Geron Corporation is a

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used ...

company located in

Foster City Foster City is a city located in San Mateo County, California. The 2020 census put the population at 33,805, an increase of more than 10% over the 2010 census figure of 30,567. Foster City is sometimes considered to be part of Silicon Valley ...

, California, which specializes in developing and commercializing therapeutic products for

cancer Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...

that inhibit

telomerase Telomerase, also called terminal transferase, is a ribonucleoprotein that adds a species-dependent telomere repeat sequence to the 3' end of telomeres. A telomere is a region of repetitive sequences at each end of the chromosomes of most euka ...

Drug candidates

Cancer therapies

Geron Corporation has sponsored human clinical trials of several potential anti-cancer products. *

Imetelstat Imetelstat (development code GRN163L) is an experimental anticancer drug. The first telomerase inhibitor to enter clinical trials, As of early 2023, it was in Phase 2/ 3 trials for various cancer types. Chemically, imetelstat is a synthetic co ...

(GRN163L) is a drug that targets telomerase. In studies conducted at

Johns Hopkins University Johns Hopkins University (Johns Hopkins, Hopkins, or JHU) is a private research university in Baltimore, Maryland. Founded in 1876, Johns Hopkins is the oldest research university in the United States and in the western hemisphere. It consi ...

, GRN163L was active against both CD138+ and CD138neg cancer stem cells and eliminated the colony forming potential of both by five weeks. Similarly, GRN163L inhibited the ''

in vitro ''In vitro'' (meaning in glass, or ''in the glass'') studies are performed with microorganisms, cells, or biological molecules outside their normal biological context. Colloquially called " test-tube experiments", these studies in biology ...

'' clonogenic growth of CD138neg Multiple Myeloma Cancer Stem Cells isolated from the bone marrow aspirates of patients with multiple myeloma. On November 3, 2014, the

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

removed the full clinical hold on imetelstat and declared the company's clinical development plan as acceptable. In 2014, Geron licensed imetelstat to

Janssen Biotech Janssen Pharmaceuticals is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen. In 1961, Janssen Pharmaceuticals was purchased by New Jersey-based American c ...

. In 2017, imetelstat was granted

fast track status Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical ne ...

by the FDA for certain patients with myelodysplastic syndrome. In 2018,

returned the rights to imetelstat to Geron.

is currently in two Phase 3 trials: NCT02598661, a study of the drug's ability to reduce the transfusion requirements of patients with

myelodysplastic syndrome A myelodysplastic syndrome (MDS) is one of a group of cancers in which immature blood cells in the bone marrow do not mature, and as a result, do not develop into healthy blood cells. Early on, no symptoms typically are seen. Later, symptoms may ...

(MDS), and NCT04576156, an investigation of the drug's effect on the overall survival of patients with

myelofibrosis Primary myelofibrosis (PMF) is a rare bone marrow blood cancer. It is classified by the World Health Organization (WHO) as a type of myeloproliferative neoplasm, a group of cancers in which there is growth of abnormal cells in the bone marrow. ...

. * A trial of GRNVAC1, a telomerase vaccine being used on patients with prostate cancer was carried out at Duke University. Geron's progress with telomerase vaccines attracted a modest monetary investment in 2005 from

Merck Merck refers primarily to the German Merck family and three companies founded by the family, including: * the Merck Group, a German chemical, pharmaceutical and life sciences company founded in 1668 ** Merck Serono (known as EMD Serono in the Unite ...

. *GRN1005, an LRP-directed conjugate of

paclitaxel Paclitaxel (PTX), sold under the brand name Taxol among others, is a chemotherapy medication used to treat a number of types of cancer. This includes ovarian cancer, esophageal cancer, breast cancer, lung cancer, Kaposi's sarcoma, cervical canc ...

, was in phase II clinical trials for brain cancer but discontinued based on preliminary results in 2012.

Telomerase activation

In addition to testing drug candidates that exploit cancer cell's dependence on telomerase, Geron is researching the possible applications of activating the enzyme in normal cells to delay cellular senescence. The company is in the early stages of developing a telomerase based treatment for

HIV The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...

called TAT0002, which is the saponin

cycloastragenol Cycloastragenol is a triterpenoid isolated from various legume species in the genus ''Astragalus'' that is purported to have telomerase activation activity. A preliminary ''in vitro'' study on human CD4 and CD8 T cells found that cycloastragenol ...

in Chinese herb ''

Astragalus propinquus ''Astragalus propinquus'' (syn. ''Astragalus membranaceus'', commonly known as Mongolian milkvetch in English; 'Хунчир' in Mongolian; ''huáng qí'' (), ''běi qí'' () or ''huáng huā huáng qí'' (), in Mongolia, is a flowering plant i ...

''. Geron has granted a license to Telomerase Activation Sciences to sell TA-65, the telomerase activator agent also derived from

astragalus ''Astragalus'' is a large genus of over 3,000 species of herbs and small shrubs, belonging to the legume family Fabaceae and the subfamily Faboideae. It is the largest genus of plants in terms of described species. The genus is native to tempe ...

. In October 2010 Intertek/AAC Labs, an ISO 17025 internationally recognized lab, found the largest component of TA-65 to be cycloastragenol. Geron originally investigated telomerase as a means of understanding and modifying human aging. However, Geron has ceased aging research of any kind.

Stem cell therapies

On January 23, 2009, Geron received

approval to begin Phase I testing of GRNOPC1 in humans. GRNOPC1 is an embryonic stem cell based drug that is designed to treat specific forms of

spinal cord injury A spinal cord injury (SCI) is damage to the spinal cord that causes temporary or permanent changes in its function. Symptoms may include loss of muscle function, sensation, or autonomic function in the parts of the body served by the spinal cor ...

through

remyelination Remyelination is the process of propagating oligodendrocyte precursor cells to form oligodendrocytes to create new myelin sheaths on demyelinated axons in the CNS. This is a process naturally regulated in the body and tends to be very efficient i ...

of damaged

axon An axon (from Greek ἄξων ''áxōn'', axis), or nerve fiber (or nerve fibre: see spelling differences), is a long, slender projection of a nerve cell, or neuron, in vertebrates, that typically conducts electrical impulses known as action p ...

s. This trial does not involve direct use of stem cells however, as GRNOPC1 is composed of

oligodendrocyte Oligodendrocytes (), or oligodendroglia, are a type of neuroglia whose main functions are to provide support and insulation to axons in the central nervous system of jawed vertebrates, equivalent to the function performed by Schwann cells in the ...

progenitor cells derived from embryonic stem cell lines. Studies have shown significant restoration of mobility in animals with spinal injuries that received cells. Geron also has several other embryonic stem cell treatments that are still in the preclinical phase, including GRNCM1, a treatment for heart disease, and GRNIC1, a treatment for

diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level ( hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ...

. In tests with diabetic mice, 80% of the mice given GRNIC1 were still alive in 50 days while the entire control group, which was given no treatment, perished. Geron sold its human stem cell research assets to Asterias in 2013.

GRNOPC1

As of October 2010 and November 2010, One of Geron's most highly publicized trial therapy products has been GRNOPC1, a stem cell therapy designed to heal severe spinal cord injuries. The cells in the GRNOPC1 therapy have been coaxed into becoming early

myelinated Myelin is a lipid-rich material that surrounds nerve cell axons (the nervous system's "wires") to insulate them and increase the rate at which electrical impulses (called action potentials) are passed along the axon. The myelinated axon can be l ...

glial cells Glia, also called glial cells (gliocytes) or neuroglia, are non-neuronal cells in the central nervous system (brain and spinal cord) and the peripheral nervous system that do not produce electrical impulses. They maintain homeostasis, form myel ...

, a type of cell that insulates

nerve cells A neuron, neurone, or nerve cell is an electrically excitable cell that communicates with other cells via specialized connections called synapses. The neuron is the main component of nervous tissue in all animals except sponges and placozoa. ...

. For every GRNOPC1 cell that is injected in the patient, they become six to ten cells in a few months. In October 2011 updated results on four patients were released. The trial was discontinued in Nov 2011. In early 2013 BioTime, whose CEO at the time was Geron founder Michael D. West, acquired 400 patents and other intellectual property related to embryonic stem cells from Geron and later went on to restart the trial.

Patent issues

Geron Corporation initially held exclusive rights to three cell types derived from

embryonic stem cell Embryonic stem cells (ESCs) are pluripotent stem cells derived from the inner cell mass of a blastocyst, an early-stage pre- implantation embryo. Human embryos reach the blastocyst stage 4–5 days post fertilization, at which time they consist ...

s, as the result of paying for the research originally conducted by Dr. James Thomson at the University of Wisconsin–Madison. The patents on the other three cell types are owned by the

Wisconsin Alumni Research Foundation The Wisconsin Alumni Research Foundation is the independent nonprofit technology transfer organization serving the University of Wisconsin–Madison and Morgridge Institute for Research. It provides significant research support, granting tens o ...

(WARF). WARF and Geron did not charge academics to study human stem cells but did charge commercial users. In 2001 WARF came under public pressure to widen access to human stem-cell technology, and they launched legal action against Geron Corporation to recover some of the previously sold rights. The two sides agreed that Geron would keep the rights to only three cell types. In October 2006, a legal challenge was mounted to overturn these patents by The Foundation for Taxpayer and Consumer Rights and the non-profit patent-watchdog

Public Patent Foundation In public relations and communication science, publics are groups of individual people, and the public (a.k.a. the general public) is the totality of such groupings. This is a different concept to the sociological concept of the ''Öffentlichkei ...

. They contended that two of the patents granted to WARF are invalid because they cover a technique published in 1992 for which a patent had already been granted to an Australian researcher. Another part of the challenge came from the molecular biologist

Jeanne Loring Jeanne Frances Loring (born May 4, 1950) is an American stem cell biologist, developmental neurobiologist, and geneticist. She is the founding Director of the Center for Regenerative Medicine and emeritus professor at the Scripps Research Insti ...

who stated that

University of Wisconsin–Madison A university () is an institution of higher (or tertiary) education and research which awards academic degrees in several academic disciplines. Universities typically offer both undergraduate and postgraduate programs. In the United Stat ...

stem cell pioneer James Thomson's techniques (currently patents held by WARF) are rendered obvious by a 1990 paper and two textbooks. The outcome of this legal challenge was particularly relevant to the Geron Corporation as it can only license patents that are upheld. The patents were ultimately upheld when the reexamination concluded in 2008. As an interim measure, on January 23, 2007, WARF relaxed the stem cell patents, allowing industry-sponsored research at academic and non-profit institutions without a license. WARF will allow easier and simpler cost free cell transfers among researchers and would not require a license or agreement from California's taxpayer-funded stem cell research program.

Politics

As a participant in the then-controversial stem cell and cloning area, Geron Corporation was asked to testify about its technology before the U.S. Congress. In 2001, when Congress was attempting to ban all forms of cloning, then Geron CEO Thomas Okarma spoke before Congress to preserve cloning for therapeutic purposes.

References

External links

*{{Official, http://www.geron.com Biotechnology companies of the United States Stem cells Cancer organizations based in the United States Companies based in Menlo Park, California Life sciences industry Biotechnology companies established in 1990 1990 establishments in California

Company information