Bellus Health (Innodia), Inc.

MIAMI BEACH, Fla., April 08, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), (“SAB” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced their Chief Medical Officer, Dr. Alexandra Kropotova, MD, MBA will share an overview of the SAB-142 clinical development plan and anticipated milestones at the INNODIA Annual Meeting in Leuven, Belgium on April 11, 2024. SAB will be featured as a key partner at the upcoming global T1D meeting. INNODIA accelerates the development of disease modifying therapies for T1D by supporting medicine developers with the following services: teams of leading experts to advise medicine developers; a best-in-class network of accredited clinical trial sites in Europe; a gateway to top notch professionals and research labs working on T1D; and access to a qualified community of people and families living with T1D. INNODIA Managing Director Manuela Battaglia, Ph.D, said of the partnership, “SAB-142 is an exciting therapy in development, and we are optimistic about partnership opportunities for upcoming clinical trials with this novel agent. Our partnership will provide SAB – as with all our partners – access to our network of clinical trial sites and T1D experts as we work together to accelerate this important therapy.” “INNODIA has been an exceptional partner as we move our SAB-142 development plan forward,” noted Dr. Kropotova. “There is urgent and unmet global need for disease-modifying autoimmune therapies that address the underlying cause of disease, and we look forward to working with INNODIA’s network of clinicians and scientists as we advance SAB-142 and work to delay the progression of type 1 diabetes.” Dr. Kropotova’s presentation will highlight the latest developments and upcoming milestones from the company’s lead clinical program, SAB-142, a novel biologic being developed for delaying onset and progression of Type 1 diabetes in adults and children. About INNODIA INNODIA is the largest European Network dedicated to preventing and curing type 1 diabetes (T1D) and represents the point of contact between those who want to develop new therapies and those who have the tools and experience to do so. With the aim of spurring transformational innovation in T1D, INNODIA provides full support to SMEs, biotechs, and other entities that might otherwise not invest in T1D R&D due to high barriers to entry and low returns (www.innodia.org). INNODIA convenes entities often with different incentives but united in the desire to address the same unifying unmet medical need: the lack of definitive cures for people living with type 1 diabetes. About SAB Biotherapeutics, Inc. SAB Biotherapeutics (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets type 1 diabetes (T1D) with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: https://www.SAB.bio/ and follow SAB on Twitter and LinkedIn. Forward-Looking Statements Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including the development and efficacy of our T1D program, and other discovery programs, the closing of each tranche of the Company’s previously announced private placement offering, the timely funding to the Company by each investor in the private placement offering, financial projections and future financial and operating results (including estimated cost savings and cash runway), the outcome of and potential future government, and other third-party collaborations or funded programs. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, each as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Media Relations:khollon@sab.bio Investor Relations:matt@milestone-advisorsllc.com

Exceeded target enrollment with 110 patients randomized across 28 clinical sites in Europe, the United States and Australia Efficacy proof-of-concept data from IMPACT is expected in Q1 2024. Following the positive interim biomarker analysis reported earlier last year, these data results will inform final Phase 3 protocol design while also further supporting IMCY-0098 and our Imotope™ mode of action Critical unmet need remains for effective prevention strategies or curative therapies in Type 1 diabetes beyond insulin replacement that can delay disease onset or arrest progression and improve patient quality of life LIEGE, BELGIUM / ACCESSWIRE / March 1, 2023 / Imcyse, a clinical-stage biopharmaceutical company pioneering the development of a new class of active and specific immunotherapies for the treatment of severe autoimmune diseases, today announced completion of patient enrollment in its Phase 2 IMPACT ( IM CY-0098 P roof of AC tion in T ype 1 Diabetes) trial of its lead product candidate IMCY-0098, a proinsulin-derived Imotope™ engineered to halt the progression and prevent early-onset Type 1 diabetes (T1D). "Reaching the enrollment target is a key milestone in our effort to advance IMCY-0098 as a disease-modifying treatment and clinical proof of concept for the Imotope™ platform," said Denis Bedoret, CEO of Imcyse. "Imcyse has made significant strides in the past year evolving into a clinical-stage company, with two candidates now in clinical development and other programs advancing towards the clinic. We are encouraged by the strength of our IMCY-0098 data to date, including our Phase 1 EXALT study and the IMPACT biomarker interim analysis, and we look forward to reporting topline IMPACT results in the first quarter of 2024." Jean Van Rampelbergh, CCDO of Imcyse added: "The potential of Imotopes™ to not only slow but also halt disease progression represents an innovative therapeutic approach that could transform the T1D treatment landscape. The successful recruitment of IMPACT has been the result of a fantastic collaboration with our partners, and we would like to thank INNODIA, T1D UK, as well as all clinical trial physicians and staff, including in Australia, Lithuania and the US, for their dedication to this program." IMPACT is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, dose comparison study designed to evaluate proof of concept efficacy of IMCY-0098 in adults with newly diagnosed T1D. The study is conducted in collaboration with INNODIA, the largest European T1D network comprised of 40 members, including academic institutions, industrial partners and patient organizations. The study exceeded its recruitment target, with a total of 110 patients enrolled and randomized across 28 clinical sites in Europe, the United States and Australia. Patients are randomized 1:1:1 to receive multiple doses plus a booster of 450 μg IMCY-0098, 1350 μg IMCY-0098 or placebo. The primary endpoint is the change from baseline in C-peptide level. Secondary endpoints include hemoglobin A1C levels, insulin use and continuous glucose monitoring. In addition, biomarker analysis will characterize the immune signature induced by IMCY-0098. Topline results are expected in the first quarter of 2024, based on the 48-week follow up period built into the study. Data from a previously reported interim biomarker analysis of the Phase 2 IMPACT study showed that IMCY-0098 treatment induces an insulin-specific cytolytic CD4+ immune signature, concomitant with prevention of the expansion of insulin-specific pathogenic Th17 T-cells. In addition, IMCY-0098 demonstrated a favorable safety and tolerability pro the Phase 1 EXALT trial, with no statistically significant difference in adverse events between placebo group and treated group. Results from the Phase 2 IMPACT trial are expected to inform the design of a Phase 3 trial. "Type 1 diabetes is a debilitating, lifelong disease linked to a multitude of other problems that impact overall health. There remains a critical unmet need for effective prevention strategies or causal therapies beyond insulin replacement that can improve patient quality of life," commented Prof. Dr. Chantal Mathieu Principal Investigator of the IMPACT study and Coordinator at T1D consortium INNODIA . "Imcyse's immunotherapy approach is very promising as it targets the underlying cause of the disease by reprogramming the immune system so that it no longer attacks and destroys insulin-producing beta cells in the pancreas. I am delighted to see that recruitment in the Phase 2 trial is now complete, and I look forward to the further development of this promising candidate." The IMPACT clinical trial is supported by the Walloon Region of Belgium under grant agreement N° 8234. For more information on this clinical trial, please visit: , NCT04524949. ### ABOUT TYPE 1 DIABETES In T1D, beta-cells in the pancreas are destroyed due to an improper immune response. This damage to the pancreas causes the organ to stop producing insulin, the hormone that controls blood-sugar levels. In most cases, the onset of T1D occurs in children and adolescents, but it can also affect adults. ABOUT IMCY-0098 IMCY-0098, the Company's most advanced Imotope™ in development, is designed to halt the progression of diabetes by stopping the body's immune system from attacking beta-cells. With early intervention the aim is to preserve the pancreas' ability to produce insulin and allow patients to manage the disease without the need for daily insulin injections. The Imcyse approach is unique and distinct to general tolerance induction or overall "immune-suppression". Imotopes™ specifically target the autoimmune pathway without harming the rest of the immune system. ABOUT IMCYSE Imcyse is a clinical stage biopharmaceutical company pioneering the development of a new class of active specific immunotherapies for the treatment of severe chronic autoimmune diseases. The company's unique technology platform allows it to locally target immune cells involved in the destruction of the diseased organ. This platform is based on the administration of Imotopes™, which are synthetic peptides encompassing a T cell epitope and an active thioredox motif. , Imotopes™ generate cytolytic CD4 T-cells that specifically eliminate autoantigen-presenting cells and autoantigen-specific lymphocytes involved in the disease pathways. Imcyse's approach, sustained over time, may help to prevent and treat diseases with no current therapeutic options and to potentially cure patients without impairing their immune defenses. The company has established proof of concept in several indications and has completed its first clinical trial in type 1 diabetes with promising results and is expecting top-line data from the fully enrolled Phase 2 study in 2024. A clinical Phase 1/2 clinical trial in Multiple Sclerosis (MS) was initiated in April 2022. Beyond type 1 diabetes and MS, Imcyse is developing a pipeline of Imotopes™ for the treatment of several autoimmune diseases in large and rare disease indications. Imcyse was founded as a spin-off from the Catholic University of Leuven and is headquartered in Liège, Belgium. ABOUT INNODIA INNODIA, a consortium of 40 European partners funded by the European Commission, brings together a large team of international academic researchers and the most important pharmaceutical companies active in diabetes research. The project has been launched to advance understanding of type 1 diabetes and develop tools and technologies that will allow health professionals to predict, evaluate and prevent the onset and progression of the condition. INNODIA has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115797 (INNODIA) and No 945268 (INNODIA HARVEST) as part of the Horizon 2020 European program. CONTACT: Imcyse S.A. Jean Van Rampelbergh Chief Clinical Development Officer Mail: contact@imcyse.com Investor Relations: Life Sci Advisors Chuck Padala, Managing Director Mail: chuck@lifesciadvisors.com Tel: +1-646-627-8390 For Media Inquiries: MC Services AG Anne Hennecke / Julia Bittner Mail: imcyse@mc-services.eu Tel.: +49 (0) 211-529-252-28 SOURCE: Imcyse View source version on accesswire.com: