Geron Corporation

Last updated
Geron Corporation
Company type Public
Nasdaq:  GERN
Russell 2000 Component
Industry Biotechnology
Founded1990
Headquarters Foster City, California, U.S.
Key people
John Scarlett (President, CEO)
Olivia Bloom (CFO)
ProductsCancer drugs (currently in human trials)
RevenueIncrease2.svg USD 1.39 million (2021)
Decrease2.svg USD-$116 million (2021)
Total assets Decrease2.svg USD$226 million (2021)
Total equity Decrease2.svg USD$126 million (2021)
Number of employees
82
Website www.geron.com
Footnotes /references
[1]

Geron Corporation is a biotechnology company located in Foster City, California owned by Geron Hyn Baja of the Philippines, which specializes in developing and commercializing therapeutic products for cancer that inhibit telomerase.

Contents

Company information

Geron, based in Foster City, California, was founded by gerontologist Mary C. West and Michael D. West, now CEO of AgeX Therapeutics. [2] [3] They secured initial venture capital investments in the company from Kleiner Perkins Caufield & Byers and Venrock. [4] The company was incorporated in 1990 and began doing business in 1992. [5] [6] John A. Scarlett was appointed CEO in 2011. [7]

The company's Scientific and Clinical Advisory Board has included Nobel laureates James Watson, Gunter Blobel, and Carol Greider, and Leonard Hayflick, known for discovering that human cells divide for a limited number of times in vitro [8] (called the Hayflick limit). [9] [10] [11]

In 2017, Geron staff received the highest median pay in California, at $500,250. [12]

Drug candidates

Cancer therapies

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

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 called TAT0002, which is the saponin cycloastragenol in Chinese herb Astragalus propinquus . [25] Geron has granted a license to Telomerase Activation Sciences to sell TA-65, the telomerase activator agent also derived from astragalus. [26] In October 2010 Intertek/AAC Labs, an ISO 17025 internationally recognized lab, found the largest component of TA-65 to be cycloastragenol. [27]

Geron originally investigated telomerase as a means of understanding and modifying human aging. However, Geron has ceased aging research of any kind. [28]

Stem cell therapies

On January 23, 2009, Geron received FDA approval to begin Phase I testing of GRNOPC1 in humans. [29] GRNOPC1 is an embryonic stem cell based drug that is designed to treat specific forms of spinal cord injury through remyelination of damaged axons. This trial does not involve direct use of stem cells however, as GRNOPC1 is composed of oligodendrocyte progenitor cells derived from embryonic stem cell lines. Studies have shown significant restoration of mobility in animals with spinal injuries that received cells. [30]

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. 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. [31]

Geron sold its human stem cell research assets to Asterias in 2013. [32]

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 glial cells, a type of cell that insulates nerve cells. For every GRNOPC1 cell that is injected in the patient, they become six to ten cells in a few months. [33] In October 2011 updated results on four patients were released. [34] 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 [35] [36] and later went on to restart the trial. [37]

Patent issues

Geron Corporation initially held exclusive rights to three cell types derived from embryonic stem cells, as the result of paying for the research originally conducted by Dr. James Thomson at the University of Wisconsin–Madison. [38] The patents on the other three cell types are owned by the Wisconsin Alumni Research Foundation (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. [39]

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. [40] 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 who stated that University of Wisconsin–Madison stem cell pioneer James Thomson's techniques (currently patents held by WARF) are rendered obvious by a 1990 paper and two textbooks. [41] The outcome of this legal challenge was particularly relevant to the Geron Corporation as it can only license patents that are upheld. [42] The patents were ultimately upheld when the reexamination concluded in 2008. [43]

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. [44] 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. [45]

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. [46] [47] [48]

Related Research Articles

<span class="mw-page-title-main">Stem cell</span> Undifferentiated biological cells that can differentiate into specialized cells

In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can change into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of cell in a cell lineage. They are found in both embryonic and adult organisms, but they have slightly different properties in each. They are usually distinguished from progenitor cells, which cannot divide indefinitely, and precursor or blast cells, which are usually committed to differentiating into one cell type.

<span class="mw-page-title-main">Telomerase</span> Telomere-restoring protein active in the most rapidly dividing cells

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 eukaryotes. Telomeres protect the end of the chromosome from DNA damage or from fusion with neighbouring chromosomes. The fruit fly Drosophila melanogaster lacks telomerase, but instead uses retrotransposons to maintain telomeres.

<span class="mw-page-title-main">Multiple myeloma</span> Cancer of plasma cells

Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Often, no symptoms are noticed initially. As it progresses, bone pain, anemia, kidney dysfunction, and infections may occur. Complications may include hypercalcemia and amyloidosis.

<span class="mw-page-title-main">Embryonic stem cell</span> Type of pluripotent blastocystic 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 of 50–150 cells. Isolating the inner cell mass (embryoblast) using immunosurgery results in destruction of the blastocyst, a process which raises ethical issues, including whether or not embryos at the pre-implantation stage have the same moral considerations as embryos in the post-implantation stage of development.

<span class="mw-page-title-main">Lenalidomide</span> Pair of enantiomers

Lenalidomide, sold under the brand name Revlimid among others, is a medication used to treat multiple myeloma, smoldering myeloma, and myelodysplastic syndromes (MDS). For multiple myeloma, it is used after at least one other treatment and generally with dexamethasone. It is taken by mouth.

<span class="mw-page-title-main">Michael D. West</span> American biogerontologist

Michael D. West is an American biogerontologist, and a pioneer in stem cells, cellular aging and telomerase. He is the founder and CEO of AgeX Therapeutics, a startup focused on the field of experimental gerontology.

The stem cell controversy is the consideration of the ethics of research involving the development and use of human embryos. Most commonly, this controversy focuses on embryonic stem cells. Not all stem cell research involves human embryos. For example, adult stem cells, amniotic stem cells, and induced pluripotent stem cells do not involve creating, using, or destroying human embryos, and thus are minimally, if at all, controversial. Many less controversial sources of acquiring stem cells include using cells from the umbilical cord, breast milk, and bone marrow, which are not pluripotent.

Stem-cell therapy uses stem cells to treat or prevent a disease or condition. As of 2016, the only established therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone marrow transplantation, but the cells can also be derived from umbilical cord blood. Research is underway to develop various sources for stem cells as well as to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes and heart disease.

Mecasermin rinfabate, also known as rhIGF-1/rhIGFBP-3, is a drug consisting of recombinant human insulin-like growth factor 1 (IGF-1) and recombinant human insulin-like growth factor binding protein-3 (IGFBP-3) which is used for the treatment of amyotrophic lateral sclerosis.

<span class="mw-page-title-main">Induced pluripotent stem cell</span> Pluripotent stem cell generated directly from a somatic cell

Induced pluripotent stem cells are a type of pluripotent stem cell that can be generated directly from a somatic cell. The iPSC technology was pioneered by Shinya Yamanaka and Kazutoshi Takahashi in Kyoto, Japan, who together showed in 2006 that the introduction of four specific genes, collectively known as Yamanaka factors, encoding transcription factors could convert somatic cells into pluripotent stem cells. Shinya Yamanaka was awarded the 2012 Nobel Prize along with Sir John Gurdon "for the discovery that mature cells can be reprogrammed to become pluripotent."

<span class="mw-page-title-main">Telomerase reverse transcriptase</span> Catalytic subunit of the enzyme telomerase

Telomerase reverse transcriptase is a catalytic subunit of the enzyme telomerase, which, together with the telomerase RNA component (TERC), comprises the most important unit of the telomerase complex.

<span class="mw-page-title-main">Sierra Sciences</span> Biotechnology company

Sierra Sciences, LLC is a biotechnology company founded by William H. Andrews, former director of molecular biology at Geron Corporation. Andrews founded Sierra Sciences in 1999 in Reno, Nevada with the goal of preventing and/or reversing cellular senescence, and ultimately curing diseases associated with human aging, including the aging process itself.

<span class="mw-page-title-main">Panobinostat</span> Chemical compound

Panobinostat, sold under the brand name Farydak, is a medication used for the treatment of multiple myeloma. It is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor.

Gustav Gaudernack is a scientist working in the development of cancer vaccines and cancer immunotherapy. He has developed various strategies in immunological treatment of cancer. He is involved in several ongoing cellular and immuno-gene therapeutic clinical trials and his research group has put major efforts into the development of various T cell-based immunotherapeutic strategies.

<span class="mw-page-title-main">Daratumumab</span> Monoclonal antibody

Daratumumab, sold under the brand name Darzalex, is an anti-cancer monoclonal antibody medication. It binds to CD38, which is overexpressed in multiple myeloma cells. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.

William Henry Andrews is an American molecular biologist and gerontologist whose career is centered on searching for a cure for human aging. Andrews is the founder and president of the biotechnology company Sierra Sciences. In the 1990s, he led the team at Geron Corporation that was the first to successfully identify the genes for human enzyme telomerase. This enzyme is responsible for preventing telomeres from shortening in human primordial germ cells.

The Food and Drug Administration (FDA) approved the first clinical trial in the United States involving human embryonic stem cells on January 23, 2009. Geron Corporation, a biotechnology firm located in Menlo Park, California, originally planned to enroll ten patients with spinal cord injuries to participate in the trial. The company hoped that GRNOPC1, a product derived from human embryonic stem cells, would stimulate nerve growth in patients with debilitating damage to the spinal cord. The trial began in 2010 after being delayed by the FDA because cysts were found on mice injected with these cells, and safety concerns were raised.

Bryant Villeponteau is an American scientist, entrepreneur, and longevity expert who has worked in both academia and industry.

Spinal cord injury research seeks new ways to cure or treat spinal cord injury in order to lessen the debilitating effects of the injury in the short or long term. There is no cure for SCI, and current treatments are mostly focused on spinal cord injury rehabilitation and management of the secondary effects of the condition. Two major areas of research include neuroprotection, ways to prevent damage to cells caused by biological processes that take place in the body after the injury, and neuroregeneration, regrowing or replacing damaged neural circuits.

Hans Keirstead is a medical scientist and entrepreneur specializing in stem cell research.

References

  1. "Geron 2021 10K Annual Report". U.S. Securities and Exchange Commission. Retrieved 9 May 2022.
  2. "Anti-ageing drugs are coming that could keep you healthier for longer". New Scientist. April 24, 2019.
  3. Pollack, Andrew (May 18, 2011). "A Blood Test Offers Clues to Longevity". New York Times.
  4. "SEC Schedule 13G, filed Feb. 17, 1999".
  5. "Human tests of Geron's spinal-cord medication put on hold". The Mercury News. 2009-08-18. Retrieved 2020-04-29.
  6. Binstock, Robert H. (2003-07-22). "BOOKS OF THE TIMES; Quest for Infinite Youth Raises Hopes and Cash". The New York Times. ISSN   0362-4331 . Retrieved 2020-04-29.
  7. Leuty, Ron (30 September 2011). "Chip Scarlett's skills may pay off - again - at Geron". San Francisco Business Times. Retrieved 15 November 2016.
  8. Hayflick L (1965). "The limited in vitro lifetime of human diploid cell strains". Experimental Cell Research. 37 (3): 614–636. doi:10.1016/0014-4827(65)90211-9. PMID   14315085.
  9. "Geron Corporation 10K 1996".
  10. Hall, Stephen (2003). "Merchants of Immortality: Chasing the New Dream of Life Extension". Houghton Mifflin. ISBN   0547561571. Page 151.
  11. Monmaney, Terence (14 January 1998). "Scientists Give Cell Apparent Immortality". Los Angeles Times.
  12. Salisbury, Ian (May 29, 2018). "This Map Shows the Best-Paying Company In Every State". Money.com . Archived from the original on September 30, 2020.
  13. "Imetelstat Sodium". NCI Drug Dictionary. National Cancer Institute. Retrieved 15 November 2016.
  14. Brennan, Sarah K.; Wang, Qiuju; Tressler, Robert; Harley, Calvin; Go, Ning; Bassett, Ekaterina; Huff, Carol Ann; Jones, Richard J.; Matsui, William; Swarbrick, Alexander (1 September 2010). "Telomerase Inhibition Targets Clonogenic Multiple Myeloma Cells through Telomere Length-Dependent and Independent Mechanisms". PLOS ONE. 5 (9): e12487. Bibcode:2010PLoSO...512487B. doi: 10.1371/journal.pone.0012487 . PMC   2931698 . PMID   20824134.
  15. Alex Planes (November 3, 2014). "Why Geron Corporation Shares Skyrocketed". The Motley Fool.
  16. Fitzhugh, Michael (17 November 2014). "'New chapter' as Geron lands potential $935M imetelstat deal with Janssen". BioWorld.
  17. "Geron Announces Global Strategic Collaboration with Janssen to Develop and Commercialize Imetelstat". Investor Relations: Press Release. Geron. Archived from the original on September 5, 2015. Retrieved 2018-02-25.
  18. Corporation, Geron. "Geron Announces Fast Track Designation Granted to Imetelstat for Lower Risk myelodysplastic syndromes". GlobeNewswire News Room. Retrieved 2018-02-25.
  19. "Geron shares crater as Janssen bows out of imetelstat pact once worth up to $935M". FierceBiotech. Retrieved 2021-01-05.
  20. Geron Corporation (2021-01-04). "A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment". Clinical Trials.
  21. Geron Corporation (2020-12-23). "A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients With Intermediate-2 or High-risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK)-Inhibitor". Clinical Trials.
  22. Harley, Calvin B. (March 2008). "Telomerase and cancer therapeutics". Nature Reviews Cancer. 8 (3): 167–179. doi:10.1038/nrc2275. PMID   18256617. S2CID   39599576.
  23. "Geron plans stock offering, Merck buying $18M in shares". 12 September 2005.
  24. "Geron Scraps GRN1005, Cuts Jobs". Zacks Investment Research. Retrieved 15 November 2016.
  25. Fauce, Steven Russell; Jamieson, Beth D.; Chin, Allison C.; Mitsuyasu, Ronald T.; Parish, Stan T.; Ng, Hwee L.; Ramirez Kitchen, Christina M.; Yang, Otto O.; Harley, Calvin B.; Effros, Rita B. (2008). "Telomerase-Based Pharmacologic Enhancement of Antiviral Function of Human CD8+ T Lymphocytes". The Journal of Immunology. 181 (10): 7400–7406. doi: 10.4049/jimmunol.181.10.7400 . PMC   2682219 . PMID   18981163.
  26. Borrell, Brendan (2 August 2012). "Lawsuit challenges anti-ageing claims". Nature. 488 (7409): 18. Bibcode:2012Natur.488...18B. doi: 10.1038/488018a . PMID   22859181.
  27. American Analytical Chemistry Laboratories Analysis Document #100710-236 of TA-65
  28. Ron Leuty (November 15, 2012). "Geron to sell embryonic stem cell business to BioTime". San Francisco Business Times. Retrieved 2020-12-14.
  29. "Despite Bush Veto, Stem Cell Research Abounds - Forbes.com". Forbes. Archived from the original on February 4, 2007.
  30. Keirstead HS, Nistor G, Bernal G, et al. (May 2005). "Human embryonic stem cell-derived oligodendrocyte progenitor cell transplants remyelinate and restore locomotion after spinal cord injury". J. Neurosci. 25 (19): 4694–705. doi:10.1523/JNEUROSCI.0311-05.2005. PMC   6724772 . PMID   15888645.
  31. News: Geron Presents New Data That Document Progress in Development of Therapeutic Products from Human Embryonic Stem Cells. Genetic Engineering & Biotechnology News - Biotechnology from Bench to Business
  32. "Geron Announces Record Date for Distribution of Asterias Series A Common Stock". Yahoo Finance. Retrieved 15 November 2016.
  33. CNN Rachel Meade Reports (October 13, 2010)
  34. "Geron (GERN) updates Clinical Data from GRNOPC1 Spinal Cord Injury Trial". 20 Oct 2011. Archived from the original on 2011-10-23.
  35. "Geron's Stem Cell Program Sold". The Scientist. October 2, 2013.
  36. "BioTime acquires stem cell assets from Geron, raises $10 million". San Francisco Business Times. January 7, 2013.
  37. "Funding windfall rescues abandoned stem-cell trial". Nature. June 3, 2014.
  38. Westhoff, Julia (22 January 2002). "WARF, Geron reach settlement". The Badger Herald.
  39. Regalado, Antonio; Hamilton, David P. (18 July 2006). "How a University's Patents May Limit Stem-Cell Research". Wall Street Journal.
  40. Kintisch, E. (21 July 2006). "Groups Challenge Key Stem Cell Patents". Science. 313 (5785): 281. doi: 10.1126/science.313.5785.281 . PMID   16857907. S2CID   167760607.
  41. Loring, Jeanne (8 November 2007). "A patent challenge for human embryonic stem cell research". Nature Reports Stem Cells. doi:10.1038/stemcells.2007.113.
  42. "Stem Cell Patents Come Under Fire". Center for Genetics and Society. Associated Press. 19 July 2006.
  43. WARF press release
  44. Somers, Terri (23 January 2007). "Stem cell scientists shout out hallelujah". The San Diego Union-Tribune.
  45. "Wisconsin Group Eases Stem Cell Patent Restrictions After FTCR". PUBPAT. 23 January 2007. Retrieved 5 September 2013.
  46. Herper, Matthew (April 5, 2001). "Geron's Cloning Quandary - Forbes.com". Forbes.
  47. "Online Extra: Thomas Okarma: Don't Ban Stem-Cell Research". BusinessWeek. 2 June 2003. Archived from the original on 22 May 2011.
  48. "House Hearing, 107th Congress - The Human Cloning Prohibition Act of 2001 and The Cloning Prohibition Act of 2001", U.S. Government Publishing Office, 20 June 2001