London, May 17, 2022 – NanoMab Technology Limited, a privately held biopharmaceutical company focussing on the development of next generation radiopharmaceuticals for cancer precision therapies, today announced the dosing of the first patient in a phase II clinical trial in partnership with Lantheus and King’s College London. The phase II trial is a non-randomised, non-blinded, single centre study evaluating PD-L1 expression in Non-small Cell Lung Cancer (NSCLC) patients using 99mTc Labelled Anti-PD-L1 single domain antibody (NM-01).
NM-01 is a camelid single-domain antibody (sdAb) that targets Programmed death-ligand 1 (PD-L1), an immune checkpoint protein that is overexpressed and exploited by cancer cells in evading the immune system. Over the past decade, immunotherapies that target these immune checkpoint proteins have brought about a revolutionary approach for the treatment of cancer, however, Professor Gary Cook, MD, King’s College London, and principal investigator of the trial, goes on to mention “while checkpoint inhibitor therapies targeting PD1 or PD-L1 have improved the prognosis for NSCLC patients, there are often unpredictable outcomes with these therapies for patients. PELICAN will help us determine if NM-01 can aid in selecting responders to checkpoint inhibitor therapies, thereby getting the right treatments to the right patients while sparing non-responders from unnecessary side-effects, procedures, and costs.”
To date, 45 patients have undergone NM-01 imaging and no adverse events related to the administration of 99mTc-NM-01 have been reported. The PELICAN study is expected to recruit 15 patients by the end of the year, with the primary endpoint to measure PD-L1 expression in NSCLC (primary tumour and metastatic lesions) using 99mTc-NM-01 SPECT/CT in comparison to PD-L1 expression assessed by diagnostic biopsies. Secondary endpoints include measuring intra- and inter-tumoral heterogeneity within the primary and metastatic tumours. More information, including exploratory objectives and eligibility criteria, is available at www.clinicaltrials.gov: NCT04992715.
“This is an important step forward in our development of NM-01 as a non-invasive in vivo imaging and patient selection tool for immune checkpoint drugs, and I am extremely proud of this NanoMab team which has developed this from a conceptual stage to now a Phase 2 first-of-its-kind IND clinical trial ” said Dr. Hong Hoi Ting, Co-founder and Non-Executive Director of NanoMab Technology Limited. “We are excited about the potential to address an unmet clinical need in oncology, and know that Lantheus, a leader in the development and commercialization of imaging agents, is the right partner for this program.”
The start of this Phase II trial is a tribute to the hardworking efforts of the team and NanoMab would like to take the opportunity to express its utmost gratitude to those involved in achieving this significant milestone. PELICAN will build on the already robust preclinical and phase I data obtained in previous years, and we are looking forward to the exciting data that comes from this clinical trial.
NanoMab Technology Ltd Team
Top Row: Dr. Gitasha Chand
Second Row: Dr. Nicholas Wong, Dr. Levente Meszaros
Middle Row: Mr. Henry Ho, Dr. Hong Hoi Ting, Mr. Wenhua Huang
Fourth Row: Ms. Echo Wang, Ms. Yina Cai
Bottom Row: Mr. Joshua Needham-Clark
About NanoMab Technology Limited
NanoMab is a privately held biopharmaceutical company focusing on cancer precision therapies via the development of radiopharmaceuticals. Our goal is to develop a pipeline of theranostics with our proprietary camelid antibody platform to address the unmet medical need for cancer patients across the world. www.nano-mab.com
For more information email: info@nano-mab.com
References
Lantheus Holdings. (2022, May 13). Lantheus Announces First Patient Dosed in Phase 2 Clinical Trial of NM-01 to Monitor PD-L1 Expression in Non-Small Cell Lung Cancer (NSCLC) Patients [Press Release]. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-first-patient-dosed-phase-2-clinical-trial-0