April 24, 2017 11:32 PM ET

Biotechnology

Company Overview of Advaxis, Inc.

Company Overview

Advaxis, Inc., a clinical stage biotechnology company, focuses on the discovery, development, and commercialization of Lm-LLO cancer immunotherapies in the United States. Its lead product Axalimogene filolisbac, an Lm-LLO immunotherapy product candidate, which completed its Phase II study for the treatment of human papilloma virus associated cancers, including cervical, head and neck, and anal cancer. The company is also developing ADXS-PSA, an Lm-LLO immunotherapy product candidate, which is in Phase I/II clinical trials designed to target the prostate specific antigen associated with prostate cancer; and ADXS-HER2, an Lm-LLO immunotherapy product candidate that is in Phase Ib clinical tria...

305 College Road East

Princeton, NJ 08540

United States

Founded in 2002

90 Employees

Phone:

609-452-9813

Fax:

609-452-9818

Key Executives for Advaxis, Inc.

Chief Executive Officer, President and Director
Age: 51
Total Annual Compensation: $1.7M
Chief Financial Officer, Executive Vice President and Corporate Secretary
Age: 35
Total Annual Compensation: $1.0M
Chief Scientific Officer and Executive Vice President
Age: 56
Total Annual Compensation: $1.3M
Compensation as of Fiscal Year 2016.

Advaxis, Inc. Key Developments

Advaxis Appoints Anthony Lombardo as Chief Business Officer

Advaxis said that Anthony Lombardo, an industry veteran with nearly 30 years' experience in the field of life sciences, has joined the company as chief business officer. Lombardo is a senior leader with experience in helping global companies achieve significant growth.

Advaxis Presents Oral Late-breaking Data on Phase 2 GOG-0265 Study of Axalimogene Filolisbac

Advaxis, Inc. presented data from the GOG-0265 study at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer in National Harbor, MD. GOG-0265 is a single arm, Phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC). The primary endpoints of the study were to assess the safety and efficacy of axalimogene filolisbac in women with PRmCC. The primary efficacy endpoint was overall survival at 12 months from initial treatment with axalimogene filolisbac. The primary safety endpoints were to evaluate the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects. The final efficacy results of GOG-0265 demonstrated that 38% of patients (n = 19/50) with heavily pretreated PRmCC were alive 12 months following treatment with axalimogene filolisbac. The GOG-0265 study protocol used a logistic model-based calculation to establish the expected 12-month survival rate. The model identified the key prognostic factors of age, race and performance status significantly related to survival from a database of approximately 500 patients with PRmCC who participated in 17 previous phase 2 studies conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology. Using this model, the expected 12-month survival rate of patients enrolled in the study was calculated to be 24.5%. As a result, the 38% 12-month survival rate of patients treated with axalimogene filolisbac represents a 52% improvement over the expected survival rate and is the highest 12-month survival rate achieved to date in this setting. The probability of this survival improvement being detected by chance versus a true treatment effect was calculated to be 0.02. A compelling and ongoing complete response of 18.5 months was observed and the longest ongoing survival is 40.6 months. The safety profile was consistent with previous clinical experience. The most common Grade 1 or Grade 2 treatment-related adverse events (TRAEs) were hypotension and symptoms related to cytokine release (e.g., nausea, chills, fever). Eighteen out of 50 patients experienced a Grade 3 TRAE and two out of 50 patients experienced a Grade 4 TRAE, which were hypotension and symptoms related to cytokine release. Highlights from Dr. Leath’s presentation include: A 38% (n = 19/50) 12-month survival rate in second- and third-line PRmCC treated with axalimogene filolisbac, representing a 52% improvement over the expected 12-month milestone survival rate of 24.5%; Eight patients remain alive as of January 31, 2017 (Range 12.02 – 40.6 months); Disease control (complete response, partial response, or stable disease) was achieved in 32% of patients based on investigator assessment of best response; A durable complete response in a patient with PRmCC previously treated with chemotherapy and bevacizumab remains ongoing at 18.5 months; Results compare favorably to GOG Study 227C of bevacizumab, which demonstrated a 12-month milestone overall survival (OS) rate of 30% in a similar patient population which subsequently supported regulatory approval in first-line treatment in combination with chemotherapy in 2014; Consistent with its immunotherapy mechanism of action, axalimogene filolisbac demonstrated a promising plateau in the survival curve, indicating potential long-term clinical benefit for a subset of patients with PRmCC; Axalimogene filolisbac was generally well-tolerated, with primarily infusion-associated, low grade, transient TRAEs (=30%), such as fatigue, chills, anemia, nausea and fever; Only 2 patients experienced grade 4 TRAEs. Advaxis plans to initiate a global, phase 3 randomized registration study in patients with metastatic cervical cancer later in 2017.

Advaxis, Inc. Appoints Al Blunt as its Vice President of Medical

Advaxis, Inc. announced Al Blunt, M.D., has joined the company as Vice President of Medical. Dr. Blunt joins Advaxis from Covance, where he was Executive Medical Director for Oncology. Dr. Blunt joined Covance in 1998, holding several positions increasing in responsibility over nearly 20 years. As Vice President of Medical for Advaxis, Dr. Blunt is responsible for leading the company’s clinical development strategy and activities from pre-clinical to commercial phase trials, including development of trial protocols to preparing regulatory filings, and participating in interactions with regulatory authorities relating to clinical matters. Dr. Blunt’s appointment was effective March 7, 2017.

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