ADXS-504 / Ayala Pharma, OS Therapies - LARVOL DELTA

Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Mark Stein | Trial completion date: Sep 2024 ➔ Sep 2026 | Trial primary completion date: Sep 2022 ➔ Sep 2024

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ayala Pharmaceuticals Announces Second Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Milestones:...Data from Phase 1 trial of ADXS-504: ADXS-504 is being evaluated in a Phase 1 investigator-sponsored study at Columbia University in patients with biochemically recurrent (early) prostate cancer. Readout of initial clinical and PSA data are expected in 2023."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ayala Pharmaceuticals Announces First Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Milestones:...Data from Phase 1 trial of ADXS-504: ADXS-504 is being evaluated in a Phase 1 investigator-sponsored study at Columbia University in patients with biochemically recurrent (early) prostate cancer. Readout of initial clinical and PSA data are expected in 2023."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of ADXS-504 Monotherapy to Enroll More Patients With Early Prostate Cancer (Targeted Oncology) - P1 | N=9 | NCT05077098 | Sponsor: Columbia University | "The phase 1 study evaluating ADXS-504 monotherapy (NCT05077098) for the treatment of early prostate cancer is expanding enrollment to include 6-9 more patients with early prostate cancer who will receive the second experimental dose level of the drug, announced Advaxis, Inc, in a press release."

P1 data

Advaxis Updates on the Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer (GlobeNewswire) - "Advaxis, Inc...announced an update on the Phase 1 clinical study evaluating ADXS-504, the company’s off-the-shelf neoantigen drug candidate, in patients with biochemically recurrent (early) prostate cancer that is being conducted at Columbia University Irving Medical Center....Patients have experienced mild and short-lived flu-like symptoms after the infusion of ADXS-504 at both the first and second dose levels. The trial is currently expanding enrollment at the second dose level by up to six additional patients for a total of nine patients. The study investigators will evaluate the immunogenicity data after all of the patients at the higher dose level have completed the study treatment."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

A phase I study of ADXS-504, a cancer type specific immunotherapy, for patients with biochemically recurrent prostate cancer. (ASCO 2022) - P1 | "Immunologic activity will be evaluated by ELISpot analysis, flow cytometry, and multiplex assays and blood samples will be collected for gene sequencing analysis. The study is currently open to enrollment."

Clinical • IO biomarker • P1 data • Genito-urinary Cancer • Immunology • Oncology • Prostate Cancer • Solid Tumor

Ayala Pharmaceuticals and Advaxis Enter into Merger Agreement (Advaxis, Inc Press Release) - "Ayala Pharmaceuticals...announced that they have entered into a definitive merger agreement. The merger would result in a combined company that will focus predominantly on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors and Advaxis’s candidate ADXS-504 in development for prostate cancer....we believe we have the cash to advance the combined portfolio through key milestones in 2023, including longer-term data from Part A of RINGSIDE, clarity on the registration path for AL101 in recurrent/metastatic adenoid cystic carcinoma (ACC) and initial clinical and PSA data from the Phase 1 trial of ADXS-504 in prostate cancer."

M&A • P2/3 data • Desmoid Tumors • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Advaxis and Ayala Pharmaceuticals Enter into Merger Agreement (GlobeNewswire) - "Ayala Pharmaceuticals, Inc....and Advaxis, Inc....announced that they have entered into a definitive merger agreement. The merger would result in a combined company that will focus predominantly on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors and Advaxis’s candidate ADXS-504 in development for prostate cancer....'We believe we have the cash to advance the combined portfolio through key milestones in 2023, including longer-term data from Part A of RINGSIDE, clarity on the registration path for AL101 in recurrent/metastatic adenoid cystic carcinoma (ACC) and initial clinical and PSA data from the Phase 1 trial of ADXS-504 in prostate cancer'...Upon completion of the merger, Ayala stockholders will own approximately 62.5% of the combined company’s outstanding common stock and Advaxis stockholders will own approximately 37.5%, subject to the terms of the merger agreement."

M&A • P1 data • P2 data • Adenoid Cystic Carcinoma • Genito-urinary Cancer • Oncology • Prostate Cancer

Advaxis Updates on the Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer (GlobeNewswire) - "Advaxis, Inc...today announced an update on the Phase 1 clinical study evaluating ADXS-504, the company’s off-the-shelf neoantigen drug candidate, in patients with biochemically recurrent (early) prostate cancer that is being conducted at Columbia University Irving Medical Center."

P1 data

Advaxis Updates on the Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer (GlobeNewswire) - "Advaxis, Inc...announced an update on the Phase 1 clinical study evaluating ADXS-504, the company’s off-the-shelf neoantigen drug candidate, in patients with biochemically recurrent (early) prostate cancer that is being conducted at Columbia University Irving Medical Center....The Phase 1 open-label dose escalation study completed evaluation of the safety and tolerability of the first dose level (DL-1 1e7 CFU) and has initiated enrollment of the second dose level cohort (DL-2 1e8 CFU)...The preliminary clinical assessment of patients at the first dose level has shown that ADXS-504 monotherapy is safe and well tolerated. Clinical and immunogenicity data, including PSA values, for patients in both cohorts will be presented at a future medical conference."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

Advaxis to Present Updated Clinical and Immunogenicity Data from Ongoing Phase 1/2 Trial of ADXS-503 in Metastatic Non-Small-Cell Lung Cancer (NSCLC) and Study Design of ADXS-504 Trial in Early Prostate Cancer at the American Society of Clinical Oncology (Yahoo Finance) - P1/2 | N=74 | NCT03847519 | Sponsor: Advaxis, Inc. | "These results from the clinical study ADXS-503-101 evaluating the ADXS-503 construct, which is designed to target certain cancers’ commonly occurring hotspot mutations and other tumor-associated antigens, will be presented at the ASCO Annual Meeting to be held on June 4-7, 2022, along with the trial design of the study of the second construct from the ADXS-HOT program, ADXS-504....Overall response rate (ORR) was 14% (2/14) and Disease Control Rate (DCR) was 36% (5/14); Two durable partial responses (PR) sustained for over 9 months and 21 months, respectively; Three durable cases of stable disease (SD) lasting for over 3, 5 and 14 months, respectively."

Clinical protocol • P1/2 data • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Thoracic Cancer • Urothelial Cancer

Advaxis to Present at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting (GlobeNewswire) - "Advaxis...announced that it will present data from the Phase 2 study of ADXS-503 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer and data from the Phase 1 study of ADXS-504 in patients with biochemically recurrent prostate cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually, on June 3-7, 2022."

P1 data • P2 data • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Thoracic Cancer • Urothelial Cancer

Advaxis Reports Fiscal Year 2021 Financial Results and Provides a Business Update (GlobeNewswire) - "...'Major milestones for the ADXS-503 trial in the second half of 2022 include updated clinical and immunogenicity data for all patients in Stage 1 in Part B and from up to 10 patients in Part C. Also, initial clinical and immunogenicity data from the ADXS-504 trial in early prostate cancer are expected to be reported in the second half of this year'."

P1 data • P1/2 data • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer (clinicaltrials.gov) - P1; N=21; Recruiting; Sponsor: Mark Stein

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Advaxis Reports 3rd Quarter Ended July 31, 2021 Financial Results and Provides a Business Update (GlobeNewswire) - “The combined company anticipates the following milestones across the combined pipeline over the next 12-18 months…Initiated Phase 1 clinical trial of ADXS-504 being conducted at Columbia University Irving Medical Center for the treatment of biochemically recurrent prostate cancer, expanding the off-the-shelf ADXS-HOT program to a second indication…Research and development expenses for the third quarter of fiscal year 2021 were $1.70 million, compared with $3.46 million for the third quarter of fiscal year 2020. The decrease of $1.76 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued.”

Commercial • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer

Advaxis Announces Initiation of Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer (GlobeNewswire) - "Advaxis....announced the initiation of its Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, being conducted at Columbia University Irving Medical Center, is the first clinical evaluation of ADXS-504, Advaxis’ off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer....The Phase 1 open-label dose escalation study will evaluate the safety and tolerability of two dose levels (1e7 and 1e8 CFU) of ADXS-504 monotherapy, administered via infusion every four weeks for six total doses in 9-18 patients with biochemically recurrent prostate cancer..."

New P1 trial • Oncology • Prostate Cancer

Advaxis and Biosight Announce Entry into Definitive Merger Agreement (GlobeNewswire) - “The combined company plans to advance its pipeline through multiple clinical trials, and anticipates the following milestones over the next 12-18 months: Topline results from the ongoing Phase 2 trial of aspacytarabine, which has completed enrolment, as first-line therapy in AML patients who are unfit for standard chemotherapy; Results from the Phase 2 trial of aspacytarabine in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM) in patients with relapsed/refractory AML and higher-risk Myelodysplastic Syndrome (MDS); Initiation in the U.S. of a second, Phase 2 trial of aspacytarabine in patients with relapsed/refractory AML and higher-risk MDS; Results from the ongoing Phase 1/2 trial with ADXS-503 in combination with pembrolizumab in non-small cell lung cancer; and Results from the Phase 1 trial of ADXS-504 in biochemically recurrent prostate cancer.”

Clinical data • New P2 trial • Acute Myelogenous Leukemia • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Prostate Cancer

Off-the-Shelf Immunotherapy ADXS-504 Under Evaluation in Biochemically Recurrent Prostate Cancer (OncLive) - "'Currently, men with biochemically recurrent prostate cancer are either monitored for a period of time without intervention or may be started on medicine to decrease the level of testosterone in the body, which can have significant adverse effects,' Mark Stein, MD...stated in a press release. 'Therefore, we need new approaches to stimulate the body's immune system to control the prostate cancer...We are excited to have the opportunity to explore the potential of ADXS-504 immunotherapy as a novel treatment modality for biochemically recurrent prostate cancer.'"

Media quote

Advaxis Announces Receipt of Second Milestone Payment Under ADXS-HER2 Licensing Agreement with OS Therapies (GlobeNewswire) - "Advaxis...announced that the Company has received the second milestone payment related to its licensing agreement for ADXS31-164, also known as ADXS-HER2, to OS Therapies for evaluation in the treatment of osteosarcoma in humans....'This funding milestone for OS Therapies brings OST-HER2, originally ADXS-HER2, one step closer to the clinic,' said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis....'We look forward to leveraging these resources as we advance ADXS-503, currently being evaluated in our Phase 1/2 study in NSCLC, and ADXS-504 for early-stage prostate cancer, which is on-track to enter the clinic in Q2 2021.'"

Licensing / partnership • New trial • Genito-urinary Cancer • Oncology • Osteosarcoma • Prostate Cancer • Sarcoma

Advaxis Announces Agreement with Columbia University Irving Medical Center to Fund Phase 1 Study of ADXS-504 for the Treatment of Early Prostate Cancer (GlobeNewswire) - “Advaxis, Inc…announced an agreement with Columbia University Irving Medical Center to fund a Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, expected to begin in Q2 2021, will be the first clinical evaluation of ADXS-504, Advaxis’ off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer.”

Licensing / partnership • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer

Advaxis Reports First Quarter Ended January 31, 2021 Financial Results and Provides a Business Update (GlobeNewswire) - "'We are encouraged by the growing body of evidence that suggest ADXS-503 has the potential to synergistically enhance and/or restore sensitivity to checkpoint inhibitors...Based on our encouraging data, we are prioritizing the ongoing and recently expanded ADXS-503 trial in diverse treatment settings for NSCLC....Our strengthened balance sheet leaves us well positioned to continue progress with our off-the-shelf neoantigen immunotherapy ADXS-HOT program, including our planned expansion into prostate cancer with ADXS-504, and we look forward to providing study updates in the coming months.'...Research and development expenses for the first quarter of fiscal year 2021 were $2.6 million, compared with $4.9 million for the first quarter of fiscal year 2020."

Clinical • Commercial • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer

Advaxis Announces FDA Clearance of New IND for ADXS-504 for Treatment of Prostate Cancer (GlobeNewswire) - “Advaxis, Inc…announced the U.S. Food and Drug Administration (FDA) has cleared a new Investigational New Drug (IND) application for the initiation of an Investigator Sponsored Phase 1 clinical study of ADXS-504, the Company’s off-the-shelf neoantigen ADXS-HOT candidate for prostate cancer. This new IND is in addition to the Advaxis sponsored IND, previously announced in January 2020. Advaxis intends to first advance the clinical evaluation of ADXS-504 through an Investigator Sponsored Phase 1 study in prostate cancer patients with biochemical recurrence which remains on-track for initiation in the fourth quarter this year.”

IND • Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Cancer

Phase update (GlobeNewswire) - Preclinical➔P1, Prostate Cancer

Phase shift • Prostate Cancer

Advaxis reports second quarter ended April 30, 2020 financial results and provides a business update (GlobeNewswire) - '"...we are expanding Part B, dose level 1, to enroll up to an additional 15 patients who have progressed on KEYTRUDA® to further characterize the clinical activity of ADXS-503 in combination with KEYTRUDA®…In addition, we have opened enrollment in Part C to evaluate ADXS-503 in combination with KEYTRUDA® as a first line treatment for patients with metastatic NSCLC….We look forward to continued execution and the expansion of our HOT program to new indications including our planned Phase 1 study of ADXS-504 in prostate cancer patients with biochemical recurrence which we expect to enter the clinic by the end of this year."'

Enrollment status • New P1 trial • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer

Advaxis reports first quarter ended january 31, 2020 financial results and provides a pipeline update (GlobeNewswire) - "''We have started our fiscal year with encouraging positive data presented in our ADXS-PSA and ADXS-503 clinical programs...We continue to execute on our HOT off-the-shelf program in NSCLC with enrollment continuing in the combination arm of the study, Part B, and a planned initiation of Part C which will move combination therapy to a first-line setting, later this year. We are also planning to move an additional HOT construct, ADXS-504, for prostate cancer, into the clinic later this year'....'We are currently evaluating next steps for our ADXS-PSA program based on the promising increases in median overall survival observed in combination with KEYTRUDA.'"

Enrollment status • New trial • Trial status