Sio Gene Therapies

American pharmaceutical company

Sio Gene Therapies, Inc.

Formerly| Axovant Gene Therapies
Company type| Public

Traded as

| Nasdaq: SIOX
Industry| Biopharmaceutical
Founded| October 2014; 10 years ago (2014-10)
Founder| Vivek Ramaswamy
Defunct| April 5, 2023 (2023-04-05)
Headquarters| New York City

Key people

| Pavan Cheruvu (CEO)
Owner| Roivant Sciences (25%)
Website| siogtx.com

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

[edit]

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][1][5] 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.[6][7] Intepirdine was Axovant's only product.[8]

Although no clinical development took place, Axovant held its IPO in June 2015 and raised $315 million,[4] 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.[7] It has been accused of being a pump-and-dump scheme.[14][15][16][7]

The company also entered clinical trials for dementia with Lewy bodies,[17] which were unsuccessful as well. Consequently, Axovant announced in 2018 that it has discontinued development of intepirdine.[18]

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[5] and intended to develop it as a treatment for Lewy body dementia.[19] 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 and that therefore its development would be discontinued.[20]

In 2016 Axovant partnered with NFL broadcaster Solomon Wilcots to raise awareness of Alzheimer's clinical trials[21][22] 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,[21] 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.[23]

Axovant logo from 2014 to 2020

In 2017, David Hung joined the company as CEO.[24]

In 2018, David Hung resigned and Pavan Cheruvu became the new CEO.[25]

In December 2018, Axovant added two gene therapy programs[which?] to treat GM1 gangliosidosis and Tay–Sachs and Sandhoff diseases.[26][27]

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.[28]

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.[29]

On April 5, 2023, the shareholders of Sio Gene Therapies voted to liquidate and dissolve the company.[30]

## References

[edit]

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