Advaxis Inc. (NASDAQ:ADXS) has announced that the FDA has cleared its new Investigational New Drug Application to commence the Investigator Sponsored Phase 1 ADXS-504 clinical study. ADXS-504 is the company’s off-the-shelf neoantigen ADXS-Hot prostate cancer candidate.
New IND for ADXS-504
The new IND comes at the back of the Advaxis sponsored IND announced at the beginning of this year. The company plans to first advance ADXS-504 clinical evaluation via an Investigator Sponsored first phase study in prostate cancer individuals with biochemical recurrence that is on track for commencement in Q4 2020.
Kenneth Berlin, the CEO and president of the company stated that they were delighted to announce the ADXS-504 HOT prostate study’s transition to an investigator-sponsored trial. He added that the collaboration with a prestigious academic medical center will help accelerate enrolment and the whole program because the company will gain access to leading expertise and a high number of patients. Berlin said that the partnership is a vital strategic decision that will conserve resources that can be leveraged in supporting the expansion of the HOT program in non-small cell lung cancer.
Advaxis to commence Phase 1 study before the end of 2020
To date, the data generated with ADXS-503 ion NSCLC has been promising, leaving the company upbeat that its off-the-shelf neoantigen program will offer well-tolerated therapies with strong adaptive and innate immune responses and possible clinical activity. The CEO confirmed that Advaxis was looking forward to commencing its Phase 1 study with ADXS-504 monotherapy in prostate cancer patients before the end of this year.
The company develops its antigen delivery products based on the Listeria monocytogenes (Lm) technology platform. The platform employs live attenuated Lms that have been bioengineered to secrete adjuvant/antigen fusion proteins. The Lm-based varieties are a major advancement in immunotherapy because they integrate with various functions to become single immunotherapy. They have been designed so they can access and direct antigen-presenting cells, thus stimulating anti-tumor T-Cell immunity and activating the immune system with comparable adjuvants.