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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

The post NanoMab Announces First Patient Dosed in Phase II Clinical Trial of Novel Radiolabelled Single Domain Antibody (NM-01) in Patients with Non-Small Cell Lung Cancer appeared first on NanoMab.

Dr. Chand, who most recently held the position of Clinical Research Director, has been committed to NanoMab since it was founded in 2016 and her extensive experience in the development of radiopharmaceuticals and early phase clinical trials will be invaluable to her new role. The appointment as Managing Director is a true testament to her exceptional leadership capabilities and NanoMab’s success in developing outstanding leaders. As Managing Director, NanoMab is confident the company’s future is in very capable hands and that she is the ideal candidate to lead the company forward and achieve its ambitions.

Dr. Meszaros has served as Senior Project Manager since joining NanoMab in 2018, playing a fundamental role in the technical aspects and preclinical evaluation of the development of ^99mTc-NM-01 and NM-02. His wealth of technical expertise in radiopharmaceutical development over the past couple of years has been extraordinary and has better positioned NanoMab to succeed in today’s ever evolving biopharmaceutical industry. We are delighted to appoint him as Director of Technical Operations at NanoMab Technology (UK) Ltd. and are confident that he will excel in his new role.

In addition to the internal promotions, Gitasha and Levente have taken up new roles at NanoMab’s licensee company, Radiopharm Theranostics Ltd (ASX: RAD) to ensure a smooth transition in the development of NanoMab’s platform of single domain antibody products. Gitasha has joined RAD as Global Medical Director and Levente as the Global Director of Translational Science. Radiopharm Theranostics Managing Director and CEO Riccardo Canevari welcomed the new appointments. “We are excited to add these highly experienced and specially skilled professionals to the RAD management team and I am confident (Scot), Gitasha and Levente will add enormous value to RAD in their new roles,” he said.

For more information email:  info@nano-mab.com

NanoMab Technology Limited 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

Radiopharm Theranostics Ltd (ASX:RAD) is a developer of world-class platform of radiopharmaceutical products for both diagnostics and therapeutic use.

Article Reference:

https://assets.website-files.com/61947d47ec3d405195f23d06/61bfb5b69a323619c5ab7726_Expansion%20of%20RAD%20Management%20Team.pdf

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The agreements grant RAD full rights to develop three of NanoMab’s single-domain antibody assets: NM-02, NM-03, and NM-04; respectively targeting HER-2 (breast cancer), TROP-2 (triple negative breast cancer), and PTK7 (multiple solid tumours) biomarkers. RAD is an ASX-listed company led by a strong global team with world-class experience, who aim to develop radiopharmaceutical products for both diagnostic and therapeutic uses in areas of high unmet medical needs. RAD is the latest venture of Australian bioentrepreneur, Paul Hopper, who is behind numerous successful companies developing oncology drugs.

Additionally, an agreement issuing the full IP right to develop NM-05 (sdAb targeting FAP) has been established with Full-Life Technologies (HK) Ltd. Full-life is a global nuclear health company seeking to tackle two core issues experienced in the radiopharmaceuticals sector; the ability to produce primarily alpha- and beta- medical radioisotopes in quantity, and the development of an innovative translational research platform for Targeted-Radiotherapy.

NanoMab believes these exclusive licensing agreements have formalised the strategic collaborations between the respective parties, which will speed up the development and commercialisation of our unique platform of immuno-oncology theranostic drugs to aid patients in the battle against aggressive cancers.

For more information email:  info@nano-mab.com

NanoMab Technology Limited 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

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Lantheus’ Press Release

The post Lantheus Holdings Announces Submission of Drug Master File for NM-01 in the U.S. appeared first on NanoMab.

https://www.sciencedirect.com/science/article/pii/S1359644620304190

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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, NanoManb’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.”

For more information:

Paul Edwards. Tel: +44 (0)7771 575374

Email:  p.m.edwards@nano-mab.com

Media

Richard Hayhurst/Janet Joy RHApr

Tel: +44 (0)7711 821 527

richard@rhapr.eu or jan@rhapr.eu

Notes to editors

NanoMab Technology Limited 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

The post NanoMab receives MHRA approval to commence a Phase 2 Clinical Study to investigate PD-L1 expression using its NM-01 product as a tool for non-invasive in vivo imaging. appeared first on NanoMab.

For more information:
Paul Edwards. Tel: +44 (0)7771 575374
Email: p.m.edwards@nano-mab.com
Media
Richard Hayhurst/Janet Joy RHApr Tel: +44 (0)7711 821 527 richard@rhapr.eu or jan@rhapr.eu

Notes to editors

NanoMab Technology Limited 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
OncoBeta® GmbH with its headquarters located in Garching n. Munich, Germany, is a medical device and radiochemical company, specializing in the development and commercialization of state-of-the-art, innovative radioisotope therapies and products utilizing Rhenium-188. OncoBeta® offers an innovative Skin Cancer Therapy targeting non-melanoma skin cancers and produces Tungsten -188/Rhenium-188 (W/Re-188) Generators for commercial use. www.oncobeta.com

The post NanoMab and OncoBeta outline the pathway to a Strategic Alliance and Supply Agreement, focused on the secure supply of Rhenium-188 for NanoMab’s range of Therapeutic Radiopharmaceuticals appeared first on NanoMab.

Professor Gary Cook, Professor of PET Imaging at King’s College London said, “We have scanned our first participant; the images I reviewed are of excellent quality and clearly show the heterogeneity of PD-L1 expression between tumours”.

Paul Edwards, Nanomab’s CEO commented, “This mechanistic study is a precursor to the Phase II

Clinical Study which we plan to commence early next year, having submitted our application to the MHRA last month. 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 patients’ treatment regime and disease progression. This could potentially be the best companion diagnostic for immune checkpoint drugs. The submission of this protocol is a significant step forward for NanoMab”

We also continue to make strong progress with NM-02, a therapeutic product for the treatment of HER2 positive cancers. We anticipate commencing an FIH study over the next 3-6 months with the aim of starting a Clinical Study Protocol in the next 12 months.

For more information:

Paul Edwards. Tel: +44 (0)7771 575374

Email:  p.m.edwards@nano-mab.com

Media

Richard Hayhurst/Janet Joy RHApr Tel: +44 (0)7711 821 527 richard@rhapr.eu or jan@rhapr.eu

Notes to editors

NanoMab Technology Limited 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

The post NanoMab announces the commencement of the NM-01 mechanistic study (SPECT/CT radiotracer) for non-small cell lung cancer patients. appeared first on NanoMab.

The study 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.

Paul Edwards, Nanomab’s CEO commented, “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. The submission of this protocol is a significant step forward for NanoMab”

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 next 3-4 months with the aim of commencing a Clinical Study Protocol in the next 12 months.

For more information:

Paul Edwards. Tel: +44 (0)7771 575374

Email:  p.m.edwards@nano-mab.com

Media

Richard Hayhurst/Janet Joy RHApr

Tel: +44 (0)7711 821 527

richard@rhapr.eu or jan@rhapr.eu

Notes to editors

NanoMab Technology Limited 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

The post NanoMab Submits a request to the MHRA to commence a Phase 2 Clinical Study to investigate PD-L1 expression using its NM-01 product as a tool for non-invasive in vivo imaging appeared first on NanoMab.