2 September 2024

CRISM Therapeutics Corporation

("CRISM", "CRISM Therapeutics" or the "Company")

Innovation Passport Award  

CRISM Therapeutics Corporation (AIM: CRTX), the innovative UK drug delivery company focused on the localised delivery of chemotherapy drugs, is pleased to announce that the Company has been awarded an Innovation Passport from the UK Medicine and Healthcare products Regulatory Agency (MHRA) for its lead programme, ChemoSeed® in high grade gliomas.

Award of an Innovation Passport is the first step in the MHRA's Innovative Licensing and Access Pathway (ILAP) programme, which aims to accelerate the development of innovative technologies in areas of unmet medical need by providing access to a broad range of support throughout the product design, development and approvals process.

CRISM Therapeutics' Innovation Passport award recognises ChemoSeed for high grade gliomas as a promising innovative technology in an area of unmet medical need and will enable CRISM to benefit from expedited and increased access to medical, regulatory and scientific stakeholders. The next stage in the ILAP programme for ChemoSeed is the creation of a Target Development Profile (TDP), which will establish the optimal approach for the clinical development of ChemoSeed. 

The TDP is supported by the TDP toolkit, which seeks to bring clinically important and promising medicines to patients faster and more efficiently. Further details of the TDP toolkit are available at this link: https://www.gov.uk/guidance/the-target-development-profile-toolkit

Separately, the Company is pleased to announce it has received £25,000 in Grant Funding (the "Grant") from SPARK The Midlands, a network which aims to bridge the gap between medical research discoveries of novel therapeutics, medical devices and diagnostics and real-world clinical use. SPARK The Midlands is the first UK branch of the globally recognised SPARK Stanford programme found in over sixty locations globally. SPARK awarded the project funding and support as part of its first cohort seeing the clear unmet clinical need that CRISM is seeking to address. SPARK The Midlands is supported by Innovate UK and the West Midlands Combined Authority.

Commenting on the Innovation Passport award and Grant, CRISM Therapeutics CEO Andrew Webb said: "The award of this Innovation Passport for ChemoSeed in high grade gliomas and access to the Innovative Licensing and Access Pathway represents a significant milestone in the development of ChemoSeed and this award alongside the grant funding from SPARK is an important endorsement for CRISM Therapeutics.  The award validates the potential of our lead product to change the treatment landscape for brain tumours and will assist CRISM in potentially providing ChemoSeed to patients on a faster timescale compared with traditional routes."

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About CRISM Therapeutics Corporation

CRISM Therapeutics Corporation has developed an innovative drug delivery technology to improve the clinical performance of cancer treatments for solid tumours through the local delivery of chemotherapy drugs.

ChemoSeed, CRISM's lead product, can be implanted directly into the tumour or the resection margin following the removal of a tumour. This directs that therapeutic concentrations of chemotherapy drugs reach the deep-seated tumour tissue or cover the entire resection margin. In the case of treating high-grade glioma, ChemoSeeds can be implanted during surgery thereby bypassing the blood brain barrier, which prevents other treatments from being able to reach the tumour and be effective.

CRISM plans to submit a clinical trial application in H2 2024 for ChemoSeed® in high-grade glioma.  Based on preclinical data, the Tessa Jowell BRAIN MATRIX Scientific Advisory Board has approved ChemoSeed in a phase II platform clinical trial which is an efficient and cost-effective clinical development opportunity.

For more information please visit: https://www.crismtherapeutics.com/

About The Innovative Licensing and Access Pathway

The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. These medicines include new chemical entities, biological medicines, new indications and repurposed medicines.

The ILAP is open to both commercial and non-commercial developers of medicines (UK based and or global). It comprises an Innovation Passport designation, a target development profile (TDP) and provides applicants with access to a toolkit to support the design, development and approvals process.

For more information: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway

About SPARK The Midlands

For more information on SPARK The Midlands, please visit: https://www.sparkthemidlands.co.uk/