Company Overview of Advaxis, Inc.
Advaxis, Inc., a clinical stage biotechnology company, focuses on the discovery, development, and commercialization of Listeria monocytogenes (Lm) technology based immunotherapies in the United States. It is developing Axalimogene filolisbac and ADXS-Dual that are Lm-LLO immunotherapy product candidates for the treatment of human papilloma virus associated cancers, including cervical, and head and neck cancers. The company is also developing Axalimogene filolisbac for the treatment of anal cancer; ADXS-PSA, an Lm-LLO immunotherapy product candidate, which is designed to target the prostate specific antigen associated with prostate cancer; and ADXS-NEO, an individualized Lm technology antigen...
305 College Road East
Princeton, NJ 08540
Founded in 2002
Key Executives for Advaxis, Inc.
Executive VP, Principal Accounting Officer, CFO & Corporate Secretary
Total Annual Compensation: $1.0M
Executive VP & Chief Scientific Officer
Total Annual Compensation: $1.3M
Compensation as of Fiscal Year 2016.
Advaxis, Inc. Key Developments
Advaxis, Inc. Submits Conditional Marketing Authorization Application for Axalimogene Filolisbac for the Second-Line Treatment of Metastatic Cervical Cancer in European Union
Feb 15 18
Advaxis, Inc. has submitted a conditional Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the company’s lead Lm Technology product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent, recurrent or metastatic carcinoma of the cervix (PRmCC). The MAA submission is built around data from the GOG-0265 study which examined overall survival rates in 50 women and showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with PRmCC, representing a 55% improvement over an expected, model-predicted,12-month survival rate of 24.5%. More than 50% of treated women in this study had previously received multiple prior lines of therapy including treatment with bevacizumab and subsequently experienced progression of their disease. In the GOG-0256 study, axalimogene filolisbac was generally well-tolerated with mostly Grade 1 and 2 flu-like adverse events associated with cytokine release which were managed with standard medical care. This safety profile is consistent with the ongoing clinical experience of axalimogene filolisbac across all clinical trials. The EMA will evaluate the totality of the data, including results from GOG-0265 as well as supportive data from other clinical trials evaluating axalimogene filolisbac. In parallel with the MAA review process, the company will continue assessing partnership opportunities for the potential commercialization of axalimogene filolisbac in Europe. The company has also decided to align and simplify its strategy by using axalimogene filolisbac exclusively in all ongoing and planned HPV-related cancer clinical trials, including the upcoming ADVANCE trial, previously planned with ADXS-DUAL. The strategic decision to harmonize all trials to axalimogene filolisbac is based on its clinical profile to date in over 250 patients, and its demonstration of similar activity in both HPV 16 and 18 subtypes in GOG-0265. The company believes that harmonizing to a single product candidate for all HPV-related programs will streamline developmental, regulatory and commercialization strategies.
Advaxis Announces Publication of Phase 2 Results Evaluating Axalimogene Filolisbac for the Treatment of Recurrent Metastatic Cervical Cancer in the International Journal of Gynecological Cancer
Feb 12 18
Advaxis, Inc. announced that data from an earlier Phase 2 clinical study of axalimogene filolisbac (ADXS11-001) as a treatment for persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) was accepted for publication in the May edition of peer-reviewed International Journal of Gynecological Cancer. This multicenter, randomized Phase 2 study conducted in India compared axalimogene filolisbac as a monotherapy with axalimogene filolisbac in combination with chemotherapy (cisplatin) in 110 patients with PRmCC. The primary endpoint was overall survival (OS), and patients were followed every three months for up to 18 months for tumor response and survival status. The 12-month OS rate was approximately 35% (n = 38/109). Median OS was 8.28 months in the axalimogene filolisbac monotherapy arm and 8.78 months in the combination arm (p=non-significant). Overall, approximately 25% of patients (n = 27/109) reached the 18-month survival milestone. There were 3 confirmed complete responses (RECIST 1.1) and 1 confirmed partial response. The most commonly reported treatment related adverse events were mild-to-moderate and related to cytokine release symptoms (chills, fever, vomiting and nausea), consistent with the observed safety profile in later clinical studies.
Advaxis, Inc. Announces Study Results of Axalimogene Filolisbac
Jan 25 18
Advaxis, Inc. announced data from the investigator-initiated study evaluating the Company’s proprietary Lm-based antigen delivery product, axalimogene filolisbac (ADXS11-001), in combination with chemoradiation as a treatment for high-risk, locally advanced anal cancer. The Phase 1 study evaluated the safety and preliminary efficacy of the combination of ADXS11-001 with mitomycin, FU and intensity modulated radiation therapy in 10 patients with locally advanced, non-metastatic squamous cell anal cancer. Results showed that 9 patients achieved a complete response, and 8 patients (89%) remained disease free at a median follow-up of 42 months. One patient progressed, approximately 6 months post completion of study treatment and subsequently died from progressive disease, and one patient expired early in the study unrelated to study treatment. Treatment-related adverse events were consistent with the observed safety profile of ADXS11-001, and consisted of mostly grade 1-2 cytokine-release related events such as chills, headache and fever. Two patients experienced grade 3 treatment-related toxicities. There were no grade 4 events and ADXS11-001 did not cause any additive chemoradiation related toxicities. All adverse events occurred within 24 hours of treatment and resolved with standard care. These data show that ADXS11-001 can be safely administered with standard chemoradiation for patients with locally advanced, non-metastatic anal cancer.
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