ShiftBio

04/05/2026

Anti-CD47 antibodies have stalled. The target has not.

Our new Kidney International paper reports an engineered vesicle displaying a high-affinity SIRPα variant on its surface, designed to engage circulating CD47+ myeloid cells in acute kidney injury before they infiltrate the renal parenchyma.

In two AKI models, a single intravenous dose reduced BUN, creatinine, and NGAL, and reprogrammed macrophages toward a pro-resolving phenotype.

The platform combines multivalent surface display, active cellular internalization, and selective enrichment on disease-relevant immune cells. These are capabilities a monoclonal antibody does not have.

That is the asset today.

The same surface-engineering strategy extends as a delivery platform for next-generation immunology payloads, including A*O and siRNA.

Therapeutic on its own. Delivery vehicle for what comes next.

Kidney International 2026, 109:545-558.

29/12/2025

SHIFTBIO is proud to announce the publication of our latest research on our Inflammation-targeted Natural Nanoparticle (I-NNP) platform, SIRP-NNP, in the prestigious journal Kidney International. This milestone highlights our platform’s potential to redefine the treatment of Acute Kidney Injury, a condition currently lacking disease-specific therapies.

By introducing engineered SIRP-NNP, we have established a novel therapeutic approach that specifically targets CD47-overexpressing myeloid cells within the bloodstream. Unlike traditional tissue-specific delivery, our strategy focuses on therapeutic reprogramming at the systemic level. By modulating the CD47-SIRP interaction, we intercept and transform circulating immune cells into pro-resolving phenotypes before they can infiltrate and damage organ tissues. This NNP-based strategy actively promotes tissue repair while providing a scalable and safer alternative to conventional cell-based therapies, presenting a promising path for clinical translation and large-scale manufacturing.

In addition to therapeutic efficacy, our study highlights the potential of urinary CD47 as a non-invasive biomarker. This discovery offers a new tool for early detection and real-time monitoring of kidney injury.
We invite our partners and the scientific community to explore how SHIFTBIO is leveraging advanced NNP engineering to lead the next wave of treatments for inflammatory diseases!

For more information: https://www.kidney-international.org/article/S0085-2538(25)01022-1/abstract

29/12/2025

The SHIFTBIO team had the privilege of joining the 7th CNS Drug Delivery Summit. Our CEO Prof. Gihoon Nam took the stage to address one of the most critical hurdles in the CNS industry, creating a dual-mechanism shuttle that enhances both Blood-Brain Barrier pe*******on and parenchymal delivery.

A key highlight was sharing how SHIFTBIO is utilizing AI developed in collaboration with Dassault Systèmes to engineer our proprietary Natural Nanoparticle platform that solves this delivery trade-off.

Throughout the summit, we engaged in in-depth discussions with various CNS experts and Big Pharma representatives regarding our BBB-penetrating drug delivery platform. We look forward to continuing these conversations and exploring impactful collaborations! 🚀

For more details: https://lnkd.in/edzWaAvj

03/11/2025

We are thrilled and honored to share that our CEO, Prof. Gihoon Nam, was an invited speaker at Dassault Systèmes’ Science Week 2025 in Boston! 🎤🌟

During his talk, Prof. Nam showcased the progress of our AI-driven drug-delivery platform, developed on Dassault’s 3DEXPERIENCE through a powerful three-year collaboration with BIOVIA. He also shared our broader vision to leverage Dassault’s Virtual Twin Experience across the entire drug-development lifecycle, from discovery and CMC to clinical studies and final approval.

To make this vision a reality, ShiftBio is expanding our foundational partnership with Dassault Systèmes and deepening our collaboration with the BIOVIA Research Team to overcome the delivery void with our platform.

Our ultimate goal is to become a flagship reference, a small biotech that fully embraces the power of the 3DEXPERIENCE ecosystem, seamlessly connecting the virtual and real worlds from discovery through full development.

This vision reflects our shared belief that digital AI and simulation are no longer optional: they are essential to meaningful innovation. 🚀

31/10/2025

Celebrating Science, Collaboration, and Innovation!

At the 2025 DIPS Global Tech Con, Dr. Yoonjeong Choi represented SHIFTBIO, introducing our AI-Driven Natural Drug Delivery Platform — a next-generation technology that merges biological insight with digital intelligence.

Together with distinguished experts, she explored how AI can accelerate drug development and how global collaboration can fuel the next wave of biomedical innovation.

We’re excited to be part of this global movement shaping the future of therapeutics.

17/10/2025

We are thrilled to announce major momentum in our pipeline, driven by our proprietary Natural Drug Delivery Platform.

In oncology, we have successfully completed a Pre-IND meeting with the U.S. FDA for SBI-101, our novel candidate targeting PD-1 blockade resistant Cold Tumors. This marks a crucial step forward in addressing a major unmet need for cancer treatment.

Simultaneously, we are accelerating another program (SBI-102) toward clinical entry in Australia. We have partnered with a leading global CRO for our NNP-based candidate for inflammatory and autoimmune diseases. Building on its existing Orphan Drug Designation (ODD) from the FDA, our immediate next step is to submit our clinical trial application to the TGA.

These parallel advancements highlight the immense potential of our NNP platform to tackle challenging diseases. We are more committed than ever to progressing our therapies for patients around the globe!

For more details, please refer to below links
SBI-101: https://www.sciencedirect.com/science/article/pii/S016836592200637X
SBI-102: https://www.nature.com/articles/s41467-025-57133-w

Acute liver failure arises from rapid cell death and impaired liver regeneration. Here, the authors show that scalable, high-purity engineered extracellular vesicles derived from stem cells promote the clearance of dying hepatocytes and drive liver repair through in vivo macrophage reprogramming.

14/10/2025

It was an honor to be featured at Try Everything 2025, Seoul's iconic global festival where the future of technology and innovation is shaped. The event is a critical nexus for Korean startups to connect with the world and share their expansion journeys. For ShiftBio, an early member and past winner of the Korea Conference community, being invited back as a mentor to this pivotal gathering was a profound honor.

The mentorship and investment from this community have been a critical catalyst for our growth, providing a crucial foundation for achieving our company's key milestones. Now, we are applying our Natural drug delivery platform technology to tackle immense unmet needs in areas like CNS and Inflammation diseases. This journey would not be possible alone, and we remain committed to innovating for global health while supporting the next generation. We extend our sincere gratitude to the Seoul Metropolitan Government for hosting, with a special acknowledgment to Jenny Chu, the Korea Conference, and our dedicated colleagues for their unwavering support!

25/09/2025

SHIFTBIO CEO Gi-hoon Nam met with Pascal Daloz, CEO of Dassault Systèmes, and Woonsung Jung, Managing Director, Dassault Systèmes Korea, in Seoul to discuss deepening collaboration. Over the past three years, SHIFTBIO has actively applied Dassault’s 3DEXPERIENCE platform to accelerate the design and validation of our Natural Nanoparticle (NNP) drug delivery platform. This collaboration has reduced trial and error in discovery and strengthened our ability to translate science into real-world therapeutic opportunities.

At the meeting, both sides reaffirmed a shared vision of combining AI-powered design with digital platforms to de-risk the development of next-generation therapeutics. SHIFTBIO has also been invited to speak at Dassault’s upcoming Science in the Age of Experience event in Boston this October, engaging with global pharma leaders, regulators, and innovators.

Together, SHIFTBIO and Dassault aim to pioneer a new paradigm in advanced therapeutics, making innovation more accessible and impactful for patients worldwide!

Find out more about the event: https://lnkd.in/gC6Vet7g

08/08/2025

GEN Genetic Engineering & Biotechnology News has recognized SHIFTBIO as a leading innovator in EV-based drug delivery in the Asia-Pacific region. The article highlights how our NNP-Design AI™ platform and large-scale manufacturing capabilities are redefining the field.

Our lead program, SBI-102, harnesses macrophage reprogramming to target inflammatory diseases and is steadily progressing toward clinical entry. In parallel, we are advancing brain-targeted and inflammation-targeted delivery systems powered by our NNP-Design AI™ platform—opening new frontiers in precision medicine.

SHIFTBIO’s mission goes beyond research. We are building a future that delivers real, lasting impact for patients and society.

https://hubs.ly/Q03yKthd0

With greater investment to improve the scalability and consistency of manufacturing, EV-based medicine is poised to shape therapeutics delivery in the near future.

29/05/2025

🚀 MAKING THE IMPOSSIBLE POSSIBLE: Breakthrough Published in Biomaterials!

SHIFTBIO proudly announces groundbreaking research published in Biomaterials (IF 14.0+) - solving one of medicine's greatest challenges: turning unstable therapeutics into powerful, targeted treatments.

🎯 The Challenge We Solved: Apelin peptides showed promise for Pulmonary Arterial Hypertension (PAH) but vanished within hours in the bloodstream - until now.

⚡ Our Innovation: ✅ IFITM3-based EV platform - engineered for optimal C-terminal cargo display ✅ 24-hour plasma stability vs.

27/02/2025

시프트바이오가 첫 번째 신약 프로그램 연구 성과를 Nature Communications에 게재하며, 세포외소포(Extracellular Vesicle, EV) 기반 신약 개발의 가능성을 입증했습니다. 이번 연구에서는 ‘Dual-mode of action을 통한 In vivo 대식세포 리프로그래밍 기전’과 ‘고순도·고효율 EV 대량 생산 공정 확립’을 제시하며, 차세대 약물 전달 기술의 새로운 기준을 마련했습니다.

기사에서도 언급된 대로, 시프트바이오는 이번 연구 성과를 시작으로 세포 자체를 사용하지 않으면서도 기존 전달체 기술로는 도달할 수 없는 부위까지 약물을 전달하는 혁신적인 인비보(In vivo) 세포 치료제를 지속적으로 공개할 예정입니다.

신약 개발의 새로운 패러다임을 제시하고, 글로벌 바이오 시장에서 독보적인 기술력을 확보해 나갈 시프트바이오의 내일을 더욱 기대해 주시기 바랍니다. 감사합니다.

[의학신문·일간보사=오인규 기자] 시프트바이오는 첫 번째 신약 프로그램 연구 성과가 세계적 학술지인 네이처 커뮤니케이션스(Nature Communications)에 게재됐다고 26일 밝혔다.시프트바이오는 최근 자사 공식...