Argos is developing its second Arcelis product candidate, AGS-004, for the treatment of HIV and has completed patient enrollment in a phase 2b clinical trial of AGS-004 that is being funded entirely by the NIH under a $39.3 million contract. Preliminary data from this randomized, double-blind, placebo-controlled study are expected by mid-2014.
The Company plans to focus development of AGS-004 in combination with other therapies for the eradication of HIV. The current standard of care, antiretroviral drug therapy, can reduce levels of HIV in a patient´s blood, increase the patient’s life expectancy and improve the patient´s quality of life. However, antiretroviral drug therapy cannot eliminate the virus, which persists in latently infected cells, remains undetectable by the immune system and can recur. In addition, antiretroviral therapy requires daily, life-long treatment and can have significant side effects. Argos believes that by combining AGS-004 with therapies that are being developed to expose the virus in latently infected cells to the immune system, eradication of the virus is possible. In addition, Argos also plans to explore the use of AGS-004 monotherapy to provide long-term control of HIV viral load in otherwise immunologically healthy patients and eliminate their need for antiretroviral drug therapy.
Argos has a significant intellectual property estate generated by its scientific leadership in the immunotherapy field. The Company’s patents and patent applications are directed to one or more aspects of the Arcelis technology platform or Arcelis-based products. Specifically, these patents and patent applications are collectively directed to:
- Arcelis-based compositions of matter and products;
- methods of manufacturing Arcelis-based products;
- methods of using Arcelis-based products for treatment of tumors;
- compositions used in the manufacture of Arcelis-based AGS-004 products; and
- equipment intended to be used for the automated manufacture of Arcelis-based products.
Argos believes that all of the above aspects of the Arcelis technology platform are required to successfully produce Arcelis-based product candidates and are covered by a combination of the Company’s patents, patent applications, trade secrets and know-how.