Cel-Sci Corporation

Last updated
Cel-Sci Corporation
Company type Public
AMEX:  CVM
IndustryBiotechnology
Founded1983
FounderMaximilian de Clara
Headquarters
Vienna, Virginia
,
United States
Key people
Geert Kersten, CEO
ProductsMultikine, LEAPS, HGP-30
RevenueUS$559,000 [1]  (2020)
US$−20 million (2019)
US$−22 million (2019)
Website https://cel-sci.com/

Cel-Sci Corporation (NYSE American: CVM), is a biotechnology company that tests drugs for the treatment of cancer, autoimmune and infectious diseases through the research and development of immunotherapy products.

Contents

Cel-Sci's main product is the drug Multikine, an immunotherapeutic agent designed to fight cancer by stimulating the body's immune system. Multikine is currently in Phase III of Clinical Trials with the Food and Drug Administration (FDA). Multikine has also been referred to as Leukocyte Interleukin Injection (LI). [2] Multikine was in Phase II testing of patients with head and neck cancer in the early 2000s, in which it demonstrated tumor-reducing ability. [3] [4] In January 2007, the US cleared the Phase 3 trial and Multikine was designated as an orphan drug by the FDA for neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck. [5] [6] A total of 928 patients were enrolled in the head and neck cancer drug trial at that time. [2] Subsequently, in June 2021, the company announced that the study missed its primary endpoint. [7]

History

Cel-Sci Corporation was founded in 1983 in Germany by Maximilian de Clara of Switzerland, who was also the president of the company until his resignation in 2016. [8]  Geert Kersten, de Clara's stepson, [9] has been the company's CEO since 1995. [10] The company went public in the year of its founding. [11] The investment firm that took the company public later folded. [9]

The company's United States research and development operations were based in Baltimore, Maryland in the mid-1990s. [12]

In May 1992, the U.S. Securities and Exchange Commission issued a cease and desist order against the company's then-President, Maximilian de Clara. This order stated that from August 1988 through June 1991, de Clara was 2–31 weeks late to file 16 forms documenting his sales of over $2.6 million of Cel-Sci stock. [13]

CEO Geert Kersten confirmed that Cel-Sci paid an analyst from the brokerage firm of Honolulu Securities Inc. to write a research report on the company's stock, though the analyst claimed that being paid did not affect the conclusion that Cel-Sci's stock was undervalued. [9]

In 1997, Cel-Sci bought a technology which enabled regulation of immune system responses that they had been licensing from the Dutch company Sittona. [12]

Mysterious cash offer

The New York Times reported that in 1999, Cel-Sci received an unsolicited cash offer of $124 million from an unidentified person in Argentina. [14]

Arbitration victory

In 2018, Cel-Sci won a 4.5-year-long arbitration suit filed in October 2013 against CRO InVentiv Health for breach of contract. The arbitrator awarded Cel-Sci $2.9 million in damages because the CRO failed to enroll the required number of patients over a period of 2 years, thus delaying the clinical development of Multikine. Later, the FDA lifted their clinical hold imposed on Cel-Sci in August 2017. This allowed the company to advance to Phase III of their head and neck cancer study. [15] [16]

2020 trading halt

On February 26, 2020, Cel-Sci's stock dropped 42.4% before a trading halt was issued for news pending. [17] The company then released a letter to shareholders concerning the Phase III trial. [18]

Multikine stage 3 study results

On June 28, 2021, Cel-Sci announced that the study missed its primary endpoint as the higher risk subgroup did not achieve a 10% improvement in overall survival even though the lower risk subgroup did. Kersten declared that the company would apply for FDA approval of the drug despite the study's missed endpoint. Following the announcement, Cel-Sci's stock lost between 40-50% of its value in one day as trading was halted at least 3 times. [7] [19]

Other products

Cel-Sci has also worked on LEAPS (Ligand Epitope Antigen Presentation System), a system of therapeutic vaccines for rheumatoid arthritis. [20]

The company is also testing HGP-30 to determine if it is an effective treatment against the AIDS virus. [21] [22] [23] In 1996, The Washington Post reported that the company was conducting its testing without the backing of the FDA because they couldn't agree on study details with said regulatory organization. Analysts were quoted as stating that this decision could cause the company delays in the event that it has to redo its research to meet FDA standards. [9]

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References

  1. ↑ "Cel-Sci Corporation Income Statement". Yahoo! Finance. Retrieved 27 May 2020.
  2. 1 2 "Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity - Full Text View - ClinicalTrials.gov". ClinicalTrials.gov. U.S. National Library of Medicine. October 1, 2019. Retrieved 19 March 2020.
  3. ↑ "Washington Techway, Cel-Sci CEO Geert Kersten". Live Online (Press conference transcript). Washington, D.C.: The Washington Post. May 30, 2001. Retrieved 22 Feb 2020.
  4. ↑ "A Phase III Study of the Effects of Multikine on Cancer of the Oral Ca". Research Summaries. London: NHS Health Research Authority. January 23, 2015. Retrieved 11 March 2020.
  5. ↑ "Cel-Sci Receives Orphan Drug Designation for Its Cancer Drug Multikine". WCG FDANews. WIRB-Copernicus Group. June 13, 2007. Retrieved 22 Feb 2020.
  6. ↑ Plunkett, Jack W., ed. (2007). Plunkett's Biotech and Genetics Industry Almanac 2008 : Biotech & Genetics Industry Market Research, Statistics, Trends & Leading Companies. Plunkett, Jack W. Houston, Texas: Plunkett Research Ltd. CEL-SCI CORPORATION. ISBN   978-1-59392-087-6. OCLC   154805775 – via Google Books (Preview).
  7. 1 2 Lenihan, Rob (28 June 2021). "CEL-SCI Tumbles After Study Misses Primary Endpoint". TheStreet . Retrieved 30 June 2021.
  8. ↑ "BRIEF-CEL-SCI announces resignation of its founder, Maximilian De Clara, for health reasons". Reuters (Brief). September 6, 2016. Retrieved 22 Feb 2020.
  9. 1 2 3 4 Day, Kathleen (5 August 1996). "In Search of a Cure -- and a New Image" . Retrieved 2 June 2020.
  10. ↑ "Geert R Kersten, Cel-Sci Corp: Profile and Biography - Bloomberg Markets". Bloomberg.com. Retrieved 2 June 2020.
  11. ↑ "test approval sends aids drug company stocks higher". The Desert Sun. 9 March 1990. p. 26. Retrieved 2020-03-20.
  12. 1 2 "CEL-SCI buys rights to new technology". Business Digest. The Sun (Final ed.). Baltimore, Maryland: Times Mirror. March 18, 1997. p. 2C – via Newspapers.com.
  13. ↑ "Maxamilian de Clara Ordered to Cease and Desist - SEC News Digest" (PDF). Retrieved 2 June 2020.
  14. ↑ "CEL-SCI Corporation". The New York Times. ISSN   0362-4331 . Retrieved 2020-03-20.
  15. ↑ Zacks Small Cap Research (October 16, 2018). "CVM: A New Solution in Head & Neck Cancer". Yahoo! Finance. Retrieved 22 Feb 2020.
  16. ↑ "BRIEF-FDA removes clinical hold on Cel-Sci head & neck cancer trial". Reuters (Brief). August 14, 2017. Retrieved 19 March 2020.
  17. ↑ "CEL-SCI CORP (CVM) Halted for News Pending". 26 February 2020. Retrieved 27 May 2020.
  18. ↑ Betz, Brandy (26 February 2020). "CEL-SCI releases Multikine-related shareholder letter" . Retrieved 27 May 2020.
  19. ↑ Block, Jonathan M. (28 June 2021). "CEL-SCI plummets 43% after phase 3 immunotherapy data misses primary endpoint". Seeking Alpha . Retrieved 30 June 2021.
  20. ↑ "New Vaccine in the Treatment of Rheumatoid Arthritis". BioSpectrum Asia. Singapore: MM ACTIV. July 9, 2019. Retrieved 11 March 2020.
  21. ↑ "HGP-30 AIDS VACCINE SAFE IN TRIAL" . BioWorld. Clarivate. December 3, 1992. Retrieved 21 Feb 2020.
  22. ↑ "HIV HGP-30W vaccine (Cel-Sci)". Drugs in R&D. 1 (6): 453–455. 1999. doi:10.2165/00126839-199901060-00007. ISSN   1174-5886. PMID   10566082. S2CID   28618646.
  23. ↑ "Test approval sends 2 AIDS-drug companies' stock higher". The Desert Sun. Vol. 62, no. 186. Palm Springs, California: Gannett. Associated Press. March 9, 1990. p. C4 – via Newspapers.com.
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