SC451 by Sana Biotechnology: status and timeline

SC451

Develop a potentially curative, manufacturably scalable cell therapy for type 1 diabetes using iPSC-derived islet cells engineered to evade immune rejection without immunosuppression.

ProtoStage 2 of 5

IND filing planned 2026; phase 1 trial expected early 2026.

Updated Dec 2025Checked 11 Oct0 updates this week

Milestones

Next · GMP manufacturing process development

FDA INTERACT meeting heldQ3 2025Complete.
GMP manufacturing process developmentTarget 2025Current milestone.
IND application plannedTarget Q1 2026Not yet reached.
Phase 1 trial initiationTarget Q2 2026Not yet reached.
First-in-human dataTarget 2027Not yet reached.

Most important updates

Sana announces SC451 IND filing planned for 2026 and strategic collaboration with Mayo ClinicDec 2025

Upcoming

2025GMP manufacturing process development (next)
Q1 2026IND application planned
Q2 2026Phase 1 trial initiation
2027First-in-human data

Current obstacles

Differentiation consistencyGenerating iPSC-derived islet cells with uniform maturation, function, and glucose responsiveness at manufacturing scale remains a key technical challenge.
GMP manufacturing scale-upTranslating successful small-scale protocols to GMP-compliant, large-scale production requires process optimization and quality control systems.

Physics limits

iPSC maturationiPSC-derived islet cells may not fully replicate primary islet cell maturity and function; achieving equivalent glucose responsiveness and insulin secretion is a technical goal.
Off-target cell differentiationDuring differentiation, some cells may not become islets, reducing efficiency and potentially introducing unwanted cell types; controlling cell fate remains challenging.

How it works

3 parts

iPSC source

Unlimited stem cells

Induced pluripotent stem cells from a single donor can be expanded indefinitely, providing unlimited material for manufacturing.

Differentiation

Become islet cells

iPSCs are differentiated via controlled protocols into functional pancreatic islet cells containing insulin-producing beta cells.

HIP engineering

Immune evasion

The same HIP modifications used in UP421 are applied to hide SC451 cells from immune detection, enabling transplantation without immunosuppression.

Spec sheet

Spec	SC451
Cell source	O-negative iPSC-derived pancreatic islets^R (reported)
Immune evasion platform	HIP (hypoimmune platform, same as UP421)^R (reported)
Manufacturing approach	Scalable GMP iPSC production and differentiation^R (reported)

^R reported by the company

Update log

1 update

Dec 2025

Major: Sana announces SC451 IND filing planned for 2026 and strategic collaboration with Mayo ClinicPressResearch

About Sana Biotechnology

The team behind SC451

Sana Biotechnology

UP421, SC451, hypoimmune islet cells, type 1 diabetes

Sana Biotechnology develops engineered pancreatic islet cell therapies using its hypoimmune (HIP) platform to enable transplants without immunosuppression. Founded 2018, Seattle; NASDAQ public (SANA) since February 2021.

UP421 (primary islet cells) achieved insulin production without immunosuppression in trial; published NEJM 14-month follow-up data.
SC451 (iPSC-derived islets) planned IND filing 2026; uses same hypoimmune technology; Mayo partnership for development.
HIP platform genetically modifies cells to hide from immune system, enabling transplants without lifelong immunosuppressive drugs.

sana.com (opens sana.com)Company profile →

Founded: 20188 yrs
Headquarters: United States
Status: Public
Listed: SANA (opens google.com)NASDAQ
Valuation: public
Last round: IPO4 Feb 2021
Works in: BiotechCell & organ therapies
Coverage: 2 programs · 3 updateslatest 1 Jul 2026checked 11 Oct
Partners: Mayo Clinic (opens mayoclinic.org)Uppsala University Hospital (opens akademiska.se)
People: Steve Harr (opens investors.sana.com)CEO

Spec

SC451

Cell source

O-negative iPSC-derived pancreatic islets^R (reported)

Immune evasion platform

HIP (hypoimmune platform, same as UP421)^R (reported)

Manufacturing approach

Scalable GMP iPSC production and differentiation^R (reported)