A Phase 1-2 Dose-Escalation and Safety Study of ADXS31-142 Alone and of ADXS31-142 in Combination With Pembrolizumab (MK-3475) in Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer

A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 and pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer. Part A will be dose-determining part of ADXS31-142 monotherapy. Part B will be dose-determining part of ADXS31-142 and pembrolizumab (MK-3475) in combination. Part B expansion will treat additional participants with the recommended dose from Part B.

Start Date04 Jun 2015

Sponsor / Collaborator

Advaxis, Inc.

[+1]

100 Clinical Results associated with Prostate cancer vaccine(Advaxis, Inc.)

100 Translational Medicine associated with Prostate cancer vaccine(Advaxis, Inc.)

100 Patents (Medical) associated with Prostate cancer vaccine(Advaxis, Inc.)

Literatures (Medical) associated with Prostate cancer vaccine(Advaxis, Inc.)

08 Jun 2022·The oncologistQ2 · MEDICINE

ADXS31142 Immunotherapy ± Pembrolizumab Treatment for Metastatic Castration-Resistant Prostate Cancer: Open-Label Phase I/II KEYNOTE-046 Study

Q2 · MEDICINE

Article

Author: Fong, Lawrence ; Gutierrez, Andres A ; Stein, Mark N ; Lam, Elaine T ; Parsi, Megan ; Mega, Anthony ; Haas, Naomi B ; Vangala, Surya ; Tutrone, Ronald

Abstract:

Background:

ADXS31-142 is an attenuated Listeria monocytogenes-based immunotherapy targeting prostate-specific antigen (PSA), being evaluated as monotherapy and combined with pembrolizumab for metastatic castration-resistant prostate cancer (mCRPC).

Patients and Methods:

The 2-part phase I/II KEYNOTE-046 study enrolled men with mCRPC who have progressed after 2 or fewer prior systemic treatment regimens in the metastatic setting. In Part A, intravenous ADXS31-142 monotherapy was given every 3 weeks (q3w) to 3 dose-escalation cohorts. In Part B, ADXS31-142 (1 × 109 colony-forming units) plus pembrolizumab (200 mg) was administered intravenously q3w for 3 doses with a fourth pembrolizumab dose 3 weeks later (12-week cycles) for up to 24 months or until progression/toxicity. Endpoints included safety, overall response rate, progression-free survival (PFS), overall survival (OS), and immunogenicity.

Results:

Fifty patients received ADXS31-142 alone (n = 13) or with pembrolizumab (n = 37). Among the 37 RECIST-evaluable patients (n = 8 Part A; n = 29 Part B), there were no objective responses. Median PFS was 2.2 months (95% CI: 0.8-7.4) with monotherapy and 5.4 months (95% CI: 2.3-7.9) with the combination; median OS was 7.8 months (95% CI: 4.4-18.5) and 33.7 months (95% CI: 15.4–not evaluable), respectively. Promising OS benefit was observed in combination-treated patients who had received prior docetaxel (16.0 months, 95% CI: 6.4-34.6; n = 20) and those with visceral metastasis (16.4 months, 95% CI 4.0-not evaluable; n = 11). All patients had ≥1 treatment-related adverse event, mostly grade 1/2 manageable events. No additive toxicity was observed with combination treatment.

Conclusions:

Combining ADXS31-142 with pembrolizumab was safe and well tolerated. The observed OS in mCRPC warrants further testing of this combination.

Clinical Trial registration:

NCT02325557.

01 Dec 2012·Cancer immunology, immunotherapy : CIIQ2 · MEDICINE

Combined immunotherapy with Listeria monocytogenes-based PSA vaccine and radiation therapy leads to a therapeutic response in a murine model of prostate cancer

Q2 · MEDICINE

Article

Author: Chandan Guha ; Anu Wallecha ; Laibin Liu ; Huagang Zhang ; Patrice Cohen ; Raquibul Hannan ; Reshma Singh ; John Rothman ; Alan Alfieri

Radiation therapy (RT) is an integral part of prostate cancer treatment across all stages and risk groups. Immunotherapy using a live, attenuated, Listeria monocytogenes-based vaccines have been shown previously to be highly efficient in stimulating anti-tumor responses to impact on the growth of established tumors in different tumor models. Here, we evaluated the combination of RT and immunotherapy using Listeria monocytogenes-based vaccine (ADXS31-142) in a mouse model of prostate cancer. Mice bearing PSA-expressing TPSA23 tumor were divided to 5 groups receiving no treatment, ADXS31-142, RT (10 Gy), control Listeria vector and combination of ADXS31-142 and RT. Tumor growth curve was generated by measuring the tumor volume biweekly. Tumor tissue, spleen, and sera were harvested from each group for IFN-γ ELISpot, intracellular cytokine assay, tetramer analysis, and immunofluorescence staining. There was a significant tumor growth delay in mice that received combined ADXS31-142 and RT treatment as compared with mice of other cohorts and this combined treatment causes complete regression of their established tumors in 60 % of the mice. ELISpot and immunohistochemistry of CD8+ cytotoxic T Lymphocytes (CTL) showed a significant increase in IFN-γ production in mice with combined treatment. Tetramer analysis showed a fourfold and a greater than 16-fold increase in PSA-specific CTLs in animals receiving ADXS31-142 alone and combination treatment, respectively. A similar increase in infiltration of CTLs was observed in the tumor tissues. Combination therapy with RT and Listeria PSA vaccine causes significant tumor regression by augmenting PSA-specific immune response and it could serve as a potential treatment regimen for prostate cancer.

News (Medical) associated with Prostate cancer vaccine(Advaxis, Inc.)

16 Feb 2023

·www.prnewswire.com

DelveInsight Evaluates a Robust Prostate Cancer Pipeline as 170+ Influential Pharma Players to Set Foot in the Domain

Prostate cancer is the most common cancer in men and accounts for the second most cancer deaths among men globally. The rise in the number of cases of prostate cancer has led to growing government funding and rising initiatives by public and private organizations to spread awareness about prostate cancer. The emergence of strong pipeline drugs and the presence of novel prostate cancer treatments are the prominent factors that will escalate the growth rate of the prostate cancer therapeutics market. LAS VEGAS, Feb. 16, 2023 /PRNewswire/ -- DelveInsight's ' Prostate Cancer Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline prostate cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the prostate cancer pipeline domain. Key Takeaways from the Prostate Cancer Pipeline Report DelveInsight's prostate cancer pipeline report depicts a robust space with 170+ active players working to develop 200+ pipeline therapies for prostate cancer treatment. Key prostate cancer companies such as Merck & Co, Pfizer, Orion, Zenith Epigenetics, ESSA Pharma, RhoVac, AstraZeneca, Advaxis, Inc., Tracon Pharmaceuticals Inc., Bristol-Myers Squibb, Laekna Limited, Bracco Diagnostics, Inc, Arvinas Inc, Epizyme, Regeneron Pharmaceuticals, Veru Inc., Eli Lilly and Company, Exelixis, Luye Pharma Group, Amgen, Innocrin Pharmaceutical, Bayer, Nymox Pharmaceutical, Matrix Biomed, Tavanta Therapeutics, Fortis Therapeutics, Inc., Janssen Research & Development, LLC, Clarity Pharmaceuticals, Leap Therapeutics, Hinova pharmaceuticals, Vaccitech, Cardiff Oncology, Suzhou Kintor Pharmaceuticals, Teneobio, Inc., Janux Therapeutics, Fusion Pharmaceuticals, Corbus Pharmaceuticals, BioXcel Therapeutics, Onxeo S.A, Ayala Pharmaceuticals, HOOKIPA Pharma, Nuvation Bio, Ambrx, enGene, Jemincare, CellVax Therapeutics, POINT Biopharma, Oncternal Therapeutics, Immunic AG, BioNTech SE, and others are evaluating new prostate cancer drugs to improve the treatment landscape. Promising prostate cancer pipeline therapies in various stages of development include Pembrolizumab, Talazoparib, ODM-208, ZEN 3694, EPI-7386, RV 001, Adavosertib, Capivasertib, ADXS31-142, TRC253, Nivolumab, LAE001, BR55, ARV-110, Tazemetostat, REGN5678, VERU-111, Abemaciclib, Cabozantinib, LY01005, Tarlatamab, VT-464, BAY2315497, NX-1207, MBM-02, TAVT-45, FOR46, JNJ-78278343, 64Cu-SAR-bisPSMA, DKN-01, HC-1119, ChAdOx1-MVA 5T4, Onvansertib, GT0918, TNB-585, JANX007, 225Ac-PSMA I&T, CRB-701, BXCL701, AsiDNA, ADXS-504, HB-300, NUV-868, ARX517, JMKX002992, Zilovertamab, IMU-935, BNT112, and others. In February 2023, Fusion Pharmaceuticals announced the acquisition from RadioMedix, Inc. of the investigational new drug application for an ongoing Phase II clinical trial (the "TATCIST" trial) evaluating 225Ac-PSMA I&T, a small molecule targeting prostate-specific membrane antigen ("PSMA") expressed on prostate cancers. Following the closing, the alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial will be known as FPI-2265. In February 2023, Corbus Pharmaceuticals entered into an exclusive licensing agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited for development and commercialization of CRB-701 (SYS6002): a novel clinical-stage antibody drug conjugate (ADC) targeting Nectin-4. The agreement covers exclusive commercialization rights to CRB-701 in the United States, Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia. CSPC will retain all rights to SYS6002 in the remaining global markets. Clinical development is underway and will focus on urothelial cancer and other Nectin-4-positive solid tumors, potentially including lung, breast and prostate cancer. In February 2023, BioXcel Therapeutics, Inc.reported full data from its Phase IIa trial of BXCL701, the Company's investigational, oral innate immune activator, in combination with KEYTRUDA (pembrolizumab) in small cell neuroendocrine (SCNC) variant metastatic castration-resistant prostate cancer (mCRPC) patients after at least one prior line of chemotherapy for locally advanced or metastatic prostate cancer. Results will be presented in a rapid abstract presentation and a poster presentation at the 2023 American Society of Clinical Oncology Genitourinary Cancers (ASCO GU) Symposium on February 16, 2023. In January 2023, Onxeo S.A. gave an update on the clinical development program of its first-in-class drug candidate AsiDNA. Onxeo has activated its first US clinical study site, Next Oncology San Antonio. This phase I/II multicenter, basket trial intends to assess the safety and preliminary activity of AsiDNA in combination with olaparib in patients with recurrent ovarian, breast, and metastatic castration-resistant prostate cancer (mCRPC) who have progressed on previous PARP inhibitor therapy. In October 2022, Ayala Pharmaceuticals, Inc. and Advaxis, Inc. 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. In October 2022, Janux Therapeutics announced that the first patient had been dosed in Phase I clinical trial of JANX007 in subjects with metastatic castration-resistant prostate cancer (mCRPC). JANX007 is a prostate-specific membrane antigen (PSMA) directed T cell engager (TCE) and is the first product candidate utilizing Janux's TRACTr platform to be administered in humans. Request a sample and discover the recent advances in prostate cancer drug treatment @ Prostate Cancer Pipeline Report The prostate cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage prostate cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the prostate cancer clinical trial landscape. Prostate Cancer Overview Prostate cancer is a type of cancer that arises from the prostate gland. It is the second leading cause of cancer death in men in the United States. 1 in every 9 men will be diagnosed with prostate cancer during their lifetime. Prostate cancer will be diagnosed in nearly 250,000 men this year. Breaking away from a prostate tumor allows prostate cancer cells to spread. They can spread to other body parts by passing through blood vessels or lymph nodes. Cancer cells that have spread may attach to other tissues and grow to form new tumors, causing damage wherever they land. Prostate cancer symptoms vary from person to person. Some men have no symptoms at all. Common prostate cancer symptoms include blood in the urine or semen, painful ejaculation, pain or burning during urination, and others. A biopsy is a primary tool for prostate cancer diagnosis, but a doctor can use other tools to ensure that the biopsy is performed in the correct location. Doctors may, for example, use transrectal ultrasound or magnetic resonance imaging (MRI) to guide the biopsy. Find out more about drugs for prostate cancer @ New Prostate Cancer Drugs A snapshot of the Prostate Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging prostate cancer pipeline therapies @ Prostate Cancer Clinical Trials Prostate Cancer Therapeutics Assessment The prostate cancer pipeline report proffers an integral view of prostate cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Prostate Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Programmed cell death-1 receptor antagonists, Poly(ADP-ribose) polymerase inhibitors, Proto oncogene protein c-akt inhibitors, Tubulin inhibitors; Tubulin polymerisation inhibitors, Antioxidants; Blood coagulation factor inhibitors; Inflammation mediator inhibitors; RNA replicase inhibitors, Bromodomain and extraterminal domain protein inhibitors, Immunostimulants, DNA topoisomerase I inhibitors, Androgen receptor antagonists, Polycomb repressive complex 2 inhibitors Key Companies: Merck & Co, Pfizer, Orion, Zenith Epigenetics, ESSA Pharma, RhoVac, AstraZeneca, Advaxis, Inc., Tracon Pharmaceuticals Inc., Bristol-Myers Squibb, Laekna Limited, Bracco Diagnostics, Inc, Arvinas Inc, Epizyme, Regeneron Pharmaceuticals, Veru Inc., Eli Lilly and Company, Exelixis, Luye Pharma Group, Amgen, Innocrin Pharmaceutical, Bayer, Nymox Pharmaceutical, Matrix Biomed, Tavanta Therapeutics, Fortis Therapeutics, Inc., Janssen Research & Development, LLC, Clarity Pharmaceuticals, Leap Therapeutics, Hinova pharmaceuticals, Vaccitech, Cardiff Oncology, Suzhou Kintor Pharmaceuticals, Teneobio, Inc., Janux Therapeutics, Fusion Pharmaceuticals, Corbus Pharmaceuticals, BioXcel Therapeutics, Onxeo S.A, Ayala Pharmaceuticals, HOOKIPA Pharma, Nuvation Bio, Ambrx, enGene, Jemincare, CellVax Therapeutics, POINT Biopharma, Oncternal Therapeutics, Immunic AG, BioNTech SE, and others. Key Prostate Cancer Pipeline Therapies: Pembrolizumab, Talazoparib, ODM-208, ZEN 3694, EPI-7386, RV 001, Adavosertib, Capivasertib, ADXS31-142, TRC253, Nivolumab, LAE001, BR55, ARV-110, Tazemetostat, REGN5678, VERU-111, Abemaciclib, Cabozantinib, LY01005, Tarlatamab, VT-464, BAY2315497, NX-1207, MBM-02, TAVT-45, FOR46, JNJ-78278343, 64Cu-SAR-bisPSMA, DKN-01, HC-1119, ChAdOx1-MVA 5T4, Onvansertib, GT0918, TNB-585, JANX007, 225Ac-PSMA I&T, CRB-701, BXCL701, AsiDNA, ADXS-504, HB-300, NUV-868, ARX517, JMKX002992, Zilovertamab, IMU-935, BNT112, and others. Dive deep into rich insights for new drugs for prostate cancer treatment; visit @ Prostate Cancer Medications Table of Contents For further information on the prostate cancer pipeline therapeutics, reach out @ Prostate Cancer Drug Treatment Related Reports Metastatic Prostate Cancer Pipeline Metastatic Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key metastatic prostate cancer companies, including Veru, Tracon, Sotio, among others. Metastatic Castration-Sensitive Prostate Cancer Pipeline Metastatic Castration-Sensitive Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic castration-sensitive prostate cancer companies, including Merck, Pfizer, Veru, Tracon, Sotio, among others. Metastatic Hormone-Refractory Prostate Cancer Pipeline Metastatic Hormone-Refractory Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic hormone-refractory prostate cancer companies, including Merck, Pfizer, Veru, Tracon, Sotio, among others. Metastatic Castration-Resistant Prostate Cancer Epidemiology Forecast Metastatic Castration-Resistant Prostate Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the metastatic castration-resistant prostate cancer epidemiology trends. Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic castration-resistant prostate cancer companies including Zenith Epigenetics, Surface Oncology, Opna-IO LLC, Regeneron Pharmaceuticals, Veru Inc, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 1Phase 2ASCO

08 Jun 2022

·www.globenewswire.com

Advaxis Reports Second Quarter Ended April 30, 2022 Financial Results and Provides a Business Update

Announced Publication of ADXS-PSA Data in The Oncologist Presented Updated Clinical and Immunogenicity Data from Ongoing Phase 1/2 Trial of ADXS-503 in NSCLC at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting Presented study design of Phase 1 investigator-sponsor trial with ADXS-504 in biochemically recurrent prostate cancer at ASCO Announced 1-for-80 Reverse Stock Split MONMOUTH JUNCTION, N.J., June 08, 2022 (GLOBE NEWSWIRE) -- Advaxis, Inc. (OTCQX: ADXSD), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announces its financial results for the second quarter ended April 30, 2022 and provides a business update. Second Quarter Ended April 30, 2022 Financial Results and Recent Key Accomplishments: Announced publication of The KEYNOTE-046 study in The Oncologist reporting that ADXS-PSA in combination with KEYTRUDA® (pembrolizumab) is associated with prolonged overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC)Announced updated clinical and immunogenicity data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA® at the 2022 ASCO Annual Meeting in Chicago, IL In Part B, enrolling patients failing KEYTRUDA® as last therapy and receiving ADXS-503 + KEYTRUDA®, overall response rate (ORR) was 14% (2/14) and Disease Control Rate (DCR) was 36% (5/14)Long-term follow up suggests that patients who achieve durable clinical benefit upon addition of ADXS-503 to pembrolizumab include those with PD-L1 expression ≥50% and secondary resistance to KEYTRUDA®ADXS-503 has pleiotropic effects that may reverse the resistance and/or enhance the activity of KEYTRUDA® in patients with durable clinical benefit, including: the elevation of serum cytokines, the activation of Natural Killer (NK) cells, the proliferation and activation of exhausted CD8+ T-cells and the emergence of memory CD8+ T cells. In Part C, enrolling patients receiving ADXS-503 + KEYTRUDA® in the 1st-line metastatic setting, data continue to show a DCR of 67% (2/3) Announced study design for investigator-initiated trial with the second off-the-shelf, multi-neoantigen immunotherapy developed at Advaxis (ADXS-504) for biochemically recurrent prostate cancer at Columbia UniversityAnnounced 1-for-80 Reverse Stock Split The Company’s common stock will continue to trade on the OTCQX under the current symbol: “ADXS,” with a “D” placed on the ticker symbol for 20 business days after the splitThe new CUSIP number for the common stock following the Reverse Stock Split will be 007624406 Upcoming milestones Present additional clinical and immune correlative data from Phase 1/2 clinical trial of ADXS-503Present initial clinical and biomarker date from Phase 1 clinical trial of ADXS-504 Management Commentary Kenneth A. Berlin, President and Chief Executive Officer of Advaxis said, “We presented encouraging clinical results at ASCO which demonstrate the benefits that select patients are experiencing in our on-going phase 1/2 study of ADXS-503 with pembrolizumab both in the setting of failing pembrolizumab as last therapy and in the 1st-line metastatic setting. We look forward to the continuing the enrollment of patients in part B of the study with the goal of achieving the target 20% ORR and to the continued enrollment and advancement of our clinical trial of ADXS-504 in collaboration with researchers at Columbia University. In addition, we have completed the execution of the 1-for-80 reverse stock split which allows the company to pursue a return to listing on the NASDAQ.” Mr. Berlin added, “We continue to control our expenses and foresee our cash runway extending into the second fiscal quarter of 2024.” Second Quarter Ended April 30, 2022 Financial Results Research and development expenses for the second quarter of fiscal year 2022 were $1.5 million, compared with $4.3 million for the second quarter of fiscal year 2021. The reduction of $2.8 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued. General and administrative expenses for the three months ended April 30, 2022 were approximately $1.8 million, compared to $3.4 million in the same three-month period in 2021. The decrease of $1.6 million primarily relates to decreases in rent and utilities, personnel costs and consulting costs. As of April 30, 2022, the Company had approximately $32.1 million in cash and cash equivalents. About Advaxis, Inc. Advaxis, Inc. is a clinical-stage biotechnology company focused on the 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. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected clinical development of the Company’s drug product candidates, statements about the Company’s balance sheet position, and statements related to the goals, plans and expectations for the Company’s ongoing clinical studies. These and other risks are discussed in the Company’s filings with the SEC, including, without limitation, its Annual Report on Form 10-K for the year ended October 31, 2021, filed on February 14, 2022, and its subsequent periodic reports on Form 10-Q and Form 8-K. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA. Contact:Tim McCarthy, LifeSci Advisors, LLC212.915.2564tim@lifesciadvisors.com ADVAXIS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share data) April 30, 2022 October 31, 2021 (Unaudited) ASSETS Current assets: Cash and cash equivalents $32,085 $41,614 Prepaid expenses and other current assets 2,092 1,643 Total current assets 34,177 43,257 Property and equipment (net of accumulated depreciation) 84 118 Intangible assets (net of accumulated amortization) 3,220 3,354 Operating right-of-use asset (net of accumulated amortization) 26 40 Other assets 11 11 Total assets $37,518 $46,780 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $39 $87 Accrued expenses 1,738 2,836 Current portion of operating lease liability 27 28 Common stock warrant liability 563 4,929 Total current liabilities 2,367 7,880 Operating lease liability, net of current portion - 12 Total liabilities 2,367 7,892 Contingencies – Note 10 Series D convertible preferred stock- $0.001 par value; 1,000,000 shares authorized, issued and outstanding at April 30, 2022 and October 31, 2021. - - Stockholders’ equity: Series D convertible preferred stock- $0.001 par value; 0 shares authorized, 0 shares issued and outstanding at April 30, 2022 and October 31, 2021. - - Common stock - $0.001 par value; 170,000,000 shares authorized, 1,820,480 shares issued and outstanding at April 30, 2022 and October 31, 2021. 2 2 Additional paid-in capital 466,554 467,342 Accumulated deficit (431,405) (428,600)Total stockholders’ equity 35,151 38,888 Total liabilities and stockholders’ equity $37,518 $46,780 ADVAXIS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In thousands, except share and per share data) Three Months EndedApril 30, 2022 2021 Revenue 250 $1,375 Operating expenses: Research and development expenses 1,484 4,344 General and administrative expenses 1,768 3,352 Total operating expenses 3,252 7,696 Loss from operations (3,002) (6,321) Other income (expense): Interest income, net 6 2 Net changes in fair value of derivative liabilities 607 995 Other (expense) income (1) 217 Net loss before income taxes (2,390) (5,107) Income tax expense 50 - Net loss (2,440) $(5,107) Net loss per common share, basic and diluted (1.90) $(3.32) Weighted average number of common shares, basic and diluted 1,820,480 1,539,313

Financial StatementImmunotherapyASCO

06 Oct 2015

·www.biospace.com

Death Forces FDA to Place Clinical Hold on Advaxis Cancer Drug

October 7, 2015 By Alex Keown , BioSpace.com Breaking News Staff PRINCETON, N.J. – Following the death of a patient, the U.S. Food and Drug Administration (FDA) placed a hold on Advaxis ’s experimental cancer treatment axalimogene filolisbac, which is currently in mid-stage trials. In a statement issued this morning, Advaxis maintains the patient’s death was a result of the severity of her cancer and not due to the company’s experimental cancer treatment. It is seeking proof from the FDA that the drug was not a factor in the death. Still, the hold on the experimental cancer drug will cause the company to halt four clinical trials, Advaxis said. Other clinical trials, including those with the experimental ADXS-PSA and ADXS-HER2, are not affected by this hold. The company said it will continue to actively enroll and dose patients. The FDA placed a hold on the drug on Oct. 2 after the company submitted a safety report to the regulatory agency that week. The drug is being developed to treat patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy. Phase I trials released at the end of September showed treatment with axalimogene filolisbac resulted in a 38.5 percent 12-month overall survival rate in 26 patients. Patients typically fighting PRmCC who have failed at least one line of therapy have a typical survival rate of four to seven months. PRmCC is a cancer associated with the Human papillomaviruses. There are several HPV vaccines on the market, including Merck & Co. ’s Gardasil, the top selling HPV vaccine, which sells for about $113 a dose. Cervical cancer impacts about 500,000 women per year and about half of those cases are terminal, according to the U.S. Center for Disease Control . The World Health Organization has recommended universal use of vaccines against the virus. In a 2014 report, the World Health Organization (WHO) projected worldwide cancer cases will increase by 57 percent over the next 20 years, from roughly 14 million diagnoses in 2012 to approximately 22 million. Advaxis said the patient was diagnosed with end-stage cervical cancer who last received axalimogene filolisbac as part of an investigator-initiated trial in 2013. The patient was hospitalized in July 2015 and treated for Listeria monocytogenes. The cancer drug uses listeria to help trigger the body’s immune system to fight the cancerous cells. After a round of antibiotic treatment, the patient was discharged, Advaxis said. The patient was readmitted to the hospital in August 2015 with respiratory distress brought on by the cancer. The patient died that same day. Advaxis said investigations ruled the death was due to progression of her cervical cancer. Advaxis said it is working with the FDA ’s review and hopes the regulatory agency will quickly rule the drug did not play a part in the patient’s death. “ Advaxis expects that this clinical hold will be resolved expeditiously and without significant interruption to our HPV clinical development program,” the company said in a statement. If the FDA allows axalimogene filolisbac to move forward, it will eventually take aim at leading Human papillomaviruses (HPV), which can lead to cervical cancer.

VaccineClinical ResultPhase 1

100 Deals associated with Prostate cancer vaccine(Advaxis, Inc.)

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	United States	Advaxis, Inc.	04 Jun 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02325557 (KEYNOTE-046 (Part B) \| KEYNOTE-046, CTgov)	Phase 1/2	Metastatic castration-resistant prostate cancer	50	ADXS31-142+pembrolizumab	auongnvvfy = puikpahwrp wxyatpnohm (hsslamargn, mtneitaafv - lrbylzkjle) View more	-	20 Feb 2024
NCT02325557 (KEYNOTE-046 (Part B), ASCO_GU2020)	Phase 1/2	Metastatic castration-resistant prostate cancer	37	ADXS-PSA + pembrolizumab	hveywrtdte(darrdmireg) = hahbcgpboz axymnkdswv (vsywonasxg ) View more	Positive	19 Feb 2020
NCT02325557 (KEYNOTE-046, ASCO2018)	Phase 1/2	Metastatic castration-resistant prostate cancer	51	Pembrolizumab	psarqvhijo(usmvbuyudz) = 46 pts (94%) experienced treatment-related AEs (TRAE) with 16 pts having grade 3-4 events: fatigue, hypotension, hypertension, anemia. TRAEs ≥10% of any grade were cytokine release symptoms including chills, fever, nausea and hypotension. TRAE incidence was similar between groups and all resolved with supportive care. wrbwfnnzxt (jmvomouahp )	Positive	01 Jun 2018

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