MeiraGTx enters strategic collaboration with Hologen

The collaboration aims to accelerate development of AAV-GAD for Parkinson’s disease and industrialise MeiraGTx’s proprietary manufacturing process.

MeiraGTx will receive $200m in upfront consideration. MeiraGTx and Hologen will form a joint venture, Hologen Neuro AI Ltd, with Hologen fully funding the development of AAV-GAD for Parkinson’s disease through to commercialisation.

MeiraGTx has entered into clinical and commercial supply agreements with the joint venture for the manufacture of AAV-GAD and other potential locally delivered genetic medicines to the CNS. Hologen will own a minority stake in MeiraGTx’s manufacturing subsidiary.

MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced a broad strategic collaboration with Hologen Limited, a privately held, world-leading developer of multi-modal generative AI foundation models of real-world clinical data for medicine and healthcare (Large Medicine Models, LMMs).

MeiraGTx will receive $200m in upfront cash. MeiraGTx and Hologen are forming a joint venture, called Hologen Neuro AI Ltd, with an additional commitment from Hologen to fully fund the development of AAV-GAD for the treatment of Parkinson’s disease through to commercialisation.

Hologen licences its proprietary Large Medicine Model technologies for use by the joint venture for its purpose. In forming this joint venture, MeiraGTx and Hologen have created a neuro-AI company in which pioneering technologies from both MeiraGTx and Hologen are being combined to transform the discovery and development of therapies targeting CNS circuitry in neurodegenerative and neuropsychiatric disorders.

MeiraGTx retains 30% ownership in this joint venture and leads clinical development and manufacturing. MeiraGTx also enters into exclusive clinical and commercial manufacturing supply agreements with the joint venture, with Hologen holding a minority stake in MeiraGTx’s manufacturing subsidiary and contributing to its annual funding. Hologen will also deploy its unique generative AI capabilities to further accelerate and optimise the commercial potential of MeiraGTx’s proprietary manufacturing capabilities.

Zandy Forbes, co-founder, president, and CEO of MeiraGTx stated: “We are delighted to be entering into this transformative collaboration with Hologen. The initial focus of the collaboration has been to significantly increase the success probability, robustness, and commercial efficiency of the clinical development of AAV-GAD. Hologen’s AI technology has already provided robust measures of changes in brain circuitry integrated with validated, clinically meaningful endpoints in Parkinson’s disease. The use of Hologen’s AI to elucidate brain circuitry effects in this complex, heterogeneous disease has already significantly de-risked the AAV-GAD programme and is enabling identification of disease-modifying changes to the physiology of the brain in response to targeted therapy.”

Dr Forbes continued: “While this collaboration is incredibly exciting with its direct medical and commercial impact on the late-stage development of AAV-GAD, it has much broader significance for MeiraGTx and for drug development for neurological disorders in general. Hologen’s AI technology opens a new and highly detailed window onto brain circuitry in health and disease. Deploying Hologen’s models on MGT’s clinical data allows characterisation of disease modification in the CNS with unprecedented fidelity. This collaboration joins two incredibly innovative technologies to advance the potential for development of drugs that have meaningful impact on neurodegenerative and neuropsychiatric diseases, which have been largely intractable to targeted, effective treatment to date.”

Dr Forbes added: “In the area of manufacturing, we have begun applying Hologen’s generative AI technology to our extensive data sets, built over the nine years of development of our platform process, to further advance, optimise, and commercialise our internal manufacturing capabilities.”

From a financial perspective, this transaction further strengthens MeiraGTx, providing $200m in cash, along with full financing of the AAV-GAD programme as well as proportional funding of our internal manufacturing capabilities. This, in turn, allows MeiraGTx to accelerate its pivotal AAV-AQP1 Xerostomia programme, which received an RMAT in December, and expand and accelerate the development of MeiraGTx’s Riboswitch technology, supported by compelling data in metabolic disease, cell therapy, neuropathic pain, as well as heart disease—all very large areas of medical need amenable to phasic in vivo delivery of native biologic therapeutics.  

Collaboration details and financial terms:

MeiraGTx will receive $200m in upfront consideration.
MeiraGTx and Hologen form a joint venture, Hologen Neuro AI Ltd, incorporated in Guernsey, Channel Islands, with additional funding from Hologen to finance the development of the AAV-GAD programme in Parkinson’s disease through to commercialisation, as well as other locally delivered therapies to the CNS.

MeiraGTx retains a 30% ownership in Hologen Neuro AI Ltd and leads clinical development and manufacturing.

Hologen licences its proprietary Large Medicine Model technologies for use by the joint venture for its purposes.

Hologen Neuro Ltd enters into both clinical and commercial manufacturing supply agreements with MeiraGTx for exclusive manufacture of AAV-GAD and other potential locally delivered genetic medicines targeting the CNS.

Hologen holds a minority stake in MeiraGTx’s manufacturing subsidiary and will contribute to annual funding. Hologen will apply its generative AI technology to MeiraGTx’s extensive manufacturing data sets to advance, optimise, and commercialise our internal manufacturing capabilities and products.  
 

About MeiraGTx

MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage genetic medicines company with a broad pipeline of late-stage clinical programmes supported by end-to-end manufacturing capabilities. MeiraGTx has internal plasmid production for GMP, two GMP viral vector production facilities, as well as an in-house Quality Control hub for stability and release, all fit for IND through commercial supply. In addition, MeiraGTx has developed a proprietary manufacturing platform with leading yield and quality aspects and commercial readiness, core capabilities in viral vector design and optimisation, and a transformative riboswitch gene regulation platform technology that allows for the precise, dose-responsive control of gene expression by oral small molecules. MeiraGTx is focusing the riboswitch platform on the delivery of metabolic peptides, including GLP-1, GIP, Glucagon, and PYY, using oral small molecules, as well as cell therapy for oncology and autoimmune diseases, and long-term intractable pain. MeiraGTx has developed the technology to apply genetic medicine to more common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high.

For more information, please visit www.meiragtx.com  

About Hologen

Hologen Limited builds the largest, most expressive, accurate, and equitable generative AI models in healthcare, using large real-world clinical and research data sets from multiple modalities. Hologen’s Large Medical Models learn the rich biological diversity of healthy and pathological variation in unprecedented breadth and detail, providing the foundations for truly personalised medicine. By capturing complex biological heterogeneity with high fidelity, as revealed by clinical data, Hologen’s technology overcomes the insensitivity of interventional trials, enabling accurate quantification of therapeutic effects, and illuminates disease mechanisms opaque to conventional models, revealing new therapeutic and commercial opportunities. In Phase 2 and 3 trials, the technology is used to substantially increase trial success probabilities and to gain much greater control over trial design and approvability. The company was created as a spinout from UCL and KCL with the support of UCL Ventures. It is privately held.