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.)

01 Jan 2023·Journal of Cancer

Current status and progress of the development of prostate cancer vaccines.

Review

Author: Wang, Jie ; Ma, Sai ; Zhu, Huihuang ; Li, Bingheng ; Wei, Fukun ; Zhou, Kaichen ; 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.

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 ; Tutrone, Ronald ; Haas, Naomi B ; Vangala, Surya

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 Jun 2019·Cancer treatment reviewsQ1 · MEDICINE

Emerging therapeutic targets for patients with advanced prostate cancer

Q1 · MEDICINE

Review

Author: Cho, Helen K ; Sharma, Shikhar ; Saad, Fred ; Jacobs, Ira A ; Zhang, Tian ; Shore, Neal

Although recent advances in the treatment of castration-resistant prostate cancer (CRPC) have significantly improved patient outcomes, advanced prostate cancer is still associated with substantial morbidity and mortality, particularly in patients who develop resistance after multiple lines of therapy. Various cell signaling, DNA repair, and epigenetic enzymatic pathways are being targeted with small-molecule inhibitors in order to identify treatment strategies for patients with CRPC. In this review, we discuss novel targets and agents, studied preclinically and now being validated in clinical trials, including poly ADP-ribose polymerase (PARP), enhancer of zeste homologue 2 (EZH2), hedgehog pathway, MDM2/p53, and tyrosine kinase inhibitors. Further, we outline current approaches for novel prostate cancer vaccines such as DCVAC/PCa, PROSTVAC-V/F, MVI-816, CV9104, and PF-06753512. This wide spectrum of potential treatment strategies holds promise for additional improvements in the treatment of patients with CRPC, as these novel agents are aimed at targets known to be associated with growth and malignant progression of prostate cancer. If primary study endpoints are met, findings from ongoing phase III trials of well-tolerated and active combinations may provide new effective treatment options for advanced prostate cancer and thereby contribute to enhanced disease control in CRPC patients.

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. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Metastatic Castration-Sensitive Prostate Cancer Market PARP Inhibitors for Metastatic Castration-Resistant Prostate Cancer Prostate Cancer Market Outlook Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. 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

14 Oct 2022

·www.nsmedicaldevices.com

Cleveland Diagnostics Announces Favorable Medicare Local Coverage Determination and Assignment of a CPT-PLA Code for IsoPSA

CGS Administrators, Inc., the Medicare Administrative Contractor with jurisdiction over Cleveland Diagnostics, issues final Local Coverage Decision (LCD) providing coverage of the IsoPSA prostate cancer test for Medicare beneficiaries nationwide Cleveland Diagnostics announces Favorable Medicare Local Coverage Determination and Assignment of a CPT-PLA Code for IsoPSA. (Credit: Tatiana from Pixabay) Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today two significant developments regarding the reimbursement of its novel non-invasive, blood-based prostate cancer test, IsoPSA. Medicare Administrative Contractor CGS Administrators, LLC (CGS) has issued a final Local Coverage Decision (LCD) providing favorable coverage for IsoPSA. IsoPSA will now be covered for the millions of men enrolled in Medicare nationwide and provide clearer information to patients and their doctors evaluating whether prostate biopsy is appropriate for them. Medicare covers 60 million men and women beneficiaries nationwide. The effective date for the LCD is November 20, 2022. The AMA has awarded a Proprietary Laboratory Analysis code (CPT-PLA) for IsoPSA, thus providing the mechanism for payment required by payors to uniquely track and reimburse Cleveland Diagnostics for IsoPSA. This CPT-PLA code (0359U) will be effective January 1, 2023. “We are very pleased to receive Medicare coverage and AMA coding for our IsoPSA test,” said Arnon Chait, PhD, Chief Executive Officer of Cleveland Diagnostics. “These coverage and coding determinations are highly significant for physicians and patients, as they will expand access to IsoPSA, a test with multiple clinical indications related to prostate cancer, enabling better informed treatment decisions.” Up to 75% of the prostate biopsies performed in the US are negative for high-grade disease, placing undue burdens on patients, clinicians, and the healthcare system. Unlike the current standard of care in prostate cancer testing, prostate-specific antigen (PSA), which measures merely the concentration of PSA circulating in the blood, IsoPSA interrogates structural variants of PSA, providing clinicians and patients with greater clarity in identifying men who would benefit from prostate biopsy and who would not. In large, prospective multicenter studies of men scheduled for biopsy, IsoPSA demonstrated superior diagnostic accuracy compared to PSA in identifying patients with high-grade cancer. A large real-world clinical utility study has also shown that IsoPSA can reduce the number of unnecessary prostate biopsies by up to 55%. Source: Company Press Release

Collaborate

13 Jul 2022

·endpts.com

Amazon joins Fred Hutch on clinical trial for personalized cancer vaccine — report

Amazon is partnering with the Fred Hutchinson Cancer Research Center on a Phase I trial for a cancer vaccine targeting metastatic melanoma and breast cancer. The clinical trial is part of Amazon’s Grand Challenge, a secretive lab the tech giant started in 2014 to work on cancer research among a number of other efforts, and was first reported in Business Insider . According to clinicaltrials.gov , the Phase I trial will test a tumor antigen vaccine therapy alongside nivolumab (Opdivo) in patients with metastatic and refractory late stage melanoma and HR+/HER2- breast cancer. The vaccine is personalized with a combination of each patient’s own tumor antigens, and the goal is to induce T cell activity against the tumors expressing those antigens. The early stage trial testing safety of the vaccine aims to enroll 20 patients. The idea of cancer vaccines has been floated around for years, but has never quite taken off. Provenge, a prostate cancer vaccine, was approved back in 2010 but struggled in the market, and its maker Dendreon filed for bankruptcy in 2014. (The company has since pivoted to offer contract manufacturing services.) Known for its Pfizer-partnered Covid vaccine, BioNTech has also seen middling results with its personalized cancer vaccine. However, that hasn’t slowed the biotech, as it continues to test an mRNA cancer vaccine partnership with Genentech and recently expanded its collaboration with Regeneron. Jeff Bezos himself has previously funded a number of other R&D efforts, most infamously in the anti-aging space. The billionaire is a backer of Altos Labs , an anti-aging play where Nobel laureates Jennifer Doudna and Shinya Yamanaka are involved. He is also a backer of Unity Biotechnology, which recently started a Phase II trial for a small molecule treatment for age-related macular degeneration. On its new partnership, Fred Hutch said in an emailed statement:

VaccineSmall molecular drugCollaboratemRNA

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

R&D Status

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Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02325557 (CTgov)	Phase 1/2	Metastatic castration-resistant prostate cancer	50	ADXS31-142+pembrolizumab	zjvpkudrka(ihiilvxaim) = snodriawnq kxrkrvvwed (tgdabjxbsb, aecgubxwjp - bxskqyorjl) View more	-	20 Feb 2024
NCT02325557 (KEYNOTE-046 (Part B), ASCO_GU2020)	Phase 1/2	Metastatic castration-resistant prostate cancer	37	ADXS-PSA + pembrolizumab	kzjfwuzseb(exrgfweeji) = eivxgzbvhp bnpqsezycu (qinlcexljy ) View more	Positive	19 Feb 2020
NCT02325557 (KEYNOTE-046, ASCO2018)	Phase 1/2	Metastatic castration-resistant prostate cancer	51	Pembrolizumab	jwlhrterxv(ogorqgnrls) = 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. iuqbuearhe (yarirttsqs )	Positive	01 Jun 2018

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