London, November 4th, 2020: NanoMab Technology Limited, a privately held biopharmaceutical company focussing on cancer precision therapies, today announced that it had received CTA Acceptance from the Medicines Healthcare products Regulatory Agency (MHRA) to carry out a Phase II clinical Study for its NM-01 product.
The study (“PELICAN”) will investigate the assessment of programmed death ligand 1 (PD-L1) expression using 99mTc-NM-01 as a SPECT/CT radiotracer and its correlation to PD-L1 expression results based on routine immunohistochemical (IHC) testing in biopsy diagnostic specimens. The study will be carried out at King’s College London and Guy’s and St. Thomas’s NHS Trust with Professor Gary Cook acting as the Chief Investigator. It is anticipated that the first study patients will be enrolled in early 2021.
Paul Edwards, NanoMab’s CEO commented, “This is a huge step forward for the Company and illustrates our ability to develop a product from our R&D base in China and then to rapidly address the regulatory requirements in the UK to gain our first MHRA CTA acceptance.
This obviously requires a lot of hard work and dedication from our team across two continents as well as our clinical and regulatory advisors. I would like to thank everyone who was involved”.
Dr. Hong Hoi Ting, NanoMab’s co-founder and CSO said, “Our goal is to develop NM-01 as a common and affordable tool to enable non-invasive in vivo imaging. This would allow the measurement of PD-L1 expression before, during and after treatment within one to two hours from injection, which would provide clinicians with valuable information for patient’s treatment regime and disease progression. This could potentially be the best companion diagnostics for immune checkpoint drugs.
We also continue to make strong progress with NM-02, a therapeutic product for the treatment of HER2 positive cancers. We anticipate carrying out an FIH study over the coming months with the aim of commencing a Clinical Study Protocol in the next 12 months.”