[8-K] iBio, Inc. Reports Material Event
iBio, Inc. announced new preclinical pharmacokinetic data for IBIO-610, a potentially first-in-class Activin E antibody. In obese non-human primates, IBIO-610 showed an extended half-life of 33.2 days. Using an allometric scaling model for half-life–extended antibodies, the company reports a predicted human half-life of up to 100 days, which could lower dosing to once every six months and improve patient experience.
The data will be presented by Cory Schwartz, Ph.D., during an oral session at ObesityWeek 2025 in Atlanta, held November 4–7, 2025. The announcement was shared via press release furnished with this report, which includes forward-looking statement disclosures.
iBio, Inc. ha annunciato nuovi dati farmacocinetici preclinici per IBIO-610, un anticorpo Activin E potenzialmente di prima classe. Nei primati non umani obesi, IBIO-610 ha mostrato un'emivita estesa di 33,2 giorni. Utilizzando un modello di scalamento allometrico per anticorpi con emivita estesa, l'azienda riporta un'emivita umana prevista fino a 100 giorni, il che potrebbe ridurre la somministrazione a una volta ogni sei mesi e migliorare l'esperienza del paziente.
I dati saranno presentati da Cory Schwartz, Ph.D., durante una sessione orale a ObesityWeek 2025 a Atlanta, dal 4 al 7 novembre 2025. L'annuncio è stato condiviso tramite comunicato stampa fornito con questo rapporto, che include divulgazioni sulle dichiarazioni previsionali.
iBio, Inc. anunció nuevos datos farmacocinéticos preclínicos para IBIO-610, un anticuerpo Activin E potencialmente de primera clase. En primates no humanos obesos, IBIO-610 mostró una vida media extendida de 33,2 días. Utilizando un modelo de escalado alométrico para anticuerpos con vida media extendida, la empresa informa una vida media humana prevista de hasta 100 días, lo que podría reducir la dosificación a una vez cada seis meses y mejorar la experiencia del paciente.
Los datos serán presentados por Cory Schwartz, Ph.D., durante una sesión oral en ObesityWeek 2025 en Atlanta, del 4 al 7 de noviembre de 2025. El anuncio se compartió vía un comunicado de prensa adjunto a este informe, que incluye divulgaciones sobre declaraciones prospectivas.
iBio, Inc.은 IBIO-610에 대한 새로운 전임상 약물동태 데이터를 발표했다, Activin E 항체의 잠재적으로 최초의 작용클래스. 비만한 비인간 영장류에서 IBIO-610은 반감기가 33.2일로 연장됐다. 반감기가 연장된 항체에 대한 등거리 규모화 모델을 사용하여 회사는 최대 100일의 인간 반감기를 예측하며, 이는 투여를 6개월마다 한 번으로 줄이고 환자 경험을 향상시킬 수 있다.
데이터는 Cory Schwartz 박사에 의해 ObesityWeek 2025의 애틀랜타에서 2025년 11월 4-7일 열리는 구두 발표 세션에서 발표될 예정이다. 이 발표는 이 보고서에 첨부된 보도자료를 통해 공유되었으며, 예측성 진술에 대한 공지가 포함되어 있다.
iBio, Inc. a annoncé de nouvelles données pharmacocinétiques précliniques pour IBIO-610, un anticorps Activin E potentiellement de première classe. Chez les primates non humains obèses, l'IBIO-610 a montré une demi-vie prolongée de 33,2 jours. En utilisant un modèle d'échelle allométrique pour les anticorps à demi-vie étendue, la société rapporte une demi-vie humaine prédite allant jusqu'à 100 jours, ce qui pourrait réduire les doses à une fois tous les six mois et améliorer l'expérience des patients.
Les données seront présentées par Cory Schwartz, Ph.D., lors d'une séance orale à ObesityWeek 2025 à Atlanta, du 4 au 7 novembre 2025. L'annonce a été communiquée via un communiqué de presse joint à ce rapport, qui comprend des divulgations relatives aux déclarations prospectives.
iBio, Inc. gab neue präklinische pharmakokinetische Daten zu IBIO-610 bekannt, ein potenziell erster-in-der-Klasse Activin E-Antikörper. Bei übergewichtigen nicht-menschlichen Primaten zeigte IBIO-610 eine verlängerte Halbwertszeit von 33,2 Tagen. Mithilfe eines allometrischen Skalierungsmodells für Halbwertszeit-erweiterte Antikörper meldet das Unternehmen eine prognostizierte menschliche Halbwertszeit von bis zu 100 Tagen, was die Dosierung auf alle sechs Monate reduzieren und die Patientenerfahrung verbessern könnte.
Die Daten werden von Cory Schwartz, Ph.D., während einer mündlichen Sitzung bei ObesityWeek 2025 in Atlanta vorgestellt, die vom 4. bis 7. November 2025 stattfindet. Die Ankündigung wurde über eine Pressemitteilung geteilt, die diesem Bericht beigefügt ist und Vorhersageaussagen enthält.
أعلنت iBio, Inc. عن بيانات حركية دوائية مخبرية جديدة لـ IBIO-610، وهو جسم مضاد Activin E يمكن أن يكون من فئة الأولى من نوعها. في الرئيسيات غير البشرية المصابة بالسمنة، أظهر IBIO-610 عُمر نصف ممتد قدره 33.2 يومًا. باستخدام نموذج قياس مقارن للنصف العمر للأجسام المضادة ذات النصف العمر الطويل، تقترح الشركة عمرًا نصفه بشري متوقع يصل إلى 100 يوم، وهو ما قد يقلل من عدد الجرعات إلى مرة كل ستة أشهر ويحسن تجربة المريض.
سيقدّم البيانات الدكتور كوري شوارتز، دكتوراه، خلال جلسة شفهية في ObesityWeek 2025 في أتلانتا، التي ستعقد في الفترة من 4 إلى 7 نوفمبر 2025. تم مشاركة الإعلان عبر بيان صحفي مُرفَق بهذا التقرير، الذي يتضمن إفصاءات حول البيانات التطلعية.
- None.
- None.
Insights
NHP PK shows long half-life; human benefit remains predictive.
iBio reports IBIO-610 half-life of 33.2 days in obese non-human primates. The company applies an allometric scaling model to estimate a human half-life of up to 100 days, implying potential twice-yearly dosing and a simpler treatment schedule.
These findings are preclinical and the 100-day figure is a model-based prediction. Real-world human pharmacokinetics can differ due to target engagement, distribution, and clearance characteristics not captured in animal data.
The next concrete step disclosed is an oral presentation at ObesityWeek on
iBio, Inc. ha annunciato nuovi dati farmacocinetici preclinici per IBIO-610, un anticorpo Activin E potenzialmente di prima classe. Nei primati non umani obesi, IBIO-610 ha mostrato un'emivita estesa di 33,2 giorni. Utilizzando un modello di scalamento allometrico per anticorpi con emivita estesa, l'azienda riporta un'emivita umana prevista fino a 100 giorni, il che potrebbe ridurre la somministrazione a una volta ogni sei mesi e migliorare l'esperienza del paziente.
I dati saranno presentati da Cory Schwartz, Ph.D., durante una sessione orale a ObesityWeek 2025 a Atlanta, dal 4 al 7 novembre 2025. L'annuncio è stato condiviso tramite comunicato stampa fornito con questo rapporto, che include divulgazioni sulle dichiarazioni previsionali.
iBio, Inc. anunció nuevos datos farmacocinéticos preclínicos para IBIO-610, un anticuerpo Activin E potencialmente de primera clase. En primates no humanos obesos, IBIO-610 mostró una vida media extendida de 33,2 días. Utilizando un modelo de escalado alométrico para anticuerpos con vida media extendida, la empresa informa una vida media humana prevista de hasta 100 días, lo que podría reducir la dosificación a una vez cada seis meses y mejorar la experiencia del paciente.
Los datos serán presentados por Cory Schwartz, Ph.D., durante una sesión oral en ObesityWeek 2025 en Atlanta, del 4 al 7 de noviembre de 2025. El anuncio se compartió vía un comunicado de prensa adjunto a este informe, que incluye divulgaciones sobre declaraciones prospectivas.
iBio, Inc.은 IBIO-610에 대한 새로운 전임상 약물동태 데이터를 발표했다, Activin E 항체의 잠재적으로 최초의 작용클래스. 비만한 비인간 영장류에서 IBIO-610은 반감기가 33.2일로 연장됐다. 반감기가 연장된 항체에 대한 등거리 규모화 모델을 사용하여 회사는 최대 100일의 인간 반감기를 예측하며, 이는 투여를 6개월마다 한 번으로 줄이고 환자 경험을 향상시킬 수 있다.
데이터는 Cory Schwartz 박사에 의해 ObesityWeek 2025의 애틀랜타에서 2025년 11월 4-7일 열리는 구두 발표 세션에서 발표될 예정이다. 이 발표는 이 보고서에 첨부된 보도자료를 통해 공유되었으며, 예측성 진술에 대한 공지가 포함되어 있다.
iBio, Inc. a annoncé de nouvelles données pharmacocinétiques précliniques pour IBIO-610, un anticorps Activin E potentiellement de première classe. Chez les primates non humains obèses, l'IBIO-610 a montré une demi-vie prolongée de 33,2 jours. En utilisant un modèle d'échelle allométrique pour les anticorps à demi-vie étendue, la société rapporte une demi-vie humaine prédite allant jusqu'à 100 jours, ce qui pourrait réduire les doses à une fois tous les six mois et améliorer l'expérience des patients.
Les données seront présentées par Cory Schwartz, Ph.D., lors d'une séance orale à ObesityWeek 2025 à Atlanta, du 4 au 7 novembre 2025. L'annonce a été communiquée via un communiqué de presse joint à ce rapport, qui comprend des divulgations relatives aux déclarations prospectives.
iBio, Inc. gab neue präklinische pharmakokinetische Daten zu IBIO-610 bekannt, ein potenziell erster-in-der-Klasse Activin E-Antikörper. Bei übergewichtigen nicht-menschlichen Primaten zeigte IBIO-610 eine verlängerte Halbwertszeit von 33,2 Tagen. Mithilfe eines allometrischen Skalierungsmodells für Halbwertszeit-erweiterte Antikörper meldet das Unternehmen eine prognostizierte menschliche Halbwertszeit von bis zu 100 Tagen, was die Dosierung auf alle sechs Monate reduzieren und die Patientenerfahrung verbessern könnte.
Die Daten werden von Cory Schwartz, Ph.D., während einer mündlichen Sitzung bei ObesityWeek 2025 in Atlanta vorgestellt, die vom 4. bis 7. November 2025 stattfindet. Die Ankündigung wurde über eine Pressemitteilung geteilt, die diesem Bericht beigefügt ist und Vorhersageaussagen enthält.
أعلنت iBio, Inc. عن بيانات حركية دوائية مخبرية جديدة لـ IBIO-610، وهو جسم مضاد Activin E يمكن أن يكون من فئة الأولى من نوعها. في الرئيسيات غير البشرية المصابة بالسمنة، أظهر IBIO-610 عُمر نصف ممتد قدره 33.2 يومًا. باستخدام نموذج قياس مقارن للنصف العمر للأجسام المضادة ذات النصف العمر الطويل، تقترح الشركة عمرًا نصفه بشري متوقع يصل إلى 100 يوم، وهو ما قد يقلل من عدد الجرعات إلى مرة كل ستة أشهر ويحسن تجربة المريض.
سيقدّم البيانات الدكتور كوري شوارتز، دكتوراه، خلال جلسة شفهية في ObesityWeek 2025 في أتلانتا، التي ستعقد في الفترة من 4 إلى 7 نوفمبر 2025. تم مشاركة الإعلان عبر بيان صحفي مُرفَق بهذا التقرير، الذي يتضمن إفصاءات حول البيانات التطلعية.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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Item 7.01. Regulation FD Disclosure.
On October 30, 2025, iBio, Inc. (the “Company”) issued a press release announcing new preclinical data from its obese non-human primate (NHP) study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate supported by preclinical data. The data will be presented by Cory Schwartz, Ph.D., Director of Research and Early Development of the Company, during an oral session at ObesityWeek 2025, taking place November 4, 2025 through November 7, 2025 in Atlanta.
Results from the obese NHP study evaluating IBIO-610 are set forth below:
The pharmacokinetic data, to be presented at ObesityWeek, demonstrates IBIO-610 has an extended half-life in obese NHP of 33.2 days. Based on an allomeric scaling model of half-life extended antibodies, it is predicted IBIO-610 will have a half-life in humans of up to 100 days, reducing the dosing frequency to once every six months, which has the potential to significantly improve patient experience.
PK of IBIO-610 in NHPs and Allometric Scaling Predicting Human Half-life
The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
Item 8.01. Other Events.
On October 30, 2025, the Company issued a press release announcing new preclinical data from its obese NHP study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate supported by preclinical data. The data will be presented by Cory Schwartz, Ph.D., Director of Research and Early Development of the Company, during an oral session at ObesityWeek 2025, taking place November 4, 2025 through November 7, 2025 in Atlanta.
Results from the obese NHP study evaluating IBIO-610 are set forth below:
The pharmacokinetic data, to be presented at ObesityWeek, demonstrates IBIO-610 has an extended half-life in obese NHP of 33.2 days. Based on an allomeric scaling model of half-life extended antibodies, it is predicted IBIO-610 will have a half-life in humans of up to 100 days, reducing the dosing frequency to once every six months, which has the potential to significantly improve patient experience.
PK of IBIO-610 in NHPs and Allometric Scaling Predicting Human Half-life
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
| Description |
99.1 | Press Release issued by iBio, Inc., dated October 30, 2025 | |
104 | Cover Page Interactive Data File (embedded within the XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: October 30, 2025 | IBIO, INC. | ||
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By: | /s/ Marc A. Banjak | ||
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| Name: | Marc A. Banjak |
Title: | Chief Legal Counsel | ||
FAQ
What did iBio (IBIO) announce in its 8-K?
What is IBIO-610?
What were the key NHP results for IBIO-610?
What is the predicted human half-life for IBIO-610?
How often could IBIO-610 be dosed in humans based on the model?
Where and when will the data be presented?
Does the announcement include forward-looking statements?
