Advaxis Outperformed on a Negative Market Day
Advaxis’ (ADXS) stock rallied today as the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on its product AIM2CERV (axalimogene filolisbac). The product is in a Phase 3 clinical trial on patients with high-risk locally advanced cervical cancer. In its letter the FDA acknowledged that the Company has satisfactorily addressed all hold questions.
The Story Behind the Partial Clinical Hold
On January 23, 2019 the FDA placed a partial clinical hold on the trial requesting additional information pertaining to the product’s certain chemistry, manufacturing and controls (CMC) matters. The FDA did not cite any safety issues related to the trial. All enrolled patients continued to receive treatment per trial protocol. However, during the partial hold, no new patients were permitted to enroll in the AIM2CERV trial.
Comments from the President and CEO of Advaxis
Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, stated, “The Advaxis team worked diligently to provide a comprehensive response back to the FDA’s requests for additional CMC information, and through constructive dialogue, we successfully resolved the partial clinical hold. “Our product has demonstrated a manageable safety profile in the over 400 patients we have dosed to date, and we look forward to working with our clinical research organization to reopen enrollment at AIM2CERV sites….”
The Product, AIM2CERV (axalimogene filolisbac)
Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers. The product acts by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment against immunologic attack.
Some Results from Phase 2
Results from a Phase 2 trial evaluating axalimogene filolisbac on persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) showed a 12-month overall survival rate of 38% in 50 patients. The trial’s expected improvement of patient population was improved by 52%; over the 12-month overall survival rate, based on prognostic factors.
Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. Furthermore, the immunotherapy received orphan drug designation in three clinical indications.
Advaxis, Inc. is a late-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. The firm’s platform technology utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. The firm believes that the Lm-based strains represent a significant advancement in immunotherapy as they integrate multiple functions into single immunotherapy. These strains are designed to access, and direct, antigen presenting cells to: stimulate anti-tumor T cell immunity, activate the immune system (with the equivalent of multiple adjuvants) and simultaneously reduce tumor protection in the tumor microenvironment, to enable T cells to eliminate tumors.
Advaxis programs in various stages of clinical development comprise:
- ADXS-HPV: For cervical cancer;
- ADXS-NEO: A personalized neoantigen-directed therapy for multiple cancers;
- ADXS-503: For non-small cell lung cancer;
- ADXS-HOT: Off-the-shelf neoantigen-directed program and
- ADXS-PSA: For prostate cancer.
The news rallied the small firm’s stock on a negative market day. ADXS is currently trading at $3.47, UP 7.10%. Regardless of whether or not the market takes this stock price further, up or down today, it is worth following up on.
ADXS could be presenting an investment opportunity in a small biotech firm.