Inovio Pharmaceuticals

Last updated
Inovio Pharmaceuticals
Type Public
Nasdaq:  INO
Industry Biotechnology
Founded1999
Headquarters Plymouth Meeting, Pennsylvania
Key people
Jacqueline Shea, Ph.D. (President and CEO)
ProductsDNA-based Medicines and Vaccines [1]
RevenueIncrease2.svg $7 Million(2020) [2]
Number of employees
262 [3]
Website inovio.com

Inovio Pharmaceuticals is an American biotechnology company focused on the discovery, development, and commercialization of synthetic DNA products for treating cancers and infectious diseases. In April 2020, Inovio was among some 100 companies, academic centers, or research organizations developing a vaccine candidate for treating people infected with COVID-19, with more than 170 total vaccine candidates in development (June 2020). [4] [5]

Contents

Technology

The Inovio technology is based on inserting engineered DNA into cells, where it becomes transcribed into mRNA and translated into proteins. The proteins encoded by the DNA elicit immune response to antigens from cancers and viruses, by stimulating the production of T cells and antibodies that aid recovery. [6] The technology can be "targeted" to specific types of cancer and immune diseases, such as those produced by a virus. [6]

During a meeting of the White House Coronavirus Task Force in March 2020, CEO, Joseph Kim, said that Inovio scientists had designed a vaccine candidate (INO-4800) for the COVID-19 coronavirus in January, in three hours, after the virus' genetic sequence was first published. [7]

Shareholders sued Inovio in August 2020, claiming it exaggerated evidence of its coronavirus vaccine's efficacy in order to boost its stock price. [8]

License of electroporation device

In 2006, Inovio licensed "certain patented technology relating to the delivery of gene-based therapeutics into skin", as well as patents "involving the delivery of genes or drugs via ex vivo , intratumoral and intramuscular electroporation... The ex-vivo patents are relevant to the delivery of genes to dendritic and stem cells." [9]

Licence of US7328064B2

Sometime after its publication in February 2008, Inovio was assigned a patent for "an apparatus [that provides] for injecting a fluid into body tissue, the apparatus comprising: a hollow needle; and a fluid delivery means, wherein the apparatus is adapted to actuate the fluid delivery means in use so as to automatically inject fluid into body tissue during insertion of the needle into the said body tissue." [10]

Cellectra injection device

To facilitate use of its potential products, Inovio manufactures a proprietary injection device, called "Cellectra", which the company describes as providing a "brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA." [11] The small device, which runs on "AA" batteries, is designed for use in the field under the difficult conditions of an epidemic. [12]

In June 2020 – in anticipation of the Inovio COVID-19 vaccine candidate becoming successful – the US Department of Defense invested US$71 million to further develop Cellectra as a handheld device and to preorder an undisclosed number of the devices. [13]

Vaccine development

Inovio's logo prior to 2020 Inovio Pharmaceuticals logo.jpg
Inovio's logo prior to 2020

In a 2016 dose-escalation Phase I clinical trial to assess safety after intramuscular injection in healthy adults, the Inovio vaccine candidate, INO-4700 (also called GLS-5300) for development against Middle East respiratory syndrome (MERS) coronavirus, proved to be safe with only mild symptoms and no adverse effects. [14] The trial also demonstrated immunogenicity by dose-independent immune responses detected in more than 85% of subjects after two vaccinations that were durable a year later. [14]

In 2016, Inovio was involved, along with their partners GeneOne Life Science, in an attempt to control the Zika virus outbreak in Miami. In fact, they "were the first to initiate a human Zika DNA vaccine trial... [for] the safety, tolerability, and immunogenicity of GLS-5700 in 40 healthy adults. The trial's estimated completion date is November 2017." Then in Puerto Rico, where a Zika emergency had been declared, they did a study with 160 previously healthy adults using their proprietary "Cellectra-3P" technology. [15] Preliminary results for the Miami trial were self-reported at the end of 2017. [16] [17]

In February 2020 after receiving details of the genetic sequence of the coronavirus, Inovio announced that it had produced a preclinical DNA-based vaccine as a potential therapy for COVID-19. [7] [18] Inovio is in competition to develop a coronavirus vaccine with numerous other companies, which were conducting preclinical or early-stage human research on more than 170 vaccine candidates, as of late June. [5] In April 2020, Inovio began a Phase I trial of the COVID-19 vaccine candidate, INO-4800. [19] In May 2021, Inovio announced the results of preclinical studies on a "pan-SARS-CoV-2" DNA vaccine (INO-4802) and plans to initiate phase I/II studies. The vaccine incorporates common overlapping mutations from several SARS-COV-2 variants of concern isolated from several different countries including Brazil and India. [20]

Partnerships

In January 2020, the Coalition for Epidemic Preparedness Innovations (CEPI) announced it would grant of up to $9 million to Inovio for development of a vaccine against SARS-CoV-2. [21] Inovio has partnerships to develop its COVID-19 vaccine candidate with CEPI, the South Korean National Institute of Health, and the International Vaccine Institute. [22]

Clinical research

Inovio is collaborating with Beijing Advaccine Biotechnology Co., a Chinese biotech firm, [18] in order to speed its acceptance by regulatory authorities in China, with plans to begin human clinical trials of a candidate vaccine in China during the first half of 2020. [4] [23] Inovio has partnerships with manufacturers to scale up production of a vaccine if preliminary efficacy trials are successful. [18] In April 2020, the company began human Phase I safety studies of its lead vaccine (INO-4800) in the United States, and a Phase I-II trial in South Korea, to test for immunization against the COVID-19 virus. [4] [24] In April 2021, the US Department of Defense discontinued funding of future phase III trials of INO-4800. [25] The company is planning to conduct phase III trials outside the United States.[ citation needed ]

On 9 July it decided to conduct phase 3 trials in partnership with Beijing based Advaccine Pharmaceutical company. [26]

In early June, Inovio partnered with the International Vaccine Institute and Seoul National University, South Korea, to advance human research on INO-4800 in a Phase I-II safety and efficacy trial to be conducted on 120 participants at Seoul National University Hospital beginning in June. [27] The trial is funded by the Coalition for Epidemic Preparedness Innovations and supported by the Korea Centers for Disease Control and Prevention and the Korea National Institute of Health. [27]

History

Inovio was formerly known as Electrofect, which was founded in Oslo, Norway in 1999. The company was renamed to Inovio in October 2001. [28]

See also

Related Research Articles

GeoVax is a clinical-stage biotechnology company initially established primarily to develop an effective and safe vaccine against many serious human diseases for which there are significant unmet medical needs. GeoVax’ novel development platform builds on the proven clinical and commercial success of the Modified Vaccinia Ankara (MVA) vector technology, with improvements to antigen design and manufacturing capabilities. GeoVax technology approach uses recombinant DNA or recombinant viruses to produce virus-like particles (VLPs) in the person being vaccinated. In human clinical trials of the company’s HIV vaccines, GeoVax demonstrated that VLPs are safe and eliciting both strong and durable humoral and cellular immune response.

Universal flu vaccine Vaccine that prevents infection from all strains of the flu

A universal flu vaccine is a flu vaccine that is effective against all influenza strains regardless of the virus sub type, antigenic drift or antigenic shift. Hence it should not require modification from year to year. As of 2021 no universal flu vaccine had been approved for general use, several were in development, and one was in clinical trial.

The Coalition for Epidemic Preparedness Innovations (CEPI) is a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging infectious diseases (EID).

A Zika virus vaccine is designed to prevent the symptoms and complications of Zika virus infection in humans. As Zika virus infection of pregnant women may result in congenital defects in the newborn, the vaccine will attempt to protect against congenital Zika syndrome during the current or any future outbreak. As of April 2019, no vaccines have been approved for clinical use, however a number of vaccines are currently in clinical trials. The goal of a Zika virus vaccine is to produce specific antibodies against the Zika virus to prevent infection and severe disease. The challenges in developing a safe and effective vaccine include limiting side effects such as Guillain-Barré syndrome, a potential consequence of Zika virus infection. Additionally, as dengue virus is closely related to Zika virus, the vaccine needs to minimize the possibility of antibody-dependent enhancement of dengue virus infection.

Vaxart American biotechnology company based in San Francisco

Vaxart, Inc. is an American biotechnology company focused on the discovery, development, and commercialization of oral recombinant vaccines administered using temperature-stable tablets that can be stored and shipped without refrigeration, eliminating the need for needle injection. Its development programs for oral vaccine delivery include prophylactic, enteric-coated tablet vaccines for inhibiting norovirus, seasonal influenza, respiratory syncytial virus, and human papillomavirus. It was founded in 2004 by Sean Tucker.

COVID-19 vaccine Vaccine designed to provide acquired immunity against SARS-CoV-2

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID‑19).

Access to COVID-19 Tools Accelerator G20 COVID-19 global initiative

The Access to COVID-19 Tools Accelerator, or the Global Collaboration to Accelerate the Development, Production and Equitable Access to New COVID-19 diagnostics, therapeutics and vaccines, is a G20 initiative announced by pro-tem Chair Mohammed al-Jadaan on 24 April 2020. A call to action was published simultaneously by the World Health Organization (WHO) on 24 April. As of January 2022, it was the largest international effort to achieve equitable access to COVID-19 health technologies.

Bharat Biotech Indian multinational biotechnology company and vaccine manufacturer

Bharat Biotech International Limited (BBIL) is an Indian multinational biotechnology company headquartered in the city of Hyderabad, India engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products.

CoVLP COVID-19 vaccine candidate produced in a plant

CoVLP is a COVID-19 vaccine developed by Medicago in Canada and GlaxoSmithKline (GSK). It is a coronavirus virus-like particle vaccine grown in the Australian weed, Nicotiana benthamiana.

CureVac COVID-19 vaccine Vaccine candidate against COVID-19

The CureVac COVID-19 vaccine was a COVID-19 vaccine candidate developed by CureVac N.V. and the Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine showed inadequate results in its Phase III trials with only 47% efficacy. In October 2021 CureVac abandoned further development and production plans for CVnCoV and refocused efforts on a cooperation with GlaxoSmithKline.

ZyCoV-D Vaccine candidate against COVID-19

ZyCoV-D is a DNA plasmid-based COVID-19 vaccine developed by Indian pharmaceutical company Cadila Healthcare, with support from the Biotechnology Industry Research Assistance Council. It is approved for emergency use in India.

Inovio COVID-19 vaccine COVID-19 vaccine candidate

Inovio COVID-19 vaccine is a COVID-19 vaccine candidate developed by Inovio Pharmaceuticals.

SCB-2019 Vaccine candidate against COVID-19

SCB-2019 is a protein subunit COVID-19 vaccine developed by Clover Biopharmaceuticals using an adjuvant from Dynavax technologies. Positive results of Phase I trials for the vaccine were published in The Lancet and the vaccine completed enrollment of 29,000 participants in Phase II/III trials in July 2021. In September 2021, SCB-2019 announced Phase III results showing 67% efficacy against all cases of COVID-19 and 79% efficacy against all cases of the Delta variant. Additionally, the vaccine was 84% effective against moderate cases and 100% effective against hospitalization.

BriLife Vaccine candidate against COVID-19

BriLife, also known as IIBR-100, is a replication-competent recombinant VSV viral vectored COVID-19 vaccine candidate. It was developed by the Israel Institute for Biological Research (IIBR). The IIBR partnered with the US-based NRx Pharmaceuticals to complete clinical trials and commercialize the vaccine. A study conducted in hamsters suggested that one dose of the vaccine was safe and effective at protecting against COVID-19.

Viral vector vaccine Type of vaccine

A viral vector vaccine is a vaccine that uses a viral vector to deliver genetic material coding for a desired antigen into the recipient's host cells. As of April 2021, six viral vector vaccines have been authorized for use in humans in at least one country: four COVID-19 vaccines and two Ebola vaccines.

Corbevax Vaccine against COVID-19

Corbevax is a protein subunit COVID-19 vaccine developed by Texas Children's Hospital Center for Vaccine Development and Baylor College of Medicine in Houston, Texas and Dynavax technologies based in Emeryville, California. It is licensed to Indian biopharmaceutical firm Biological E. Limited (BioE) for development and production.

GX-19 Vaccine candidate against COVID-19

GX-19 is a COVID-19 vaccine candidate developed by Genexine consortium.

SKYCovione Vaccine candidate against COVID-19

SKYCovione is a COVID-19 vaccine candidate developed by SK Bioscience and the Institute for Protein Design of the University of Washington, It is South Korea’s first homegrown Covid-19 vaccine and utilizes GSK's AS03 adjuvant technology.

COVID-19 vaccine clinical research

COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness and safety. As of August 2022, forty vaccines are authorized by at least one national regulatory authority for public use:

Noora (vaccine) Vaccine candidate against COVID-19

Noora is a COVID-19 vaccine candidate developed by Baqiyatallah University of Medical Sciences in Iran.

References

  1. ↑ "Home". inovio.com.
  2. ↑ "Inovio Pharmaceuticals Revenue 2006-2021 | INO".
  3. ↑ "Inovio Pharmaceuticals Number of Employees 2006-2021 | INO".
  4. 1 2 3 Thanh Le, Tung; Andreadakis, Zacharias; Kumar, Arun; Gómez Román, Raúl; Tollefsen, Stig; Saville, Melanie; Mayhew, Stephen (9 April 2020). "The COVID-19 vaccine development landscape". Nature Reviews Drug Discovery. 19 (5): 305–306. doi: 10.1038/d41573-020-00073-5 . ISSN   1474-1776. PMID   32273591.
  5. 1 2 "COVID-19 vaccine tracker (Select vaccine tab)". Airtable. 22 June 2020. Retrieved 23 June 2020.
  6. 1 2 Roybal, Kole T.; Lim, Wendell A. (26 April 2017). "Synthetic immunology: Hacking immune cells to expand their therapeutic capabilities". Annual Review of Immunology. 35 (1): 229–253. doi:10.1146/annurev-immunol-051116-052302. ISSN   0732-0582. PMC   5555230 . PMID   28446063.
  7. 1 2 Ciara Linnane (8 March 2020). "Inovio shares rally after biotech says human trials of coronavirus vaccine will start in April". MarketWatch. Retrieved 8 March 2020.
  8. ↑ Gelles, David; Murphy, Heather (11 August 2020). "This Company Boasted to Trump About Its Covid-19 Vaccine. Experts Are Skeptical". The New York Times. ISSN   0362-4331. Archived from the original on 25 November 2020. Retrieved 25 September 2020.
  9. ↑ "Inovio's License of Electroporation Intellectual Property Includes Skin Delivery Technology Used in Anthrax Collaboration". Business Wire. Berkshire Hathaway. 5 July 2006.
  10. ↑ "Electroporation device and injection apparatus". USPTO. US7328064B2.
  11. ↑ "Proprietary smart devices (Cellectra)". Inovio Pharmaceuticals. 2020. Retrieved 23 June 2020.
  12. ↑ "INOVIO Receives $71 Million Contract From U.S. Department of Defense To Scale Up Manufacture of CELLECTRA® 3PSP Smart Device and Procurement of CELLECTRA® 2000 for COVID-19 DNA Vaccine" (PDF).
  13. ↑ Lee, Jaimy (23 June 2020). "Inovio shares jump on government funding for vaccine device". MarketWatch. Retrieved 2 June 2020.
  14. 1 2 Modjarrad, Kayvon; Roberts, Christine C; Mills, Kristin T; Castellano, Amy R; Paolino, Kristopher; Muthumani, Kar; Reuschel, Emma L; Robb, Merlin L; Racine, Trina; Oh, Myoung-don; Lamarre, Claude; Zaidi, Faraz I; Boyer, Jean; Kudchodkar, Sagar B; Jeong, Moonsup; Darden, Janice M; Park, Young K; Scott, Paul T; Remigio, Celine; Parikh, Ajay P; Wise, Megan C; Patel, Ami; Duperret, Elizabeth K; Kim, Kevin Y; Choi, Hyeree; White, Scott; Bagarazzi, Mark; May, Jeanine M; Kane, Deborah; Lee, Hyojin; Kobinger, Gary; Michael, Nelson L; Weiner, David B; Thomas, Stephen J; Maslow, Joel N (2019). "Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial". The Lancet Infectious Diseases. 19 (9): 1013–1022. doi: 10.1016/s1473-3099(19)30266-x . ISSN   1473-3099. PMC   7185789 . PMID   31351922.
  15. ↑ Fellner, C. (2016). "Zika in America: The Year in Review". P & T: A Peer-Reviewed Journal for Formulary Management. 41 (12): 778–791. PMC   5132420 . PMID   27990081.
  16. ↑ Tebas, Pablo; Roberts, Christine C.; Muthumani, Kar; Reuschel, Emma L.; Kudchodkar, Sagar B.; Zaidi, Faraz I.; White, Scott; Khan, Amir S.; Racine, Trina; Choi, Hyeree; Boyer, Jean; Park, Young K.; Trottier, Sylvie; Remigio, Celine; Krieger, Diane; Spruill, Susan E.; Bagarazzi, Mark; Kobinger, Gary P.; Weiner, David B.; Maslow, Joel N. (2017). "Safety and Immunogenicity of an Anti–Zika Virus DNA Vaccine — Preliminary Report". New England Journal of Medicine. doi:10.1056/NEJMoa1708120. PMC   6824915 . PMID   28976850.
  17. ↑ Kudchodkar, Sagar B.; Choi, Hyeree; Reuschel, Emma L.; Esquivel, Rianne; Jin-Ah Kwon, Jackie; Jeong, Moonsup; Maslow, Joel N.; Reed, Charles C.; White, Scott; Kim, J. Joseph; Kobinger, Gary P.; Tebas, Pablo; Weiner, David B.; Muthumani, Kar (2018). "Rapid response to an emerging infectious disease – Lessons learned from development of a synthetic DNA vaccine targeting Zika virus". Microbes and Infection. 20 (11–12): 676–684. doi: 10.1016/j.micinf.2018.03.001 . PMC   6593156 . PMID   29555345. S2CID   4871206.
  18. 1 2 3 Mike Freeman. "Is a vaccine for the coronavirus coming? Inovio says it has designed one in San Diego". Los Angeles Times . Retrieved 17 February 2020.
  19. ↑ Clinical trial number NCT04336410 for "Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers" at ClinicalTrials.gov
  20. ↑ "Inovio's Pan-COVID-19 Vaccine Candidate Can Provide Immune Responses Against Variants, Animal Study Shows". 12 May 2021.
  21. ↑ "Plymouth Meeting's Inovio Pharmaceuticals granted $9 million to develop a vaccine for current coronavirus in China". More Than The Curve. 24 January 2020. Retrieved 17 February 2020.
  22. ↑ "IVI, INOVIO, and KNIH to partner with CEPI in a Phase I/II clinical trial of INOVIO's COVID-19 DNA vaccine in South Korea". International Vaccine Institute. 16 April 2020. Retrieved 23 June 2020.
  23. ↑ Mazumdar, Tulip (30 January 2020). "Coronavirus: Scientists race to develop a vaccine". BBC News - Health. Retrieved 3 February 2020.
  24. ↑ "IVI, INOVIO, and KNIH to partner with CEPI in a Phase I/II clinical trial of INOVIO's COVID-19 DNA vaccine in South Korea". International Vaccine Institute. 2020-04-16. Retrieved 2020-04-23.
  25. ↑ "Inovio To Conduct Phase-3 Trials Of COVID-19 Vaccine Outside the US As US Govt Stops Funding".
  26. ↑ "INOVIO Expands Partnership with Advaccine to Conduct Global Phase 3 Efficacy Trial of COVID-19 DNA Vaccine Candidate, INO-4800".
  27. 1 2 "IVI and SNU partner to trial Inovio Covid-19 vaccine in Korea". Clinical Trials Arena. 2020-06-05. Retrieved 2020-06-08.
  28. ↑ "INOVIO technology that delivers". 2002-06-05. Archived from the original on 2002-06-05. Retrieved 2021-11-26.

Further reading

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.