Preclinical · Grant-supported

Off-the-shelf and bedside HSC engineering.

Banked engineered allogeneic HSCs — plus a bedside autologous path — for scalable, affordable treatment of genetic and immune disorders.

Engineering stem cells into off-the-shelf medicines.

Banked engineered allogeneic HSPCs for genetic and immune disorders, complemented by an autologous path for tolerance and a bedside manufacturing platform.

Hemavive engineers healthy-donor hematopoietic stem and progenitor cells with a single editing toolbox, tuned per program — so cells can be banked, cryopreserved and infused without HLA matching or donor-search delay.

The access gap

Curative gene therapy already works. Almost nobody can get it.

~300,000
born each year with SCD or β-thalassemia
$2.2M
list price per patient
3–4 mo
centralized GMP manufacturing
a few hundred
patients treated worldwide

Personalized manufacturing and busulfan conditioning keep curative therapy out of reach for almost everyone who needs it.

The backbone

Three pillars on one HSC engineering foundation.

Banked donor products for diseases that need cells now, an autologous path for diseases that need tolerance, and a manufacturing concept that could bring both to the bedside.

01 Off-the-shelf · Allogeneic
Banked engineered donor HSPCs

Radiation injury, hemoglobinopathies and immune deficiencies — engineered to stay invisible to recipient immunity for as long as each disease requires.

Three lead programs · Preclinical
Explore pillar 01 →
02 Autologous · Tolerance
Autologous HSC engineering

A patient's own HSCs engineered to teach their immune system what to tolerate — in transplantation and in autoimmune disease.

Platform direction
Explore pillar 02 →
03 ECEP · Bedside
Closed-loop extracorporeal platform

A closed, automated engineering concept designed to bring controlled cell engineering to the point of care.

Enabling technology · In development
Explore pillar 03 →
Pillar 01 · Three lead programs

Engineered to be invisible to the recipient immune system.

Each program is defined by two independent design choices: how the cells achieve immune invisibility, and how long the graft is meant to persist. The same editing toolbox serves all three.

Lead program
UHRP-Bridge
Radiation injury

A stockpiled, off-the-shelf hematopoietic bridge for radiation-induced marrow failure. Active collaboration with HJF / AFRRI.

63,000
potential casualties, per RITN planning
View program →
Hemoglobinopathies
Permanent invisibility · Durable graft
SCD & β-thalassemia

A banked, one-time infusion designed for durable, transfusion-independent correction — without a donor search.

7.7M+
living with SCD worldwide
View program →
Immune deficiencies
Developmental invisibility · Durable graft
SCID & selected IEIs

A banked allogeneic HSPC product for rapid immune reconstitution, with HLA class I restored as the cells mature.

2–3k
new SCID cases per year
View program →
How the editing works All three lead programs are preclinical.
Editing precision

The cassette goes where we choose it to go.

Homology-directed repair places the cassette at a defined locus with known copy number and endogenous regulation left intact. Approved lentiviral products integrate semi-randomly — variable copy number and expression, and an insertional-mutagenesis risk to monitor for years.

Splitting the nuclease and the repair template across two vectors breaks the single-vector packaging limit.

Read the platform page →
High-level schematic of Hemavive's two-vector homology-directed knock-in approach.
Two-vector homology-directed knock-in — the cassette lands at a chosen locus.
ECEP™ · In development

A closed, automated path to point-of-care manufacturing.

Hemavive is developing a closed-loop extracorporeal engineering concept designed to bring controlled cell engineering closer to the patient — reducing manufacturing complexity, improving standardization, and supporting scalable therapeutic workflows.

About ECEP
Time to treat
months → 12–24 h
Cost per patient
$2–3M → ~$200K

Targets, not results. ECEP is in development, not yet clinically validated, and not required for the lead program's first IND-enabling path.

Pillar 02 · The autologous platform

The same platform, turned toward tolerance.

Two directions apply HSC engineering to the patient's own cells, through two distinct mechanisms. Both are platform directions, not active clinical programs today.

Direction A · Longer-term
Transplant tolerance

Molecular mixed chimerism — a recipient's own HSCs engineered to present defined donor identity, so their immune system is educated to accept the graft. The graft itself is left biologically untouched.

Read more →
Direction B · Exploratory
Autoimmune disease

Lineage-directed immunoregulatory programs designed to act only where inflammation is — off in the stem cell, off in healthy tissue, on in the inflamed gut or CNS.

Read more →
Regional development

Building a regional development and manufacturing presence in the Middle East.

Sickle cell disease and β-thalassemia are highly prevalent across the region. Hemavive is developing regional collaborations for co-development, local manufacturing and access.

Why the region
High hemoglobinopathy prevalence and established transplant centres
Focus
Co-development, local manufacturing, and patient access

Partner with Hemavive.

Hemavive is engaging with strategic investors, grant partners, engineering partners, and scientific collaborators to advance platform proof-of-concept studies.

Detailed technical materials are available under CDA / NDA.