NANTES, France, Jan. 25, 2018 (GLOBE NEWSWIRE) — OSE Immunotherapeutics (ISIN:FR0012127173) (Mnémo:OSE), today announces that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent that further expands the Company’s intellectual property portfolio around Tedopi®, a combination of neoepitopes optimised to induce specific T activation in immuno-oncology.
The new patent extends the U.S. protection of Tedopi® to several combinations of neoepitopes (peptides from various tumourous antigens optimized to bind strongly with HLA-A2 and T lymphocyte receptors) for use in cancer treatment, complementary to those already covered under existing intellectual property. Tedopi®, being evaluated in a Phase 3 clinical trial in patients with advanced or metastatic non-small cell lung cancer (NSCLC), was previously granted orphan drug designation in the U.S. in this indication.
“Following this patent being granted in Europe, Australia, Canada and Japan, this allowance from the USPTO significantly strengthens the patent protection of Tedopi® and reinforces its position as a key product in our immuno-oncology portfolio. Patient accrual in the Phase 3 trial in advanced lung cancer will resume in the first quarter of 2018, upon approval by the competent authorities of the program’s new recruitment strategy, which is focused on a subgroup of patients who have failed a previous treatment with immune checkpoint inhibitors. The trial addresses a specific population for which there are currently no approved treatment options, and for which a significant medical need exists,” said Dominique Costantini, CEO of OSE Immunotherapeutics.
Tedopi® is a combination of 10 neoepitopes that generate a specific response from the T cytotoxic cells against the malignant cells, which express at least one of these tumorous antigens and an associated T helper response.
ABOUT OSE IMMUNOTHERAPEUTICS
Our ambition is to become a world leader in activation and regulation immunotherapies:
OSE Immunotherapeutics is a biotechnology company focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology, autoimmune diseases and transplantation. The company has several scientific and technological platforms: neoepitopes, agonist or antagonist monoclonal antibodies, ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical portfolio offers a diversified risk profile.
In immuno-oncology:
- Tedopi®, 10 combined neo-epitopes to induce a specific T lymphocyte activation. Phase III trial in advanced NSCLC: after temporary pause of new patient accrual end of June 2017, new recruitment strategy in December 2017, following the recommendation of the trial’s Independent Data Monitoring Committee, to focus the trial on patients who failed a previous treatment with a PD-1/PD-L1 immune checkpoint inhibitor. Enrollment will resume after formal approval of the new recruitment strategy from the Competent Authorities.
Phase II with Tedopi® in combination with an immune checkpoint inhibitor planned in advanced pancreatic cancer, in collaboration with GERCOR, a cooperative group of clinical research. - OSE-172, new generation checkpoint inhibitor targeting myeloid cells via the SIRP-α receptor – In preclinical development for several cancer models. Clinical program planned end of 2018.
- OSE-703, cytotoxic monoclonal antibody against the alpha chain of IL-7R – Under a research collaboration with Memorial Sloan Kettering Cancer Center, New York.
In auto-immune diseases and transplantation:
- FR104, CD28-antagonist in immunotherapy – Phase 1 trial completed – For the treatment of autoimmune diseases and for use with transplantation – Licensed to Janssen Biotech Inc. to pursue clinical development.
- OSE-127, interleukin receptor-7 antagonist – In preclinical development for inflammatory bowel diseases and other autoimmune diseases. Clinical phase planned end of 2018. License option agreement with Servier for the development and commercialization.
The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter global agreements at different stages of development with major pharmaceutical players.
Immunotherapy is a highly promising and growing market. By 2023 Immunotherapy of cancer could represent nearly 60% of treatments against less than 3% at present * and the projected market is estimated at $67 billion in 2018 **. There are more than 80 autoimmune diseases that represent a significant market including major players in the pharmaceutical industry with sales towards $10 billion for the main products. The medical need is largely unmet and requires the provision of new innovative products involved in the regulation of the immune system.
*Citi Research Equity
**BCC Research
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Contacts
| OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 143 297 857 French Media: FP2COM |
U.S. Media: LifeSci Public Relations Matt Middleman, M.D. matt@lifescipublicrelations.com +1 646 627 8384 U.S. and European Investors |
Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.
These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import.
Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance.
This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 28 April 2017 under the number R.17-038, including the annual financial report for the fiscal year 2016, available on the OSE Immunotherapeutics’ website.
Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.
