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Lineage derives its cell therapies from established cell lines that self-renew and expand through the standard cellular division process, mitosis. Therefore, Lineage’s research and development efforts do not require any additional donor tissue or cells to continue advancing. The specialized cells within these self-renewing cell lines that contain the unique ability to develop into any adult human cell are called pluripotent cells. Lineage’s proprietary process, which leverages decades of institutional experience to trigger the self-renewing pluripotent cells to become any adult cell intended, has the potential to improve therapy across a broad range of underserved medical needs.
Unlike many other traditional pharmaceutical products that have extensive and costly development costs, Lineage’s pluripotent derived cell therapies can be brought to market much faster and more affordably. Documented medical issues have identified cell types which are dysfunctional or deficient in the patient. Because this target cell information has already been validated by scientific research, the essential information is already available for Lineage to use in directing the pluripotent cells.
Lineage Cell Therapeutics Inc. currently has five therapies in development, with three undergoing clinical trials. These cell therapies are aimed at treating dry Age-related Macular Degeneration (AMD) with Geographic Atrophy (GA), Spinal Cord Injury, and Non-Small Cell Lung Cancer.
Age-related Macular Degeneration (AMD) afflicts 15 million people in the United States and is a leading cause of vision loss for people over aged 65 in the developed world. The disease is characterized by the progressive deterioration of a part of the retina called the macula, which leads to impairment of central vision and often results in legal blindness. Although there are two versions of this condition, dry AMD and wet AMD, the majority 85-90% have dry AMD, for which there are no FDA approved therapies. Dry AMD advances towards geographic atrophy (GA) in the eye, whereby photoreceptors and the cells that are essential for retina support and nourishment, retinal pigment epithelium (RPE) cells, deteriorate.
In partnership with Roche, Lineage is testing the efficacy of OpRegen in phase 1-2 clinical trials. OpRegen is a cell replacement therapy that is administered through an injection of RPE cells into the retina to preserve or improve vision. Clinical trials have shown promising results, with subjects exhibiting greater gains in visual function and a decrease in the area of geographic atrophy.
Apart from degenerative diseases, Lineage’s pipeline can also ease the burdens of traumatic injuries.
Spinal cord injuries (SCIs) are a significant burden for patients and caregivers, with lifetime healthcare costs reaching upwards of $5 million per patient and a high unemployment rate 10 years post-injury. There are approximately 18,000 spinal cord injuries per year in the United States but no FDA approved drug treatments. Lineage is partnered with the California Institute of Regenerative Medicine (CIRM) in developing OPC1, which is currently in phase 1-2 clinical trials. OPC1 hopes to enable improved functionality in the upper body to increase self-care ability and lower healthcare costs.
OPC1 is a cell replacement therapy where cells are injected at the site of injury in the spine and develop into oligodendrocytes. These cells support the nerve cell’s ability to send and receive signals by insulating the nerve, similar to how electrical wires are encased in rubber. Oligodendrocytes are lost during a SCI, which negatively affects electrical impulses traveling through the central nervous system and causes loss of motor function and chronic pain. Trials of OPC1 have shown positive indications, with patients showing an increase in upper body motor-function and some becoming almost completely independent. Along with reducing the effects of traumatic injuries, Lineage’s cell therapies can improve the body’s immune response to cancer.
Millions of people are diagnosed with cancer every year and it’s a leading cause of death globally. Conventional responses to cancer incorporate a combination of surgery with chemotherapy and/or radiation therapy, which can have a wide range of adverse side effects for patients. To offer cancer patients a more tolerable therapy with improved effectiveness, Lineage is developing VAC, its immuno-oncology platform that loads dendritic cells with antigens to fight cancer. Dendritic cells are the most potent antigen-presenting cells in our bodies. They identify what is causing harm and instruct our bodies to eliminate unwanted and harmful cells, including cancer.
From this VAC platform, Lineage is developing VAC2, a non-patient specific cancer vaccine that stimulates an immune response to the hTERT antigen, which is often present in cancer cells. VAC2 is in clinical testing for non-small cell lung cancer (NSCLC), where preliminary results have shown exceptional promise. VAC2 has been able to initiate a strong immune response in all dosed patients and has been well tolerated, with no adverse effects reported.
Lineage Cell Therapeutics has no commercially approved product candidates and therefore has generated no product revenue from commercial sales. The company has so far funded operations through issuance of equity securities, sale of common stock from its former subsidiaries, proceeds from research grants, collaboration agreements, royalties, and the sale of research products and services.
Although its collaboration agreement with Roche for its OpRegen could be quite lucrative, with $50 million already paid and the potential for an additional $620 million on the table if certain milestones are achieved, the company expects to incur significant operating losses for the foreseeable future. Lineage Cell Therapeutics will need additional capital to continue operations and may seek the funding from further equity offerings, debt financings, formation of strategic alliances, or collaboration agreements.
Due to its enormous potential, competition is fierce in the cell therapy industry and it’s filled with many major pharmaceuticals and biotechnology companies that boast extensive resources beyond that of Lineage Cell Therapeutics. However, the fact that all three of Lineage’s product candidates in clinical testing have the backing of high-quality partners is a very positive sign for the future of its therapies. With so many potential applications across a broad spectrum of clinical needs, it wouldn’t be surprising to eventually see commercialization of Lineage’s pluripotent derived cell therapies for at least a few medical issues.