Agenus' HerpV, a therapeutic vaccine for the treatment of genital herpes, is in a Phase 2 trial. 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
Recently, GlaxoSmithKline (GSK) successfully developed the first malaria vaccine, RTS,S, which will be able to prevent children from contracting malaria and other malaria-related diseases. GlaxoSmithKline, in collaboration with Agenus (AGEN), will develop this vaccine.
R&D funding and base for market selection
For its R&D and to run its trial studies, GlaxoSmithKline received around $200 million from the Bill & Melinda Gates Foundation, which contributed its financial, scientific, and managerial expertise to develop RTS,S more efficient. It has invested around $350 million to date and is planning to invest another $260 million to develop RTS,S as a complete vaccine to prevent malaria in young children and infants.
To evaluate the efficiency of its RTS,S malaria vaccine, GlaxoSmithKline is working with 11 African research centers in seven African countries. The company selected the African countries for its trial studies because malaria claims around 660,000 lives every year, mostly in sub-Sahara Africa. GlaxoSmithKline, with its research centers, took all initiatives for overall development of this vaccine, and it is focusing on making it more effective in preventing this dangerous disease in children. With all these efforts, the company was able to attain superior efficacy and safety endpoint in its trial phases
GSK’s plans to submit a regulatory application in 2014 for a Scientific Opinion of the European Medicines Agency (EMA) on RTS,S safety, efficacy and quality. If the EMA give a positive opinion, and there is satisfactory public health information from the Phase 3 program, the World Health Organization has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible in 2015, paving the way for potential decisions by African nations for large-scale implementation of the vaccine through their national immunization programs.
September 26, 2013
07:04 EDT AGEN Agenus, VaxLogic execute QS-21 Stimulon adjuvant licensing agreement
Agenus announced that it is has entered into a non-exclusive license agreement with VaxLogic, a subsidiary of PharmLogic, for the use of QS-21 Stimulon adjuvant in the development of select addiction, allergy and respiratory disease vaccine candidates. This agreement enables VaxLogic to immediately utilize the QS-21 Stimulon adjuvant in development for a nicotine addiction vaccine, and contemplates expansion into the following additional vaccine indications such as poison ivy, peanut allergy, insect allergy, shellfish allergy, allergic rhinitis, and allergic asthma. These vaccine candidates are in preclinical testing and are being developed by VaxLogic in collaboration with Cornell University. Under the terms of the licensing agreement with VaxLogic, Agenus will receive an upfront payment and certain milestone and royalty payments should the vaccine candidates advance through clinical development and regulatory approval. In addition, Agenus will receive an equity stake in VaxLogic.
Remember it is outstanding results and CLDX is an example in front for what investors thinks during PH-III.
Agenus plans to discuss a late-stage trial with the U.S. Food and Drug Administration, based on the trial data.
A preliminary analysis of the study in May had showed that the vaccine had a 146 percent increase in progression-free survival when compared with the standard-of-care.
"We are impressed by the data and look forward to feedback from the FDA regarding next steps," Roth Capital Partners analyst Joseph Pantginis wrote in a note, raising the price target on the stock to $15.
Bottom line is Option exercised as to TIMMING TO BUY ! and NOT WAIT.
Monday, September 23, 2013 at 12 noon ET
Andrew T. Parsa, MD, PhD, Michael J. Marchese Professor and Chair, Department of Neurological Surgery at Northwestern University School of Medicine;
John A. Boockvar, MD, Professor of Neurological Surgery and Co-director of the Brain and Spinal Tumor Program at the Weill Cornell Brain and Spine Center.
The overwhelmingly most important vote of confidence in the drug comes from the National Cancer Institute that is funding almost all of the expense in an ongoing phase II trial of Prophage in recurrent glioblastoma. American Brain Tumor Association.
AGEN is NASDAQ listed not OTC company. AGEN is monitored and controlled by SEC antitrust regulations, it's not a game announcement as AF indicated.
Offering was announced longback Bottom line is - Results are excellent and Agenus plans to hold an end of Phase 2 meeting with the FDA and most likely FDA might agree to give marketing approval of the HSPPC-96 vaccine as a treatment for patients with newly diagnosed GBM.