OSE Immunotherapeutics Introduces Novel Bispecific “Cis-Unmasking” Technology for Cytokine Drug Design with Improved Therapeutic Index

Friday, October 18, 2024

OSE Immunotherapeutics SA presents OSE-CYTOMASK, its novel bispecific Cis-Unmasking 1 cytokine technology during selected oral presentations for international conferences:

  • Festival of Biologics in Basel, Switzerland (October 17, 2024)
  • 16th Protein & Antibody Engineering Summit (PEGS) Europe Summit in Barcelona, ​​Spain (November 7, 2024 )
  • Antibody Therapeutics Xchange in Brussels (November 18, 2024)

OSE-CYTOMASK is a proprietary, innovative, non-cleavable linker technology that creates a new class of cytokine-based therapies with regulated and targeted activity. This technology would enable the delivery of highly active drugs with an improved therapeutic index. The communications highlight the design of this new technology through two first preclinical programs based on masked anti-PD1 cytokines (IL-2 and IL-15) in oncology, with conditional Cis-Unmasking and Cis-Potentiation of tumor-specific T cells expressing PD1 or other immune targets.

Aurore Morello, Director of R&D at OSE Immunotherapeutics , comments: “We are very pleased to present our novel OSE-CYTOMASK technology at renowned scientific conferences. Our innovative linker technology enables preferential and conditional “Cis-Unmasking” of cytokines, for example via targeting PD1 on tumor-specific T cells, without the need for protease cleavage technologies or cytokine mutagenesis to suppress the activity outside the tumor associated with significant toxicity of this class of drugs. The preclinical efficacy observed in monotherapy and the good safety profile of our two first selected drug candidates pave the way for a potential innovative and first-in-class treatment for patients awaiting new therapeutic options in oncology.”

Nicolas Poirier, CEO of OSE Immunotherapeutics , added: “We are proud of the breakthrough achieved by our research team on these new programs. This highly innovative technology promises to unlock the full potential of cytokines in oncology by significantly increasing the therapeutic index of this class of drugs. We are also interested in the potential applications of this new technology in the field of autoimmune and inflammatory diseases.”

Immunostimulatory cytokines are a class of highly potent drugs for reactivating the immune system against tumors. However, their narrow therapeutic index is associated with significant toxicity and limited drug exposure in the tumor microenvironment, which hinders their clinical development.

Current approaches to conditional cytokine masking, based on theoretical unmasking activity in the tumor microenvironment using linker technologies cleavable by enzymes produced more selectively by tumors, have already shown their limitations due to the heterogeneous expression of proteases in tumors (variable activation in the tumor depending on the patient) and the non-specific expression of these proteases in non-tumor sites (activation of the cytokine outside the tumor). We have designed an innovative recombinant non-cleavable linker technology, allowing conditional and specific delivery of cytokine activity only where it is needed, thanks to an original targeted "Cis-Unmasking" mechanism independent of protease expression.

The OSE-CYTOMASK technology was first used as a complement to our proprietary anti-PD1 bispecific BiCKI® platform to improve the therapeutic index of highly active cytokines (e.g. IL-2, IL-15…). The Company presented two first preclinical programs with a masked anti-PD1/IL-2 and a masked anti-PD1/IL-15 whose robust preclinical efficacy has been demonstrated in monotherapy with a high antitumor response and eradication rate in different models (e.g. orthotopic pancreatic tumor, melanoma or colon cancer) in the absence of dose-response toxicity. These results confirm a significant improvement in the therapeutic index of IL-2 and IL-15 thanks to the innovative OSE-CYTOMASK linker technology.

Presentation information

Festival of Biologics (October 17, 2024)
Presenter: Aurore Morello, PhD., Director of Research at OSE Immunotherapeutics
“OSE- Cytomask Technology: Cis-Demasking Cytokine Technology for targeted Delivery”

Protein & Antibody Engineering Summit (PEGS) Europe Summit ( November 7 , 2024 – 4:40 PM ) Presenter: Nicolas Poirier, PhD., CEO & Scientific Director of OSE Immunotherapeutics “OSE-CYTOMASK: Cis-Demasking Cytokine Technology with Non-Cleavable Linker”

Antibody Therapeutics Xchange ( November 18, 2024 - 09:05 - 10:05 )
Presenter: Aurore Morello, PhD., Director of Research at OSE Immunotherapeutics
“Addressing challenges faced for optimal bi-specific and Immunocytokines engineering”

About OSE Immunotherapeutics

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 pipeline includes:

  • Tedopi® ( off-the-shelf , neoepitope-based T-cell activation immunotherapy against cancer cells   ): 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; ongoing randomized Phase 3 registration trial (Artemia) in second-line NSCLC in HLA-A2+ patients with secondary resistance. Other trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors.
  • OSE-127 - Lusvertikimab (humanized monoclonal antibody antagonist of the IL-7 receptor): positive Phase 2 efficacy results in ulcerative colitis (CoTikiS study); preclinical research work in progress in leukemia.
  • OSE-279 (anti-PD1): First positive results from the ongoing Phase 1/2 study in solid tumors.
  • 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); Phase 1 successfully completed in the United States (promoter Veloxis Pharmaceuticals, Inc.).
  • Anti-SIRPα monoclonal antibodies developed in partnership with Boehringer Ingelheim (BI) in advanced solid tumors and cardiovascular, renal and metabolic (CVRM) diseases; positive Phase 1 dose escalation results in monotherapy and in combination; start of Phase 2 in CVRM diseases planned for the end of 2024.
  • ABBV-230 (ChemR23 agonist monoclonal antibody) developed in partnership with AbbVie in chronic inflammation.

Immunotherapeutics aims to create significant value through its three proprietary 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. ABBV-230 (licensed to AbbVie) is the first candidate from this platform, other research programs are underway on novel 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 770371 (licensed to Boehringer Ingelheim) is the most advanced candidate generated by this platform. Other research programs are ongoing, in particular the novel anti-CLEC-1 monoclonal antibody that has shown positive preclinical results as a monotherapy.
  • BiCKI® Platform , a bifunctional fusion protein platform built around an anti-PD1 backbone fused to novel immunotherapy targets to increase antitumor efficacy with cis-potentiating tumor-specific T cells. A first program was acquired by Boehringer Ingelheim. OSE-CYTOMASK is an innovative technology for the design of cytokine-based drugs with an improved therapeutic index.
  • Therapeutic mRNA platform that enables delivery of innovative RNA-encoded immunotherapy to the site of inflammation to locally control and/or suppress the immune response and inflammation.

More information on OSE Immunotherapeutics assets is available on the Company's website: http://ose-immuno.com
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Contacts

Sylvie Détry
sylvie.detry@ose-immun.com

Nicolas Poirier
Chief Executive Officer nicolas.poirier@ose-immun.com

French Media: FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 6 07 768 283

US Media Contact
RooneyPartners LLC
Kate Barrette
kbarrette@rooneypartners.com>
+1 212 223 0561

Forward-Looking Statements

This press release contains, either expressly or implicitly, information and statements that may be considered forward-looking statements concerning OSE Immunotherapeutics. They are not historical facts. These information and statements include financial projections that are based on assumptions or suppositions made by OSE Immunotherapeutics' management in light of their experience and their perception of historical trends, current economic and industry conditions, future developments and other factors that they believe to be appropriate.

These forward-looking statements can often be identified by the use of the conditional and by the verbs "expect", "anticipate", "believe", "plan" or "estimate" and their declensions and conjugations as well as by other similar words. Although OSE Immunotherapeutics' management believes that these forward-looking statements are reasonable, OSE Immunotherapeutics' shareholders and other investors are cautioned that their realization is subject by nature to numerous known or unknown risks and uncertainties, which are difficult to predict and beyond the control of OSE Immunotherapeutics. These risks may imply that actual results and developments actually achieved differ significantly from those indicated or induced in these forward-looking statements. These risks include in particular those developed or identified in the public documents filed by OSE Immunotherapeutics with the AMF. Such forward-looking statements are in no way a guarantee of future performance. This press release includes only summary information and should be read in conjunction with the OSE Immunotherapeutics Universal Registration Document, filed with the AMF on April 30, 2024, including the 2023 annual financial report, available on OSE Immunotherapeutics' website. OSE Immunotherapeutics does not undertake any obligation to update any forward-looking information or statements, except as required by applicable laws and regulations.

 

Source: globenewswire.com