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Agenus Reports Fourth Quarter And Year End 2012 Financial Results

Highlights for 2012

  • In November, the second complete set of results from the Phase 3 trial of GSK's RTS,S malaria vaccine candidate (also known as Mosquirix ), which contains Agenus' QS-21 Stimulon adjuvant ®1 (QS-21 Stimulon), were published online in the New England Journal of Medicine. In this trial, infants (aged 6-12 weeks at first vaccination) receiving the RTS,S vaccine candidate experienced one-third fewer episodes of both clinical and severe malaria and experienced similar reactions to the injection when compared to those who received the control meningococcal C conjugate vaccine. Both co-primary endpoints in the large ongoing efficacy trial were met.
  • In October, the company began a Phase 2 randomized, double-blind, multicenter study for HerpV, a recombinant "off-the-shelf" therapeutic vaccine candidate for the treatment of genital herpes in herpes simplex virus 2 (HSV-2) positive subjects. HerpV contains QS-21 Stimulon. The study designated as protocol C-400-02 has recently completed enrollment and data results are expected during the fourth quarter of 2013. The primary aim of the study is to test the biological efficacy of the HerpV vaccine as measured by effect on genital HSV-2 viral shedding. 
  • In August, data from the Phase 1 trial for Prophage Series G-200 (HSPPC-96; vitespen) were published by Clinical Cancer Research in an article titled, "Individual patient-specific immunity against high-grade glioma after vaccination with autologous tumor derived peptides bound to the 96 KD chaperone protein." This data showed that a tumor specific immune response to peptides bound to gp96 can be generated with autologous HSPPC-96 derived from glioblastoma (GBM) patients undergoing surgical resection and the observations provide evidence for a general mechanism to elicit individual patient-specific immune responses that appear to correlate with clinical outcome. 
  • In July, GSK's herpes zoster vaccine candidate (HZ/su), which contains QS-21 Stimulon as a component of GSK's adjuvant system, commenced a global, randomized, placebo-controlled Phase 3 clinical trial for the prevention of shingles (herpes zoster) in immunocompromised patients. This study will include approximately 200 clinical sites and enroll more than 1,400 patients 18 years of age or older undergoing hematopoietic stem cell transplantation (HCT). The immunocompromised study represents the continuation of a Phase 3 clinical program that began in August 2010, which includes over 30,000 adult patients.
  • In June, Agenus met the qualifications to join the broad-market Russell 3000 ®Index, Russell 2000 ® Index, Russell Global Index, and Russell Microcap ® Index.
  • In March, GSK and Agenus amended the QS-21 Stimulon license and manufacturing agreement to include additional rights for the use of Agenus' proprietary QS-21 Stimulon in GSK adjuvant systems. In addition, Agenus agreed to grant GSK the first right to negotiate for the purchase of Agenus or certain of its assets. Under the terms of the agreement, GSK paid Agenus a non-refundable payment of $9 million, of which $2.5 million is creditable against future manufacturing technology transfer royalty payments. The agreement also included royalty payments for an undisclosed indication upon commercialization of a vaccine product.

Between Agenus and its partners, a total of 19 vaccine programs are in clinical development of which 17 contain QS-21 Stimulon. They include, but are not limited to:
  • Phase 3: GSK's RTS,S for malaria 2
  • Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with resected melanoma 2
  • Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with resected non-small cell lung cancer 2
  • Phase 3: GSK's HZ/su for shingles 2
  • Phase 2: Janssen's  ACC-001 for Alzheimer's disease

Agenus' pipeline programs include:
  • Phase 2: HerpV (contains QS-21 Stimulon) for genital herpes
  • Phase 2: Prophage Series G-100 for newly diagnosed glioma
  • Phase 2: Prophage Series G-200 for recurrent glioma

Saponin Platform: QS-21 Stimulon ® Adjuvant

Agenus' QS-21 Stimulon adjuvant is one of the most widely tested vaccine adjuvants under development. QS-21 Stimulon is designed to strengthen the body's immune response to a vaccine's antigen, thus making it more effective. QS-21 Stimulon is a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to play an important role for several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. Licensees of QS-21 Stimulon include GSK and Janssen Alzheimer Immunotherapy. Agenus is generally entitled to receive milestone payments as QS-21 Stimulon-containing programs advance, as well as royalties for 10 years after commercial launch, with some exceptions.

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