SAB BIO Highlights Data in Multiple Presentations at EASD
SAB Biotherapeutics (NASDAQ: SABS) presented multiple studies at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD), highlighting data for their novel SAB-142 treatment for type 1 diabetes (T1D).
The presentations featured results from their Phase 1 clinical study of SAB-142, a fully human anti-thymocyte immunoglobulin (ATG), which demonstrated sustained immunomodulation without causing prolonged lymphodepletion. The company also shared data about SAB-142's pharmacokinetic profile and discussed the INNODIA-sponsored MELD-ATG study, which validated the disease-modifying potential of ATG therapy in T1D patients.
SAB BIO is currently initiating its Phase 2b SAFEGUARD study for SAB-142 in new-onset Stage 3 autoimmune T1D patients, collaborating with INNODIA and leading European T1D centers.
SAB Biotherapeutics (NASDAQ: SABS) ha presentato diversi studi durante la 61ª Riunione Annuale dell'Associazione europea per lo studio del diabete (EASD), evidenziando dati sul loro innovativo trattamento SAB-142 per il diabete di tipo 1 (T1D).
Le presentazioni hanno incluso i risultati del loro studio clinico di Fase 1 di SAB-142, un'immunoglobulina anti-tiomocita completamente umana (ATG), che ha dimostrato una modulazione immunitaria sostenuta senza causare una deplezione linfocitaria prolungata. L’azienda ha inoltre condiviso dati sul profilo farmacocinetico di SAB-142 e ha discusso lo studio MELD-ATG sponsorizzato da INNODIA, che ha convalidato il potenziale di modifica della malattia della terapia ATG nei pazienti con T1D.
SAB BIO sta attualmente avviando il suo studio di Fase 2b SAFEGUARD per SAB-142 in nuovi pazienti con diabete autoimmune T1D in fase avanzata (Stadio 3), collaborando con INNODIA e con i principali centri europei specializzati nel T1D.
SAB Biotherapeutics (NASDAQ: SABS) presentó varios estudios en la 61.ª Reunión Anual de la Asociación Europea para el Estudio de la Diabetes (EASD), destacando datos sobre su innovador tratamiento SAB-142 para la diabetes tipo 1 (DT1).
Las presentaciones incluyeron los resultados de su ensayo clínico de Fase 1 de SAB-142, una inmunoglobulina anti-timocito totalmente humana (ATG), que demostró una modulación inmunitaria sostenida sin causar una depleción linfocitaria prolongada. La compañía también compartió datos sobre el perfil farmacocinético de SAB-142 y discutió el estudio MELD-ATG patrocinado por INNODIA, que validó el potencial de modificación de la enfermedad de la terapia ATG en pacientes con DT1.
Actualmente, SAB BIO está iniciando su estudio de Fase 2b SAFEGUARD para SAB-142 en pacientes con diabetes autoinmune de onset reciente en estadio 3, colaborando con INNODIA y con los principales centros europeos de T1D.
SAB Biotherapeutics (NASDAQ: SABS)는 EASD(당뇨병 연구를 위한 유럽 학회) 61회 연례 회의에서 여러 연구를 발표하며, 신개발 SAB-142 치료법이 제시된 제1형 당뇏(T1D)에 대한 데이터를 강조했습니다.
발표에는 SAB-142의 1상 임상 연구 결과가 포함되어 있는데, 이는 전인간형(완전 인간) 항흉작 면역글로불린(ATG)으로서 지속적인 면역 조절을 보여주되, 장기간의 림포감소(depletion)를 유발하지 않는다는 점을 보여주었습니다. 또한 SAB-142의 약물동력학 프로필에 대한 데이터와 INNODIA 주관 MELD-ATG 연구를 논의했으며, ATG 치료의 질병 수정 가능성을 T1D 환자에서 확인했습니다.
SAB BIO는 현재 새로운 발병 3단계 자가면역 T1D 환자들을 대상으로 2상 2b SAFEGUARD 연구를 시작하고 있으며, INNODIA 및 유럽의 주요 T1D 센터들과 협력하고 있습니다.
SAB Biotherapeutics (NASDAQ: SABS) a présenté plusieurs études lors de la 61e Réunion Annuelle de l’Association Européenne pour l’Etude du Diabète (EASD), mettant en avant des données sur leur nouveau traitement SAB-142 pour le diabète de type 1 (DT1).
Les présentations incluaient les résultats de leur essai clinique de phase 1 de SAB-142, une immunoglobuline anti-thymocyte entièrement humaine (ATG), qui a démontré une modulation immunitaire soutenue sans provoquer une lymphodéplétion prolongée. L’entreprise a également partagé des données sur le profil pharmacokinetique de SAB-142 et a discuté de l’étude MELD-ATG sponsorisée par INNODIA, qui a validé le potentiel de modification de la maladie par la thérapie ATG chez les patients DT1.
SAB BIO lance actuellement son essai de phase 2b SAFEGUARD pour SAB-142 chez des patients atteints de DT1 auto-immune en stade 3 nouvellement diagnostiqués, en collaboration avec INNODIA et les principaux centres européens du diabète.
SAB Biotherapeutics (NASDAQ: SABS) präsentierte mehrere Studien auf dem 61. Jahrestreffen der European Association for the Study of Diabetes (EASD) und hob Daten zu ihrem innovativen SAB-142-Behandlungsmittel für Typ-1-Diabetes (T1D) hervor.
Die Präsentationen enthielten Ergebnisse ihrer Phase-1-Studie von SAB-142, einer vollständig menschlichen anti-T-Zell-Immunoglobulin (ATG), die eine anhaltende Immunmodulation zeigte, ohne eine lang anhaltende Lymphozytopenie zu verursachen. Das Unternehmen teilte zudem Daten zum pharmakokinetischen Profil von SAB-142 und diskutierte die INNODIA-gestützte MELD-ATG-Studie, die das krankheitsmodifizierende Potenzial der ATG-Therapie bei T1D-Patienten bestätigte.
SAB BIO beginnt derzeit mit der Phase-2b SAFEGUARD-Studie zu SAB-142 bei neu diagnostizierten Autoimmun-T1D-Patienten im Stadium 3, in Zusammenarbeit mit INNODIA und führenden europäischen T1D-Zentren.
SAB Biotherapeutics (NASDAQ: SABS) قد قدمت عدة دراسات في الاجتماع السنوي الحادي والستين للجمعية الأوروبية لدراسة السكري (EASD)، مع التركيز على بيانات علاج SAB-142 لمرض السكري من النوع الأول (T1D) الجديد.
تضمنت العروض نتائج دراسة المرحلة 1 السريرية لـ SAB-142، وهي جسيمات مناعية مضادّة للخلايا التيموكون (ATG) بشرية بالكامل، أظهرت تعديلًا مناعيًّا مستدامًا دون التسبب في استنزاف لمُدام للغدد اللمفاوية لفترة طويلة. كما قدمت الشركة بيانات عن الملف الدوائي الحركي لـ SAB-142 وناقشت دراسة MELD-ATG المدعومة من INNODIA التي أ verifiedpotنال احتمالية تعديل المرض بواسطة علاج ATG في مرضى T1D.
تقوم SAB BIO حاليًا ببدء دراسة المرحلة 2ب SAFEGUARD لـ SAB-142 عند مرضى T1D المناعيين حديثي الظهور في المرحلة 3، بالتعاون مع INNODIA وبمراكز رائدة في أوروبا لمرض السكري من النوع 1.
SAB Biotherapeutics (NASDAQ: SABS) 在第61届欧洲糖尿病研究协会（EASD）年会上展示了多项研究，重点介绍他们的新型 SAB-142 治疗 Type 1 糖尿病 (T1D) 的数据。
演示包括他们的 1 期临床研究结果，SAB-142 为一种完全人源的抗胸腺细胞免疫球蛋白（ATG），显示出持续的免疫调节作用而不会造成长期淋巴细胞耗竭。公司还分享了 SAB-142 的药代动力学特征数据，并讨论了由 INNODIA 赞助的 MELD-ATG 研究，该研究在 T1D 患者中验证了 ATG 疗法的疾病修饰潜力。
SAB BIO 目前正在启动其面向新发的 3 期自身免疫性 T1D 患者的 2b 期 SAFEGUARD 研究，并与 INNODIA 及欧洲领先的 T1D 中心合作。
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Insights
SAB's SAB-142 shows promising immunomodulatory effects without sustained lymphodepletion in T1D trials, positioning it as potentially best-in-class.
SAB Biotherapeutics presented multiple datasets at the European Association for the Study of Diabetes (EASD) conference highlighting their lead candidate SAB-142, a fully human anti-thymocyte immunoglobulin (ATG) for type 1 diabetes (T1D). The company's presentations focused on both preclinical and Phase 1 data as they advance into their Phase 2b SAFEGUARD study for newly-diagnosed T1D patients.
The Phase 1 data revealed a critical differentiation point from existing rabbit-derived ATG therapies - SAB-142 demonstrated sustained immunomodulation without causing prolonged lymphodepletion of CD4+ T-cells, which typically persists for up to two years with rabbit ATG. This pharmacological profile could translate to an improved safety profile while maintaining efficacy.
The pharmacokinetic data presented showed SAB-142 has dose-proportional and reproducible profiles with an optimal combination of short pharmacokinetics but sustained immunomodulatory effects extending to Day 120. Importantly, no major differences were observed between healthy volunteers and T1D patients in how they processed the drug.
Complementing SAB's presentations, the INNODIA-sponsored MELD-ATG study results provided external validation for the ATG approach, demonstrating that rabbit ATG met its primary endpoint of C-peptide preservation at 12 months. This study identified both effective standard (2.5 mg/kg) and minimum effective low doses (0.5 mg/kg), with the latter showing statistically significant improvements in glycemic control (HbA1c).
This wealth of data strengthens the scientific rationale for SAB-142 as the company progresses its clinical development program, leveraging partnerships with INNODIA and leading European T1D research centers that previously conducted the MELD-ATG study.
-As SAB initiates its Phase 2b SAFEGUARD study for SAB-142 in new-onset Stage 3 autoimmune T1D patients, EASD provided an opportunity to connect with many T1D thought leaders that will participate in the study-
-Data in multiple SAB presentations and INNODIA’s MELD-ATG study provide further validation for SAB-142 as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach poised to redefine treatment of T1D-
MIAMI, Sept. 19, 2025 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), (“SAB BIO” or the “Company”), a clinical-stage biopharmaceutical company that is developing human anti-thymocyte immunoglobulin (ATG) for delaying the onset or progression of type 1 diabetes (T1D), today highlighted multiple presentations made at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) held from September 15-19, 2025.
The Company had four oral presentations, as well as one invited presentation at an INNODIA-hosted symposium at EASD.
Samuel J. Reich, Chairman and CEO of SAB BIO, stated, “SAB was honored to present both preclinical and Phase 1 data for our multi-specific, fully human anti-thymocyte IgG, SAB-142, which is being evaluated for new-onset Stage 3 autoimmune T1D patients in our Phase 2b SAFEGUARD clinical study. At the conference, we also connected with global patient advocacy groups, principal investigators, and key opinion leaders, to continue building strong partnerships to support the success of this important trial.”
Select Presentation Highlights
- On September 15, 2025, Executive Vice President and Chief Medical Officer of SAB BIO, Alexandra Kropotova, M.D., presented at the EASD INNODIA-hosted symposium, “Working to Change the Lives of People Impacted by Type 1 Diabetes Through Unique Disease-Modifying Therapy”, on September 16, 2025, Dr. Kropotova presented “Immunomodulation without Sustained Lymphodepletion: SAB-142, a Fully Human Anti-Thymocyte Globulin”, and on September 18, 2025, presented “Mechanism of Action of a Fully Human Anti-Thymocyte Globulin, SAB-142, for the Treatment of Type 1 Diabetes”.
In all three presentations, Dr. Kropotova discussed how SAB-142 demonstrated a clinically validated, multi-specific mechanism of action with sustained immunomodulation in a Phase 1 clinical study. Further, SAB-142 does not cause a sustained lymphodepletion unlike rabbit ATG, which causes a decrease in CD4+ T-cells for up to two years. The Phase 1 study was a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose, adaptive design clinical study in 68 healthy volunteers and patients with established T1D. Based on results from the study, SAB-142 has the potential to be a best-in-class T1D immunotherapy.
- On September 18, 2025, Eric Sandhurst, Ph.D., Director, Program Management, at SAB BIO presented, “Novel Pharmacokinetic Assay for Measuring SAB-142, a Fully Human Anti-Thymocyte Globulin”, showing SAB-142 demonstrates a dose-proportional and reproductible pharmacokinetic (PK) profile, as measured by a novel PK assay that was validated for accuracy, precision, selectivity and range. Specifically, the study found that SAB-142 offers the optimal combination of a short PK profile and a sustained immunomodulatory effect out to Day 120 and that there were no major differences in the SAB-142 PK profile between healthy volunteers and T1D patients.
Dr. Alexandra Kropotova of SAB BIO commented, “SAB has been working closely with ATIC on advancing SAB-142 from its early days of clinical development and enrollment of Phase 1 patient cohort to the recently initiated Phase 2b SAFEGUARD study. ATIC is leading the charge to bring revolutionary disease modifying therapies to patients in the T1D field. We were very fortunate to be able to leverage their collaborative clinical trial network of leading researchers throughout Australia and New Zealand to have a timely completion of our Phase 1 trial of SAB-142.”
Additionally, at EASD, results from the INNODIA-sponsored MELD-ATG study confirmed the disease-modifying potential of rabbit ATG in new-onset Stage 3 autoimmune T1D patients. The trial met its primary endpoint of C-peptide preservation at 12 months with the 2.5 mg/kg dose, while also identifying 0.5 mg/kg as the minimum effective low dose. In addition, a favorable trend in metabolic outcomes was observed with statistically significant results for HbA1C improvement vs. placebo with the minimum effective low dose.
Mr. Reich commented on the results, “The MELD-ATG study findings presented today further demonstrate the great therapeutic potential of a multi-specific anti-thymocyte therapy for patients with newly diagnosed T1D. The study showed that patients who received rabbit ATG had statistically significant preservation of C-peptide and statistically significant improvement in glycemic control. These results strengthen our confidence and excitement in SAB’s fully human, multi-specific ATG because it has the same validated mechanism of action as rabbit ATG with the potential for an improved safety profile and the ability to re-dose patients which is critical in this patient population.”
INNODIA, which conducted the MELD-ATG study, serves as SAB’s key partner in Europe. Notably, SAB is collaborating with INNODIA and the same leading European T1D centers that recently completed the MELD-ATG study. The INNODIA organization and these centers will now bring their expertise to advance SAB-142 into a Phase 2b clinical study.
About MELD-ATG
Minimum Effective Low Dose (MELD)-anti-thymocyte globulin (ATG) was a Phase 2, double-blind, randomized, placebo-controlled, multi-arm, adaptive dose-ranging, parallel-cohort trial done in 14 accredited trial centers in eight European countries. The study evaluated rabbit ATG in participants aged 5–25 years, diagnosed with clinical, stage 3 type 1 diabetes 3–9 weeks before treatment.
About INNODIA
INNODIA is the largest European Network dedicated to preventing and curing type 1 diabetes 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. INNODIA accelerates the development of therapies to prevent and cure type 1 diabetes.
For more information, visit https://www.innodia.org/.
About EASD Annual Meeting
The EASD Annual Meeting is one of the largest diabetes conferences in the world, attracting thousands of delegates. The program showcases the latest results from basic and clinical research.
For more information, visit https://www.easd.org/annual-meeting/easd-2025/.
About SAB BIO
SAB BIO is a clinical-stage biopharmaceutical company focused on developing human, multi-specific, 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 autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D 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 BIO’s 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.
Forward-Looking Statements
Certain statements made in this current report 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 statements about the Company’s expectations regarding the completion, timing and size of the private placement, the potential exercise of warrants in the private placement, the Company’s expected cash runway, the intended use of the net proceeds, and the development and clinical trial results of the Company’s T1D program and other discovery programs.
These statements are based on the current expectations of SAB BIO 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, 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 BIO 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
Investor Relations:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Media Inquiries:
SAB BIO
Sheila Carlson
scarlson@sab.bio
FAQ
What were the key findings of SAB-142 Phase 1 clinical trial for type 1 diabetes?
What is the current development stage of SAB Biotherapeutics' SAB-142?
How did the MELD-ATG study results support SABS's development of SAB-142?
What makes SAB-142 different from existing ATG treatments?
Who is collaborating with SAB Biotherapeutics on the SAB-142 clinical trials?
