Interleukin-7(Cytheris SA)

NANTES, France I July 24, 2024 I OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today reported first positive results from its CoTikiS randomized, double-blind, placebo-controlled, Proof of Concept phase 2 study of Lusvertikimab, a pure antagonist of IL-7 receptor, demonstrating significant efficacy results measured by the improvement of the Modified Mayo Score** (at week 10 primary endpoint of the treatment induction phase). A favorable safety profile was observed during both the induction phase and during the 6 months of open-label extension phase trial. Nicolas Poirier, Chief Executive Office of OSE Immunotherapeutics , comments: “We are very excited to share these first positive Phase 2 efficacy results for Lusvertikimab in ulcerative colitis, a disabling chronic relapsing inflammatory bowel disease with a patient population in regular need of alternative new therapies. This clinical proof of concept study establishes Lusvertikimab as a potential first-in-class with novel therapeutic options, based on its differentiated mechanism of action as a pure interleukin-7 antagonist. We are optimistic about the potential for patients , these positive clinical efficacy and safety results represent a strong catalyst for future opportunities and enhances OSE presence in this growing field of chronic Immune inflammation. Frédérique Corallo, CMO Immuno-Inflammation commented:” We are very grateful to the patients who participated in this trial, study investigators, and the global team involved for their strong commitment to achieve this important clinical milestone ”. She added “ Lusvertikimab has shown very interesting efficacy results with the two doses tested at week-10, in particular on endoscopic improvement, and reinforced efficacy signal for 34 weeks in the open-label extension. A good safety profile was observed in the whole patient population. The full data set will be completed in a specific communication and presented at future medical congresses. Lusvertikimab (OSE127) phase 2 Proof of Concept study vs Placebo in Patients with Moderate to Severe Active Ulcerative Colitis (NCT04882007 – CoTikiS) : The randomized, double-blind Phase 2 clinical trial CoTikiS has evaluated the efficacy and the safety of Lusvertikimab versus placebo in 136 patients with moderate to severe active UC who failed, lost response, or were intolerant to previous treatment(s)*. Primary endpoint was the efficacy assessment of Lusvertikimab versus placebo on the reduction of the Modified Mayo score** at week 10. Primary endpoint** : a significant decrease of the Modified Mayo Score (MMS) is achieved versus placebo at week 10: The 850 mg group (n=50, Placebo n=49) in the principal analysis obtained significant results at week 10 versus Placebo on the improvement of the MMS with a -0.82 (95%CI: -1.63. -0.01) difference µ in treatment effect between lusvertikimab and placebo (p=0.047). The 450 mg group (n=35, Placebo n=49) obtained significant results versus placebo (the 450 mg group was considered as exploratory as prematurely interrupted***) with a difference µ of -1.17 (95%CI: -2.18; -0.16) between lusvertikimab and placebo (p=0.023). The global treatment effect is significant considering the 450+850mg groups together versus placebo showing a difference µ of -0.88 (95%CI: -1.64; -0.12) between lusvertikimab and placebo (p= 0.024). Safety results: no safety signal was reported by the Data Safety Monitoring Board during the trial . Both doses of lusvertikimab show favorable safety profile in comparison with placebo, with similar rates of adverse events across the 3 treatment groups. * Previous corticosteroids, Immunosuppressive agents or previous biological treatments ** Ulcerative Colitis is a chronic inflammatory disease of the rectum and colon characterised by mucosal inflammation, abdominal pain associated with symptoms and frequency of diarrhoea and rectal bleeding. The moderate to severe UC is measured by a Modified Mayo Score ( MMS) between 4 and 9, inclusive . The primary endpoint is the mean change at Week 10 from baseline in the Modified Mayo Score, a Disease Activity Index for UC defined by the addition of the stool frequency and the rectal bleeding sub-scores (two patient’s clinical elements as Patient Reported Outcomes) and the endoscopic sub-score (mucosal endoscopy activity), assessed by an endoscopist through a central reading platform. µ Least Square Mean Difference between lusvertikimab and placebo=difference between groups of the Mean change in MMS between baseline and W10 (Analysis of Covariance model) *** An interim Futility analysis performed early (33% of patients) by the IDMC proposed interruption of the 450 mg group for risk of futility but not confirmed at final analysis. The 850 mg group was hence considered as primary analysis. About OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: OSE Immunotherapeutics expects to generate further significant value from its proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com . Click and follow us on X and LinkedIn SOURCE: OSE Immunotherapeutics

This regulatory milestone marks an acceleration of the process around NT-I7's potential first indication, after other recent positive news. NeoImmuneTech's NT-I7 has shown potential in nonclinical studies to address the immunosuppressive effects of ARS. ROCKVILLE, Md. , June 4, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to NT-I7 (efineptakin alfa) for the treatment of Acute Radiation Syndrome (ARS). This regulatory milestone follows the ODD granted to NT-I7 by the FDA in the US for the same indication in November 2023. It is the second ODD received by NT-I7 from the EMA, following the one granted in Idiopathic CD4+ Lymphocytopenia (ICL) in May 2017. ARS is a critical condition resulting from a high dose of radiation exposure, causing severe, sometimes fatal damage to the bone marrow and the immune system. Currently, there are no treatments available that effectively promote T cell recovery after such exposure. NT-I7, a novel long-acting human interleukin-7 (IL-7), has shown promise to accelerate T cell reconstitution and enhance the immune response, offering a potential solution for this medical unmet need. Clinical studies have shown that NT-I7 significantly boosts T cell counts, while maintaining a high level of safety and tolerability. NeoImmuneTech is actively developing NT-I7 in ARS through partnerships with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and Duke University. Recently, Duke University secured a $6 million grant from NIAID for NT-I7 development in ARS. Luke Oh, Ph.D., President and Chief Executive Officer of NeoImmuneTech, said: "We are thrilled to see the deep interest of the scientific and regulatory community around the potential use of NT-I7 as a medical countermeasure in ARS. The EMA Orphan Drug Designation marks a new milestone for us, following our recent pre-IND discussions we had with the FDA to accelerate our development program. It is an important acknowledgment of the potential that NT-I7 holds in providing a beacon of hope for the treatment of ARS." ODD is a status assigned to a medicine intended for use against a rare disease or condition. The designation provides incentives to advance the development of treatments for rare diseases, including reduced fees for multiple steps in the development process, such as protocol assistance, marketing authorization applications, and inspections before authorization. About Acute Radiation Syndrome (ARS) Acute Radiation Syndrome (ARS) is an acute illness caused by irradiation of the entire body by a high dose of penetrating radiation in a very short period of time (typically a matter of minutes or less). Examples of people who suffered from ARS are individuals exposed during the Hiroshima and Nagasaki atomic bombings, and the firefighters that responded after the Chernobyl Nuclear Power Plant incident in 1986.[1] About NT-I7 (efineptakin alfa) (rhIL-7-hyFc) NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. About NeoImmuneTech, Inc. NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and has a strong executive team with rich industry experience. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit . Forward-looking Statements The statements contained herein may contain certain forward-looking statements relating to NeoImmuneTech, Inc. (the "Company") that are based on its beliefs and expectations about the future. These forward-looking statements are based on a number of assumptions about the future, some of which are beyond the Company's control and are not a guarantee of future performance or developments. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that arise after the date of these documents. Accordingly, you should not place reliance on any forward-looking information or statements contained herein. Some of the data contained in these documents were obtained from various external sources, and the Company has not independently verified such data. Accordingly, the Company makes no representations as to the accuracy or completeness of the data, and such data involves risks and uncertainties and is subject to change based on various factors. [1] SOURCE The NeoImmuneTech, Inc