Advaxis, Inc., a clinical stage biotechnology company, focuses on the discovery, development, and commercialization of proprietary cancer immunotherapies. The company’s immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm or Listeria), bioengineered to secrete antigen/adjuvant fusion proteins. ADXS-HPV ADXS-HPV is an Lm-LLO immunotherapy product candidate for the treatment of human papilloma virus (HPV)-associated cancers. The company completed a Phase 2 study in 110 patients with recurrent cervical cancer in India. ADXS-HPV has received United States Food and Drug Administration (FDA) orphan drug designation for three HPV-associated cancers: cervical, head and neck, and anal cancer. The company is in the process of developing two other cancer immunotherapies. ADXS-PSA is its Lm-LLO immunotherapy product candidate designed to target the PSA antigen associated with prostate cancer. The FDA has cleared its Investigational New Drug (IND) application, and the company intends to initiate a Phase 1/2 clinical trial alone and in combination with KEYTRUDA (pembrolizumab). Intellectual Property The company’s patent portfolio includes 53 issued patents and 75 pending patent applications. The company has issued patents directed to methods of treatment by using its product candidates ADXS-HPV and ADXS-PSA in the United States, which would expire between 2015 and 2026. The company has pending patent applications for use of its product candidates ADXS-HPV, ADXS-PSA, ADXS-HER2 covering the following indications: a her2/neu-expressing cancer, a prostate cancer, cervical dysplasia, and cervical cancer. Collaborations, Partnerships and Agreements Biocon Limited: In 2014, the company entered into a distribution and supply agreement with Biocon Limited, a company incorporated under the laws of India (Biocon). Pursuant to the agreement, the company granted Biocon an exclusive license (with a right to sublicense) to use its data from clinical development activities, regulatory filings, technical, manufacturing and other information and know-how to enable Biocon to submit regulatory filings for ADXS-HPV in the following territories: India, Malaysia, Bangladesh, Bhutan, Maldives, Myanmar, Nepal, Pakistan, Sri Lanka, Bahrain, Jordan, Kuwait, Oman, Saudi Arabia, Qatar, the United Arab Emirates, Algeria, Armenia, Egypt, Eritrea, Iran, Iraq, Lebanon, Libya, Sudan, Syria, Tunisia and Yemen; and import, promote, market, distribute and sell pharmaceutical products containing ADXS-HPV. Global BioPharma, Inc.: In 2013, the company entered into an exclusive licensing agreement for the development and commercialization of ADXS-HPV with Global BioPharma, Inc. (GBP), a Taiwanese based biotech company. GBP plans to conduct registration trials with ADXS-HPV for the treatment of advanced cervical cancer and will explore the use of its lead product candidate in other indications, including lung, head and neck, and anal cancer. Merck & Co., Inc.: In 2014, the company entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., pursuant to which the parties would collaborate on a Phase 1/2 dose-escalation and safety study. MedImmune/AstraZeneca: The company has entered into a clinical trial collaboration agreement with MedImmune LLC (MedImmune), the biologics research and development arm of AstraZeneca, where it intends to collaborate on a Phase 1/2 study to evaluate safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with investigational Lm-LLO cancer immunotherapy, ADXS-HPV, as a combination treatment for patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer. Aratana Therapeutics Inc. (Aratana) In 2014, the company entered into a definitive exclusive license agreement with Aratana. Pursuant to the Aratana agreement, the company granted Aratana an exclusive, worldwide, royalty-bearing, license, with the right to sublicense, under certain Advaxis proprietary technology that enables the design of an immunotherapy utilizing live attenuated Lm bioengineered to secrete fusion proteins consisting of antigen and adjuvant molecules, including certain ‘Constructs’ and related ‘Compounds’ in order for Aratana to develop and commercialize animal health products containing or incorporating Compounds (Products) for use in non-human animal health applications that would be targeted for treatment of osteosarcoma and other cancer indications in animals. Significant Events On January 7, 2015, Advaxis, Inc. announced that it is entering into a clinical trial collaboration agreement with the GOG Foundation, Inc. to evaluate the safety and efficacy of Advaxis's lead cancer immunotherapy, ADXS-HPV, in a global Phase 3 cervical cancer trial. ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene. In January 2015, Advaxis said it's entering a clinical trial collaboration agreement with GOG Foundation, to evaluate the safety and efficacy of the company's lead cancer immunotherapy, ADXS-HPV, in a global Phase 3 cervical cancer trial. In February 2015, Advaxis announced that it has agreed to collaborate with Incyte Corporation to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy with Incyte's investigational oral indoleamine 2,3-dioxygenase 1 inhibitor, epacadostat to treat cervical cancer. In April 2015, Advaxis is entering into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group Foundation to evaluate the safety and efficacy its lead cancer immunotherapy, ADXS-HPV in a Phase 2/3 anal cancer trial. In May 2015, Advaxis, Inc. has entered into a non-exclusive research and clinical trial collaboration agreement with Sorrento Therapeutics, Inc. to evaluate combinations of Advaxis'sLm-LLO cancer immunotherapy technology platform, including ADXS-HPV, ADXS-PSA and ADXS-HER2, with Sorrento's fully human antibodies targeting immune checkpoints, including GITR, OX40, LAG-3 and TIM-3. History Advaxis, Inc. was founded in 2002.
advaxis inc (ADXS:NASDAQ CM)
305 College Road East
Princeton, NJ 08540
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