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iBio Expands Cardiometabolic and Obesity Program with Anti-Myostatin Antibody Discovered Using its Proprietary Platform, In-Licensed from AstralBio

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iBio has expanded its cardiometabolic and obesity program by in-licensing an anti-myostatin antibody (IBIO-600) from AstralBio for $750,000 in common stock, with potential milestone payments up to $28 million. The antibody was discovered using iBio's proprietary technology and is designed for subcutaneous administration with extended half-life potential.

The company also launched a new bispecific antibody program targeting myostatin/activin A for obesity and cardiometabolic disorders treatment. In preclinical studies, IBIO-600 showed potent myostatin inhibition in human muscle cells and demonstrated 10-fold higher FcRn receptor binding affinity than normal IgG, suggesting potential for reduced dosing frequency. First data from non-human primate studies are expected in early 2025, with clinical investigations planned for 2026.

iBio ha ampliato il suo programma cardiometabolico e per l'obesità acquisendo un anticorpo anti-myostatin (IBIO-600) da AstralBio per 750.000 dollari in azioni ordinarie, con potenziali pagamenti per traguardi fino a 28 milioni di dollari. L'anticorpo è stato scoperto utilizzando la tecnologia proprietaria di iBio ed è progettato per una somministrazione sottocutanea con potenziale di lunga durata.

L'azienda ha anche lanciato un nuovo programma di anticorpi bispecifici che mirano a myostatin/activin A per il trattamento dell'obesità e dei disturbi cardiometabolici. Negli studi preclinici, IBIO-600 ha mostrato una potente inibizione della myostatin nelle cellule muscolari umane e ha dimostrato un'affinità di legame al recettore FcRn dieci volte superiore rispetto all'IgG normale, suggerendo un potenziale per una frequenza di somministrazione ridotta. I primi dati dagli studi su primati non umani sono attesi all'inizio del 2025, con indagini cliniche programmate per il 2026.

iBio ha ampliado su programa cardiometabólico y de obesidad al adquirir un anticuerpo anti-myostatin (IBIO-600) de AstralBio por 750.000 dólares en acciones ordinarias, con pagos potenciales por hitos de hasta 28 millones de dólares. El anticuerpo fue descubierto utilizando la tecnología propia de iBio y está diseñado para administración subcutánea con un potencial de vida media prolongada.

La empresa también lanzó un nuevo programa de anticuerpos bispecíficos que apunta a myostatin/activin A para el tratamiento de la obesidad y los trastornos cardiometabólicos. En estudios preclínicos, IBIO-600 mostró una potente inhibición de myostatin en células musculares humanas y demostró una afinidad de unión al receptor FcRn diez veces mayor que la IgG normal, sugiriendo un potencial para una frecuencia de dosis reducida. Se esperan los primeros datos de estudios en primates no humanos a principios de 2025, con investigaciones clínicas programadas para 2026.

iBio는 AstralBio로부터 750,000달러의 보통주로 항-myostatin 항체(IBIO-600)의 라이센스를 취득하여 심혈관 대사 및 비만 프로그램을 확대했습니다. 이 항체는 iBio의 독점 기술을 사용하여 발견되었으며, 피하 투여를 위해 설계되었고 긴 반감기 잠재력을 가지고 있습니다.

회사는 비만 및 심혈관 대사 질환 치료를 위한 myostatin/activin A를 목표로 하는 새로운 이중 특이성 항체 프로그램도 출시했습니다. 전임상 연구에서 IBIO-600은 인간 근육 세포에서 강력한 myostatin 억제를 보여주었고, 정상 IgG보다 10배 더 높은 FcRn 수용체 결합 친화성을 나타내어 투여 빈도를 줄일 가능성을 시사했습니다. 비인간 영장류 연구의 첫 데이터는 2025년 초에 예상되며, 임상 연구는 2026년에 예정되어 있습니다.

iBio a élargi son programme cardiométabolique et d'obésité en acquérant un anticorps anti-myostatine (IBIO-600) d'AstralBio pour 750 000 dollars en actions ordinaires, avec des paiements potentiels de jalons allant jusqu'à 28 millions de dollars. L'anticorps a été découvert grâce à la technologie propriétaire d'iBio et est conçu pour une administration sous-cutanée avec un potentiel de demi-vie prolongée.

L'entreprise a également lancé un nouveau programme d'anticorps bispécifiques ciblant myostatine/activin A pour le traitement de l'obésité et des troubles cardiométaboliques. Dans des études précliniques, IBIO-600 a montré une inhibition puissante de la myostatine dans les cellules musculaires humaines et a démontré une affinité de liaison au récepteur FcRn dix fois supérieure à celle de l'IgG normale, suggérant un potentiel pour une réduction de la fréquence des dosages. Les premières données des études sur les primates non humains sont attendues début 2025, avec des investigations cliniques prévues pour 2026.

iBio hat sein Programm zur Behandlung von Herz-Kreislauf-Erkrankungen und Fettleibigkeit durch den Erwerb eines Anti-Myostatin-Antikörpers (IBIO-600) von AstralBio für 750.000 Dollar in Stammaktien erweitert, mit potenziellen Meilensteinzahlungen von bis zu 28 Millionen Dollar. Der Antikörper wurde mithilfe der proprietären Technologie von iBio entdeckt und ist für die subkutane Verabreichung mit einem verlängerten Halbwertszeit-Potenzial konzipiert.

Das Unternehmen hat auch ein neues bispezifisches Antikörperprogramm ins Leben gerufen, das myostatin/activin A zur Behandlung von Fettleibigkeit und kardiometabolischen Störungen anvisiert. In präklinischen Studien zeigte IBIO-600 eine starke Myostatin-Hemmung in menschlichen Muskelzellen und wies eine zehnfach höhere FcRn-Rezeptorbindungsaffinität als normales IgG auf, was auf das Potenzial für eine reduzierte Dosierungsfrequenz hinweist. Erste Daten aus Studien mit nichtmenschlichen Primaten werden Anfang 2025 erwartet, klinische Untersuchungen sind für 2026 geplant.

Positive
  • In-licensed potentially best-in-class anti-myostatin antibody with extended half-life potential
  • Preclinical studies show 10-fold higher FcRn receptor binding affinity than normal IgG
  • Development costs to $750,000 in stock upfront, preserving cash
  • Rapid development timeline with clinical trials planned for 2026
Negative
  • Future milestone payments up to $28 million could impact cash flow
  • No clinical data available yet, only preclinical results
  • Additional stock issuance for upfront payment causes dilution

Insights

The in-licensing deal for IBIO-600 and launch of a bispecific antibody program represents a strategic expansion into the lucrative obesity and cardiometabolic therapeutics market. The $750,000 upfront payment in stock plus potential $28 million in milestone payments appears relatively cost-effective for accessing this technology. The 10-fold higher FcRn receptor binding affinity could enable less frequent dosing - a significant competitive advantage in the obesity market where patient compliance is crucial.

The dual approach targeting both myostatin and activin A through a bispecific antibody is scientifically sound, as these pathways work synergistically in muscle growth regulation. Early preclinical data showing potent myostatin inhibition in human muscle cells is promising, though the real test will be the upcoming NHP study results in early 2025.

With a modest market cap of $22.4 million, this deal structure intelligently preserves cash by using stock for the upfront payment. The milestone-heavy structure ($28 million) aligns incentives and reduces near-term financial burden. The obesity therapeutics market is projected to reach $100 billion by 2030, making this a high-potential revenue opportunity if successful.

The rapid 7-month development timeline from inception to NHP studies demonstrates efficient R&D execution and could accelerate time-to-market. However, investors should note that clinical trials are still >1 year away (2026) and substantial capital will be needed to fund development through approval.

This program targets a critical unmet need in the obesity market - the challenge of muscle loss during weight reduction. Current GLP-1 treatments like Wegovy and Zepbound don't directly address muscle preservation, creating an opportunity for differentiation. The extended half-life profile could enable monthly or less frequent dosing versus weekly GLP-1 injections, potentially improving the competitive position.

The combination approach with a bispecific antibody targeting both myostatin and activin A appears novel in the obesity space. If successful, this could create a new therapeutic class offering superior outcomes through simultaneous fat reduction and muscle preservation - a highly attractive profile for both patients and prescribers.

Building on the success of the anti-Myostatin program, iBio Launches New Program Featuring Myostatin + Activin A Bispecific Antibody Designed to Promote Weight Loss, Prevent Muscle Loss and Weight Regain, Potentially Enabling Less Frequent Dosing than Current Obesity Treatments

SAN DIEGO, Jan. 02, 2025 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA: IBIO), an AI-driven innovator of precision antibody immunotherapies, today announced the expansion of its cardiometabolic and obesity treatment development program by in-licensing a potentially best-in-class long-acting anti-myostatin antibody from AstralBio, Inc. The antibody, now named IBIO-600, was identified by AstralBio using iBio’s proprietary technology stack and was designed for subcutaneous administration with the potential for an extended half-life.

Pursuant to the agreement, AstralBio will receive an upfront payment of $750,000, which iBio has paid by issuing its common stock to AstralBio. In addition, AstralBio will be eligible for development and commercialization milestone payments totaling up to $28 million. If iBio sublicenses the licensed product, AstralBio will receive low to mid-single-digit sublicense fees on the proceeds of the sublicense fees. iBio is solely responsible for the research and development, manufacturing and commercialization activities of the licensed product.

In parallel, iBio initiated a bispecific antibody program targeting myostatin/activin A to treat obesity and cardiometabolic disorders, leveraging its proprietary Drug Discovery Platform as well as the technology of IBIO-600. The myostatin licensing agreement and planned myostatin/activin A bispecific antibody program follows a drug discovery and development collaboration between iBio and AstralBio initiated less than a year ago. iBio plans to enter into clinical investigation in obesity and cardiometabolic disorders in 2026.

“The rapid advancement of a highly differentiated and developable anti-myostatin antibody in just seven months from inception to dosing in a non-human-primate study is a testament to the power and speed of our Drug Discovery Platform and our collaboration with AstralBio to deliver results quickly,” said Martin Brenner, Ph.D., DVM, iBio’s CEO and Chief Scientific Officer. “Our goal is to develop therapeutics that offer patients quality weight loss by reducing obesity, preserving muscle mass, and promoting muscle growth while avoiding weight regain. Adding a novel myostatin/activin A bispecific antibody expands our pipeline of obesity drug candidates and has potential as a treatment for several additional cardiometabolic disorders.”

In preclinical studies, IBIO-600 exhibits potent inhibition of myostatin in human muscle cell precursors, effectively blocking its inhibitory effects on muscle growth. Additionally, IBIO-600 has been engineered to bind to the FcRn receptor with more than 10-fold higher affinity than normal IgG, supporting the potential for reduced dosing frequency. The molecule has been advanced into non-cGMP in vivo studies in rodents and non-human primates (NHP) with the first data read-outs expected in early 2025. iBio plans to use the machine-learning and epitope-steering capabilities of the Stable HU antibody optimizer with advanced mammalian display, both components of its proprietary Drug Discovery Platform, to rapidly design and produce additional multispecific antibodies targeting, TGF-beta (TGFb) superfamily, including Myostatin and Activin A, in in vitro studies.

ABOUT iBio

iBio (NYSE: IBIO) is a cutting-edge biotech company leveraging AI and advanced computational biology to develop next-generation biopharmaceuticals for cardiometabolic diseases, obesity, cancer and other hard-to-treat diseases. By combining proprietary 3D modeling with innovative drug discovery platforms, iBio is creating a pipeline of breakthrough antibody treatments to address significant unmet medical needs. Our mission is to transform drug discovery, accelerate development timelines, and unlock new possibilities in precision medicine.  For more information, visit www.ibioinc.com or follow us on LinkedIn.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statement regarding the potential of the new myostatin + activin A bispecific to promote weight loss while preventing muscle loss and weight regain as well as less frequent dosing than current obesity treatments; IBIO-600 having an extended half-life; the planned entry into clinical investigation in obesity and cardiometabolic disorders in 2026; developing therapeutics that offer patients quality weight loss by reducing obesity while preserving muscle mass, promoting muscle growth and avoiding weight regain; the myostatin + activin A bispecific antibody having the potential to treat several additional cardiometabolic disorders; data read-outs in early 2025 from the non-cGMP in vivo rodent and non-human primates (NHP) studies; and the use of the machine-learning and epitope-steering capabilities of the Stable HU antibody optimizer with advanced mammalian display to rapidly design and produce additional multispecific antibodies targeting, TGF-beta (TGFb) superfamily, including Myostatin, Activin A in in vitro studies. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to develop a best-in-class lead molecule with an extended half-life and subcutaneous dosing that promotes weight loss while preventing muscle loss and weight regain as well as less frequent dosing than current obesity treatments with an extended shelf life; the ability to derive favorable results from the non-cGMP in vivo studies in rodents and non-human primates (NHP); the ability to enter into clinical investigation in obesity and cardiometabolic disorders in 2026; the myostatin + activin A bispecific antibody having the potential to treat several additional cardiometabolic disorders; and the other factors discussed in the Company’s filings with the SEC including the Company’s Annual Report on Form 10-K for the year ended June 30, 2024. The information in this release is provided only as of the date of this release, and the Company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Corporate Contacts:

iBio, Inc.
Investor Relations
ir@ibioinc.com

Media Contacts:

Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604


FAQ

What is the potential market impact of IBIO-600 for iBio's obesity treatment program?

IBIO-600 shows promise in treating obesity while preserving muscle mass, with potential for less frequent dosing due to its enhanced FcRn receptor binding affinity, which could provide a competitive advantage in the obesity treatment market.

When will iBio begin clinical trials for IBIO-600?

iBio plans to begin clinical investigations for obesity and cardiometabolic disorders in 2026.

What are the financial terms of iBio's licensing agreement with AstralBio?

iBio paid $750,000 in common stock upfront, with potential development and commercialization milestone payments up to $28 million, plus low to mid-single-digit sublicense fees.

What are the key preclinical findings for IBIO-600?

IBIO-600 showed potent myostatin inhibition in human muscle cells and demonstrated 10-fold higher FcRn receptor binding affinity than normal IgG, suggesting potential for reduced dosing frequency.

When will the first data from IBIO-600's non-human primate studies be available?

The first data read-outs from non-human primate studies are expected in early 2025.

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