Innate Immunotherapeutics

Innate Immunotherapeutics (INNM) was a biopharmaceutical company, previously known as Virionyx, with headquarters in Sydney, Australia and a branch in Auckland, New Zealand. Their focus in 2009 was the "development of a new generation of immune response modifier for potential use in the treatment of a range of infectious diseases, certain cancers, and as a novel cellular and humoral adjuvant, "[2] and developed a proprietary multiple sclerosis drug, MIS416.[3] In April 2009 the firm changed its name to Innate Immunotherapeutics to reflect their focus on the development of MIS416, and moved their headquarters from Auckland, New Zealand to Sydney, Australia.[2] On June 22, 2017, Innate Immunotherapeutics announced that the MIS416 clinical trials undertaken to evaluate its efficacy in managing secondary progressive multiple sclerosis (SPMS),[4][5][6][7] had "failed to show any clinically meaningful benefit or statistical significance."[8] These findings resulted in the stocks crashing on the Australian Securities Exchange (ASX).[8]

Innate Immunotherapeutics Limited
IndustryBiotechnology
PredecessorVirionyx
SuccessorAmplia Therapeutics Limited
Headquarters
Sydney
,
Australia[1]
Key people
Simon Wilkinson CEO[1]
ProductsMIS416
Websitehttps://www.ampliatx.com

Innate Immunotherapeutics received media attention in 2018 after its majority owner US Congressman Chris Collins was arrested for insider trading.[9] In September, 2018, the company changed its name to Amplia Therapeutics Limited.[10]

History

In 2009, Gill Webster, Ph.D., was Innate Therapeutics' chief scientific officer.[2] By 2009, MIS416 had "shown promising activity in preclinical proof-of-principle studies in cancer, infectious and autoimmune diseases[2] In a 2009 article published by BioPharm International, researchers discussed the potential of the then-novel, MIS416 adjuvant as a therapeutic vaccine "for patients with cancer or acquired chronic infections, such as HIV, hepatitis, tuberculosis, and malaria".[3]

MIS416 is "a myeloid-directed microparticle immune response modifier (derived from Cutibacterium acnes), which was originally developed as a vaccine adjuvant."[11][12] "MIS416 has been suggested to modulate T-cell-mediated autoimmune responses in EAE by simultaneously activating innate Toll-like receptor 9 and nucleotide-binding oligomerization domain-containing protein 2."[11][12]

According to White, O'Sullivan, Stone and La Flamme in their January 31, 2014 PLoS One article, the "restricted uptake of MIS416 by phagocytic cells results in targeted modulation of the innate wing of the immune system, which contrasts with soluble agonists, which can directly activate a broader range of innate and adaptive immune subsets".[13]:9[11] White, O'Sullivan, Stone and La Flamme also found that MIS416 "[suppressed] the development of proinflammatory T helper (Th)1, Th2, and Th17 cells in EAE, and [increased] the serum levels of IFN-γ and IFN-γ-associated proteins in 19 patients with SPMS."[13][11]

"MIS416 was initially used in patients with SPMS outside of a formal clinical trial setting under compassionate use legislation in New Zealand."[11]

Shirani also reported in 2016, that a "phase IIb trial [was] underway to further investigate the effect of MIS416 in progressive forms of MS (NCT02228213)".[11][14]

On June 22, 2017, Innate Immunotherapeutics announced that the MIS416 clinical trials had "failed to show any clinically meaningful benefit or statistical significance."[8] Their stocks immediately crashed on the Australian Securities Exchange (ASX).[8]

On August 31, Innate Immunotherapeutics CEO announced that the firm would be closing over the next few months.[15]

Innate's board of directors included Chairman Warwick Tong, CEO Simon Wilkinson, Robert Peach, Christian Behrenbruch, Christopher Burns, and Andrew J. Cooke.[16]

Chris Collins involvement

Innate Immunotherapeutics's largest stockholder by August 2016, the United States congressman Chris Collins (R-N.Y.), had begun investing in the company in 2002.[17] Over the years Collins raised money for the company and was invited to serve on its board of directors.[17]

In August 2016 Collins purchased 4 million more shares in Innate Immunotherapeutics making him the largest shareholder. At the same time Tom Price, who until 29 September 2017 was the 23rd United States Secretary of Health and Human Services, purchased 400,613 Innate Immunotherapeutics shares valued at $100,000 to $250,000.[6] Senator Ron Wyden (D-Oregon) raised potential concerns about Price's Innate Immunotherapeutics investments which "could be affected by legislation that comes before Congress."[6]

By June 8, 2017, Collins had announced that Innate's drug had just "completed a Phase 2B clinical trial", and Innate Immunotherapeutics "hopes to sell off the product later [in 2017]."[17] On June 22, 2017, Collins learned through a "private email from [Innate Immunotherapeutics]' chief executive that the clinical trials for the "potentially lucrative experimental drug had failed." Collins' son, Cameron Collins, who held Innate Immunotherapeutics shares, avoided over $570,000 in losses by selling his stocks on June 22, after his father had warned him that the Phase 2B clinical trials had failed.[18] By June 8, 2017 the price per share in the United States' over-the-counter (OTC) market of INNMF, had dropped to 58 cents per share".[4] By June 27, it was reported that Collins, who was the largest INNMF stockholder, "incurred a paper loss of nearly $17 million".[8]

In May 2017, White House ethics investigators "began probing Collins for his role in recruiting investors to buy stock in Innate Immunotherapeutics after several complaints were filed".[17] Members of Congress are explicitly barred from trading stocks using insider information."[17] In October 2017, the Office of Congressional Ethics (OCE) said they had "substantial reason" to believe that Collins had improperly used his public office to benefit Innate, and had forwarded nonpublic information to other investors.[19]

On August 8, 2018, Collins, his son Cameron, and Cameron's fiancée's father Stephen Zarsky were arrested on insider trading charges.[20] Collins resigned on October 1, 2019, the day before he pleaded guilty to insider trading.[21][9] He was sentenced to 26 months in prison,[22] while Cameron was sentenced to probation and community service.[23]

MIS416

MIS416 is a vaccine adjuvant and "immunogen co-delivery system".[3] In 2011, in an NIH publication MIS416 was described as a "non-toxic microparticle adjuvant derived from Propionibacterium acnes comprising immunostimulatory muramyl dipeptide and bacterial DNA promotes cross-priming and Th1 immunity".[24] In 2015, Innate Immunotherapeutics described it as an "immunomodulator" for "patients with chronic progressive multiple sclerosis".[25]

Clinical trials

Innate Immunotherapeutics undertook a 12-month clinical study (NCT02228213) with 13 patients with early funding from the research arm, Fast Forward LLC, of the National MS Society in the U.S. In 2016, the Phase 2B, placebo-controlled clinical trial of MIS416 which includes nine patients from the original trial, was underway.[1][26][27] Research on MIS416 is undertaken in collaboration with Raleigh, North Carolina's INC Research under the tenure of CEO Alistair Macdonald.[28]

Renamed to Amplia Therapeutics

On September 5, 2018, Innate Immunotherapeutics changed their name to Amplia Therapeutics (Stock Code ASX: ATX)[29][30]

References
  1. Semedo, Daniela (April 15, 2016). "Innate Immunotherapeutics Fully Enrolls Phase 2 Study of Drug Candidate to Treat SPMS". Multiple Sclerosis News Today. Retrieved August 8, 2018.
  2. Virionyx Changes Name to Innate Therapeutics, Advances Novel Immune Stimulant, MIS416, to Clinical Trials, Auckland, New Zealand, April 17, 2009, retrieved January 24, 2017 Contact Joan E. Kureczka, Kureczka/Martin Associates, MSEM Founder and Principal and the Vivant Group, San Francisco, California
  3. Gill A. Webster and Frank B. Gelder (January 2, 2009), The Therapeutic Vaccine Potential of MIS416 Adjuvant: Linking innate and adaptive immunity through the activation of multiple innate host defenses, BioPharm International Supplements, BioPharm International, retrieved January 24, 2017CS1 maint: uses authors parameter (link)
  4. "Innate Immunotherapeutics Ltd Stock Chart (INNMF)", NASDAQ, January 24, 2017, retrieved January 24, 2017
  5. Kaplan, Thomas; Rappeport, Alan; Huetteman, Emmarie (January 24, 2017). "Trump's Health Nominee Defends Stock Deals as 'Ethical, Above Board, Legal and Transparent'". New York Times. Retrieved January 24, 2017.
  6. Katie Thomas (January 24, 2017), "Australian Drug Maker Has Low Profile but Powerful Backers in Washington", The New York Times, The New York Times, retrieved January 24, 2017
  7. Bill 4848, US Congress, March 2016, retrieved January 24, 2017, introduced by Tom Price(R-GA-6) on March 23, 2016 to House Energy and Commerce Committees: House - Energy and Commerce; Ways and Means Latest Action:03/30/2016 Referred to the Subcommittee on Health on March 30, 2016
  8. LaMotta, Lisa (June 27, 2017). "Innate becomes the latest loser in MS". BioPharma Dive. Retrieved August 8, 2018.
  9. "Behind the Collins scandal: How one phone call devastated two families". The Buffalo News. 2020-01-13. Retrieved 2020-01-24.
  10. "Announcements and Reports | Amplia Therapeutics Limited". www.ampliatx.com. Retrieved 2020-04-16.
  11. Shirani, Afsaneh; Okuda, Darin T.; Stüve1, Olaf (January 2016). "Therapeutic Advances and Future Prospects in Progressive Forms of Multiple Sclerosis". Neurotherapeutics. 3 (1): 58–69. doi:10.1007/s13311-015-0409-z. PMC 4720678. PMID 26729332.
  12. 96. Girvan RC, Knight DA, O'Loughlin CJ, Hayman CM, Hermans IF, Webster GA. MIS416, a non-toxic microparticle adjuvant derived from Propionibacterium acnes comprising immunostimulatory muramyl dipeptide and bacterial DNA promotes cross-priming and Th1 immunity. Vaccine. 2011;29:545–557. doi:10.1016/j.vaccine.2010.10.040
  13. Madeleine, White; Webster, Gill; O'Sullivan, David; Stone, Sarrabeth; La Flamme, Anne Camille (January 31, 2014). "Targeting innate receptors with MIS416 reshapes Th responses and suppresses CNS disease in a mouse model of multiple sclerosis". PLoS One. 9 (1): e87712. doi:10.1371/journal.pone.0087712. PMC 3909208. PMID 24498172. [PMC free article] [PubMed] [Cross Ref]
  14. "MIS416", Innate Immunotherapeutics, archived from the original on August 14, 2015, retrieved June 14, 2015
  15. "Innate Immunotherapeutics faces closure: CEO Simon Wilkinson". The Australian. August 31, 2017.
  16. "Investors Fact Sheet". Innate Immunotherapeutics Limited. North Melboure. nd. Retrieved August 8, 2018.
  17. Wong, Scott (June 8, 2017). "Exclusive: GOP lawmaker talked stocks with colleagues". Retrieved June 8, 2017. The Buffalo News reported that many in the [Buffalo]’s business elite had bought stock in the drug company after hearing from Collins...Collins first invested in Innate Immunotherapeutics, which has developed a drug to fight advanced multiple sclerosis, about 15 years ago. He said he’s raised money for the company during tough times and has earned a spot on its board of directors...[In August 2016, Collins] purchased an additional 4 million shares. On [January 27, 2017] the stock hit an all-time high of $1.83 per share, but it was trading at 74 cents per share on [May 7, 2017].
  18. Feuer, Alan; Goldmacher, Shane (August 8, 2018). "New York Congressman Chris Collins Is Charged With Insider Trading". The New York Times. Retrieved August 8, 2018.
  19. Tau, Byron (October 12, 2017). "Congressional Ethics Office Says New York Republican May Have Violated Law". Wall Street Journal. ISSN 0099-9660. Retrieved August 8, 2018.
  20. Breuninger, Kevin (August 8, 2018). "New York GOP Rep. Chris Collins to be indicted on insider trading charges". CNBC. Retrieved August 8, 2018.
  21. "The Latest: Speaker Pelosi's office says Collins resigning". AP NEWS. September 30, 2019. Retrieved September 30, 2019.
  22. Zremski, Jerry (January 17, 2020). "An anguished Chris Collins faces 26 months in prison". The Buffalo News. Retrieved January 17, 2020.
  23. "Son of former Congressman Chris Collins sentenced to 5 years of probation". WGRZ. Retrieved 2020-01-24.
  24. Girvan RC, Knight DA, O'Loughlin CJ, Hayman CM, Hermans IF and Webster GA (January 10, 2011). "MIS416, a non-toxic microparticle adjuvant derived from Propionibacterium acnes comprising immunostimulatory muramyl dipeptide and bacterial DNA promotes cross-priming and Th1 immunity". Vaccine. 29 (3): 545–57. doi:10.1016/j.vaccine.2010.10.040. PMID 21034827.CS1 maint: uses authors parameter (link)
  25. Luckey, Alison M; Anderson, Tim; Silverman, Michael H; Webster, Gill (January 2015). "Safety, tolerability and pharmacodynamics of a novel immunomodulator, MIS416, in patients with chronic progressive multiple sclerosis". Multiple Sclerosis Journal: Experimental, Translational and Clinical. 1: 2055217315583385. doi:10.1177/2055217315583385. PMC 5433401. PMID 28607691.
  26. "Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis". United States Library of Medicine (NIH). Clinical trials (NCT02228213). July 14, 2017. Retrieved August 8, 2018.
  27. Dutt, Streetama (July 17, 2017). "MIS416 for Secondary Progressive Multiple Sclerosis". Multiple Sclerosis News Today via BioNews Services. Dallas, Texas. Retrieved August 8, 2018.
  28. "INC Research". INCR (NASDAQ)]. Raleigh, North Carolina. According to SEC filings, INCR CEO Alistair Macdonald, who established INC Research in October 1, 2016, holds $2,669,127 in company stocks after selling shares worth $69,437.50 on January 20, 2017.(NASDAQ:INCR)
  29. "Amplia Announcement".
  30. "Share Price & Information - ASX". www.asx.com.au. Retrieved 2020-04-16.
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