This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
OSE Immunotherapeutics
Limited Company (Société anonyme) with a Board of Directors with a capital of € 4 353 555.40
Registered office: 22 Boulevard Benoni Goullin 44200 Nantes
479 457 715 Nantes Trade and Companies Register
2023 UNIVERSAL REGISTRATION DOCUMENT INCLUDING THE ANNUAL FINANCIAL REPORT
This Universal Registration Document has been filed on April 30, 2024, with the AMF, as the competent authority and without its
prior approval, in accordance with Article 9 of (EU) Regulation 2017/1129. The Universal Registration Document may be used for
the purposes of a public offer of securities or the admission of securities to trading on a regulated market if it is supplemented by
a securities note and, where applicable, a summary and its supplement (s). The whole is approved by the AMF in accordance with
EU Regulation 2017/1129.
Pursuant to Article 19 of Regulation (EU) No 2017/1129 of the European Parliament and of the Council, the following information is incorporated by reference in this registration document:
- The consolidated financial statements and the corresponding audit reports appearing on pages 241 - 263 of the universal registration document for fiscal year 2022 filed with the AMF on April 28, 23 under No. D23-0386 (https://www.ose-immuno/financial-statements)
- The consolidated financial statements and the corresponding audit reports appearing on pages 190-263 of the universal registration document for fiscal year 2021 filed with the AMF on April 15, 2022, under No. D22-0298 (https://www.ose-immuno/financial-statements)
Parts not included in such document(s) are either irrelevant to the investor or covered elsewhere in the registration document or universal registration document.
Due to technical constraints, the update of the universal registration document is set on April 15, 2024 for a publication on April 30, 2024.
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
Copies of this Universal Registration Document are available, on request and free of charge, during normal business hours, at the registered office of OSE Immunotherapeutics, 22 Boulevard Benoni Goullin, 44200 Nantes, and on the Company's website www.ose-immuno.com, as well as on the AMF website (www.amf-france.org).
The information incorporated by reference should be read in accordance with the cross-reference table at the end of this Universal Registration Document. Any information not indicated in this cross-reference table but forming part of the documents incorporated by reference is provided for information purposes only.
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
WARNING
This Universal Registration Document and the documents incorporated herein by reference, contain information about the Company's objectives and development areas. This information is sometimes identified by the use of the future or conditional tense and by forward-looking terms such as "consider", "envisage", "think", "aim", "expect", "intend", "should", "aspire", "estimate", "believe", "wish", "may", or, where applicable, the negative form of these same terms, or any other variant or similar terminology.
The reader's attention is drawn to the fact that these objectives and development areas depend on circumstances or events whose occurrence or outcome is uncertain.
These objectives and development areas are not historical data and should not be interpreted as guarantees that the facts and data referenced will occur, that assumptions will be correct or that objectives will be achieved. By their very nature, these objectives may not be achieved and the statements or information appearing in this Universal Registration Document may prove to be erroneous, without the Company in any way being obliged to update them, subject to applicable regulations and, in particular, the French Financial Markets Authority's General Regulation and European Regulation No. 596/2014 of the European Parliament and of the Council of April 16, 2014 on market abuse (market abuse regulation).
Investors are advised to give careful consideration to the risk factors described in section 3 of this Universal Registration Document, "Risk factors", before making any investment decisions. The occurrence of some, or all, of these risks is likely to have a negative impact on the Company's business, financial position, net financial income or its objectives. In addition, other risks that the Company has not yet identified or considers immaterial, at the date of the present Universal Registration Document, may have the same negative impact and investors may lose all, or part, of their investment.
This Universal Registration Document also contains information about the Company's business as well as the market and industry in which it operates. This information is primarily taken from studies carried out by internal and external sources (analysts' reports, expert studies, industry publications and any other information published by market research companies, public corporations and bodies). The Company believes that this information gives a true and fair picture of the market and the industry in which it operates and faithfully reflects its competitive position. Although this information is considered to be reliable, it has not been independently verified by the Company and the Company cannot guarantee that a third party using different methods to gather, analyze or calculate this market data would obtain the same results. The Company, the Company's direct or indirect shareholders and investment services providers cannot give any assurances or guarantees as to the accuracy of this information.
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
Summary
1 RESPONSIBLE PERSONS, THIRD-PARTY INFORMATION, EXPERTS' REPORTS AND APPROVAL FROM THE COMPETENT
AUTHORITY | 11 | ||
1.1 | PERSON RESPONSIBLE FOR THE UNIVERSAL REGISTRATION DOCUMENT | 11 | |
1.2 | STATEMENT BY THE PERSON RESPONSIBLE FOR THE UNIVERSAL REGISTRATION DOCUMENT | 11 | |
1.3 | STATEMENT BY A PERSON ACTING AS AN EXPERT IN RESPECT OF THIS DOCUMENT | 11 | |
1.4 | THIRD-PARTYINFORMATION | 11 | |
1.5 | APPROVAL OF THE UNIVERSAL REGISTRATION DOCUMENT | 11 | |
2 | AUDITORS | 12 | |
2.1 | STATUTORY AUDITORS | 12 | |
2.2 | INFORMATION ON AUDITORS THAT HAVE RESIGNED, BEEN REMOVED OR NOT BEEN REAPPOINTED | 12 | |
3 | RISK FACTORS | 13 | |
3.1 | RISKS LINKED TO THE DEVELOPMENT OF DRUG CANDIDATES | 15 | |
3.1.1 | Risks linked to product development | 15 | |
3.1.2 | Risks linked to the completion of the clinical and preclinical phases of its products in development | 16 |
3.1.3 Risks of sub-contractor default (in particular those linked to clinical study outsourcing and product
manufacturing) | 19 | ||
3.1.4 | Risk of dependency or operational delay in relation to programs under development | 20 | |
3.1.5 | Risks linked to the immuno-therapeutic approaches selected by the Company | 23 | |
3.2 | RISKS LINKED TO THE PARTNERSHIP STRATEGY | 26 | |
3.2.1 | Risks linked to research and dependency on current and future partnerships | 26 | |
3.2.2 | Risks linked to potential conflicts could affect the Company's relationship with its licensees | 30 | |
3.3 | RISKS LINKED TO MARKETING | 31 | |
3.3.1 | Risks linked to obtaining a Marketing Authorization (MA) | 31 | |
3.3.2 | Risks linked to the lack of commercial success of the products | 31 | |
3.3.3 | Risks linked to changes in drug reimbursement policies | 33 | |
3.4 | RISKS LINKED TO CAPITAL REQUIREMENTS | 33 | |
3.4.1 | Risks linked to uncertain additional fundings | 33 | |
3.4.2 | Risks linked to the availability of public grants and research tax credits | 37 | |
3.4.3 | Valuation of intangible assets and impairment tests | 37 | |
3.5 | RISKS LINKED TO INTELLECTUAL PROPERTY RIGHTS | 37 | |
3.5.1 | Risks linked to uncertain protection of patents and other intellectual property rights | 37 | |
3.5.2 | Risks linked to legal liability, in particular product liability risks | 38 | |
3.5.3 | Risks linked to patents and intellectual property rights held by third parties | 39 | |
3.6 | RISK LINKED TO THE CONTROL SYSTEM FOR FOREIGN INVESTORS IN FRANCE | 39 | |
3.7 | INSURANCE AND RISK COVERAGE | 40 | |
3.8 | EXCEPTIONAL EVENTS AND LITIGATION | 41 | |
4 | INFORMATION ABOUT THE ISSUER | 42 | |
4.1 | COMPANY NAME | 42 | |
4.2 | PLACE OF REGISTRATION AND REGISTRATION NUMBER | 42 |
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
4.3 | DATE AND TERM OF INCORPORATION | 42 |
4.4 | REGISTERED OFFICE, LEGAL FORM AND LEGISLATION | 42 |
5 BUSINESS OVERVIEW | 43 | |
5.1 | PRINCIPAL ACTIVITIES | 43 |
5.1.1 | Proprietary products in clinical development | 43 |
5.1.2 | Clinical products developed in partnership | 57 |
5.1.3 | Myeloid checkpoint inhibitor platform | 65 |
5.1.4 | Pro-resolutive monoclonal antibody platform | 66 |
5.1.5 | Cytokine platform | 67 |
5.1.6 | Research and Development | 68 |
5.2 | PRINCIPAL MARKETS | 68 |
5.2.1 | Immuno-oncology market | 68 |
5.2.2 | Immuno-inflammatory disease market | 70 |
5.2.3 | Renal Transplant Market | 71 |
5.2.4 | Chronic Inflammation Market | 71 |
5.3 | IMPORTANT EVENTS IN THE DEVELOPMENT OF THE COMPANY'S BUSINESS | 72 |
5.4 | STRATEGY AND OBJECTIVES | 75 |
5.4.1 | A dynamic partnership development strategy based on a portfolio of innovative products | 76 |
5.4.2 | Clinical development of proprietary products | 77 |
5.4.3 Research & Development: active pursuit of new innovative research programs, proprietary research platforms,
evolution of the product portfolio to clinical phase | 79 | |
5.5 | RESEARCH & DEVELOPMENT, PATENTS AND LICENSES | 80 |
5.5.1 | Industrial property | 80 |
5.5.2 | Brands and domain names | 102 |
5.6 | COMPETITIVE POSITION | 102 |
5.6.1 | NSCLC treatments | 102 |
5.6.2 | Existing second-line therapies for advanced lung cancer and choice of comparator for Phase 3 | 104 |
5.6.3 | Immuno-Inflammation | 108 |
5.7 | INVESTMENTS | 116 |
5.7.1 | Key investments made by the Company | 116 |
5.7.2 | Future key investments | 116 |
5.7.3 Information on joint ventures or companies in which the Company holds a capital share likely to have a significant
impact on the valuation of its assets and liabilities, its financial position or results | 116 | ||
5.7.4 | Environmental impacts of investments made by the Company | 116 | |
6 | ORGANIZATIONAL STRUCTURE | 118 | |
6.1 | OVERVIEW OF THE COMPANY | 118 | |
6.2 | SUBSIDIARIES AND INVESTMENTS | 118 | |
7 | REVIEW OF THE FINANCIAL POSITION AND RESULTS | 119 | |
7.1 | FINANCIAL POSITION | 119 | |
7.2 | OPERATING PROFIT | 120 | |
7.2.1 | Key factors affecting operating revenues | 120 |
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
7.2.2 | Explanation of material changes in revenue or net income in the comparative annual financial statements | 121 |
8 CAPITAL RESOURCES | 122 | |
8.1 | INFORMATION ON THE ISSUER'S CAPITAL | 122 |
8.2 | CASH FLOW | 123 |
8.2.1 | Statement of cash flow | 123 |
8.3 | FINANCING REQUIREMENTS AND STRUCTURE | 124 |
8.3.1 | Financing requirements | 124 |
8.3.2 | Financing structure | 124 |
8.4 RESTRICTIONS ON THE USE OF CAPITAL RESOURCES THAT HAVE MATERIALLY AFFECTED, OR COULD MATERIALLY AFFECT, DIRECTLY OR INDIRECTLY, THE
ISSUER'S OPERATIONS | 130 | ||
8.5 | EXPECTED FINANCING SOURCES | 130 | |
9 REGULATORY ENVIRONMENT | 131 | ||
9.1 | INTRODUCTION | 131 | |
9.2 | PRECLINICAL STUDIES | 131 | |
9.3 | CONDUCT AND REGULATION OF CLINICAL TRIALS | 132 | |
9.3.1 | Clinical trial authorization in the European Union | 132 | |
9.3.2 | Authorization of clinical trials in the United States | 134 | |
9.3.3 | Publication of information on clinical trials | 134 | |
9.4 | REGULATION OF MARKETING AUTHORIZATIONS | 134 | |
9.4.1 | Community procedures | 135 | |
9.4.2 | Registration procedures outside the EU | 136 | |
9.4.3 | Exceptions to the usual registration procedures | 136 | |
9.4.4 | Orphan drugs | 137 | |
9.5 | FRENCH SUNSHINE ACT - TRANSPARENCY OF INTERESTS | 138 | |
10 | INFORMATION ON TRENDS | 139 | |
10.1 | MAIN TRENDS SINCE THE END OF THE LAST FISCAL YEAR | 139 |
10.2 TRENDS, UNCERTAINTIES, DEMANDS, COMMITMENTS OR EVENTS THAT ARE REASONABLY LIKELY TO HAVE A MATERIAL EFFECT ON THE COMPANY'S PROSPECTS 143
11 | PROFIT/(LOSS) FORECASTS OR ESTIMATES | 144 | |
12 | ADMINISTRATIVE, MANAGEMENT AND SUPERVISORY BODIES, AND SENIOR MANAGEMENT | 145 | |
12.1 | MANAGEMENT AND DIRECTORS | 145 | |
12.1.1 | Composition of the Board of Directors | 145 | |
12.1.2 | Composition of the operational management team | 148 | |
Disclosures about the Management team and directors | 149 | ||
12.1.3 | Potential conflicts of interest of the members of the Board of Directors and Executive Management | 149 | |
13 | COMPENSATION AND BENEFITS | 150 | |
13.1 | TOTAL GROSS COMPENSATION FOR MEMBERS OF THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT | 150 | |
13.2 | AMOUNTS PROVISIONED OR RECOGNIZED BY THE COMPANY FOR THE PURPOSE OF PAYING PENSIONS, RETIREMENT OR OTHER BENEFITS | 159 | |
14 | OPERATING PROCEDURES OF THE ADMINISTRATIVE AND MANAGEMENT BODIES | 160 | |
14.1 | OPERATING PROCEDURES AND TERMS OF OFFICE OF THE MEMBERS OF THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT | 160 | |
14.1.1 | Board of Directors (Articles 19 to 22 of the bylaws) | 160 |
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14.1.2 | Executive Management (Articles 23 to 26 of the bylaws) | 164 |
14.2 INFORMATION ON THE SERVICE CONTRACTS BETWEEN THE MEMBERS OF THE BOARD OF DIRECTORS AND THE EXECUTIVE MANAGEMENT AND THE
COMPANY OR ONE OF ITS SUBSIDIARIES | 165 |
14.2.1 Agreements between the Company, a director, the Chief Executive Officer or a Deputy Chief Executive Officer..165
14.3 | COMMITTEES | 165 | |
14.3.1 | Audit Committee | 166 | |
14.3.2 | Appointments and Compensation Committee | 167 | |
14.3.3 | Scientific Advisory Board | 168 | |
14.4 | STATEMENT ON CORPORATE GOVERNANCE | 168 | |
14.5 | CHANGES TO THE CORPORATE GOVERNANCE | 169 | |
15 | EMPLOYEES | 170 | |
15.1 | HUMAN RESOURCES | 170 | |
15.1.1 | Number of employees | 170 | |
15.2 | EMPLOYEE SHAREHOLDING AND STOCK OPTIONS | 170 | |
15.2.1 | Share subscription warrants (BSA) and founders' share warrants (BSPCE) | 170 | |
15.2.2 | Free share allocations | 173 | |
15.3 | INCENTIVE AND PROFIT-SHARINGCONTRACTS | 173 | |
16 | MAIN SHAREHOLDERS | 174 | |
16.1 | CHANGES IN SHAREHOLDING STRUCTURE | 174 | |
16.1.1 | Changes in shareholding over 2 years | 174 | |
16.1.2 | Distribution of capital on the registration date of this Universal Registration Document | 174 | |
16.2 | DOUBLE VOTING RIGHTS | 174 | |
16.3 | CONTROL OF THE ISSUER | 174 | |
16.4 | AGREEMENTS THAT MAY LEAD TO A CHANGE IN CONTROL | 174 | |
17 | RELATED-PARTY TRANSACTIONS | 175 | |
17.1 | SIGNIFICANT AGREEMENTS WITH RELATED PARTIES | 175 | |
17.1.1 | Agreement between Company subsidiaries and shareholders | 175 | |
17.1.2 | Transactions with related parties | 175 |
18 FINANCIAL INFORMATION CONCERNING THE ISSUER'S ASSETS, LIABILITIES, FINANCIAL POSITION AND PROFIT OR
LOSS 177
18.1 FINANCIAL INFORMATION CONCERNING THE HISTORICAL FINANCIAL INFORMATION'S ASSETS, LIABILITIES, FINANCIAL POSITION AND PROFIT OR
LOSS 177
18.1.1 | Historical financial information | 177 |
18.1.2 | Change of accounting reference date | 195 |
18.1.3 | Accounting standards | 195 |
18.1.4 | Change of accounting standards | 195 |
18.1.5 | Annual financial statements for the fiscal year ended December 31, 2023 | 195 |
18.1.6 | CONSOLIDATED ACCOUNTS FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023 | 235 |
18.2 | INTERIM FINANCIAL INFORMATION | 290 |
18.3 | AUDITING OF HISTORICAL ANNUAL FINANCIAL INFORMATION | 290 |
18.3.1 | Auditing of historical annual financial information | 290 |
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18.3.2 | Other information audited by statutory auditors | 290 | |
18.3.3 | Other information non-audited by statutory auditors | 290 | |
18.4 | PRO FORMA FINANCIAL INFORMATION | 290 | |
18.5 | DIVIDEND POLICY | 290 | |
18.5.1 | Dividend payment policy | 290 | |
18.5.2 | Dividends paid in the last three fiscal years | 291 | |
18.6 | LEGAL AND ARBITRATION PROCEEDINGS | 291 | |
18.7 | SIGNIFICANT CHANGE IN FINANCIAL POSITION | 291 | |
19 | ADDITIONAL INFORMATION | 292 | |
19.1 | SHARE CAPITAL | 292 | |
19.1.1 | Issued capital | 292 | |
19.1.2 | Non-equity shares | 292 | |
19.1.3 | Treasury shares | 292 | |
19.1.4 | Potential capital | 292 |
19.1.5 Information on requirements governing any acquisition right and/or any obligation attached to authorized, but
not issued, capital or on any Company aiming to increase the capital | 296 |
19.1.6 Information on the share capital of any member of the Group that is subject to an option or conditional or
unconditional agreement to place it under option | 297 | |
19.1.7 | Table of the history of the Company's share capital | 298 |
19.2 | COMPANY'S CONSTITUTION AND BYLAWS AS OF THE DATE OF THIS UNIVERSAL REGISTRATION DOCUMENT | 299 |
19.2.1 | Company's purpose (Article 2) | 299 |
19.2.2 | Rights attached to shares (Articles 11 to 18) | 299 |
19.2.1 Company bylaws, charters or regulations that may have the effect of delaying, postponing or preventing a change of control. 303
20 | IMPORTANT CONTRACTS | 304 |
21 | PUBLICLY AVAILABLE DOCUMENTS | 305 |
22 | GLOSSARY | 306 |
APPENDIX A - BOARD OF DIRECTORS' MANAGEMENT REPORT | 310 | |
APPENDIX B - THE COMPANY'S RESULTS OVER THE LAST FIVE YEARS | 342 | |
APPENDIX C - CORPORATE GOVERNANCE REPORT | 343 | |
APPENDIX D - CORPORATE SOCIAL RESPONSABILITY (CSR) CHARTER | 377 | |
4. APPENDIX E - CROSS-REFERENCE TABLES | 385 |
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
OSE IMMUNOTHERAPEUTICS IN BRIEF
A strategy based on the development of a clinical portfolio of first-in-class assets in immuno-oncology and immuno-inflammation, and on three innovative preclinical platforms
OSE Immunotherapeutics is a clinical-stage biotechnology company specializing in therapeutic innovations in immuno-oncology and immuno-inflammation. Its Research and Development platforms are based on its recognized expertise in T lymphocyte cell immunity and myeloid cell immunity. A wealth of experience established in these two fields has enabled the development of leading "First6-in-class" products that the Company develops directly or through partnerships with the pharmaceutical industry actively seeking new therapies.
Clinical stage portfolio
Tedopi® is a therapeutic cancer vaccine activating T cells, based on modified epitopes selected from tumor antigens and being developed in Phase 3 clinical stage. The product activates T lymphocytes capable of killing tumor cells that they have learned to recognize. This product has obtained significant clinical results versus chemotherapy in Non-Small Cell Lung Cancer (NSCLC) in third line treatment in patients with secondary resistance after failure of checkpoint inhibitors [Anti PD-(L) 1] where therapeutic need is very important.
A confirmatory Phase 3 clinical trial, associated with a companion diagnostic test to identify HLA-A2-positive cancer patients eligible for treatment with Tedopi®, is under preparation to support Tedopi®'s registration as standard treatment in second line NSCLC patients with secondary resistance after failure of checkpoint inhibitors.
The specific dossier for a companion diagnostic test and the full dossier to initiate the new confirmatory Phase 3 trial of Tedopi® have received a positive review from the FDA (Food & Drug Administration) early 2024, what should enable a trial initiation in the United States in Q2 2024, and extension to Europe in S2 2024.
Patients can benefit from Tedopi® through compassionate use programs in third or further lines of treatment (post-chemotherapy and immunotherapy) currently approved in France, Italy and Spain, confirming thereby the significant medical need for new therapeutic alternatives.
Other Phase 2 clinical trials of Tedopi® in combination are ongoing with international clinical research groups.
OSE-279 is an anti-PD1 antibody that blocks a T lymphocyte brake enabling activation of non-specific T cells in oncology. It is currently in Phase 1/2 clinical trial in advanced solid tumors. Preliminary positive clinical efficacy and tolerance results have been reported so far, including a high anti-tumor response rate in difficult to treat patients. OSE-279 is also the "backbone" component of a technology called BiCKI® for new original bispecific or bifunctional therapies.
OSE-127(Lusvertikimab) is an interleukin-7 receptor (IL-7R) antagonist monoclonal antibody involved in the survival of pathogenic T lymphocytes. It is being evaluated in a Phase 2 clinical trial in ulcerative colitis, an autoimmune disease where T lymphocytes are involved. OSE-127 (Lusvertikimab) is the most advanced anti-IL-7R under clinical development, with a strong rationale in patients suffering from chronic Inflammatory Bowel Diseases (IBD) and refractory to current immunotherapies.
In March 2024, the Company announced completion of patient enrolment in this Phase 2 study conducted in ulcerative colitis. Top- line efficacy results after the induction phase (primary endpoint at week 10) and the first early assessment after six months of therapy in open-label extension are expected mid-2024.
In addition, OSE-127 (Lusvertikimab) is being developed in preclinical stage in Acute Lymphoblastic Leukemias (ALL), an indication for which the EMA (European Medicines Agency) provided a positive opinion on Orphan Drug Designation, opening future potential new indications in ALL, rare diseases with limited treatment options.
FR 104/VEL-101 is a "first-in-class"anti-CD28 monoclonal antibody capable of blocking T lymphocytes, pathogenic in transplant and autoimmune diseases, developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation indications.
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
A Phase 1/2 clinical trial (named FIRsT study) is ongoing in renal transplant under the sponsorship of the Centre Hospitalier Universitaire de Nantes. Patient enrolment in FIRsT was completed in July 2023. A longer-termfollow-up assessment is performed one year after transplantation.
In December 2023, a positive interim analysis of the study has shown the safety of the product used in combination and the first signals of efficacy in these kidney transplant recipients.
Another Phase 1 clinical trial was conducted and sponsored by Veloxis to evaluate FR104/VEL-101 subcutaneously. This trial was successfully completed in early 2023.
Following on from these two results, Veloxis plans to continue developing the product subcutaneously in an international Phase 2 study in kidney transplantation.
BI 765063 (OSE-172)and BI 770371 are anti-SIRPα monoclonal antibodies, a target expressed on myeloid cells on the SIRPα/CD-47 axis, developed in partnership with Boehringer Ingelheim in advanced solid tumors. The positive results of the Phase 1 dose escalation clinical trial as a single agent and in combination with ezabenlimab (Boehringer's PD1 antagonist) have enabled the initiation of two ongoing Phase 1 cohort expansion trials, in particular in head and neck cancer and in hepatocellular carcinoma.
In parallel, Boehringer Ingelheim is studying BI 770371 (IgG1 monoclonal antibody recognizing both the V1 and V2 variants of SIRPα) as a monotherapy and in combination with a PD1 inhibitor (ezabenlimab) in an international Phase 1 dose escalation/expansion clinical trial in patients with solid tumors.
Three preclinical platforms
The Myeloid checkpoint inhibitor platform is focused on optimizing the therapeutic potential of myeloid cells (macrophages, dendritic cells) in immuno-oncology. A first research program, SIRPα, was licensed to Boehringer Ingelheim. A second research program is ongoing on the therapeutic target, CLEC-1, a novel checkpoint inhibitor expressed by myeloid cells and discovered by the OSE Immunotherapeutics' research team in collaboration with Dr Elise Chiffoleau's team (Center for Translational Research in Transplantation and Immunology in Nantes).
The Pro-resolutivemonoclonal antibody platform is focused on controlling myeloid cell-mediated inflammation (macrophages, neutrophils). In the resolution of inflammation, OSE-230, developed in partnership with AbbVie as part of the exclusive global license and collaboration agreement signed in February 2024, is a first ChemR23 agonist antibody expressed on myeloid cells, with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity. The preclinical results, from various chronic inflammatory diseases, make of OSE-230 a first candidate for clinical stage as a new therapeutic class. The Company's research team is exploring other targets.
The Cytokine platform is focused on delivering the potential of modified cytokines in immuno-oncology and in auto-immune diseases. Preclinical efficacy results of the IL-7 modified cytokine merged with anti-PD1 antibody OSE-279(BiCKI®-IL-7) were presented at several international congresses. This bifunctional therapy targets PD1 and simultaneously delivers the cytokine IL-7 to tumor-specificT-cells expressing PD1 through the "cis-targeting" process. This product is able to restore the function of exhausted T lymphocyte cells, a frequent cause of clinical escape of anti-PD1. It increases T stem cells capable of reconstituting memory and effector T cells to increase antitumor efficacy.
The Company's registered office is based in Nantes, the Company has been listed on Euronext Paris since 2015 and has continued its development mainly through its industrial agreements. The future activities and financing of the Company depend on a combination of factors. OSE Immunotherapeutics should be able to continue to be financed, in particular through existing or future industrial agreements or other financing, if the work in progress proves positive, also taking into account the development of competitive therapies at different stages and the regulatory approval of innovations.
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OSE Immunotherapeutics SA published this content on 15 July 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 July 2024 14:07:03 UTC.