Key Developments: Advaxis Inc (ADXS.OB)
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20 May 2013
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1,500,610
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Latest Key Developments (Source: Significant Developments)
Advaxis Inc Enters Into Memorandum Of Understanding With FusionVax, Inc
Advaxis Inc announced that it has entered into a Memorandum of Understanding (MoU) with FusionVax, Inc. (FusionVax) setting forth the main terms under which Advaxis will, subject to the entry of a definitive agreement, exclusively license its lead clinical stage product candidate, ADXS-HPV, to FusionVax for Asia. Under the terms of the MoU, Advaxis will exclusively license the rights to ADXS-HPV to FusionVax for the Asia territory, exclusive of India, for all indications. In exchange, FusionVax will pay Advaxis an up-front payment, certain event-based financial milestones, an annual exclusive licensing fee, and an annual net sales royalty in countries with issued patents. In exchange for the up-front payment, Advaxis will provide FusionVax an equal amount of Advaxis common stock. FusionVax will be responsible for conducting clinical trials and pursuing commercialization of ADXS-HPV in Asia and, in exchange, Advaxis will pay FusionVax net sales annual royalty on ADXS-HPV in the U.S. of less than 1%. The companies will share all data generated from their respective clinical trials. Under the terms of the MoU, Advaxis and FusionVax will work together over the next six months to enter into a definitive exclusive licensing agreement based upon these terms. FusionVax has agreed to place into escrow a portion of the first event-based milestone pending the execution of a definitive licensing agreement. Full Article
Advaxis, Inc. Research Accepted For American Association Of Immunologists Annual Meeting, Demonstrates Reduction Of Tumor Defenses
Advaxis, Inc. announced that an abstract has been selected for poster & block symposium presentations at the American Association of Immunologists (AAI) Annual Meeting 2012 in Boston, MA, from May 4-8. The abstract is number 1334438, poster P150, entitled “Treatment with Lm-LLO immunotherapies lead to decreased Tregs and MDSC in the tumor microenvironment” by Dr. Reshma Singh, et al., Advaxis. The abstract will show that in pre-clinical research (Lm)-LLO-based immunotherapies that secrete LLO-antigen fusion proteins reverse the immune suppression that exists within tumors to protect them from the immune system. Not only are the percentages of Regulatory T cells (Tregs) and Myeloid Derived Suppressor Cells (MDSC) in tumors reduced, but the immunosuppressive activity of these cells that persists is also reduced. Moreover, as this effect is not seen in the spleen or other non-cancerous (normal) peripheral tissues, it appears to be limited to the tumor microenvironment. These findings suggest that the side effects against normal tissues that are associated with immune-checkpoint blocking agents may not occur with Lm-LLO agents. Full Article
Advaxis, Inc. Reports Preliminary Safety And Survival Data From Phase 2 Trial In Recurrent/Refractory Cervical Cancer
Advaxis, Inc. announced the preliminary data on the safety and clinical benefit of ADXS-HPV from an ongoing randomized Phase 2 trial of ADXS-HPV with or without cisplatin in Indian women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. Dr. John Rothman, Advaxis Executive Vice President of Science and Operations, presented the preliminary data at the World Cancer Immunotherapy Conference in San Diego, California on January 25, 2012. The advanced cervical cancer study is being conducted at 17 sites in India, and as of January 25, 2012, 87 out of a planned 110 patients have been enrolled in the study. The objectives of this Phase 2 trial are to assess the safety and efficacy of ADXS-HPV (1x109 cfu) with and without cisplatin (40 mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. As of January 20, 2012, 87 patients have received 195 doses of ADVS-HPV. 34% of patients (a total of 30) have experienced a ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events that were transient, comprised of non-cumulative flu-like symptoms that responded to symptomatic treatment, or resolved on their own; and 1 Grade 3 event. Full Article
Advaxis, Inc. Reports Preliminary Data from ADXS-HPV Phase 2 Trial in Patients with Recurrent/Refractory Cervical Cancer At AACR India
Advaxis, Inc. announced preliminary data on the safety and clinical benefit of ADXS-HPV from an ongoing randomized Phase 2 trial of ADXS-HPV +/- cisplatin in Indian women with recurrent/refractory cervical cancer at the AACR New Horizons in Cancer Research: Biology to Prevention to Therapy conference on December 14th, 2011 at the Leela Kempinski Gurgaon in Gurgaon, Delhi (NCR), India. Dr. Partha Basu, a leading investigator on the trial, was 1 of 6 authors invited to give an oral presentation during the December 14, plenary session on cervical cancer. These data were further described in a poster presentation on December 16, by co-author, Dr. Robert Petit, Advaxis VP of Clinical Operations and Medical Affairs. As of December 5, 2011, 75 patients have received 176 doses of ADVS-HPV with 29 (39%) patients experiencing a drug-related adverse event, consisting of Grade 1 or 2, transient, non-cumulative flu-like symptoms that responded to symptomatic treatment or resolved on their own. No serious adverse events related to ADXS-HPV have occurred. The primary endpoint is overall survival, and although early in the trial, clinical responses have been seen alone or in combination with chemotherapy and have included 1 complete response and 3 partial responses with >60% reduction in tumor burden among 31 patients scanned. Enrollment in the trial continues and evaluation of safety, clinical response, and overall survival is ongoing. Full Article
Advaxis, Inc. Revises Protocol For CIN Study
Advaxis, Inc. announced that it has submitted a protocol revision that has passed FDA review for the enrollment of the next 40 subject “mid strength” dose cohort in the dose-ranging Phase II study of ADXS-HPV, an immunotherapy for Cervical Intraepithelial Neoplasia (CIN). The revised protocol eliminates a staggered dosing design that required two pauses in recruitment to evaluate the safety of all three doses in two successive small groups of patients. The pauses consumed about 5 months in the recently completed low dose cohort that took about 14 months to complete. The ADXS-HPV CIN study is a randomized, single blind, placebo controlled Phase II dose-ranging study designed to assess the safety and efficacy in up to 3 different dose cohorts. Full Article
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