PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced the following updates to its clinical programs.
ADXS-HOT: Cancer Type-Focused Hotspot/Off-the-Shelf Neoantigen-Directed Therapies – The ADXS-HOT program is a cancer-type specific immunotherapy that targets hotspot mutations, cancer testis antigens and oncofetal antigens. The first drug candidate from this program, ADXS-503, is designed to target most types of non-small cell lung cancer (NSCLC) and is currently being evaluated in a Phase 1/2 clinical trial, enrolling patients at five sites. The first dose level with monotherapy in Part A, (1 X108 CFU) has been completed and the Part A-second dose level (5 X108 CFU) and Part B in combination with a checkpoint inhibitor are currently open to enrollment. The Company plans to report immune response data from Part A monotherapy by the end of 2019.
Advaxis intends to file an investigational new drug (IND) application for its ADXS-504 (HOT Prostate) program by the end of 2019 and has completed manufacturing of its ADXS-506 (HOT Bladder) construct, enabling the construct to enter clinical development in the future.
ADXS-NEO: Personalized, Neoantigen-Directed Therapy – ADXS-NEO is a personalized neoantigen-directed immunotherapy designed to activate a patient’s immune system in a range of cancers. The company has enrolled its last patient in Part A, the monotherapy portion of its Phase 1 dose-escalation study, which was planned to be followed by Part B, dose escalation in combination with a checkpoint inhibitor. Data previously released on the ADXS-NEO program demonstrated the tolerability, to date, of this construct at 1 X108 CFU and indicated signals of a robust anti-tumor immune response. Additionally, the signals of anti-tumor immune responses included a strong CD8+ T cell reactivity generated against personalized as well as hotspot mutations, which provided valuable insight for the company’s HOT constructs. As the company moves into the combination arm of its HOT NSCLC study, it has determined that the information gained from the HOT NSCLC study will provide an opportunity to demonstrate the effects of its neoantigen constructs used in combination with a checkpoint inhibitor, thereby minimizing the benefits of entering Part B of the ADXS-NEO study. Therefore, the company has elected to not continue into Part B of the ADXS-NEO study in combination with a checkpoint inhibitor. The company plans to continue to dose the last patient enrolled in Part A in accordance with the protocol and cease further enrollment. The company intends to publish the final results from Part A of the ADXS-NEO study at a future medical meeting and close its ADXS-NEO program IND thereafter.
ADXS-PSA: Prostate Cancer – The company recently reported updated data for its Phase 1/2 KEYNOTE-046 study of ADXS-PSA, alone and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for unselected and advanced patients with metastatic castration-resistant prostate cancer (“mCRPC”).
The median overall survival for this patient population in the combination arm was 33.6 months (95% CI, range 15.4-33.6 months). These results are encouraging as the patient population in the combination arm (n=37) had high Gleason scores (9), MSI-high negative status, visceral metastatsis in 30%, prior chemotherapy in 57% and one to two prior next generation hormonal agents in >80% of patients. The company is in discussions with potential partners regarding opportunities to expand or advance this mCRPC program.
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.”
About Advaxis, Inc.
Advaxis, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
