Oncimmune Regulatory News (ONC)

21 December 2021

Oncimmune Holdings plc

("Oncimmune" or the "Company")

ImmunoINSIGHTS commercial update

ImmunoINSIGHTS master service agreement ("MSA") signed with top 5 global pharma company

Contract signed under MSA to provide autoantibody profiling of patients in autoimmune trials

Contract signed with EORTC to profile autoantibodies in participants in co-funded EORTC Melanoma Group and MSD EORTC1325/KEYNOTE-054 KEYTRUDA® trial in melanoma

Oncimmune Holdings plc (AIM: ONC.L), the leading global immunodiagnostics group, today announces that the Company has signed further commercial contracts within its ImmunoINSIGHTS pharma services business.

MSA and Commercial Contract Signed with Leading Global Pharmaceutical Company

Following the recent signing of a MSA with a leading global pharmaceutical company, the Company is pleased to report that it has signed a commercial contract to provide autoantibody biomarker services. A second contract has been agreed and is expected to be signed in the next few days. Both programmes are scheduled to complete and be invoiced by the end of FY2022 and the Company expects these programmes to lead to follow-on studies.

Under the first contract, Oncimmune will develop a multiplexed assay to measure Immunoglobulin E (IgE) autoantibodies on its SeroTagTM platform for planned autoimmune studies. In the second, pending contract, Oncimmune will evaluate the autoantibody profiles of patient samples collected in an autoimmune trial for chronic idiopathic urticaria1 ("CIU"). This study will measure the autoimmune profile in chronic, idiopathic (meaning 'of unknown cause') cases of CIU and aims to uncover insights that will support the clinical development of a therapeutic for CIU.

Commercial Collaboration Agreement Signed with The European Organisation for Research and Treatment of Cancer ("EORTC")

The Company has signed an autoantibody profiling collaboration with the EORTC, an independent, non-profit cancer research organisation whose mission is to coordinate and conduct international translational and clinical research to improve the standard of cancer treatment for patients. The new research project, co-funded with the EORTC Melanoma Group and MSD, will evaluate the autoantibody profiles of patient samples collected in the ongoing phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, as monotherapy for surgically resected, high-risk melanoma.

The project will explore autoantibody profiles as biomarkers of clinical response in patients with melanoma recruited onto the EORTC1325/KEYNOTE-054 trial, which assessed pembrolizumab versus placebo in an adjuvant setting (in which the drug is administered after surgery). Pembrolizumab is an immune check point inhibitor ("CPI") with uses in over 15 types of cancer, including for the treatment of melanoma skin cancer, non-small cell lung cancer, bladder cancer and Hodgkin lymphoma.

The project will use the Company's SeroTag immuno oncology discovery array to explore the response to therapy and the potential for immune related adverse events ("irAEs") among patients treated with pembrolizumab, nivolumab and ipilimumab. The utility of the Company's SeroTag immuno oncology discovery array was previously reported when the results of a prior study were presented at the American Society of Clinical Oncology ("ASCO") meeting in 2020.2 The aim of this new research project is to explore whether autoantibody patterns are associated with recurrence-free survival in the adjuvant setting.

Oncimmune has already studied autoantibodies in patients receiving CPI therapy, including pembrolizumab, and this research project builds on this scientific knowledge, expanding the discovery antigen set and focusing on recurrence among patients treated with pembrolizumab in the adjuvant setting.

New Academic Collaborations expand use of ImmunoINSIGHTS Technology Platform into CAR-T and CAR-NK Cell Therapies with New Academic Collaborations

Additionally, the Company is also in the final stages of agreeing two new collaborations with world-leading US-based academic institutes. These new collaborations will in part focus on new market segments for our existing technology platform, including chimeric antigen receptor cell therapy cells ("CAR-T") and chimeric antigen receptor natural killer cells ("CAR-NK"). CAR-T and CAR-NK cell therapies are some of the fastest growing segments in the pharmaceutical market globally and represent significant clinical and commercial growth opportunities for the ImmunoINSIGHTS business.

Dr Adam M Hill, CEO of Oncimmune said: "Earlier this month we reported on the commercial momentum we have experienced in Q2 FY2022 and committed to update investors on further commercial progress before the end of the calendar year. We are therefore delighted to announce the signing of this MSA with a leading global pharma group, which has enabled the awarding of a contract utilising our ImmunoINSIGHTS autoantibody biomarker service and a second contract expected to be signed in the next few days. We are also excited to have signed the agreement with EORTC for a profiling collaboration for the important, much-needed drug, KEYTRUDA.

"These agreements further demonstrate the applicability and significance of our ImmunoINSIGHTS service to key players within both the pharmaceutical industry and research field and represents another endorsement of the capabilities of ImmunoINSIGHTS to contribute to medical innovation. We also have forthcoming collaborations with two leading US-based academic institutions within CAR-T and CAR-NK represent an exciting expansion of our technology platform into these fast-growing markets.

"These contracts announced today and earlier this month underpin the commercial momentum we are currently experiencing and we look forward to building on this in the coming months."

1 CIU, also known as hives, is a skin disease which is often caused by an allergic reaction to food or drugs. In a small number of cases, the disease is chronic and of unknown cause.

2 Hassel, J.C., et al. (2020). Autoantibodies as predictors for survival and immune-related adverse events in checkpoint inhibition therapy of metastasised melanoma. J. Clin. Oncol. 38, 10011-10011.

For further information:

Oncimmune Holdings plc

Dr Adam M Hill, Chief Executive Officer

Matthew Hall, Chief Financial Officer

contact@oncimmune.co.uk

Singer Capital Markets (Nominated Adviser and Joint Broker)

Aubrey Powell, Harry Gooden, George Tzimas, James Fischer

+44 (0)20 7496 3000

WG Partners (Joint Broker)

David Wilson, Nigel Barnes

+44 (0)203 705 9321

Media enquiries:

FTI Consulting

Ben Atwell, Michael Trace, Alex Davis

Oncimmune@fticonsulting.com

+44 (0)20 3727 1000

About Oncimmune

Oncimmune is a leading immunodiagnostics developer, primarily focused on the growing fields of immuno-oncology, autoimmune disease and infectious diseases. Oncimmune has a diversified and growing revenue both from its portfolio of diagnostic products to detect early-stage cancer and its contract discovery and development service business whose platform delivers actionable insights into therapies to the Company's pharmaceutical and biotech partners.

Our understanding of the immune system enables us to harness its sophisticated response to disease to detect cancer earlier and to support the development of better therapies. The key to improving cancer survival is early detection and better selection for therapy. As a company, we are driven by our passion to improve cancer survival and to give people extra time.

Oncimmune's ImmunoINSIGHTS platform enables life science organisations to optimise drug development and delivery, leading to more effectively targeted and safer treatments for patients. Oncimmune's immunodiagnostic technology, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis. Our lead diagnostic test, EarlyCDT Lung, targets a vast market estimated to grow to £3.8bn by 2024. With over 200,000 tests already performed for patients worldwide and its use being supported by peer reviewed data in over 12,000 patients, we are poised to become an integral component of future lung cancer detection programmes, globally.

Oncimmune's diagnostic products business is located at its laboratory facility in Nottingham, UK and its ImmunoINSIGHTS service business at its discovery research centre in Dortmund, Germany. The ImmunoINSIGHTS business development team are based in the US and Europe and Oncimmune is seeking to replicate the Dortmund facility in the US in the medium term.

For more information, visit www.oncimmune.com

About the EORTC

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.

For further information, please visit www.eortc.org

What is ImmunoINSIGHTS?

The ImmunoINSIGHTS service business leverages Oncimmune's technology platform and methodologies across multiple diseases, to offer life-science organisations actionable insights for therapies across the development and product lifecycle. Our core immune-profiling technology is underpinned by our library of over eight thousand immunogenic proteins, one of the largest of its kind. This helps identify trial participants and patients into clinically relevant subgroups, enabling development of targeted and more effective treatments.

What is SeroTag?

Oncimmune's proprietary biomarker discovery engine, which is leveraged in our ImmunoINSIGHTS services to discover and validate novel biomarkers can help stratify patients in multiple cancer indications and with different autoimmune diseases.

This high-throughput, multiplex technology is based on one of the largest, in-house protein libraries, as well as a unique, ever-growing repository of disease data for indications including, but not limited to, autoimmune diseases and cancer. As a result, SeroTag is helping to address and monitor a number of challenges currently hindering the successful development and broader application of both cancer immunotherapies and treatments for autoimmune diseases.

The platform is being applied to discover and validate biomarkers and develop precision diagnostic tools from minimally invasive liquid biopsies. SeroTag analyses autoantibodies-some of the most stable analytes-and is used most frequently for the identification of IgG isoforms, in addition to IgM and IgA, from just a few drops of serum.

The SeroTag platform acts as the primary discovery engine that feeds into the creation of Oncimmune's NavigAIDTM disease-specific stratification panels. These precision medicine tools which are enabling patient and disease stratification and support therapeutic development.