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.

开始日期2015-06-04

申办/合作机构

Advaxis, Inc.

[+1]

100 项与 Prostate cancer vaccine(Advaxis, Inc.) 相关的临床结果

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项与 Prostate cancer vaccine(Advaxis, Inc.) 相关的文献（医药）

2024-03-01·Vaccine

Primary cancer prevention for cancers with no known infectious etiology: Time for a new paradigm

Article

作者: Roach, Mack ; Rappuoli, Rino ; Black, Steven

Vaccines developed for hepatitis B and human papilloma virus infections have been very successful in reducing the burden of cancer due to these infections. In the past decade, our understanding of the immunology of cancer has greatly improved and important progress has been made in the use of immunotherapy for several cancers. However, for the majority of cancers, an infectious etiology is either unknown or does not exist. Prostate cancer, for which no infectious etiology is known, is the most common cancer in men in the United States. Here we discuss the rationale for developing a preventive vaccine for prostate cancer, discuss a possible approach for further work in this area and a means of testing the effectiveness of a prostate cancer prevention vaccine in a clinical trial.

2023-01-01·Journal of Cancer

Current status and progress of the development of prostate cancer vaccines

Review

作者: Wang, Jie ; Ma, Sai ; Zhu, Huihuang ; Li, Bingheng ; Zhou, Kaichen ; Wei, Fukun ; Mao, Lijun ; Kan, Yi

At present, common treatments of prostate cancer mainly include surgery, radiotherapy, chemotherapy and hormone therapy. However, patients have high recurrence rate after treatment, and are prone to castration-resistant prostate cancer. Tumor vaccine is based on tumor specific antigen (TSA) and tumor associated antigen (TAA) to activate specific immune response of the body to cancer cells. With continuous maturity of tumor vaccine technology, different forms of prostate cancer vaccines have been developed, such as cellular vaccines, extracellular-based anti-tumor vaccines, polypeptide vaccines, and nucleic acid vaccines. In this review, we summarize current status and progress in the development of prostate cancer vaccines.

2022-06-08·The oncologist2区 · 医学

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

2区 · 医学

Article

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

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.

项与 Prostate cancer vaccine(Advaxis, Inc.) 相关的新闻（医药）

2023-02-16

·PRNewswire

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

临床1期临床2期ASCO会议

2022-06-08

·GlobeNewswire-Health Care

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

财报免疫疗法ASCO会议

2011-08-11

·BioSpace

Advaxis, Inc. Completes Pre-IND Meeting for ADXS-PSA

PRINCETON, N.J--(BUSINESS WIRE)--Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has completed a pre-IND (Investigational New Drug) meeting with the FDA on August 10 to discuss the development plan for ADXS-PSA, a construct for the treatment of prostate cancer. The FDA addressed the company’s questions and provided guidance on the requirements to IND to initiate clinical trials. This IND is expected to be filed before the end of the year.

100 项与 Prostate cancer vaccine(Advaxis, Inc.) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床2期	美国	Advaxis, Inc.	2015-06-04

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02325557 (KEYNOTE-046 (Part B) \| KEYNOTE-046, CTgov)	临床1/2期	转移性去势抵抗性前列腺癌	50	ADXS31-142+pembrolizumab	憲窪襯窪蓋獵鏇製憲襯(淵餘齋憲窪積憲餘願淵) = 顧觸鑰繭夢衊網齋鑰顧願觸顧衊積鏇顧鬱鹹網 (夢蓋齋鹽鏇糧願壓淵淵, 觸醖構範齋廠壓憲醖蓋 ~ 壓範築襯獵願積餘窪構) 更多	-	2024-02-20
NCT02325557 (KEYNOTE-046 (Part B), ASCO_GU2020)	临床1/2期	转移性去势抵抗性前列腺癌	37	ADXS-PSA + pembrolizumab	鏇鬱願膚齋選糧願餘築(繭齋鹹憲蓋製糧鬱膚願) = 繭鹽膚選蓋蓋鑰構壓憲鏇壓鑰網廠廠鏇窪鏇願 (觸築壓鹹憲遞憲鏇淵築 ) 更多	积极	2020-02-19
NCT02325557 (KEYNOTE-046, ASCO2018)	临床1/2期	转移性去势抵抗性前列腺癌	51	Pembrolizumab	膚顧遞簾鬱壓憲衊糧範(醖遞鏇鑰夢襯範糧蓋糧) = 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. 艱醖廠顧築簾遞齋鏇膚 (憲築淵鹽膚鬱鬱鏇齋簾 )	积极	2018-06-01