REG - Scancell Hlds - Modi-1 Vaccine Achieves Early Clinical Validation

Scancell HoldingsAnnouncement

09/01/2025 07:00

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RNS Number : 6602S  Scancell Holdings Plc  09 January 2025

 9 January 2025

Scancell Holdings plc

("Scancell" or the "Company")

 

Scancell's Modi-1 Moditope® Vaccine Achieves Early Clinical Validation in
Head and Neck Cancer

 

Modi-1 successfully achieved Simon stage 1 suggesting the combination of
Modi-1 and checkpoint blockade is beneficial in HPV negative head and
neck squamous cell carcinoma (SCCHN)

This result supports the continuation of the study in this indication

Moditope® patent granted by U.S. Patent and Trademark Office (USPTO)

 

Scancell Holdings plc (AIM: SCLP), a clinical-stage biopharmaceutical company
developing novel immunotherapies for cancer, has achieved significant clinical
and commercial milestones in its ModiFY study.

Modi-1, the lead vaccine from Scancell's Moditope® platform, is being
investigated in the open-label Phase 2a dose expansion ModiFY study. This
trial evaluates the safety, tolerability, and preliminary efficacy of Modi-1
in combination with checkpoint inhibitors (CPIs) in patients with renal and
head and neck cancers.

The cohort investigating HPV negative head and neck squamous cell carcinoma
(SCCHN) was designed to determine if the overall objective response rate (ORR)
in patients could be improved by combining Modi-1 Moditope® in combination
with standard of care single agent checkpoint inhibitor pembrolizumab. Three
of the seven evaluable patients that have received immunisation with Modi-1
Moditope® combined with a checkpoint inhibitor have demonstrated a partial
response as determined by RECIST 1.1 tumour assessment at their 25-week scan.
This equates to an ORR of 43% compared to historical ORRs of 19% for
Pembrolizumab and 13% for nivolumab. In view of the significant improvement in
response rate and the good safety and tolerability, this study is well
positioned to continue enrolment into Simon stage 2. These encouraging early
results will be further verified upon completion of this HPV (-) SCCHN Modi-1
Moditope ® + CPI cohort, after a total of up to 21 patients have been
vaccinated. In addition, there is investigator interest to evaluate
Modi-1Moditope® in the neoadjuvant setting for this indication.

The commercial positioning of Modi-1 Moditope® has been further strengthened
through approval by the U.S. Patent and Trademark Office (USPTO) for a patent
for Moditope® and successful formulation development. The patent from the
USPTO will add to the protection of the Company's pipeline of Moditope®
vaccines for the treatment of cancer, which has already been granted by the
European Patent Office, along with China, Japan and Australia.

Dr Nermeen Varawalla, Chief Medical Officer Scancell commented: "The promising
early Simon stage 1 (non-futility) read-out from the (HPV negative) SCCHN
cohort of the ModiFY Phase 2 clinical study sets the stage for Simon stage 2
and the further development of Modi-1 Moditope® in a cancer indication with
poor outcomes following standard of care."

Chief Investigator Christian Ottensmeier, Professor of Immuno-Oncology at Head
and Neck Institute, University of Liverpool, commented: "This positive
preliminary clinical read-out validates the scientific rationale for
Moditope(®) vaccines as a therapy with real potential to improve outcomes
achievable with checkpoint inhibitors alone. Given its good safety profile and
ease of use, I remain keen to continue using this vaccine as well as explore
the application of Modi-1 in the neoadjuvant setting."

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014 (MAR).

-ENDS-

For further information, please contact:

Scancell Holdings plc
 
          +44 (0) 20 3709 5700

Phil L'Huillier, CEO

Professor Lindy Durrant, CSO

Dr Jean-Michel Cosséry, Non-Executive Chairman

 

Panmure Liberum Limited (Nominated Advisor and Joint Broker)    +44 (0) 20
7886 2500

Emma Earl/ Will Goode/ Mark Rogers (Corporate Finance)

Rupert Dearden (Corporate Broking)

 

WG Partners LLP (Joint Broker)
                             +44 (0) 20 3705 9330

David Wilson/ Claes Spang/ Satheesh Nadarajah/ Erland Sternby

 

ICR Healthcare
 
+44 (0) 20 37095700

Mary-Jane Elliott/ Angela Gray/ Lindsey Neville
            scancell@icrhealthcare.com

 

About Moditope®

Moditope® is a unique class of potent off the shelf peptide vaccine targeting
tumour-specific neoantigens generated from stress-induced post translational
modifications (siPTMs) activating CD4 cytotoxic T cells via the MHC-II
presentation pathway. Modi-1 Moditope® is the lead vaccine from the Scancell
Moditope® platform. Modi-1 Moditope® targets citrullinated peptides,
combining peptides from two different proteins combined to reduce the
possibility of tumour escape. Potent T cell responses and strong anti-tumour
activity have been observed in several cancer models of different tumour
types, including squamous cell carcinoma of the head and neck, ovarian, renal
cell cancer and triple negative breast cancer, following administration of the
Modi-1 vaccine.

About the ModiFY trial

Modi-1 Moditope® is the lead candidate from the Scancell Moditope® platform.
The ModiFY study is a multicentre Phase 1/2 open label first-in-human clinical
trial with Modi-1 Moditope®, an innovative cancer vaccine targeting
citrullination in cancer, being administered alone or in combination with CPIs
in patients with head and neck and renal tumours and as a monotherapy in
patients with ovarian cancer, triple negative breast, squamous cell carcinoma
of the head and neck and renal cancer. Modi-1 stimulates CD4 T cells which may
directly impact tumour growth however in some patients if the tumour
environment is highly immunosuppressive, these T cells may need to be
protected by CPIs. This open label Phase 1/2 study is currently assessing the
safety and immunogenicity of the Modi-1 Moditope® subtype, Modi-1ev,
comprising two citrullinated vimentin peptides and a citrullinated enolase
peptide.

 About Scancell

Scancell is a clinical stage biopharmaceutical company that is leveraging its
proprietary research, built up over many years of studying the human adaptive
immune system, to generate novel medicines to treat significant unmet needs in
cancer. The Company is building a pipeline of innovative products by utilising
its four technology platforms: Moditope® and ImmunoBody® for vaccines and
GlyMab® and AvidiMab® for antibodies. Adaptive immune responses include
antibodies and T cells (CD4 and CD8), both of which can recognise damaged or
infected cells. In order to destroy such cancerous or infected cells, Scancell
uses either vaccines to induce immune responses or monoclonal antibodies
(mAbs) to redirect immune cells or drugs. The Company's unique approach is
that its innovative products target modifications of proteins and lipids. For
the vaccines (Moditope® and ImmunoBody®) this includes citrullination and
homocitrullination of proteins, whereas its mAb portfolio targets glycans or
sugars that are added onto proteins and / or lipids (GlyMab®) or enhances the
potency of antibodies and their ability to directly kill tumour cells
(AvidiMab®).

For further information about Scancell, please visit:
https://www.scancell.co.uk/ (https://www.scancell.co.uk/)

 

 

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