LEXINGTON, Mass.–(BUSINESS WIRE)–April 28, 2015–Agenus Inc. It has been a difficult ride but we have stayed the course because of our conviction that the immune system provides the key to potentially curing cancer. Agenus is the only pure play in this area, which is arguably the hottest area of cancer research. Results of the study, the largest malaria vaccine efficacy and safety trial ever conducted in Africa by GlaxoSmithKline and its partners, demonstrate that RTS,S provided young African children with significant protection against clinical and severe malaria – reducing risk by 56 percent and 47 percent, respectively, for the 12-month period following vaccination. We assess development, commercialization and partnering strategies for each of our product candidates periodically based on several factors, including pre-clinical and clinical trial results, competitive positioning and funding requirements and resources. Its Prophage series of cancer vaccines were tested in Phase III clinical trials for the treatment of renal cell carcinoma and metastatic melanoma; and are in Phase I and Phase II clinical trials for various indications, and in Phase II clinical trials for the treatment of diagnosed and recurrent glioma. Dr.
Checkpoint modulators represent an important new class of cancer immunotherapeutics. The Retrocyte Display platform uses a high-throughput approach incorporating IgG format human antibody libraries expressed in mammalian B-lineage cells. Announced GlaxoSmithKline’s (GSK) Phase 3 MAGE-A3 cancer immunotherapeutic trial for non-small cell lung cancer (NSCLC) did not show benefit in the overall study population. The company’s proprietary discovery engine Retrocyte DisplayTM is used to generate fully human and humanized therapeutic antibody drug candidates. Glioma is the deadliest form of brain cancer with an average survival of six to 14 months. And once again, we have 17 in development, many of which with our corporate partners. Advanced Medical Isotope Corp.
Such high precision in immunological targeting represents a distinctly different method for treating cancer compared to conventional anti-cancer treatments such as chemotherapy or radiation therapy. CIs are designed to trigger a specific immune response against tumor cells expressing these proteins, rallying antibodies and T-cells to recognize and attack the cancer cells in a highly specific manner and eventually eliminate them. Agenus is an immunology company developing a series of Checkpoint Modulators for the treatment of patients with cancer, infectious diseases, and other immune disorders, heat shock protein (HSP)-based vaccines, and immune adjuvants. Such factors include, but are not limited to, those described under Item 3.D ‘Risk factors’ in the company’s Annual Report on Form 20-F for 2013. QS-21 Stimulon adjuvant has become a critical component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to be essential for several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. The replay will also be available on the company’s website approximately two hours after the live call. (Nasdaq: AGEN) today announced that GlaxoSmithKline’s (NYSE: GSK) DERMAi study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeuticii (CI) trial, which contains Agenus’QS-21 Stimulon® adjuvantiii, a component of GSK’s novel adjuvant system AS15, did not meet its first co-primary endpoint.
All forward-looking statements are expressly qualified in their entirety by this cautionary statement. SECANT allows rapid generation of soluble, full-length human antibodies. About the phase III study programme Involving more than 37,000 subjects globally, the phase III programme for the candidate vaccine evaluates its efficacy, safety and immunogenicity. References 1. Ballman KV, Buckner JC, Brown PD, et al. The relationship between six-month progression- free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme. Data from multiple studies revealed that the Prophage Series vaccines are well tolerated with a very low toxicity profile.
2007;9:29–38. This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the potential therapeutic benefit of GSK’s singles vaccine candidate HZ/su in adults over the age of 50 worldwide, potential commercial sales of HZ/su and the potential for Agenus to receive milestone and royalty payments for product candidates containing Agenus’ QS-21 Stimulon generally. Lamborn KR, Yung WK, Chang SM, et al. . GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. Research and Development: Research and development expenses include the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, clinical manufacturing costs, costs of consultants, and administrative costs. 3.
Wong ET, Hess KR, Gleason MJ, et al. Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials. J ClinOncol. Agenus’ checkpoint modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. 4. Friedman HS, Prados MD, Wen PY, et al. A lot of companies develop vaccines in metastatic or stage 4 patients because, one, it’s a lot quicker, not as much money, and you can get to your endpoint a lot sooner.
Analysts expect shares to reach $15. 2009;27:4733–4740. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended June 30, 2013. Kreisl TN, Kim L, Moore K, et al. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009;27:740–745.
6. Vredenburgh JJ, Desjardins A, Herndon JE 2nd, et al. Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J Clin Oncol. 2007;25:4722–4729. 7. Sathornsumetee S, Desjardins A, Vredenburgh JJ, et al.
Phase II trial of bevacizumab and erlotinib in patients with recurrent malignant glioma. Neuro Oncol. 2010;12:1300–1310. 8. Maher EA, McKee AC. In: Atlas of diagnostic oncology. The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain.
Skarin AT, Canellos GP, editor. London: Elsevier Science; 2003. Neoplasms of the central nervous system; pp. 5–10. 9. http://www.cancer.gov/cancertopics/pdq/treatment/adultbrain/HealthProfessional/page1 10. Central Brain Tumor Registry of the United States (CBTRUS) 2010 CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2004- 2006.
They will be filing worldwide for the indications of these programs. The Wealthy Biotech Trader’s parent company is compensated $50,000 per month by Advanced Medical Isotope Corporation. v.1.2010. 12. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. NEngl J Med, 2005. 352(10): p.
987-96. 13. Wen PY, DeAngelis LM. Chemotherapy for low-grade gliomas: emerging consensus on its benefits. Neurology. 2007;68(21):1762–1763. doi: 10.1212/01.wnl.0000266866.13748.a9.