Asterias Biotherapy

Overview

Overview

Asterias Biotherapy was a biotechnology company focused on developing novel cell therapies for serious diseases, particularly in regenerative medicine and immunotherapy. The company leveraged stem cell technology and novel immunotherapy approaches to address unmet medical needs in oncology, spinal cord injury, and degenerative diseases.

The company was founded in 2009 as a subsidiary of [Geron Corporation](/companies/geron-corporation), one of the pioneering companies in human embryonic stem cell (hESC) research. Asterias was acquired by [Lineage Cell Therapeutics](/companies/lineage-cell-therapeutics) in 2019, combining the cell therapy platforms of both companies["@lineagedeal"][@lineage].

Note: Asterias is no longer an independent operating company following its acquisition. The company's programs are now continued through Lineage Cell Therapeutics.

Company History

Origins with Geron Corporation (2009-2011)

Asterias Biotherapy was founded in 2009 as a subsidiary of Geron Corporation, a company that had been at the forefront of stem cell research since the 1990s. Geron had established significant intellectual property and expertise in hESC research, and created Asterias as a vehicle to advance cell therapy programs into clinical development[@geron].

The creation of Asterias was part of Geron's strategic decision to spin out its cell therapy programs into a dedicated subsidiary, allowing for focused development and potentially separate funding. This structure enabled specialized management and dedicated resources for the cell therapy pipeline.

Independent Operations (2011-2019)

In 2011, Asterias became an independent, publicly traded company (NYSE: AST). During this period, the company:

• Advanced its stem cell programs toward clinical development
• Established manufacturing capabilities for cell therapy products
• Built a team of experts in cell biology, manufacturing, and clinical development
• Filed and received FDA clearance for clinical trials involving hESC-derived cells

Acquisition by Lineage Cell Therapeutics (2019)

In 2019, Asterias was acquired by Lineage Cell Therapeutics, another cell therapy company with complementary programs. The acquisition combined:

• Asterias's hESC-derived cell therapy programs
• Lineage's OPC (oligodendrocyte progenitor cell) technology
• Combined manufacturing capabilities and clinical expertise

Company Overview

| Attribute | Details |
|-----------|---------|
| Headquarters | Menlo Park, California, USA |
| Founded | 2009 (as Geron subsidiary) |
| Became Independent | 2011 |
| Acquired by | Lineage Cell Therapeutics (2019) |
| Focus | Cell therapy, Regenerative medicine, Immunotherapy |
| Stock Symbol | AST (former) |

Technology Platform

Asterias developed several technology platforms for cell therapy development:

Human Embryonic Stem Cell (hESC) Platform

The company utilized hESCs as the foundation for its regenerative medicine programs. hESCs possess the capacity to differentiate into any cell type in the human body, making them ideal for cell replacement therapies.

Manufacturing Capabilities

• Scalable hESC culture systems
• Defined differentiation protocols for specific cell types
• Banking and quality control systems
• GMP-compliant manufacturing processes

Key Differentiated Cell Types

• Oligodendrocyte progenitor cells (OPCs): For demyelination and spinal cord injury
• Pancreatic beta cells: For diabetes treatment
• Neural precursor cells: For neurological disorders
• Cartilage cells: For orthopedic applications[@hesc-research]

Immunotherapy Platform

Asterias also developed immunotherapy approaches, primarily focused on cancer treatment:

CAR-T Cell Therapy

VAC (Vaccinia Anticancer) Platform

• AST-VAC1: Autologous dendritic cell vaccine
• AST-VAC2: Allogeneic tumor cell vaccine

Pipeline Programs

AST-OPC1: Spinal Cord Injury Program

AST-OPC1 was Asterias's most advanced program, involving oligodendrocyte progenitor cells (OPCs) derived from hESCs for treatment of spinal cord injury.

Mechanism of Action

• Cell replacement: Transplanted OPCs can differentiate into oligodendrocytes, the cells responsible for producing myelin in the central nervous system
• Remyelination: New oligodendrocytes can remyelinate denuded axons, restoring nerve conduction
• Neuroprotection: Secretion of growth factors supporting existing neurons
• Axonal regeneration: Creating a permissive environment for axon growth

Clinical Development

• Phase 1 Trial: First-in-human study in patients with complete thoracic spinal cord injury
• Dosing: Multiple dose escalation cohorts
• Endpoints: Safety, neurological function assessment using International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

AST-VAC1: Cancer Immunotherapy

AST-VAC1 was an autologous dendritic cell vaccine programmed with tumor antigen RNA. The therapy aimed to stimulate anti-tumor immune responses in cancer patients.

Mechanism

• Patient's dendritic cells are collected and exposed to tumor-associated antigen RNA
• Activated dendritic cells are reintroduced to stimulate T-cell responses
• Designed to target specific tumor antigens

Clinical Development

• Evaluated in multiple oncology indications
• Advanced through Phase 1 and Phase 2 clinical trials
• Demonstrated evidence of immune activation in some patients

CAR-T Cell Programs

Asterias developed several CAR-T therapy programs targeting different cancers:

| Program | Target | Indication | Development Status |
|---------|--------|------------|-------------------|
| AST-CD19 | CD19 | B-cell malignancies | Preclinical |
| AST-CD20 | CD20 | B-cell lymphoma | Preclinical |
| AST-CD123 | CD123 | Acute myeloid leukemia | Preclinical |

These programs utilized next-generation CAR constructs with:

• Enhanced persistence
• Reduced tonic signaling
• Safety switches
• Multiple signaling domains[@cart-therapy]

Diabetes Program

Asterias maintained a preclinical program for pancreatic beta cell replacement:

• Approach: hESC-derived insulin-producing beta cells
• Indication: Type 1 diabetes
• Goal: Restore endogenous insulin production
• Status: Research and preclinical development

Notable Achievements

First FDA Clearance for hESC Clinical Trial

Asterias achieved a significant regulatory milestone as the first company to receive FDA clearance for a clinical trial involving hESC-derived cells. This achievement required:

• Extensive preclinical toxicology and safety studies
• Development of GMP-compliant manufacturing processes
• Detailed characterization of the cell product
• Rigorous review of clinical trial protocols

Manufacturing Excellence

The company developed robust manufacturing processes for cell therapy products:

• Scalable cell culture systems
• Cryopreservation protocols for cell banks
• Quality control assays for identity, purity, and potency
• GMP-compliant facility operations

Academic Partnerships

Asterias established partnerships with leading academic institutions:

• University of California system
• [Stanford University](/institutions/stanford)
• [Johns Hopkins University](/institutions/johns-hopkins-university)
• Multiple international research centers

Research Contributions

Asterias's research contributed to the advancement of cell therapy in several areas:

Stem Cell Biology

• Differentiation protocols for generating specific cell types
• Characterization methods for stem cell-derived products
• Understanding of cell therapy mechanisms

Clinical Cell Therapy

• Clinical trial design for cell-based therapies
• Outcome measures for neurological injury trials
• Regulatory pathway development

Manufacturing

• Scalable cell production methods
• Quality control approaches
• Shipping and storage protocols

Pipeline at Acquisition

When Asterias was acquired by Lineage Cell Therapeutics in 2019, the combined pipeline included:

| Program | Indication | Development Stage |
|---------|------------|-------------------|
| AST-OPC1 | Spinal cord injury | Phase 1 complete |
| AST-VAC1 | Cancer immunotherapy | Phase 2 |
| AST-VAC2 | Cancer immunotherapy | Phase 1 |
| CAR-T CD19 | B-cell lymphoma | Preclinical |
| CAR-T CD20 | B-cell lymphoma | Preclinical |
| Beta cells | Type 1 diabetes | Preclinical |

Legacy and Impact

Although Asterias no longer exists as an independent company, its legacy includes:

Current Status

Following the acquisition, Lineage Cell Therapeutics continues to advance the programs originally developed by Asterias:

Current Pipeline (Lineage)

• OPC1 (formerly AST-OPC1): Continued development for spinal cord injury
• VAC programs: Continued cancer immunotherapy development
• New programs: Additional cell therapy indications

Manufacturing

See Also

• [Cell Therapy](/mechanisms/cell-therapy)
• [Stem Cell Therapy](/therapeutics/stem-cell-therapy)
• [Regenerative Medicine](/mechanisms/regenerative-medicine)
• [CAR-T Cell Therapy](/therapeutics/car-t-cell-therapy)
• [Spinal Cord Injury](/diseases/spinal-cord-injury)
• [Lineage Cell Therapeutics](/companies/lineage-cell-therapeutics)
• [Geron Corporation](/companies/geron-corporation)

External Links

• [Lineage Cell Therapeutics](https://lineagecell.com)
• [Lineage Cell Therapeutics Pipeline](https://lineagecell.com/pipeline/)
• [Asterias Clinical Trials](https://clinicaltrials.gov/ct2/results?cond=&term=Asterias+Biotherapy)
• [PubMed - Stem Cell Therapy](https://pubmed.ncbi.nlm.nih.gov/?term=stem+cell+therapy)
• [PubMed - Spinal Cord Injury Cell Therapy](https://pubmed.ncbi.nlm.nih.gov/?term=spinal+cord+injury+cell+therapy)
• [PubMed - CAR-T Cell Therapy](https://pubmed.ncbi.nlm.nih.gov/?term=CAR-T+cell+therapy)

References

Pathway Diagram

The following diagram shows the key molecular relationships involving Asterias Biotherapy discovered through SciDEX knowledge graph analysis: