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/