impact of healthcare in Singapore, and an inaugural meeting of the Lancet Commission on Sustainable Healthcare in 2024.

Bristol Myers Squibb Secures FDA Approval for its Novel Small-molecule NSCLC Medication 

On November 15, Bristol Myers Squibb (BMS) announced that the U.S. FDA has granted approval for its small-molecule tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Administered as an oral therapy, Augtyro targets ROS1 oncogenic fusions, which account for about 1 to 2% of all NSCLC cases. BMS obtained Augtyro through its $4.1 billion acquisition of Turning Point Therapeutics which was completed in August 2022. Following the approval, the company stated that it plans to make Augtyro available starting in mid-December, with the ambition to challenge Pfizer’s Xalkori and Roche’s Rozlytrek in this niche lung cancer market.

UK Regulator Grants World’s First Approval for CRISPR-edited Therapy for Rare Blood Disorders

On November 16, Vertex Pharmaceuticals and CRISPR Therapeutics jointly announced that the United Kingdom (U.K.) Medicines and Healthcare Products Regulatory Agency (MHRA) has granted conditional marketing authorization for their CRISPR/Cas9 gene-edited therapy CASGEVY™ (exagamglogene autotemcel, previously known as exa-cel), for the treatment of sickle cell disease (SCD) and transfusion-dependent β-thalassemia (TDT). Reshma Kewalramani, M.D., Vertex’s CEO and President, stated in the company’s press release, “Today is a historic day in science and medicine: this authorization of CASGEVY in Great Britain is the first regulatory authorization of a CRISPR-based therapy in the world.”

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