Designed to provide protection for infants throughout an entire RSV season, AK0610 has been genetically engineered from a neutralising antibody that was isolated originally from a child who recovered from the infection
China’s NMPA approves ArkBio’s IND application for RSV neutralising antibody candidate AK0610. (Credit: mwooten from Pixabay)
Shanghai Ark Biopharmaceutical (ArkBio) is set to advance its respiratory syncytial virus (RSV) neutralising antibody candidate, AK0610, into clinical development, having received investigational new drug (IND) approval from China’s National Medical Products Administration (NMPA).
According to the Chinese biotech company, AK0610 is genetically engineered from a neutralising antibody that was isolated originally from a child who recovered from an RSV infection.
The antibody candidate is designed to provide protection for infants throughout an entire RSV season.
ArkBio acquired the intellectual properties of the drug through a licensing agreement with the Institute of Microbiology, Chinese Academy of Sciences (CAS), and Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, China.
Subsequent to the licensing, further refinement and optimisation of the drug candidate were conducted at ArkBio.
Zhengde Xie from Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, China said: “There is a huge unmet medical need for paediatric prophylaxis of RSV infection. We are delighted to see the progress of AK0610 towards clinical development and wish it a great success in upcoming clinical trials that will eventually benefit very needed pediatric population.”
Targeting the RSV pre-F protein, AK0610 is said to exhibit robust neutralising effects against RSV in both in vitro and in vivo settings. Its extended half-life positions it as a potential next-generation, long-acting antibody drug for preventing RSV, claimed the Chinese biotech firm.
ArkBio chairman and CEO Jim Wu said, “We are excited with the IND approval of AK0610 and its great potential in the field of RSV prevention.
“We sincerely thank Professor George Fu Gao, a member (academician) of CAS and his team from the Institute of Microbiology, and Professor Zhengde Xie and his team from Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, China, for their professional collaboration and scientific spirits.
“ArkBio specialises in drug discovery and development in the RSV field with a pipeline in both RSV treatment and prevention. We will strive to provide very needed RSV high-risk population and patients with efficacious prevention and treatment solutions.”