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Episode #2: Geron
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Episode #2: Geron

Geron was founded in 1990 to cure aging, built the field around telomeres & stem cells, and spent 34 years at it - only to end up with an FDA approval for a niche blood cancer drug. What took so long?

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TABLE OF CONTENTS

(00:00:00) - Introduction

(00:01:19) - Hayflick Limit

(00:08:30) - Michael West & Founding of Geron

(00:15:16) - Early Science & IP Strategy

(00:27:25) - Cloning the Telomerase Gene

(00:29:30) - Embryonic Stem Cells & Political Context

(00:44:21) - Okarma, West’s Departure & Corporate Turmoil

(01:05:08) - Spinal Cord Injury Trial

(01:30:45) - Pivot to Blood Cancer

(01:43:08) - Clinical & Commercial Drama

(02:01:45) - Legacy & Lessons

CREDITS

Co-hosted by Alex Kesin and Matthew Pech

Written, edited, and produced by Alex Kesin

Music: “Food” by nerowski

* Special thanks to the team at NFX for the use of their recording studio.

SOURCES

Last updated: March 2026

I. BOOKS

Hall, Stephen S. Merchants of Immortality: Chasing the Dream of Human Life Extension. Houghton Mifflin, 2003.

Williams, Tory. Inevitable Collision: The Inspiring Story That Brought Stem Cell Research to Conservative America.Mary Ann Liebert, Inc., 2014.

II. KEY SCIENTIFIC PUBLICATIONS

Hayflick, L. & Moorhead, P.S. “The serial cultivation of human diploid cell strains.” Experimental Cell Research 25 (1961): 585–621.

Kim, N.W. et al. “Specific association of human telomerase activity with immortal cells and cancer.” Science 266, no. 5193 (1994): 2011–2015.

Feng, J. et al. “The RNA component of human telomerase.” Science 269, no. 5228 (1995): 1236–1241.

Nakamura, T.M. et al. “Telomerase catalytic subunit homologs from fission yeast and human.” Science 277, no. 5328 (1997): 955–959.

Meyerson, M. et al. “hEST2, the putative human telomerase catalytic subunit gene, is up-regulated in tumor cells and during immortalization.” Cell 90, no. 4 (1997): 785–795.

Bodnar, A.G. et al. “Extension of life-span by introduction of telomerase into normal human cells.” Science 279, no. 5349 (1998): 349–352.

Thomson, J.A. et al. “Embryonic stem cell lines derived from human blastocysts.” Science 282, no. 5391 (1998): 1145–1147.

Asai, A. et al. “A novel telomerase template antagonist (GRN163) as a potential anticancer agent.” Cancer Research 63, no. 14 (2003): 3931–3939.

Herbert, B-S et al. “Effect of the lipid modification of GRN163.” Nature: Oncogene 24 (2005): 5765–5772.

Baerlochr, G. et al. “A pilot study of the telomerase inhibitor imetelstat for myelofibrosis.” New England Journal of Medicine 373 (2015): 908–919.

Platzbecker, U. et al. “Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge).” The Lancet (2024).

Lennox, A.L et al. “Imetelstat, a novel, first-in-class telomerase inhibitor: Mechanism of action, clinical, and translational science.” Clinical and Translational Science 17, no. 11 (2024).

Scott, C. & Magnus, D. “Wrongful Termination: Lessons From the Geron Clinical Trial” Stem Cell Reports 3, no. 5 (2014): 721–723.

III. REGULATORY & CLINICAL

Prescribing Information (Label) U.S. Food and Drug Administration. “RYTELO (imetelstat) for injection: Highlights of Prescribing Information.” NDA 217779. June 2024.

NDA Approval Letter U.S. Food and Drug Administration. “NDA Approval Letter: RYTELO (imetelstat) for injection.” NDA 217779. June 6, 2024.

Multi-Discipline Review & Evaluation U.S. Food and Drug Administration. “NDA Multi-Disciplinary Review and Evaluation: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024.

ODAC Briefing Document U.S. Food and Drug Administration. “FDA Briefing Document: Oncologic Drugs Advisory Committee Meeting, NDA 217779, Imetelstat.” March 14, 2024.

REMS/Risk Assessment Review U.S. Food and Drug Administration. “Risk Assessment and Risk Mitigation Review: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024.

Kim, N. et al. “US Food and Drug Administration Approval Summary: Imetelstat for Selected Patients With Low- to Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia.” The Oncologist (2025). PMID: 41135032.

FDA. “FDA Approves Imetelstat for Low- to Intermediate-1-Risk Myelodysplastic Syndromes with Transfusion-Dependent Anemia.” June 2024.

ICER. “Evidence Report: Treatment for Anemia in Myelodysplastic Syndrome.” August 2024.

ICER. Press Release on Imetelstat Evidence Assessment.

ClinicalTrials.gov. GRNOPC1 Phase I Trial. NCT01217008.

Myelodysplastic Syndrome Epidemiology. PMC4553145.

MDS Risk and AML Progression. Blood (2023).

IV. CORPORATE FILINGS & PRESENTATIONS

Geron Corporation. S-1 Registration Statement (1996 IPO).

Geron Corporation. Corporate presentations archive (2012–present).

Geron Corporation. 2012 R&D Strategy Presentation.

Geron Corporation. 2013 NSCLC Study Results.

Geron Corporation. 2015 Janssen/MF Collaboration Presentation. (p.41-)

Geron Corporation. 2016 Mechanism of Action Analysis (thrombocytopenia/TLR9).

Royalty Pharma. “Royalty Pharma to Acquire Royalty Interest in Geron’s Rytelo for $125 Million.” November 2024.

V. NEWS & MEDIA COVERAGE

[1994] New York Times. “Immortality Enzyme Is Discovered in Many Types of Cancer.” December 27, 1994.

[1995] New York Times. “New Light Shed on How Enzyme May Play Crucial Role in Cancer.” September 5, 1995.

[1996] New Yorker. “The New Age of Man.” September 30, 1996.

[1996] Bio.net Ageing Forum. Geron financing announcements.

[1996] Bio.net Ageing Forum. Geron NCI/SBIR grants.

[1996] Bio.net Ageing Forum. Kyowa Hakko deal.

[1996] Bio.net Ageing Forum. Kyowa Hakko deal details.

[1996] BioWorld. Geron IPO news.

[1998] ScienceDaily. “Human Embryonic Stem Cells Successfully Derived.” November 9, 1998.

[1998] New York Times. “Scientists Cultivate Cells at Root of Human Life.” November 6, 1998.

[1998] New York Times. “Essay: Immortality, of a Sort, Beckons to Biologists.” November 17, 1998.

[1999] Dooling, Richard. “Diary of an Immortal Man.” Published on KurzweilAI.net, May 1999.

[2000] Wired. “Embryonic Cell Debate Is On.” August 2000.

[2001] New York Times. “Public Lives: Cell Biologist Traded Religious Fervor for Scientific Zeal.” August 13, 2001

[2001] WARF. “WARF Amends Stem Cell Suit.”

[2001] USCCB. “Human Embryo Research Is Illegal, Immoral, and Unnecessary.”

[2002] Forbes. Stem cell coverage, January 31, 2002.

[2004] Nature Reviews - Telomere biology and cancer.

[2004] New York Times. “Cloning, Stem Cells: Medical and Ethical Issues Cloud Cloning for Therapy.” February 13, 2004.

[2004] Seattle University School of Law. “Geron and stem cell ethics.”

[2005] PharmaTimes. “Geron Leaps on Merck Deal.”

[2008] Gitschier, J. “Interview with James Thomson.” PLoS Genetics (2008).

[2010] New York Times. A First For Stem Cell Use In Therapy. October 11, 2010.

[2011] Forbes (Matthew Herper). “Stem Cell Innovator James Thomson Says Geron Blazed Trail.” November 15, 2011.

[2011] Washington Post. “First Patient to Get Stem Cell Therapy Is Identified.” April 2, 2011.

[2011] Washington Post. “Stem Cells Were God’s Will, Says First Recipient of Treatment.” April 14, 2011.

[2011] New York Times. Michael West / BioTime profile. May 19, 2011.

[2011] New York Times. “Geron Is Shutting Down Its Stem Cell Clinical Trial.” November 15, 2011.

[2011] The Guardian. “Geron Abandons Stem Cell Therapy.” November 15, 2011.

[2011] Science. “Geron Bails Out of Stem Cells.”

[2011] The Hastings Center. “Geron’s Discontinued Stem Cell Trial: What About the Research Participants?”

[2011] CIRM. “Geron Discontinues Stem Cell Program.” November 14, 2011.

[2013] The Scientist. “Geron’s Stem Cell Program Sold.” (Asterias/BioTime acquisition).

[2013] The Niche (Paul Knoepfler). Interview with BioTime CEO Michael West, Part 1.

[2013] The Niche. Interview with Mike West, Part 2: Geron hESC.

[2013] The Niche. Interview with Mike West, Part 3: Key Flaw in Stem Cell Field.

[2013] The Niche. “BioTime Subsidiary Asterias Acquires Geron Embryonic Stem Cell Program.”

[2013] Nature Medicine. “No End in Sight for Telomerase-Targeted Cancer Drugs.” January 2013.

[2016] USC Health Sciences. Kris Boesen stem cell recovery.

[2016] The Niche. “Asterias Interview: Stem Cell Spinal Cord Injury Trials Advance.” December 2016.

[2018] FierceBiotech. “Geron Craters as Janssen Bows Out of Imetelstat Pact Once Worth Up to $935M.” September 2018.

[2018] STAT News (Adam Feuerstein). “Geron Warning Signs.” September 27, 2018.

[2018] GlobeNewsWire. “Asterias Provides Update for AST-OPC1 Phase 1/2a Clinical Trial.” February 28, 2018.

[2023] Pharmaphorum. “Geron Finally Gets Close to a Product Approval with Imetelstat.”

[2023] STAT News. “Geron Success in Myelodysplastic Syndromes.” January 4, 2023.

[2024] Reuters. “US FDA Staff Flags Concerns About Geron’s Anemia Treatment.” March 12, 2024.

[2024] BioPharma Dive. “Geron Approval, Blood Disorder, Nobel Prize, Imetelstat.”

[2024] STAT News. “I Was Wrong About Geron’s Blood Cancer Drug. Now, Is It a Takeover Target?” March 18, 2024.

[2024] CIRM Blog. “Where Are They Now: Jake Javier.” August 19, 2024.

[2024] Christopher Reeve Foundation. “Pioneering Cell Transplants for the Treatment of SCI.”

[2024] Oncology Pipeline / ApexOnco. “Seven Problems Geron.”

[2024] AInvest. “Geron Navigating Legal Headwinds, Rytelo Commercial Crossroads.”

[2025] BiotechNation. “No More Transfusions: Dr. John Scarlett, CEO of Geron Corporation.”

[2025] PharmaVoice. “Geron’s Harout Semerjian on Drug Approval and Pharma.”

[2025] Investing.com. “Geron at Stifel 2025 Healthcare Conference: Strategic Adjustments for Rytelo.”

[2025] SFGate. “Geron Lays Off Third of Staff.”

[2025] Fierce Pharma. “Geron to Lay Off 13% of Workforce to Slash Operating Costs.”

[2025] PharmaTimes. PCSK9 inhibitor launch comparison. https://pharmatimes.com/web_exclusives/are_pcsk9_inhibitors_about_to_take_off_1289184/

VI. BROADCAST & VIDEO COVERAGE

CBS News, 60 Minutes. Ed Bradley segment on Geron stem cell rat study (~2006).

YouTube. Geron documentary (2003).

CNBC Mad Money. Geron coverage: July 2009.

CNBC Squawk on the Street. Geron stock down: August 2009.

KCSM Newsline. Embryonic stem cells: October 2010.

C-SPAN Weekend. Okarma interview: October 2010.

KPIX CBS 5. “First Time Ever Stem Cell Injection Spinal Cord.” October 2010.

KGO ABC World News. Stem cell coverage: October 2010.

KPIX CBS 5. Geron layoffs, pivot to cancer: November 2011.

KTVU Fox 2. Geron cancels spinal cord study, patient interview: December 2011.

CNBC Squawk on the Street. Breast cancer study halted: September 2012.

KCSM Newsline. ACT vision stem cells: January 2012.

CNBC Street Signs. Geron stock up on cancer study: November 2013.

CNBC Squawk on the Street. Hold lifted after hepatotoxicity: June 2014.

CNBC Street Signs. Geron up 60% on J&J deal: December 2014.

CNBC Mad Money. Geron coverage: May 2018.

CNBC Power Lunch. J&J leaves deal: September 2018.

YouTube. Michael D. West, Longevity Summit Dublin (2022).

CNBC Mad Money. Geron coverage: March 2023.

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