Lineage Set to Turn Cell Therapy on its Head with 3 Clinical Programs in 2021

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

Several innovative medicines have gained worldwide approval in recent years. But, areas with unsatisfied therapeutic needs still persist. The growth in pharmaceutical research and development has resulted in novel therapeutic approaches like biological drugs. And one company seems to be turning heads in cell transplant innovation.

Lineage Cell Therapeutics, Inc. LCTX, a clinical-stage biotechnology company, develops novel cell therapies for unmet medical needs. Lineage’s programs are based on a proprietary cell-based therapy platform and in-house development and manufacturing.

Lineage uses this platform to create specialized, terminally differentiated human cells from its pluripotent cell line-starting materials. These differentiated cells are developed to either replace or support cells that have become dysfunctional or absent as a result of a degenerative disease or traumatic injury or to aid the body's immune response to cancer.

The company manufactures and transplants differentiated cell types from established cell lines. This means that no undifferentiated stem cells are delivered to patients and no alternations are made to the DNA of the transplanted cells, avoiding risks associated with gene editing. It uses true allogeneic or “off-the-shelf” therapy by starting with a cell line and not a patient’s cells.

Lineage’s Ongoing Clinical Programs

The biotech company is poised to reach milestones this year with three promising clinical programs based on its unprecedented early findings — the first-ever report of retinal tissue restoration in a dry age-related macular degeneration (AMD) patient, avoidance of cavitation and upper extremity recovery in spinal cord injury patients, and high levels of T cell activity against the presented antigen (cancer platform).

All the programs are currently in Phase 1/2a clinical trials, which aim to assess the safety and tolerability of single and multiple doses.

The three clinical programs include allogeneic off-the-shelf product candidates that aid in the treatment of the following:

1. Dry Age-Related Macular Degeneration

Dry AMD is one of the leading causes of blindness for individuals over 65. There are no FDA-approved therapies to treat the disorder. 

Lineage’s OpRegen® is a cell replacement therapy composed of retinal pigment epithelium cells transplanted into the eye for the treatment of advanced dry AMD with geographic atrophy. The development of OpRegen has been partially supported by more than $14 million of grants from the Israel Innovation Authority. It has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA).

2. Acute Spinal Cord Injuries

An acute spinal cord injury (SCI) is caused by trauma to the spinal cord, which may lead to complete paralysis. When treated, some patients might recover some functions over time, but others could continue to have long-term problems. There are no FDA-approved therapeutics that can treat spinal cord injury.

OPC1, Lineage’s cell replacement therapy is comprised of oligodendrocyte progenitor cells transplanted to the patient for the treatment of acute SCI. The development of OPC1 has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM). The program has received Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of acute SCI and has been granted Orphan Drug Designation by the FDA.

3. Non-Small Cell Lung Cancer

About 80% to 85% of lung cancers are non-small cell lung cancer (NSCLC). This type of lung cancer is more common in women than in men and is likely to occur in younger people. Although it occurs mainly in current or former smokers, it is also the most common type of lung cancer seen in nonsmokers.

Lineage’s VAC2 is an allogeneic cancer immunotherapy comprised of mature, antigen-presenting dendritic cells and is currently being tested for patients with NSCLC. It has been partially supported by Cancer Research UK, the world’s largest independent cancer research charity, which is responsible for costs and conduct of the clinical trial

Source: Lineage Cell Therapeutics

Financial Updates and Upcoming Biotech Conference

Earlier in March, Lineage Cell Therapeutics reported that it had approximately $57 million in cash and cash equivalents, which the company expects to fund operations well into 2023, by which time it expects to have achieved value-creating clinical and product development milestones.

At the upcoming Biotech Small Cap Conference, Lineage Cell Therapeutics CEO Brian Culley will be speaking about allogeneic transplants, the strong commercial barriers from the inability to genericize cells, and much more. Culley has over 25 years of business and scientific experience in the life sciences industry. Before Lineage, he served as CEO at two other public companies, Artemis Therapeutics and Mast Therapeutics.

To catch the latest information from Lineage Cell Therapeutics at the upcoming Biotech Small Cap Conference, sign up to participate here.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.