| |OCTOBER 20249CD BIOPHARMA RECEIVES US FDA NOD TO COMMENCE PHASE I TRIALUS FDA NODS ASTRAZENECA'S NASAL SPRAY FOR SELF ADMINISTRATIONSuzhou-based CD Biopharma, a fast-growing biotech company in the clinical stage, has been approved by the FDA for its CD-001 Investigational New Drug (IND) application, marking the start of a phase I human trial.The company's top clinical candidate, CD-001, is developed using its unique Bispecific FusionProtein (BsFP) platform. This new treatment targets PD-1 positive CD8+ T cells with an anti-PD-1 antibody and engineered IL-21 mutant to help with medical needs in oncology and viral infections."The FDA's clearance of this IND reinforces our unwavering commitment to advancing ground breaking immunotherapies." said Dr. Jian Xu, CEO of CD Biopharma. "CD-001 shows promise as a first-in-class and best-in-class treatment, and preclinical studies have demonstrated its effectiveness in various mouse tumour models, with excellent tolerance observed in non-human primates. We are excited to move forward with patient enrollment and expect initial clinical data in the upcoming months."Established in 2021, CD Biopharma is a fast-growing clinical-stage biotech company dedicated to creating groundbreaking therapies in various areas of immunotherapy such as oncology, viral infections, and autoimmune diseases. They possess a technology platform for the exploration and development of bispecific fusion proteins. Monoclonal antibody screening, identification, and optimization were utilized to prepare antibody molecules, which were then used to construct dual-target drugs. POAstraZeneca, a worldwide biopharmaceutical company focused on science, declared that FluMist is now the sole self-administered flu vaccine approved in the United States. FluMist, a nasal spray without needles, was authorized for self-administration by adults under 49 years old or for administration by a parent/caregiver to those between 2-17 years old.The FDA approval was made on a detailed submission, which included findings from a study on usability showing that adults could give themselves or their children aged 2-49 FluMist.Ravi Jhaveri, MD, division head, infectious disease; Virginia H. Rogers Professor in Infectious Diseases, Professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine, Chicago, US, said: "For the first time, families and caregivers will be able to protect themselves against influenza with a needle-free, self-administered vaccine, from the convenience of their own home. Each year, influenza poses a significant burden for people, society and health systems; additional tools to increase access to vaccinations, while also reducing disparities, are critical.Iskra Reic, executive vice president, vaccines and immune therapies, AstraZeneca, said: "The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza. For more than 20 years, FluMist has been the only nasal spray flu vaccine licensed in the US and now it is also the only vaccine to help individuals, families and communities access an influenza vaccine conveniently through self- and caregiver administration outside of traditional healthcare settings". PO
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