REG - Scancell Hlds - Modi-1 trial open for expansion in CPI combination

Scancell HoldingsAnnouncement

31/07/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230731:nRSe6423Ha&default-theme=true

RNS Number : 6423H  Scancell Holdings Plc  31 July 2023

31 July
2023

 

Scancell Holdings plc

("Scancell" or the "Company")

 

Modi-1 trial open for expansion in combination with checkpoint inhibitors

·    Safety review committee has approved cohort expansion into renal and
head and neck patients who receive CPI as standard of care alone and in the
neoadjuvant setting

·    Cohort 4 of the ModiFY trial showed that the higher dose Modi-1 in
combination with CPI

was well tolerated with no safety concerns

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, announces that the ModiFY
trial is now open for expansion in combination with checkpoint inhibitors
(CPI) and in the neoadjuvant setting.

 

Following the successful completion of Cohort 4, where three patients received
at least two doses of Modi-1 combined with CPI, the safety review committee
has approved expansion into two cohorts of patients with renal or head and
neck cancer who receive CPI as standard of care. 21 patients will be recruited
into each cohort. Patients with triple negative breast cancer will not be
included in this part of the study as these patients receive checkpoints in
combination with chemotherapy which may induce citrullination in normal cells
and induce toxicity.

 

Additionally, recruitment into the neoadjuvant arm of the Modi-1 trial in
combination with CPI was also approved. This study will recruit 30 patients
who will be randomised at diagnosis to receive either two doses of Modi-1
three weeks apart or two doses of Modi-1 plus one dose of CPI. Tumour biopsies
will be taken prior to immunisation and from the tumour resection 6 weeks
following the initial vaccination. The two tumour samples will allow the
extent of T cell infiltration and activation pre- and post-Modi-1 vaccination
to be assessed with and without a checkpoint inhibitor.

 

Modi-1 treatment were well tolerated in Cohort 4 with no safety concerns.
Encouragingly, the first patient to be assessed has shown a tumour regression
at their first radiological assessment at 8 weeks. The remaining patients have
not yet been assessed radiologically.

 

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "This is an
important milestone for the Company as we now have approval to treat patients
with Modi-1 monotherapy or in combination with a CPI in four different tumour
types either pre- or post-tumour resection. The  information extracted from
this study will be invaluable in defining the patient population that will
benefit the most from our cancer vaccine, Modi-1."

 

The Company expects further safety, immunogenicity and efficacy data to be
available in 2023.

 

 For further information, please contact:

 Scancell Holdings plc                                                        +44 (0) 20 3709 5700

 Professor Lindy Durrant, CEO

 Dr Jean-Michel Cosséry, Non-Executive Chairman

 Stifel Nicolaus Europe Limited (Nominated Adviser and Joint Broker)          +44 (0) 20 7710 7600
 Nicholas Moore/Samira Essebiyea/William Palmer-Brown (Healthcare Investment
 Banking)
 Nick Adams/Nick Harland (Corporate Broking)

 Panmure Gordon (UK) Limited (Joint Broker)                                   +44 (0) 20 7886 2500
 Freddy Crossley/Emma Earl (Corporate Finance)
 Rupert Dearden (Corporate Broking)

 Consilium Strategic Communications                                           +44 (0) 20 3709 5700
 Mary-Jane Elliott/Matthew Neal/Chris Welsh                                   scancell@consilium-comms.com (mailto:scancell@consilium-comms.com)

 

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 and infectious disease. 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/)

 

About the ModiFY trial

 

Modi-1 is the first candidate in Scancell's Moditope(®) platform. The ModiFY
study is a multicentre Phase 1 open label first-in-human clinical trial with
Modi-1, an innovative cancer vaccine targeting citrullination in cancer, being
administered alone or in combination with CPIs in patients with head and neck,
triple negative breast and renal tumours and as a monotherapy in patients with
ovarian cancer, where there are no approved CPI therapies and in patients with
the other tumour types where CPIs are not indicated. 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 study is assessing the safety and
immunogenicity of two citrullinated vimentin peptides anda citrullinated
enolase peptide.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCSDWFUSEDSEFW