Leucid Bio provides business update and outlook for 2023

• Proprietary Lateral CAR Platform achieved pre-clinical proof-of-concept data demonstrating prolonged disease-free survival compared to other CAR T-cell products.
• Lead programme, LEU011 has completed pre-clinical development for the treatment of solid tumours and is in pre-clinical development for a range of haematological malignancies.
• Leucid expects to file its CTA to initiate the clinical trial in H1 2023 and to be dosing patients by H2 2023.
• Bolstered Senior Leadership team and restructured Executive Team to prepare the Company for its next phase of growth.
• Achieved Innovative Licensing and Access Pathway (ILAP) status enabling an accelerated time to market, facilitating patient access to medicines.

LONDON, Feb. 16, 2023 /PRNewswire/ -- Leucid Bio ("Leucid" or the "Company"), a biotech company pursuing a differentiated approach to develop next generation Chimeric Antigen Receptor T-cell (CAR-T) therapies using the Company's proprietary Lateral CAR Platform to improve treatment outcomes and save the lives of patients with refractory cancers, today provides a business update. 

Lateral CAR Platform has demonstrated exceptional efficacy compared to traditional Linear CARs

Founded to translate over 20 years of pioneering CAR-T research led by Leucid's Founder and Chief Scientific Officer, Dr John Maher at King's College London, Leucid has developed a unique Lateral CAR Platform building upon John's novel CAR-T model which develops CAR molecules designed to adopt a more natural biological configuration. 

CAR T-cell therapy is a revolutionary technology in which immune cells, called T-cells, are reprogrammed so they can recognise and destroy cancer cells. This has proven to be a powerful therapy for refractory blood cancers, but to date has lacked efficacy for the treatment of solid cancers.

Leucid's novel approach, reconfigures the way a CAR is constructed by moving the key functional components into their natural lateral position next to the plasma membrane, as opposed to a linear configuration. The technology platform gives properties to the CAR-Ts that enable them to consistently outperform previous generations of CAR-T therapies in pre-clinical studies; enhancing tumour targeting and selectivity, T-cell potency and generating a persistent long-term response with reduced toxicity.

Clinical Development - pre-clinical models demonstrate the ability to overcome key challenges in CAR T-cell treatment of solid tumours

2022 saw the pre-clinical package for the Company's lead programme LEU011, a Lateral CAR targeting NKG2D ligands, fully assembled. The NKG2D receptor is an activating immune receptor that triggers cell death upon recognition of one or more of the eight human NKG2D ligands expressed on transformed, infected or damaged cells.

Leucid has generated robust pre-clinical proof of concept data that demonstrate therapeutic potential for a range of solid tumours including colorectal, pancreatic, mesothelioma, ovarian (both epithelial and high-grade serous subtypes) and breast cancer. These studies consistently demonstrate prolonged disease-free survival compared to other CAR T-cell products, including those in clinical trials. The method of testing employed by Leucid Bio is characterised by its rigorous approach to evaluating the persistence of CAR-T anti-tumour function in vivo. By looking for long-term protection after tumour re-challenge, Leucid sets the gold standard for this type of testing.

Collaborations

Leucid holds exclusive option rights to King's College London's broad portfolio of CAR-T assets for future pipeline expansion. The Company has a laboratory base at Guy's and St Thomas' NHS Foundation Trust and is currently looking for Clean Room space ahead of Phase I clinical testing of LEU011.

Management and Senior Leadership Team Update

Over the last 18 months, the Company has successfully built its Senior Leadership team under Chief Executive Officer (CEO), Artin Moussavi, which now comprises:

• John Maher, Chief Scientific Officer - Translating over 20 years of pioneering CAR-T research, John established CAR T-cell research at King's College London in 2004 where he leads the "CAR Mechanics" group
• Mark Docherty, Chief Financial Officer and Chief Operating Officer - Seasoned Life Sciences investment and operational professional with over 25 years experience in the sector, focusing in the last 12 years on advanced therapies
• Arindam Mitra, Director CMC - Strong operations professional with a focus on early phase first in man clinical trials along with excellent knowledge of regulatory (Europe & North America) and compliance management
• Belinda Carlsen, VP Clinical Operations - More than 20 years' experience of the various aspects of clinical research, specialising in advanced therapies
• Marc Davies, VP CAR Engineering - an immunologist and molecular biologist with over 15 years' experience in the field of adoptive T-cell immunotherapy and cancer immunology

As the Company enters its next growth phase, and in order to position the Company to fully exploit all of the opportunities afforded by its strong IP position and Platform, it is an opportune time for the Board to re-configure the Management Team.  Artin Moussavi will move to the role of Chief Business Officer (CBO) to focus fully on building the Company's industry relationships. Non-Executive Chairman Ian Miscampbell will move to the role of Interim Executive Chairman as the Company actively seeks a new CEO to take Leucid's multiple programmes into clinical development, and expand on its partnerships and collaborations.

Outlook for 2023

Leucid expects to file a Clinical Trial Application (CTA) to initiate the First in Human (FiH) clinical trial of its Lateral CAR Platform in multiple programmes through Phase I/II clinical trials in H1 2023, with the aim of dosing patients by H2 2023.

Following a successful £11.5 million Series A fundraise in 2021 Leucid is now looking to raise a Series B round to finance the pivot from pre-clinical to clinical development.

Ian Miscampbell, Interim Executive Chairman at Leucid Bio, said: "Leucid Bio is in an exciting phase of expansion as we progress to first in human Proof-of-Concept for our novel Lateral CAR Platform in multiple programmes. John was the first to engineer and develop CD28-based second generation CAR technology in human T-cells 20 years ago, and has continued to innovate in the field as one of its acknowledged experts ever since.  Our proprietary platform has been built around his ground breaking research."

About Leucid Bio

Leucid Bio is a biotech company developing cell therapies for refractory cancers, especially solid tumours. Leucid was founded to translate 20 years of pioneering CAR-T research led by Dr John Maher at King's College London (KCL), Leucid Bio has developed a proprietary portfolio based upon Dr Maher's novel approach, in which the CAR structure has been redesigned to recapitulate the lateral distribution of signalling domains as observed in natural immune receptors. The technology gives properties to the CAR-Ts that enable them to consistently outperform previous generations of CAR-T therapies in pre-clinical studies; enhancing T-cell potency and generating a persistent long-term response with reduced toxicity.

Leucid, based in London, UK with its headquarters and clinical lab facilities situated at Guy's Hospital, leverages state-of-the-art GMP manufacturing in the Capital, to stay committed to its patient-centric approach on developing better cell therapies for the benefit of individuals with hard-to-treat solid tumours. 

About John Maher

John Maher is the Scientific Founder and Chief Scientific Officer of Leucid Bio and has worked on CAR T-cell immunotherapy, with a primary focus on solid tumours, for over 20 years.  The first to engineer and develop CD28-based second generation CAR technology in human T-cells, John also leads the "CAR Mechanics" research group at King's College London. He played a key role in the early development of second generation (CD28) CAR technology while a visiting fellow in the lab of Michel Sadelain at Memorial Sloan Kettering Cancer Center, an approach that has achieved significant clinical impact in haematological malignancies. His research group is focused on the development of adoptive immunotherapy using CAR engineered and gamma delta T-cells, with a primary emphasis on solid tumour types. He is Chief Investigator of a Phase 1 clinical trial in which panErbB-specific CAR T-cells are administered to patients with relapsed/ refractory head and neck cancer. John holds an FRCPath in Immunology (by examination) from Royal College of Pathologists and is registered on the General Medical Council specialist register of Clinical Immunologists. He is also a Consultant Immunologist at Eastbourne Hospital.