ADXS-NEO / Ayala Pharma - LARVOL DELTA

A Study of ADXS-NEO Expressing Personalized Tumor Antigens (clinicaltrials.gov) - P1 | N=13 | Terminated | Sponsor: Advaxis, Inc. | Unknown status ➔ Terminated; Business decision

Combination therapy • Metastases • Trial termination • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • MSI

Preliminary results of a Phase 1 trial with a personalized neoantigen vaccine (ADXS-NEO) in advanced and refractory cancer patients (SITC 2019) - "These acute adverse events were manageable and reversible with tocilizumab and/or steroids. A safe and tolerable dose of ADXS-NEO monotherapy has been established (1X108 CFU) which elicited fast and broad antitumor immunity, including T cell responses to neoantigens and antigen spreading. Enrollment in a combination therapy arm with pembrolizumab is due to start in 4Q2019."

Clinical • IO biomarker • P1 data • PD(L)-1 Biomarker • Tumor-specific neoantigens • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Expressing Personalized Tumor Antigens Study (clinicaltrials.gov) - P1; N=5; Active, not recruiting; Sponsor: Advaxis, Inc.; Trial completion date: May 2020 ➔ Jan 2022; Trial primary completion date: May 2020 ➔ Jan 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • EGFR

Expressing Personalized Tumor Antigens Study (clinicaltrials.gov) - P1; N=5; Active, not recruiting; Sponsor: Advaxis, Inc.; Recruiting ➔ Active, not recruiting; N=48 ➔ 5; Trial completion date: Sep 2020 ➔ May 2020; Trial primary completion date: Sep 2019 ➔ May 2020

Clinical • Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • EGFR

Advaxis announces business and pipeline update (Businesswire) - "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."

IND • P1 data

Advaxis reports fiscal third quarter 2019 financial results and provides pipeline update (Businesswire) - P1, N=48; NCT03265080; Sponsor: Advaxis, Inc; P1/2, N=51; KEYNOTE-046 (NCT02325557); Sponsor: Advaxis, Inc; "Presented early immune response and clinical data from the Phase 1 ADXS-NEO study...Preliminary direct ELISpot data showed that CD8+ T cell reactivity was generated in >90% of neoantigen pools from four patients so far treated (i.e., 1X 109 colony forming units (CFU) (n=2) and 1X108 CFU (n=2)) as well as antigen spreading...Findings from the first poster, 'Effects of ADXS-PSA With or Without Pembrolizumab on Survival and Antigen Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients (Results from KEYNOTE-046),' showed prolonged survival in prostate cancer patients with advanced and microsatellite-stable (MSS) disease..."

P1 data • P1/2 data

New immune data from ongoing ADXS-NEO phase 1 study support clinical potential for neoantigen-directed immunotherapies (Businesswire) - P1, N=2; "The new data were derived from deconvolution of neoantigen pools using single peptides and in vitro stimulation ELISpot assays (minimal CD8+ peptides). This has now been completed for the first two patients enrolled in this study, one with NSCLC and one with MSS-CRC...To date, dosing of ADXS-NEO at 1x108 colony forming units (CFU) has been well-tolerated in two patients. ADXS-NEO dosed at 1x109 CFU was beyond the maximum tolerated dose with reversible Grade 3 hypoxia (n=2) and Grade 3 hypotension (n=1) dose-limiting toxicities."

P1 data

Advaxis announces increasing focus on neoantigen-directed immunotherapies and closing of its phase 3 AIM2CERV study (PipelineReview) - “Advaxis, Inc….announced that it is increasing its focus on neoantigen-directed immunotherapies and closing the AIM2CERV Phase 3 clinical trial with axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer….the company plans to continue developing ADXS-NEO…and ADXS-HOT, currently in a Phase 1/2 clinical trial, for non-small cell lung cancer. The company anticipates advancing additional drug constructs from its ADXS-HOT program into the clinic over the next 18 months.”

Trial status