Ayala Pharmaceuticals Inc (ADXS)

[corvatsch]

ADXS-HPV: Axalimogene filolisbac (AXAL):
– Cervical Cancer – As announced in July, the company is in the process of winding down its Phase 3 AIM2CERV study evaluating AXAL for the treatment of patients with high-risk, locally advanced cervical cancer. As a result of the closure of this study, the company will be unblinding the data and anticipates reporting the results of the 110 patients that had been dosed with AXAL in this study by the end of 2019.
– Lung Cancer –Global BioPharma, Inc. (GBP), the company’s partner in certain Asian and African territories, anticipates initiating its Phase 2, open-label controlled trial in HPV-associated NSCLC in patients following first-line chemotherapy by the end of 2019. The study will be assessing the effects of AXAL when combined with pemetrexed in patients with HPV+ NSCLC, following first line induction therapy.
“At Advaxis, we are committed to unlocking the potential benefits of our Lm TechnologyTM platform to improve outcomes for cancer patients,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “The NEO trial has provided us with valuable proof-of-mechanism data for our HOT program, with clinical signals of generation of CD8+ T cells against hotspot mutations, antigen spreading and stable disease in two patients. While discontinuing the NEO program was a difficult decision, we ultimately believe that the off-the-shelf approach of our HOT program will allow us to more effectively evaluate our platform in a broad patient population with a more economical, commercial-ready manufacturing process while also extending our cash runway until early 2021. I want to personally thank the patients, employees and collaborating physicians who participated in or assisted with this study.” He concluded, “The strength of our technology and pipeline leave us well positioned to explore a variety of strategic opportunities heading into 2020.”