Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that it will present a poster on Advaxis’s Lm Technology™ cancer immunotherapy ADXS-HER2 at the 2015 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas during Poster Session 1 on Wednesday, December 9, 2015, from 5-7 p.m. CST.
“Standard treatments for metastatic HER2-positive breast cancer are effective, but resistance develops and different approaches are needed,” said Antoinette R. Tan, M.D., M.H.Sc., Chief of Breast Medical Oncology at Levine Cancer Institute, Carolinas HealthCare System, Charlotte, N.C. “This Phase 1b trial tests the approach of using an attenuated bacteria that has been shown in preclinical studies to disable the tumor’s ability to hide from and resist therapy, potentially offering a novel therapeutic strategy for patients with HER2-positive tumors.”
The poster, titled “A multicenter, Phase 1b, first-in-human dose-escalation study of ADXS31-164, a listeria monocytogenes-LLO immunotherapy, in patients with HER2-expressing solid tumors,” will be presented by Dr. Tan. As of October 20, 2015, this study has enrolled three patients.
The Phase 1b study in humans builds upon efficacy and safety data from Phase 1 clinical studies of ADXS-HER2 conducted in dogs with osteosarcoma, which may have important translational relevance for human patients with osteosarcoma and other HER2 expressing cancers. Preliminary data from a Phase 1 clinical trial in companion dogs with spontaneous osteosarcoma showed that administration of ADXS-HER2 following amputation and chemotherapy was safe and induced immune responses against HER2 expressing tumors in 15 out of 18 dogs. Median survival times for ADXS-HER2 treated dogs and a matched historical control group were 956 days and 423 days respectively. Overall survival rates at 1 and 2 years for dogs treated with ADXS-HER2 were 77.8 percent and 67 percent respectively and 55 percent and 28 percent respectively for the historical control group. Based on these encouraging results, ADXS-HER2 is being considered for expedited approval in 2016 by the U.S. Department of Agriculture (USDA) to treat canine osteosarcoma.
Furthermore, preliminary data from a second ongoing canine Phase 1/2 trial suggests that ADXS-HER2 in combination with palliative radiation may delay primary and metastatic tumor progression and prolong overall survival in a subset of pet dogs with spontaneous osteosarcoma that do not undergo amputation or chemotherapy.
The European Medicines Agency (EMA) recently granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma in humans. (Original Source)
Shares of Advaxis closed yesterday at $10.94, up $0.06 or 0.55%. ADXS has a 1-year high of $30.13 and a 1-year low of $3.35. The stock’s 50-day moving average is $12.04 and its 200-day moving average is $15.89.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on October 5, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on ADXS, with a price target of $30, which represents a potential upside of 174.2% from where the stock is currently trading. Separately, on September 14, FBR’s Vernon Bernardino maintained a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Vernon Bernardino have a total average return of -17.6% and -23.0% respectively. Ramakanth has a success rate of 19.3% and is ranked #3585 out of 3640 analysts, while Bernardino has a success rate of 19.0% and is ranked #3622.
Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.