OSE Immunotherapeutics and Boehringer Ingelheim Extend Their Collaboration to Develop First-in-class Treatments in Cancer and Cardiovascular, Renal and Metabolic Diseases
Thursday, May 23, 2024
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) and Boehringer Ingelheim today announce a major expansion of their collaboration.
Two new projects aimed at developing first-in-class treatments are added to the anti-SIRPα programs already under development in immuno-oncology. The first concerns the opening of a new therapeutic area for the active ingredient already developed in partnership, it will concern a larger number of patients. The second concerns the acquisition of a new asset:
- An amendment to the current collaboration and license agreement relating to the anti-SIRPα programs BI 765063 and BI 770371 (under clinical evaluation in Phase 1 studies in advanced solid tumors) provides for the extension of the development of these programs to cardiovascular, renal and metabolic diseases (CVRM).
- A new preclinical program will also be launched to develop immune cell activation treatments via the acquisition of an active ingredient from the anti-PD1/cytokine 'cis-targeting' 1 platform developed by OSE.
Affecting more than a billion people worldwide 2 , CVRM diseases are responsible for 20 million deaths per year. These diseases are interconnected, co-exist and can reinforce each other, causing a significant burden on patients' lives. Cancer causes almost 10 million deaths per year and for many patients there is no treatment or only limited treatment options.
The new development programs strengthen Boehringer Ingelheim's portfolio and reflect its strong commitment to explore and advance new treatments addressing unmet patient needs, particularly in CVRM diseases and cancer. The active ingredient from the anti-PD1/cytokine platform will expand the range of potential innovative immunomodulatory anticancer treatments from Boehringer Ingelheim. The ongoing development of anti-SIRPα antibodies in a new indication adds to the company's global CVRM portfolio with the start of a Phase 2 clinical study planned for later this year.
“We are very pleased to expand our portfolio of potential first-in-class treatments in both CVRM diseases and our portfolio of T cell-targeted cancer treatments ,” said Clive R. Wood, Corporate Senior Vice President. and Global Head of Discovery Research at Boehringer Ingelheim. “Expanding our partnership with OSE reflects our shared mission to improve the outcomes of patients affected by two of the world’s greatest health threats.”
Nicolas Poirier, CEO of OSE Immunotherapeutics, comments: “We are delighted to add two new, highly innovative development programs to our successful collaboration with Boehringer Ingelheim. We look forward to working with our partner’s scientific teams on these programs which could bring breakthrough new therapeutic options to patients suffering from CVRM diseases or cancer.”
OSE Immunotherapeutics will receive a signing payment of €13.5 million and a potential near-term milestone payment of €17.5 million in connection with the purchase of the innovative preclinical asset from the anti-PD1/cytokine cis-targeting platform. Concerning the two ongoing anti-SIRPα programs BI 765063 and BI 770371, the two companies have agreed on a partial buyout of future royalties and a one-off payment of 25.3 million euros. Furthermore, Boehringer Ingelheim will benefit from an additional buy-back option during further development which will trigger a one-off payment as well as the increase of a milestone payment on sales. All other development, regulatory and sales milestone payments up to €1.1 billion are maintained, as agreed between the parties in their initial agreement.
ABOUT BOEHRINGER INGELHEIM
Boehringer Ingelheim is a biopharmaceutical company active in human and animal health. As one of the sector's largest investors in research and development, the laboratory aims to develop innovative treatments in areas where there are significant unmet medical needs. Independent since its creation in 1885, Boehringer Ingelheim relies on a long-term vision, integrating sustainable development throughout its value chain. More than
53,500 employees work in more than 130 countries to build a healthier, more sustainable and more equitable future.
To learn more, visit www.boehringer-ingelheim.com .
ABOUT OSE I mmunotherapeutics
OSE Immunotherapeutics is a biotechnology company developing first-in-class products in immuno-oncology (IO) and immuno-inflammation (I&I). Its first-in-class clinical portfolio includes:
- Tedopi® (specific T lymphocyte activation immunotherapy against cancer cells, “ off-the-shelf ” based on neo-epitopes): the Company's most advanced product; positive results from the Phase 3 trial (Atalante 1) in non-small cell lung cancer (NSCLC) in patients with secondary resistance after failure of a checkpoint inhibitor. Other trials, promoted by clinical groups in oncology, of Tedopi® in combination are underway in solid tumors.
- OSE-279 (anti-PD1): First positive results from the ongoing Phase 1/2 study in solid tumors.
- OSE-127 - Lusvertikimab (humanized monoclonal antibody antagonist of the IL-7 receptor): Phase 2 in progress in ulcerative colitis (promoter OSE Immunotherapeutics); ongoing preclinical research work in leukemia (OSE Immunotherapeutics).
- FR104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; Phase 1/2 underway in kidney transplantation (under the promotion of the Nantes University Hospital Center); Phase 1 successfully completed in the United States (promoter Veloxis Pharmaceuticals, Inc.).
- BI 765063 and BI 770371 (anti-SIRPα monoclonal antibodies on the SIRPα/CD-47 axis): developed in partnership with Boehringer Ingelheim (BI) in advanced solid tumors; positive results from Phase 1 dose escalation in monotherapy and in combination, in particular with the anti-PD1 antibody ezabenlimab; BI-promoted international Phase 1b ongoing in combination with ezabenlimab alone or with other drugs in relapsed or metastatic head and neck cancer and hepatocellular carcinoma.
- OSE-230 (ChemR23 agonist monoclonal antibody) developed in partnership with AbbVie in chronic inflammation.
OSE Immunotherapeutics aims to create significant value through its three patented research platforms, central to its goal of delivering first-in-class, next-generation immunotherapy treatments :
- Pro-resolving monoclonal antibody platform that aims to improve the resolution of inflammation and optimize the therapeutic potential of targeting neutrophils and macrophages in I&I. OSE-230 (licensed to AbbVie) is the first candidate from this platform, other research programs are underway on new GPCR targets.
- Myeloid checkpoint platform that aims to optimize the therapeutic potential of myeloid cells in IO by targeting regulatory immune receptors expressed by macrophages and dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidates generated by this platform. Other research programs are underway, in particular the new anti-CLEC-1 monoclonal antibody which has shown positive preclinical results as a monotherapy.
- Bifunctional Checkpoint Inhibitor/Cytokine platform dedicated to optimizing Cis-delivery of cytokines in IO and I&I. BiCKI® is a bifunctional fusion protein platform built around a central anti-PD-1 backbone fused to novel immunotherapy targets to increase anti-tumor efficacy.
More information on OSE Immunotherapeutics' assets is available on the Company's website: http://ose-immuno.com
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Contacts
Boehringer Ingelheim
Communication Innovation Unit
Corporate Affairs Group
T +49 (6132) 77-90815
reinhard.malin@boehringer-ingelheim.com
OSE Immunotherapeutics
Sylvie Détry
sylvie.detry@ose-immuno.com
Nicolas Poirier
Chief Executive Officer
nicolas.poirier@ose-immuno.com
French Media: FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 6 07 768 283
U.S. Media Contact
RooneyPartners LLC
Kate Barrette
kbarrette@rooneypartners.com>
+1 212 223 0561
Forward-Looking Statements
This release contains, implicitly or expressly, information and statements that may be deemed forward-looking regarding OSE Immunotherapeutics. They do not constitute historically proven facts. This information and statements include financial projections based on assumptions or assumptions made by the management of OSE Immunotherapeutics in light of their experience and their perception of historical trends, current economic and industry conditions, future developments and other factors that they consider appropriate.
These forward-looking statements can often be identified by the use of the conditional tense and by the verbs "expect", "anticipate", "believe", "plan" or "estimate" and their variations and conjugations as well as by other similar terms. Although the management of OSE Immunotherapeutics believes that these forward-looking statements are reasonable, OSE Immunotherapeutics shareholders and other investors are alerted to the fact that their achievement is inherently subject to numerous known and unknown risks and uncertainties, which are difficult to predict. and outside the control of OSE Immunotherapeutics. These risks may cause actual results and developments to differ materially from those indicated or implied in these forward-looking statements. These risks include in particular those developed or identified in public documents filed by OSE Immunotherapeutics with the AMF. Such forward-looking statements constitute no guarantee of future performance. This press release only includes summary elements and should be read in conjunction with the Universal Registration Document of OSE Immunotherapeutics, registered by the AMF on April 30, 2024, including the 2023 annual financial report, available on the OSE website Immunotherapeutics. OSE Immunotherapeutics undertakes no obligation to update forward-looking information and statements except as required by applicable laws and regulations.
1. Cis-targeting: Bispecific antibodies have the ability to target cells in a cis or trans binding orientation. In trans binding, the antibody recognizes two different antigens, each expressed on a population of cells distinct from the other, and can link together two different populations of cells (e.g., "engager" T cells). The cis-binding bispecific antibody targets two antigens expressed on the same cell, allowing preferential activation of the desired types of immune cells while minimizing activation of other cells (Segués A. et al. International Review of Cell and Molecular Biology 2022).
2. Schechter M, Melzer Cohen C, Yanuv I, et al. Epidemiology of the diabetes-cardio-renal spectrum: a cross-sectional report of 1.4 million adults. Cardiovascular Diabetology. 2022;21(1):104. doi:10.1186/s12933-022-01521-9
Source: globenewswire.com
