Acuitas Therapeutics, originally called AlCana Technologies, is a Canadian biotechnology company based in Vancouver, British Columbia.
The company was co-founded by Pieter Cullis, Thomas Madden and Michael Hope.
AlCana Technologies was founded in February 2009 to specialize in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles.[1]
With early financial support from the National Research Council Canada's Industrial Research Assistance Program (NRC IRAP), the company spent several years establishing its research and development capabilities and building out its staff.[2] This led to its development of a viable lipid nanoparticle platform that showed promise for use in a variety of medical applications including chemotherapy, gene therapy and genetic vaccines.
An agreement was signed on July 27, 2009, mutually establishing the rights and limitations held by Alnylam Pharmaceuticals, the University of British Columbia, AlCana, Tekmira Pharmaceuticals and Protiva Biotherapeutics, while explicitly acknowledging the complex nature of the variety of relationships they all had with each other.[3]
In June 2011, Tekmira filed a lawsuit against both Alnylam and AlCana, seeking damages for (among other things) “misappropriation of trade secrets, tortious interference with contractual relations, unjust enrichment, unfair and deceptive acts and trade practices, and civil conspiracy."[4]
The case between Tekmira and Alnylam was settled in November 2012, resulting in a restructured licensing agreement allowing Alnylam to resume using Tekmira’s LNP patents under terms with new “clarity.”[5] This also allowed Acuitas to acquire a sublicense for some of the LNP technology from Tekmira - and conversely, Tekmira to use Acuitas’ RNAi tech - an arrangement which went into effect in December 2013.[6]
The National Research Council Canada (NRC) awarded Acuitas a $173,020 grant in September 2013 and a $498,640 grant in February 2015 to continue their research and development.[7][8] The purpose of both grants was “To support a firm in the Research and development in the physical, engineering and life sciences (NAICS: 541710) with a research and development project.” Both awards span more than one fiscal year.
In April 2016, Acuitas entered a development and option agreement with German biotechnology company CureVac to jointly develop a product incorporating Acuitas' LNP technology with CureVac's mRNA materials.[9][10] The encapsulated mRNA product described under the agreement was commissioned for use in in vitro and animal testing for pre-clinical trials of a vaccine candidate. Acuitas also worked on developing an mRNA vaccine against rabies.[11]
Moderna sought and received four sublicenses from Acuitas for their LNP technology in 2016.[12] This led to legal action from Arbutus Biopharma (Tekmira's successor), striking the previous contract between the two Vancouver companies and preventing Acuitas from issuing any further licenses.[13] A court decision later granted Arbutus full ownership over the licenses in question, which the company described as the consolidation of "its LNP intellectual property estate."[14] Moderna was, however, cleared to continue using the LNP tech granted under the existing four sub-licenses within Canada.[15][16]
According to president and CEO Thomas Madden, Acuitas began working towards a COVID-19 vaccine in February 2020. The company also partnered with CureVac and Imperial College London for their own vaccine trials.[11:1][17] Madden noted that the mRNA vaccine platform would allow for rapid development of updated vaccines in case the SARS-CoV-2 virus evolved beyond the immunity generated by the initial formulation, though additional clinical testing would still be required.[11:2] He also stated that the Pfizer–BioNTech COVID-19 vaccine would stop the spread of the virus and infection in vaccinated individuals.
On December 9, 2020, Acuitas released a statement celebrating Health Canada's approval of Pfizer and BioNTech's BNT162b2 COVID-19 vaccine,[18] stating they had “made history” due to their collaboration through the LNP delivery system, “a key element… in the development of this vaccine.”[19] Madden stated the company's annual revenues were "more than tens of millions of dollars" as of the end of 2020, having increased by 75% in the prior several years leading up to the COVID-19 crisis and expectations to grow by "at least that amount" through to 2022.[20]
On March 11, 2021, Deputy Prime Minister Chrystia Freeland named Acuitas in the House of Commons of Canada while discussing the need to increase biomanufacturing capacity in Canada, describing it as “an amazing B.C. company” receiving government investment.[21]
Providence Therapeutics CEO Brad Sorenson stated on April 19, 2021 that rival company Genevant Sciences had “successfully defended itself against” Acuitas and Moderna in the past.[22]
In an August 2021 presentation to Vaccine Choice Canada, David Martin said that Prime Minister Justin Trudeau misled the Canadian public by withholding information about the licensing agreements between Acuitas, Arbutus Biopharma, Pfizer, and Moderna.[23]
Acuitas entered a long-term partnership with Science World in January 2022.[24][25] In April 2022, Acuitas completed an agreement with Korean biotechnology company GC Biopharma to develop vaccines and therapeutics using their joint LNP-mRNA platform.[26] In June 2022, Acuitas donated $25,000 to the Brain Tumour Foundation of Canada to create the Frazer Anderson Pediatric Research Grant.[27] The company entered an agreement with genetic editing company Arbor Biotechnologies in August 2022 to target rare liver diseases, combining Acuitas' LNP technology with Arbor's CRISPR gene editing capabilities.[28]
On February 12, 2023, Liam Sturgess published an article on Substack titled "Follow the Patents: Lipid Nanoparticles and COVID-19 Genetic Vaccines."[29] He argued that there was no evidence to support rumours that Justin Trudeau profited directly from Acuitas, which had been shared by both Robert Malone and David Martin.[30][31] He proposed that the Government of Canada itself held a conflict of interest as they likely generated royalties through their early and ongoing investments in Acuitas, which had generated several patents tied to the COVID-19 vaccines.
On June 6, 2023, Bayer announced it had partnered with Acuitas to "support Bayer’s in vivo gene editing and protein replacement programs with the goal of specifically delivering RNA payloads to the desired target organ, the liver."[32][33]
Acuitas has partnered with several pharmaceutical companies and universities to collaboratively advance specific product candidates, as well as to support the broader development of the personalized medicine sector.
It is a member of BIOTECanada, a biotechnology industry association,[34] and Life Sciences British Columbia.[35] It has participated in research published by the University of Pennsylvania, Mount Sinai Health System, Chulalongkorn University, Thomas Jefferson University and BioNTech.[36]
Acuitas is a sponsor of the Vancouver-based Student Biotechnology Network (SBN).[37]
Rumours circulated in early 2022 that Canadian Prime Minister Justin Trudeau owned a 40% stake in Acuitas, either directly or through the Pierre Elliott Trudeau Foundation.[38] This was refuted by the Office of the Prime Minister, CEO Thomas Madden and co-founder Pieter Cullis.[39]
Acuitas Therapeutics owns or controls several notable patents, including:
Our History. Acuitas Therapeutics. Retrieved March 7, 2022, from http://archive.today/2022.03.07-235713/https://acuitastx.com/company/history/ ↩︎
Producing lipid nanoparticle technology for vaccine delivery (Acuitas Therapeutics). (2021, May 17). National Research Council Canada. https://web.archive.org/web/20230126232445/https://nrc.canada.ca/en/stories/producing-lipid-nanoparticle-technology-vaccine-delivery-acuitas-therapeutics ↩︎
Exhibit 10.2. (2009, July 27). Real Deal Docs. https://agreements.realdealdocs.com/Addendum-or-Modifications/Alnylam-Tekmira-Protiva-UBC-AlCa-2894169/ ↩︎
GlobeNewswire. (2011, June 3). Tekmira files amended complaint in Alnylam litigation. NBC News. http://archive.today/2022.03.22-142219/https://www.nbcnews.com/id/wbna43273972 ↩︎
Tekmira and Alnylam restructure relationship and settle all litigation. (2012, November 12). U.S. Securities and Exchange Commission. https://web.archive.org/web/20220322141914/https://www.sec.gov/Archives/edgar/data/1447028/000117184312004102/newsrelease.htm ↩︎
George, J. (2017, February 10). Doylestown biopharm firm granted injunction over licensing dispute. American City Business Journals. https://web.archive.org/web/20170214043742/http://www.bizjournals.com/philadelphia/news/2017/02/10/arbutus-biopharma-abus-injunction-acuitus-sales.html ↩︎
Grants and Contributions - GC-2013-Q3-23969. (2013, September 13). Government of Canada. https://archive.ph/ikPIz ↩︎
Grants and Contributions - GC-2014-Q4-26252. (2015, February 6). Government of Canada. https://archive.ph/CTkR5 ↩︎
Development and Option Agreement between CureVac AG and Acuitas Therapeutics Inc. (2016, April 29). Securities and Exchange Commission. http://archive.today/2022.09.30-212813/https://www.sec.gov/Archives/edgar/data/1809122/000110465920086354/tm2016252d12_ex10-11.htm ↩︎
Plieth, J., & Elmhirst, E. (2020, July 27). Curevac muddies the Moderna/Arbutus waters further. Evaluate Vantage. https://web.archive.org/web/20230322201623/https://www.evaluate.com/vantage/articles/news/patents-and-litigation/curevac-muddies-modernaarbutus-waters-further ↩︎
Bianchini, E. (2020, November 10). Acuitas Therapeutics: The Canadian technology that the Pfizer and BioNTech COVID-19 vaccine “can’t work without.” Yahoo News. http://archive.today/2021.11.09-104248/https://ca.news.yahoo.com/covid19-vaccine-coronavirus-canada-acuitas-therapeutics-pfizer-biontech-211410040.html?guccounter=1 ↩︎ ↩︎ ↩︎
Vardi, N. (2017, May 16). Moderna can’t escape my intellectual property, says Arbutus CEO. Forbes. http://archive.today/2022.03.22-180143/https://www.forbes.com/sites/nathanvardi/2017/05/16/moderna-cant-escape-my-intellectual-property-says-arbutus-ceo/?sh=5b6aeb01633a ↩︎
Cutler, A., Tolmie, T., & Schull, D. (2017, April 13). Arbutus injunction survives attempted appeal by Acuitas. U.S. Securities and Exchange Commission. http://archive.today/2022.03.22-180943/https://www.sec.gov/Archives/edgar/data/1447028/000117184317002101/exh_991.htm ↩︎
Tolmie, T., & Schull, D. (2018, February 22). Arbutus settles litigation, terminating Acuitas’ rights to LNP technology. Arbutus Biopharma. http://archive.today/2022.03.22-182650/https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-settles-litigation-terminating-acuitas-rights-lnp-0 ↩︎
Stendahl, M. (2018, February 22). Settlement clears Moderna to use Canadian firm’s drug delivery tech. American City Business Journals. http://archive.today/2021.08.25-231443/https://www.bizjournals.com/boston/news/2018/02/22/settlement-clears-moderna-to-use-canadian-firm-s.html ↩︎
Silbersher, Z. (2018, December 17). Does Moderna Therapeutics’ pipeline depend upon its patent dispute with Arbutus Biopharma over mRNA delivery? Markman Advisors. http://archive.today/2022.03.22-180516/https://www.markmanadvisors.com/blog/2018/12/17/does-moderna-therapeutics-pipeline-depend-upon-its-patent-dispute-with-arbutus-biopharma-over-mrna-delivery ↩︎
Lowe, D. (2021, June 17). CureVac Comes Up Short. Science. https://web.archive.org/web/20230129053807/https://www.science.org/content/blog-post/curevac-comes-short ↩︎
Health Canada. (2022, February 22). Comirnaty (tozinameran). Government of Canada. http://archive.today/2022.03.07-234135/https://covid-vaccine.canada.ca/comirnaty/product-details ↩︎
Vancouver-based Acuitas Therapeutics Makes History with First COVID-19 Vaccine Approved for Use in Canada. (2020, December 9). Acuitas Therapeutics. https://web.archive.org/web/20220428024341/https://acuitastx.com/wp-content/uploads/2020/12/Emergency-Use-Authorization-Release.pdf ↩︎
Silcoff, S. (2020, December 2). Inside Acuitas Therapeutics, the Vancouver company providing a crucial piece of Pfizer’s COVID-19 vaccine. The Globe and Mail. http://archive.today/2022.11.09-004342/https://www.theglobeandmail.com/business/article-inside-acuitas-therapeutics-the-vancouver-company-providing-a-crucial/ ↩︎
43rd Parliament, 2nd Session. (2021, March 11). Standing Committee on Finance - Evidence - Number 026 (p. 5). Speaker of the House of Commons. https://web.archive.org/web/20220306211752/https://www.ourcommons.ca/Content/Committee/432/FINA/Evidence/EV11171567/FINAEV26-E.PDF ↩︎
43rd Parliament, 2nd Session. (2021, April 19). Standing Committee on International Trade - Evidence - CIIT (43-2) - No. 24. Speaker of the House of Commons. http://archive.today/2022.03.06-224814/https://www.ourcommons.ca/DocumentViewer/en/43-2/CIIT/meeting-24/evidence ↩︎
Vaccine Choice Canada. (2021, August 21). Dr. David E. Martin drops Shocking Covid Info on Canadians! BitChute. https://web.archive.org/web/20221130214104/https://www.bitchute.com/video/ZUVtNa9xdBnW/ ↩︎
Acuitas Therapeutics. (2022, January 24). Acuitas Announces Key Partnership with Science World. Life Sciences British Columbia. http://archive.today/2022.09.29-180435/https://lifesciencesbc.ca/members/acuitas-announces-key-partnership-with-science-world/ ↩︎
Slusarchuk, C., & Redies, T. 2021/22 Annual Report. ASTC Science World Society. Retrieved September 28, 2022, from https://web.archive.org/web/20220928201947/https://www.scienceworld.ca/wp-content/uploads/20220512_2217_AnnualReport_05d.pdf ↩︎
Han-soo, L. (2022, April 29). GC to license in lipid nanoparticle delivery system from Canadian firm. Korea Biomedical Review. http://archive.today/2022.10.02-192825/http://www.koreabiomed.com/news/articleView.html?idxno=13605 ↩︎
Allison, G. (2022, September 29). Fight Like Frazer. Brain Tumour Foundation of Canada. https://web.archive.org/web/20230707180206/https://www.braintumour.ca/blog/fight-like-frazer/ ↩︎
Arbor Partners with Acuitas for Lipid Nanoparticle Delivery System for Use in Rare Liver Diseases. (2022, August 25). Global Genes. https://web.archive.org/web/20220831021841/https://globalgenes.org/2022/08/25/arbor-partners-with-acuitas-for-lipid-nanoparticle-delivery-system-for-use-in-rare-liver-diseases/ ↩︎
Sturgess, L. (2023, February 13). Follow the Patents: Lipid Nanoparticles and COVID-19 Genetic Vaccines. Substack. http://archive.today/2023.02.26-004058/https://liamsturgess.substack.com/p/follow-the-patents-lipid-nanoparticles ↩︎
Dr. David Martin – Canada, Trudeau’s Illegal Monopoly, Acuitas, CRISPR, NWO & Australia. (2022, February 18). Zeee Media. https://zeeemedia.com/interview/dr-david-martin-canada-trudeaus-illegal-monopoly-acuitas-crispr-nwo-australia/ ↩︎
The Vigilant Fox 🦊 [@VigilantFox]. (2022, February 16). “In Canada, there is speculation that Justin Trudeau and his family’s foundation holds 40% of Acuitas, which is a manufacturer of mechanic lipids used by Pfizer. Dr. Malone: ‘There appears that there may be a major financial conflict of interest on the part of Mr. Trudeau.’” [Tweet]. Twitter. https://web.archive.org/web/20220216161814/https://twitter.com/VigilantFox/status/1493982982025142279 ↩︎
Nagle, C. (2023, June 6). Bayer Strengthens Gene Therapy Portfolio With Lipid Nanoparticle Technology From Acuitas Therapeutics. Business Wire. https://web.archive.org/web/20230708013347/https://www.businesswire.com/news/home/20230606005983/en/Bayer-Strengthens-Gene-Therapy-Portfolio-With-Lipid-Nanoparticle-Technology-From-Acuitas-Therapeutics ↩︎
Taylor, N. P. (2023, June 7). Bayer bags access to gene editing delivery tech from biotech behind Pfizer’s COVID-19 vaccine. Fierce Biotech. http://archive.today/2023.07.08-013704/https://www.fiercebiotech.com/biotech/bayer-bags-access-gene-editing-delivery-tech-biotech-behind-pfizers-covid-19-vaccine ↩︎
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Our Sponsors. Life Sciences British Columbia. Retrieved April 25, 2022, from https://archive.ph/2022.04.25-063149/https://lifesciencesbc.ca/membership/our-sponsors/ ↩︎
Acuitas Therapeutics. (2022, June 30). Nature Index. https://archive.ph/2022.10.02-192130/https://www.nature.com/nature-index/institution-outputs/Canada/Acuitas Therapeutics/592d0ace140ba0976b8b4579 ↩︎
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Sadeghi, M. (2022, February 24). Fact check: Viral rumor falsely claims the Trudeau Foundation owns 40% of Acuitas Therapeutics. USA TODAY. https://web.archive.org/web/20220905232218/https://www.usatoday.com/story/news/factcheck/2022/02/24/fact-check-trudeau-foundation-doesnt-own-40-acuitas-therapeutics/6877953001/ ↩︎
Reuters Fact Check. (2022, February 18). Fact Check-Neither Justin Trudeau nor the Trudeau Foundation have shares in Acuitas Therapeutics. Reuters. https://web.archive.org/web/20230707182046/https://www.reuters.com/article/factcheck-trudeau-acuitas-idUSL1N2UT27X ↩︎