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As of 8:10 PM 09/19/14 All times are local (Market data is delayed by at least 15 minutes).

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advaxis inc (ADXS) Details

Advaxis, Inc., a clinical development stage biotechnology company, focuses on developing immunotherapies for cancer and infectious diseases. The company’s Lm -LLO immunotherapy platform technology stimulates the immune system to induce antigen-specific anti-tumor immune responses involving innate and adaptive arms of the immune system by inhibiting the T-cells, Tregs, myeloid-derived suppressor cells, and MDSC to promote immunologic tolerance of cancer cells in the tumor. Its platform technology also facilitates the immune response by altering the tumor microenvironment to reduce immunologic tolerance in the tumors that makes the tumor more susceptible to immune attack. The company has approximately 15 distinct immunotherapies in various stages of development, directly developed by the company and through strategic collaborations. Its products in clinical development stage comprise ADXS-HPV that is being evaluated in various clinical trials for cervical cancer, head and neck cancer, and anal cancer; ADXS-PSA for the treatment of prostate cancer; and ADXS-cHER2 for the treatment of overexpressing cancers, such as breast, gastric, and other cancers in humans, as well as for osteosarcoma in canines. The company has a clinical trial collaboration with MedImmune, LLC to evaluate MEDI4736, an investigational anti-PD-L1 immune checkpoint inhibitor in combination with ADXS-HPV, a cancer immunotherapy vaccine to treat patients with human papillomavirus (HPV)-associated cervical cancer, and HPV-associated head and neck cancer. Advaxis, Inc. was founded in 2002 and is based in Princeton, New Jersey.

17 Employees
Last Reported Date: 01/29/14
Founded in 2002

advaxis inc (ADXS) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $312.5K
Chief Scientific Officer and Executive Vice P...
Total Annual Compensation: $371.7K
Compensation as of Fiscal Year 2013.

advaxis inc (ADXS) Key Developments

Advaxis, Inc. Provides A Clinical Development Update for its Immunotherapy

Advaxis, Inc. announced the completion of an End of Phase 2 (EOP2) meeting with the United States Food and Drug Administration (FDA), for its lead Lm-LLO cancer immunotherapy, ADXS-HPV, for the treatment of recurrent cervical cancer in women. The purpose of the EOP2 meeting was to discuss ADXS-HPV's preclinical data, Chemistry, Manufacturing and Controls (CMC) and clinical program prior to moving ADXS-HPV forward into the next phase of clinical development in cervical cancer. At the meeting, the FDA provided guidance on the company's CMC activities and clinical development plan. The Company is in dialogue with the FDA to incorporate this valuable guidance into its planned registration program and the Company plans to submit a Phase 3 protocol for a special protocol assessment (SPA). The company is planning to initiate an adequate and well-controlled clinical trial in cervical cancer in 2015 to support a Biologics License Application (BLA) submission in the U.S. The adequate and well-controlled Phase 3 clinical trial that the company is planning to conduct will compare repeating cycles of ADXS-HPV to physician's choice of chemotherapy, in women with recurrent or persistent cervical cancer who have progressed after receiving prior approved therapy. This population has an unmet medical need because no available treatment has been shown to improve their survival. The goal of the study would be to provide clinically relevant life extension to these patients. The company has entered into a master services agreement with inVentiv Clinical Health to serve as its global contract research organization for this study.

Advaxis, Inc. and Merck Enter into Clinical Trial Collaboration Agreement

Advaxis, Inc. has entered into a clinical trial collaboration agreement with Merck, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1 antibody, pembrolizumab. The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer. Both ADXS-PSA and pembrolizumab are investigational members of a new class of cancer treatments known as immunotherapies that are designed to enhance the body's own defenses in fighting cancer. Preclinical evidence suggests that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response. Under the terms of the agreement, Advaxis and Merck will collaborate to evaluate the ADXS-PSA/pembrolizumab combination as a treatment for prostate cancer. The Phase 1 part of the trial is designed to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab, and the Phase 2 portion will assess the safety and efficacy of the combination. Advaxis will sponsor and fund the study and Merck will provide pembrolizumab. The companies will collaboratively oversee the conduct of the study, which is planned to begin in early 2015. Results from the study will be used to determine the path for further clinical development of the combination.

Advaxis, Inc. and MedImmune Collaborate on Immuno-Oncology Combination Clinical Trial

Advaxis, Inc. entered into a clinical trial collaboration with MedImmune. The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. MEDI4736 is designed to counter the tumour's immune-evading tactics by blocking a signal that helps tumours avoid detection, while ADXS-HPV enhances the ability of immune cells to combat the tumour. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can enhance overall anti-tumour response. Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted.


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