Sio Gene Therapies Explained

Sio Gene Therapies, Inc.
Former Name:Axovant Gene Therapies
Type:Public
Traded As:NASDAQ:
Industry:Biopharmaceutical
Predecessors:-->
Successors:-->
Founder:Vivek Ramaswamy
Hq Location:New York City
Areas Served:-->
Key People:Pavan Cheruvu (CEO)
Profit:-->
Profit Year:-->
Owner:Roivant Sciences (25%)

Sio Gene Therapies, Inc. (formerly known as Axovant Gene Therapies) was a clinical-stage pharmaceutical company that developed gene therapies to treat neurological disorders. The company was headquartered in New York City and was incorporated in Basel, Switzerland. The company was founded by former hedge fund analyst and 2024 Republican Party presidential primary candidate Vivek Ramaswamy[1] in October 2014 as a wholly owned subsidiary of Roivant Sciences, which was itself founded in May 2014.[2]

History

In December 2014, Axovant acquired rights to the drug intepirdine from GlaxoSmithKline.[3] Intepirdine is a potential add-on treatment to donepezil for patients with Alzheimer's disease and patients with dementia with Lewy bodies.[4] GlaxoSmithKline had sold the rights to Axovant for only $5 million, a very small amount in the pharmaceutical industry, because four clinical trials had resulted in failure.[5] [6] Intepirdine was Axovant's only product.[7]

Although no clinical development took place, Axovant held its IPO in June 2015 and raised $315 million,[8] the largest biotech IPO ever,[9] based on new phase IIB trials that were more promising.[10] The lock-up period against reselling stock was reduced to an unusually short 90 days for hedge funds that showed interest in the IPO.[11]

In July 2017, Axovant announced that the results of a phase III trial indicated that the drug was not effective for treatment of Alzheimer's disease.[12] [13] Axovant's stock lost 75 percent of its value in a single day.[14] It has been accused of being a pump-and-dump scheme.[15] [16] [17] [18]

The company also entered clinical trials for dementia with Lewy bodies,[19] which were unsuccessful as well. Consequently, Axovant announced in 2018 that it has discontinued development of intepirdine.[20]

As of 2016 Axovant was also developing a second compound, nelotanserin. Axovant acquired global rights to nelotanserin from its former parent, Roivant, which had previously bought those rights from Arena Pharmaceuticals[4] and intended to develop it as a treatment for Lewy body dementia.[21] However, in late 2018, the company announced that nelotanserin failed to meet its primary endpoint of reducing the frequency of REM sleep behavior disorder (RBD) episodes in a small Phase 2 clinical trial for the treatment of RBD in LBD patients, the drug and would be discontinued.[22]

In 2016 Axovant partnered with NFL broadcaster Solomon Wilcots to raise awareness of Alzheimer's clinical trials[23] [24] That year it also sponsored performances in several U.S cities of “Forget Me Not,” a play by Garrett Davis about an African American family coping with Alzheimer’s disease,[23] in order to raise awareness of its clinical trials in that community, because African Americans are twice as likely to develop Alzheimer’s disease as white Americans, but have been historically underrepresented in clinical research studies.[25] Also in 2016, Axovant partnered with the mobile rideshare service Lyft to transport patients in Alzheimer's disease studies to clinical facilities.[26]

In 2017, David Hung joined the company as CEO.[27]

In 2018, David Hung resigned and Pavan Cheruvu became the new CEO.[28]

In December 2018, Axovant added two gene therapy programs to treat GM1 gangliosidosis and Tay–Sachs and Sandhoff diseases.[29] [30]

In June 2019, Axovant announced a strategic partnership with Yposkesi, a leading Contract Development and Manufacturing Organization, to expand Axovant's gene therapy manufacturing capacity.[31]

In August 2019, Axovant was preparing to report data from all three clinical-stage programs in the fourth quarter of 2019, including results from the second cohort of the AXO-LENTI-PD study and data from additional children dosed with AXO-AAV-GM1 and AXO-AAV-GM2.

In November 2020, Axovant rebranded as Sio Gene Therapies.[32]

On April 5, 2023, the shareholders of Sio Gene Therapies voted to liquidate and dissolve the company.[33]

Notes and References

  1. News: Axovant Sciences founded by Indian American Vivek Ramaswamy has biggest US biotech IPO . Karerat, Raif . The American Bazaar . Germantown, Maryland . Global Media Holding . 12 Jun 2015 .
  2. Web site: 10-K For the fiscal year ended March 31, 2016. Axovant via SEC Edgar. June 6, 2016.
  3. News: Shares of Axovant, Alzheimer's Drug Developer, Surge on Trading Debut . Pollack, Andrew . . 11 Jun 2015 .
  4. News: Axovant prepares to start pair of dementia drugs trials. Financial Times. 2015-11-02. 2016-01-07. 0307-1766. David. Crow.
  5. Web site: Axovant Abandons Another Dementia Drug After Failed Trial . 2023-09-14 . BioSpace . en-US.
  6. News: Weisman . Jonathan . Robbins . Rebecca . Farrell . Maureen . 2023-06-27 . How Vivek Ramaswamy Made the Fortune Fueling His Presidential Run . en-US . The New York Times . 2023-09-14 . 0362-4331.
  7. https://www.fiercebiotech.com/biotech/why-axovant-s-315m-ipo-bonanza-should-scare-hell-out-of-you
  8. News: Axovant doubles in value after $315M IPO . Staff . Associated Press . . 12 Jun 2015 .
  9. Web site: Stevenson . Abigail . 2015-06-11 . Biggest biotech IPO ever—and the CEO is 29! . 2023-09-14 . CNBC . en.
  10. https://www.sec.gov/Archives/edgar/data/1636050/000163605016000042/a3311610k.htm
  11. Web site: Feuerstein . Adam . 2015-06-08 . Inside the Hedge Fund Club Pitching a New Alzheimer's Drug IPO . 2023-09-14 . TheStreet . en-us.
  12. Web site: Garde . Damian . Another Alzheimer's failure: Axovant's drug flops in late-stage trial . STAT . 26 September 2017.
  13. News: Herper. Matthew. Axovant Alzheimer's Drug Fails To Help Patients. Forbes. September 26, 2017. en.
  14. News: Weisman . Jonathan . Robbins . Rebecca . Farrell . Maureen . 2023-06-27 . How Vivek Ramaswamy Made the Fortune Fueling His Presidential Run . en-US . The New York Times . 2023-09-14 . 0362-4331.
  15. Web site: Smoke and mirrors: I’ve been debating Vivek Ramaswamy for 2 years. Here’s how I got past his diversionary tactics . 2023-09-14 . Fortune . en.
  16. Web site: Vivek Ramaswamy is threatening GOP heavyweights in the polls–but his business record doesn't live up to the hype . 2023-09-14 . Fortune . en.
  17. Web site: Piper . Jessica . 2023-05-14 . How Vivek Ramaswamy made a fortune before pivoting to politics . 2023-09-14 . POLITICO . en.
  18. News: Weisman . Jonathan . Robbins . Rebecca . Farrell . Maureen . 2023-06-27 . How Vivek Ramaswamy Made the Fortune Fueling His Presidential Run . en-US . The New York Times . 2023-09-14 . 0362-4331.
  19. Web site: Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study - Full Text View - ClinicalTrials.gov . 2023-09-14 . clinicaltrials.gov . en.
  20. News: Axovant slumps as it dumps lead drug intepirdine . Fierce Biotech . Jan 8, 2018.
  21. Web site: Acadia drug approval could clear way for Axovant dementia therapy . Grover, Natalie . 28 Apr 2016 . Reuters .
  22. Web site: Axovant Reports Results of Exploratory Phase 2 Clinical Study of Nelotanserin in Lewy Body Dementia Patients Experiencing REM Sleep Behavior Disorder . . 7 May 2023 . December 10, 2018.
  23. News: Henriques. Carolina. 'Huddle Up for Alzheimer's' Campaign Encourages Clinical Trial Participation. 14 November 2016. Alzheimer's News Today. 26 January 2016.
  24. News: Leuty. Ron. On sports' biggest stage, drug developers tap athletes' connections. 14 November 2016. San Francisco Business Times. 9 February 2016.
  25. News: Kunkle. Frederick. Alzheimer's risk is higher in African Americans, but many fear clinical studies. 14 November 2016. The Washington Post. 23 November 2014.
  26. News: Rockoff. Jonathan. Companies Try New Ways to Attract Patients to Drug Trials. 14 November 2016. The Wall Street Journal. 18 July 2016.
  27. News: Taylor. Nick Paul. Axovant stock jumps as Medivation founder takes CEO post. FierceBiotech. April 10, 2017. en.
  28. Web site: Axovant Sciences Announces Changes to Management Team and Board of Directors Axovant Sciences, Inc.. Axovant Sciences, Inc.. en. 2018-02-12.
  29. Keown. Alex. Axovant Licenses Two Gene Therapies Aimed at Tay–Sachs and Sandhoff Disease. BioSpace. 14 December 2018.
  30. Taylor. Nick Paul. Axovant buys more gene therapies, setting it up for a busy 2019. FierceBiotech. 14 December 2018.
  31. Web site: Yposkesi enters into strategic partnership to expand Axovant's gene therapy manufacturing capacity. en-US. 2020-03-18.
  32. Web site: Gelman . Max . 'We're not a vant': Axovant seeks to forget the past as the company rebrands to Sio Gene Therapies . Endpoints News.
  33. Web site: Sio Gene Therapy.