Advaxis Inc. (ADXS) - NASDAQ
  • Thu, Jul. 21, 11:01 AM
    | Thu, Jul. 21, 11:01 AM | 4 Comments
  • Thu, Jul. 21, 10:05 AM
    • Micro cap Advaxis (ADXS +3.8%) is up on light volume in response to its announcement that the FDA has designated lead immunotherapy candidate axalimogene filolisbac (AXAL) for Fast Track review for the adjunctive treatment of high-risk locally advanced cervical cancer. An adjunct (or adjuvant) therapy is administered in addition to the main or initial therapy in order to maximize its effectiveness.
    • Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
    • In 2014, the FDA designated AXAL an Orphan Drug for the treatment of invasive cervical cancer.
    • Axalimogene filolisbac is an immunotherapy based on the company's Lm Technology, which uses live attenuated bioengineered Listeria bacteria to deliver a fusion protein inside cancer cells which then stimulates the immune system to attack the cancer.
    | Thu, Jul. 21, 10:05 AM | 13 Comments
  • Wed, Jul. 6, 11:00 AM
    | Wed, Jul. 6, 11:00 AM
  • Wed, Jul. 6, 9:16 AM
    | Wed, Jul. 6, 9:16 AM | 3 Comments
  • Mon, May 16, 9:19 AM
    | Mon, May 16, 9:19 AM | 8 Comments
  • Thu, Apr. 28, 9:16 AM
    | Thu, Apr. 28, 9:16 AM
  • Thu, Mar. 3, 9:15 AM
    | Thu, Mar. 3, 9:15 AM | 1 Comment
  • Wed, Mar. 2, 3:46 PM
    • Investors appear to be warming to micro cap Advaxis (ADXS +24.1%) with turnover more than double the average. Shares are up almost 34% since Monday.
    • This morning, the company announced that data from a mid-stage study of lead product candidate axalimogene filolisbac (AXAL) in HPV-associated head and neck cancer will be presented at the American Association for Cancer Research Annual Meeting in April in New Orleans, LA. The Phase 2 trial is evaluating AXAL as neoadjuvant treatment prior to robot-assisted surgery in these patients. The poster, to be presented by Andrew Sikora, M.D., will present data on the effect of AXAL in targeting and inducing T cell response in the tumor microenvironment.
    • In early February, the company inked a development and commercialization deal with a Mexican specialty pharmaceutical firm for AXAL in Latin American markets.
    • In mid-December, the FDA lifted its clinical hold on AXAL that it instituted in October after a clinical trial participant tested positive for Listeria monocytogenes, the bacterium that serves as the company's therapeutic agent, and eventually died. After an investigation, it was determined that the patient expired from the progression of her cervical cancer and that the Listeria infection could have resulted from the multiple implant surgeries she had while on AXAL treatment.
    • Axalimogene filolisbac is an immunotherapy based on the company's Lm Technology, which uses live attenuated bioengineered Listeria bacteria to deliver a fusion protein inside cancer cells which then stimulates the immune system to attack the cancer.
    • Previously: FDA lifts clinical hold on Advaxis' INDs for all three product candidates; shares rise 30% (Dec. 16, 2015)
    | Wed, Mar. 2, 3:46 PM | 2 Comments
  • Thu, Feb. 4, 12:19 PM
    • Advaxis (ADXS +9.2%) enters into a co-development and commercialization agreement with privately held Mexican specialty pharmaceutical firm Especificos Stendhal SA de CV for axalimogene filolisbac (formerly ADXS-HPV) in HPV-associated cancers.
    • Under the terms of the deal, Stendahl will pay $10M toward the expenses of conducting a planned global Phase 3 study, AIM2CERV, assessing axalimogene filolisbac in women with high-risk, locally advanced cervical cancer. Advaxis will assist Stendahl to complete the study in Latin American markets while Stendahl will manage the regulatory approval process and commercialization activities.
    • The companies will share profits on an undisclosed basis.
    • Axalimogene filolisbac is an immunotherapy based on the company's Lm Technology, which uses live attenuated bioengineered Listeria bacteria to deliver a fusion protein inside cancer cells which then stimulates the immune system to attack the cancer.
    | Thu, Feb. 4, 12:19 PM | 1 Comment
  • Dec. 17, 2015, 9:20 AM
    | Dec. 17, 2015, 9:20 AM
  • Dec. 16, 2015, 12:45 PM
    | Dec. 16, 2015, 12:45 PM
  • Dec. 16, 2015, 11:55 AM
    • Micro cap Advaxis (ADXS +30%) is up on triple normal volume in response to its announcement that the FDA has lifted its clinical hold on all of its Investigational New Drug (IND) applications for axalimogene filolisbac (formerly ADXS-HPV), ADXS-PSA and ADXS-HER2. All clinical trials can now resume.
    • The agency instituted the clinical hold in October after it received the company's safety report that involved a single event in one patient with end-stage cervical cancer who showed infection by Listeria monocytogenes, the bacterium the company uses as a therapeutic agent.
    • Previously: FDA puts the brakes on clinical trials of Advaxis' axalimogene filolisbac; shares plummet 22% after hours (Oct. 6)
    | Dec. 16, 2015, 11:55 AM
  • Dec. 16, 2015, 9:14 AM
    | Dec. 16, 2015, 9:14 AM
  • Dec. 1, 2015, 10:13 AM
    • The European Medicines Agency designates Advaxis' (ADXS -1%) investigational immunotherapy ADXS-HER2 an Orphan Drug for the treatment of osteosarcoma, the most common form of primary bone cancer. Among the benefits of the status in Europe is a 10-year period of market exclusivity for the indication, if approved.
    • The FDA also tagged ADXS-HER2 an Orphan Drug for osteosarcoma in May 2014.
    • ADXS-HER2 is based on the company's Lm Technology, which uses live, attenuated bioengineered Listeria monocytogenes bacteria to deliver a fusion protein inside cancer cells which then stimulates the immune system to attack the cancer.
    • The company's Lm-based trials were recently placed on clinical hold by the FDA while an incident of Listeria infection is fully investigated.
    • Previously: FDA puts the brakes on clinical trials of Advaxis' axalimogene filolisbac; shares plummet 22% after hours (Oct. 6)
    | Dec. 1, 2015, 10:13 AM | 1 Comment
  • Oct. 7, 2015, 9:14 AM
    | Oct. 7, 2015, 9:14 AM | 4 Comments
  • Oct. 6, 2015, 4:53 PM
    • Micro cap Advaxis (NASDAQ:ADXS) craters 22% after hours on robust volume in response to its announcement that the FDA put its axalimogene filolisbac IND on clinical hold after it reviewed the company's recent safety report. The hold affects four clinical trials.
    • The safety report involved a single event in one patient with end-stage cervical cancer who last received axalimogene filolisbac in early 2013 in a company-sponsored trial. In late July 2015 the patient was hospitalized for symptoms related to her cancer. During her stay, routine blood cultures detected Listeria monocytogenes (Lm). Further analysis determined that it was the highly attenuated strain of Lm used in axalimogene filolisbac, which was incapable of causing infection and was very sensitive to antibiotics. The patient received intravenous antibiotics and was discharged. A few weeks later, the patient returned to the hospital with respiratory distress caused by her metastatic cancer and died later that day. The investigator determined that the cause of death was due to the progression of her cervical cancer.
    • It was subsequently discovered that the patient underwent multiple surgical procedures during the time she was receiving axalimogene filolisbac, including orthopedic reconstruction, a bone graft and other medical implants. The company believes that the implants could have provided a location for axalimogene filolisbac to exist within the body without causing infection.
    • Advaxis has supplied the FDA with additional information that it requested for its review and evaluation of this event. It does not anticipate a significant delay in its HPV clinical development program.
    | Oct. 6, 2015, 4:53 PM | 2 Comments
Company Description
Advaxis, Inc. is a clinical-stage biotechnology company, which intends to develop immunotherapies for cancer and infectious diseases. The company's platform technology is designed to generate a comprehensive immune response by serving as its own adjuvant, directing antigen presentation,... More
Sector: Healthcare
Industry: Biotechnology
Country: United States