A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.

Start Date05 Aug 2021

Sponsor / Collaborator

Providence Health & Services

NCT02737475 / CompletedPhase 1/2

A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors

The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in participants with solid cancers that are advanced or have spread.

Start Date17 Jun 2016

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT02234921 / CompletedPhase 1

A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer

This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.

Start Date24 Oct 2014

Sponsor / Collaborator

UbiVac, Inc.

[+3]

100 Clinical Results associated with Autophagosome vaccine(UbiVac LLC)

100 Translational Medicine associated with Autophagosome vaccine(UbiVac LLC)

100 Patents (Medical) associated with Autophagosome vaccine(UbiVac LLC)

Literatures (Medical) associated with Autophagosome vaccine(UbiVac LLC)

01 Jan 2024·Neoplasma

Tumor-derived autophagosome vaccines combined with immune adjuvants mediate antitumor immune responses via the neoantigen pathway

Article

Author: Chen, Yutong ; Yuan, Jia ; Chang, Yue ; Yue, Rongbin ; Dai, Yalan ; Zeng, Linjuan

Vaccines composed of autophagosomes derived from tumor cells called DRibbles (DRiPs-containing blebs) are involved in the cross-presentation of tumor antigens, thus inducing cross-reactive T-cell responses against the tumor. Compared with traditional tumor lysate vaccines, autophagosome vaccines were found to be better sources of multiple tumor-associated antigens (TAAs) that activate antigen-specific T-cells. However, the involvement of tumor neoantigens in the immune responses of autophagosome vaccines remains unclear. The present study showed that exogenous autophagosome vaccines (DRibbles) combined with immune adjuvants (anti-OX40 antibody and ATP) can effectively activate functional T cells in vitro. Importantly, the combination of exogenous tumor-derived autophagosome vaccines and immune adjuvants was found to induce tumor regression in B16F10 and 4T1 tumor-bearing mice. The combination of autophagosome-enriched DRibbles with anti-OX40 antibody and ATP also exhibited optimal immune stimulation and antitumor efficiency in vivo. The effectiveness of exogenous DRibble vaccines was mainly due to their enhancement of tumor immunogenicity by increasing the presentation and release of tumor neoantigens. These findings suggest that this immunotherapeutic method may be effective in the treatment of cancer.

01 Feb 2021·Cancer immunology, immunotherapy : CIIQ2 · MEDICINE

Tumor cell-derived autophagosomes (DRibbles)-activated B cells induce specific naïve CD8+ T cell response and exhibit antitumor effect

Q2 · MEDICINE

Article

Author: Dong, Hui-Xia ; Wang, Xu-Ru ; Pan, Ning ; Wen, Zhi-Fa ; Ren, Hong-Yan ; Zhao, Si-Min ; Zhang, Tian-Yu ; Wang, Li-Xin

Dendritic cell (DC) vaccine has been proved to be an effective way in cancer immunotherapy in both preclinical and clinical studies. However, limitations in DC isolation and culture have hampered its practice and promoted the development of other antigen-presenting cells (APCs) sources to fulfill that role. Our previous studies have shown that B cells loaded by tumor cell-derived autophagosomes, which we named as DRibbles (defective ribosomal products-containing blebs), could reactivate DC-induced effector T cell response. In this study, the roles of DRibble-loaded B cells in priming naïve CD8⁺ T cell responses and controlling tumors were investigated. We found that high-mobility group box 1 protein (HMGB1) on DRibbles was involved in DRibble-induced B cell activation, and the DRibble-triggered B cell phagocytosis via the caveolae-mediated endocytosis pathway. By using OT-I mouse-derived T cells, we demonstrated that DRibble-loaded B cells could activate specific naïve CD8⁺ T cells in vitro and ex vivo. In a tumor-bearing mouse model, DRibble-loaded B cells elicited systemic antitumor immunity and significantly suppressed the tumor growth. Moreover, the antitumor efficacy of DRibble-loaded B cells was enhanced when they were combined with CpG and anti-CD40 stimulation. These results suggest that DRibble-loaded B cells represent a viable and practical therapeutic vaccination strategy that might have important clinical implications for tumor immunotherapy.

01 Dec 2017·Journal for immunotherapy of cancerQ2 · MEDICINE

A pilot study of an autologous tumor-derived autophagosome vaccine with docetaxel in patients with stage IV non-small cell lung cancer

Q2 · MEDICINE

ArticleOA

Author: Fox, Bernard A ; Aung, Sandra ; Paustian, Christopher ; Urba, Walter J ; Coffey, Todd ; Ross, Helen J ; Neuberger, Michael ; Fisher, Brenda ; Hu, Hong-Ming ; Acheson, Anupama ; Moudgil, Tarsem ; Hilton, Traci ; Walker, Edwin ; Sanborn, Rachel E ; Puri, Sachin

BACKGROUND:

Tumor-derived autophagosome vaccines (DRibbles) have the potential to broaden immune response to poorly immunogenic tumors.

METHODS:

Autologous vaccine generated from tumor cells harvested from pleural effusions was administered to patients with advanced NSCLC with the objectives of assessing safety and immune response. Four patients were vaccinated and evaluable for immune response; each received two to four doses of vaccine. Study therapy included two cycles of docetaxel 75 mg/m² on days 1 and 29 to treat the tumor, release hidden antigens and produce lymphopenia. DRibbles were to be administered intradermally on days 14, 43, 57, 71, and 85, together with GM-CSF (50 μg/d x 6d, administered via SQ mini pump). Peripheral blood was tested for immune parameters at baseline and at each vaccination.

RESULTS:

Three of four patients had tumor cells available for testing. Autologous tumor-specific immune response was seen in two of the three, manifested by IL-5 (1 patient after 3 doses), and IFN-γ, TNF-α, IL-5, IL-10 (after 4 doses in one patient). All 4 patients had evidence of specific antibody responses against potential tumor antigens. All patients came off study after 4 or fewer vaccine treatments due to progression of disease. No significant immune toxicities were seen during the course of the study.

CONCLUSIONS:

DRibble vaccine given with GM-CSF appeared safe and capable of inducing an immune response against tumor cells in this small, pilot study. There was no evidence of efficacy in this small poor-prognosis patient population, with treatment not feasible. Trial registration NCT00850785, initial registration date February 23, 2009.

News (Medical) associated with Autophagosome vaccine(UbiVac LLC)

27 Jun 2023

·www.prnewswire.com

Global Cancer Vaccine Industry Worth $13.4 Billion by 2030: Use of Nanosensors in Diagnosing Cancer Expected to Create Ample Opportunities for Key Players

DUBLIN, June 27, 2023 /PRNewswire/ -- The "Cancer Vaccine Markets, 2023-2030." report has been added to ResearchAndMarkets.com's offering. The global cancer vaccine market was valued at USD 5.75 billion in 2022, and is predicted to reach USD 13.4 billion by 2030, with a CAGR of 10.7% during the forecast period, 2023 to 2030. Growth in incidences of cancer across the globe, owing to high consumption of tobacco and alcohol, along with an unhealthy diet and infections is expected to fuel the cancer vaccine market growth. However, longer timelines hinder growth of the market. On the contrary, use of nanosensors in diagnosing cancer, which include oral fluid nanosensor test (OFNASET), is expected to create ample opportunities for key players operating in the market. Market Dynamics Drivers Increase in the Prevalence of Cancer Across the Globe Growing Government, and International Organization Initiatives to Eliminate Cancer Restraints Longer Timeline Process and High Cost Opportunities Technological Advancement in Healthcare Sectors Segment Overview The global cancer vaccine market is segmented on the basis of technology, type, disease indication, end-user, and region. By technology, the market is classified into dendritic cells, recombinant vaccines, antigen/adjuvant vaccines, whole cell vaccines, and viral & DNA vaccines. By type, the market is segmented into preventive vaccines and therapeutic vaccines. By disease indication, the market is categorized into cervical cancer, prostate cancer, and others. By end-user, the market is divided into pediatrics and adults. Region wise, the market is segmented into North America, Europe, Asia-Pacific, and RoW. Regional Analysis North America estimated to hold a dominant share of the market North America dominates the cancer vaccine market and is potently expected to remain dominant throughout the forecast period. Rise in awareness regarding health among educated population has led to early diagnosis of cancer, which boosts the market growth. For instance, the Government of Canada announced that around 27,400 women were diagnosed with breast cancer in 2020. This early detection of cancer helps women to undergo treatment at the early stage, which, in turn, propels the market growth. Growth in R&D in the region, owing to collaboration among well-known big tech companies and cancer research centers for developing cancer vaccines further propel the market growth. For instance, in July 2022, Amazon collaborated with Fred Hutchinson Cancer Research Center to develop cancer vaccines for breast cancer and melanoma. Fred Hutch received permission from the U.S. Food and Drug Administration to proceed with a Phase I clinical trial. Amazon contributed scientific and machine learning expertise to a partnership with Fred Hutch to explore development of personalized treatment for certain forms of cancer. Key Market Players Emerging and efficient key players in the cancer vaccine market research include companies such as: GlaxoSmithKline PLC UbiVac, Inc. Biontech, Dendreon Pharmaceuticals, Inc. Dynavax Technologies Corporation Merck & Co. Inc. Imugene Limited Moderna, Inc. Northwest Biotherapeutics, Inc. Oxford Vacmedix Recent Developments August 2022 Merck joined hands with Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA (oRNA) therapies. The agreement will help in discovering, developing, and commercializing multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology. May 2022 Imugene Limited and City of Hope, one of the largest cancer research and treatment organizations in the United States, announced Phase 1 clinical trial to evaluate safety of novel cancer-killing virus CF33-hNIS VAXINIA. It is used in people with advanced solid tumors. June 2022 GlaxoSmithKline plc acquired Sierra Oncology, Inc., to develop targeted therapies for treatment of rare forms of cancer that includes Myelofibrosis. This acquisition aims at the development of vaccines and medicines. January 2022 Dynavax Technologies Corporation announced that Shingles vaccine is in initiation Phase 1 clinical trials. This vaccine is helpful in treating a herpes zoster virus, along with undergoing treatment for cancer patients. It treats cancer patients that are at the risk of developing shingles. June 2020 UbiVac collaborated with Bristol Myers Squibb to evaluate the tolerability, safety, and preliminary efficacy of DPV-001. DPV-001 is a cancer vaccine that instructs immune system to destroy cancer cells. Report Scope: Key Benefits The cancer vaccine market report provides quantitative analysis of the current market and estimations from 2023 to 2030, which assists in identifying the prevailing market opportunities. The study comprises a deep dive analysis of the cancer vaccine market including current and future trends to depict prevalent investment pockets in the market. Information related to key drivers, restraints, and opportunities and their impact on the cancer vaccine market is provided in the report. Competitive analysis of the market players, along with their market share in the cancer vaccine market is provided in the report. SWOT analysis and Porters Five Forces model is elaborated in the study. Value chain analysis in the market study provides a clear picture of role of stakeholders. Key Topics Covered 1. Introduction 2. Cancer Vaccine Market- Executive Summary 3. Market Overview 4. Market Share Analysis 5. Global Cancer Vaccine Market, by Technology 6. Global Cancer Vaccine Market, by Type 7. Global Cancer Vaccine Market, by Indication 8. Global Cancer Vaccine Market, by End-use 9. Global Cancer Vaccine Market, by Region 10. Company Profiles For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

VaccinePhase 1AcquisitionmRNA

29 Oct 2020

·www.ubivac.com

FDA Grants Approval for UbiVac Manufactured Coronavirus Vaccine to Start Clinical Trial

Providence St. Joseph Health, one of the national’s leading non-profit health systems, and the Providence Cancer Institute to run Phase 1 clinical trial Date: October 29, 2020 PORTLAND, OREGON, UNITED STATES, October 29, 2020 -- UbiVac Inc., a clinical stage immunotherapy company, is pleased to announce that the FDA has granted approval to commence clinical trials of the CorVax vaccine. UbiVac in collaboration with Providence Cancer Institute, a part of Providence St. Joseph Health ("Providence") and OncoSec Medical Incorporated (NASDAQ:ONCS, "OncoSec") developed this vaccine to help prevent the spread of coronavirus. For their part, UbiVac manufactured and tested the SARS-CoV-2 drug product. The trial will evaluate safety and efficacy of the vaccine to induce an immune response against the SARS-CoV-2 spike protein. “We are thrilled to bring UbiVac’s experience with complex biologics manufacturing and immunotherapy development to help address the threat posed by SARS-CoV-2” said Bernard A. Fox, III, Cofounder and COO at UbiVac. There is a great unknown with current vaccine strategies for COVID-19: Will they work in the older population and will immunity be durable? According to the World Health Organization there are 17 vaccine trials ongoing in the USA and 44 in the world. The majority of these trials are what UbiVac considers to be trials using “standard” first generation viral vaccine approaches. Unfortunately, natural infection-induced immunity to coronavirus infection appears to be of limited duration and we won’t know until late 2021 how effective the “standard” first generation vaccines currently being developed will be at protecting the older population. For these reasons, UbiVac in collaboration with colleagues at Providence and OncoSec moved forward to test a vaccine with DNA encoding both the SARS-CoV-2 spike and interleukin-12 (IL-12). This combination of DNA encoding SARS-CoV-2 spike and interleukin-12 (IL-12) is what UbiVac considers to be a second-generation vaccine for COVID-19. Preclinical studies from the Earle A. Chiles Research Institute have shown that adding IL-12 can augment the immune response of older subjects. Additionally, OncoSec had already developed, tested and demonstrated the safety of administering IL-12 plasmid in humans and preclinical studies evaluating the effectiveness of this combination immunotherapy to induce an immune response to SARS-CoV-2 will be presented by Dr. Shawn M. Jensen at the 35th Annual meeting of the Society for Immunotherapy of Cancer (SITC). In addition to safety, this clinical trial will evaluate whether older participants receiving DNA encoding both spike and IL-12 will generate a stronger and more durable immune response than participants receiving DNA for spike alone. A third-generation vaccine for COVID-19 is already in the works, and UbiVac is applying lessons learned from 30+ years of cancer vaccine research and development. In collaboration with UbiVac’s Cofounders at the Earle A. Chiles Research Institute, UbiVac is working to support the development and manufacture of microvesicle and virus-like particle vaccines for COVID-19 that take advantage of combination immunotherapy strategies. UbiVac is backing a proposal from the Earle A. Chiles Research Institute to the NIH that would support early testing of this third generation vaccine strategy for COVID-19. Successful testing of these vaccines for COVID-19 could also provide a platform for rapid development of virus-like particle vaccines for other infectious agents. “As with everything, it was a team effort” said Bernard A. Fox, PhD, Cofounder and CEO at UbiVac and Harder Family Chair for Cancer Research at the Earle A. Chiles Research Institute, a part of the Providence Cancer Institute. “This collaboration was built on the scientific knowledge, clinical experience, and regulatory understanding, of UbiVac, OncoSec and our partners at Providence. Without the dedicated clinical trials and research support teams at Providence and philanthropic support of the Portland area community, this trial would not have been possible.” About UbiVac UbiVac is a privately held, clinical stage immunotherapy company engaged in the research and development of therapeutic vaccines to combat cancer. With innovative, first-in-class platform technology that couples an off-the-shelf DC-targeted cancer vaccine with more than 100 cancer antigens for most adenocarcinomas and squamous cell cancers, plus multiple TLR/NOD agonists and DAMPs that are effective at inducing anti-cancer immune responses. UbiVac believes that DPV-001 is highly complementary to current and developing immunotherapy, chemotherapy and small molecule drug portfolios. UbiVac also has a pipeline of vaccines under development to prevent cancer in patients at high risk of developing disease and for those that have failed to respond to anti-PD-1/anti-PD-L1. Since mid-March of 2020 UbiVac has redirected substantial resources to address the pandemic caused by SARS-CoV-2. UbiVac has manufactured a vaccine for the second generation phase I trial announced here and has rushed to develop third generation vaccines in collaboration with our academic partners. In June 2020 UbiVac announced a collaboration with Bristol Myers Squibb to perform a triplet immunotherapy for advanced triple negative breast cancer utilizing DPV-001, UbiVac's lead agent. Founded by Dr. Bernard A. Fox, Dr. Hong-Ming Hu, and Mr. Bernard A. Fox, III, in Portland, Oregon in 2005, UbiVac is a spinout of the Robert W. Franz Cancer Center, Earle A. Chiles Research Institute at Providence Portland Medical Center. UbiVac Raising Equity Funding To further the research and clinical development of its DRibble Platform Vaccine technology and its third generation vaccines for COVID-19, UbiVac is currently raising equity funding from accredited investors. More information about the offering can be found at www.ubivac.com/investors. UbiVac Press@UbiVac.com Visit us on social media: Facebook Twitter LinkedIn There is a new paradigm for combating cancer at https://www.youtube.com/watch?v=7GTKYbP5fEA

VaccineImmunotherapyPhase 1

18 Oct 2020

·www.ubivac.com

Dr Bernard Fox Joins CCFDIE Immunotherapy Workshop to Talk UbiVac's Combination Immunotherapy for Advanced Breast Cancer

China Center for Food and Drug International Exchange hosts International Immunotherapy Experts to Discuss State-of-Art and Future Treatments for Cancer Date: October 17, 2020 BEIJING, CHINA, -- UbiVac Inc’s co-founder and CEO, Bernard A. Fox, PhD, joined luminaries and regulatory experts to present work from UbiVac and colleagues at the Chiles Research Institute, during the opening session of the China Center for Food and Drug International Exchange (CCFDIE) Cancer Immunotherapy Workshop held 16-17 October in Beijing, China. Other speakers that joined Dr. Fox in the session included Dr. Steven A. Rosenberg, Surgery Branch, NCI, NIH; Dr. Lieping Chen, Yale School of Medicine; Dr Ke Liu, CBER, FDA,; Dr. Janis Taube, Johns Hopkins Medical University; Dr. Elsa Anagnostou, Johns Hopkins Kimmel Cancer Center; and Dr. Gary Nolan, Stanford University Medical School There is good News for the majority of patients with cancer whose tumor's have a low number of mutations. Dr. Fox reviewed published peer-reviewed preclinical and human data from investigators at MD Anderson, the US National Cancer Institute, Stanford, and the Earle A. Chiles Research Institute documenting the development of anti-cancer T cell responses to shared, non-mutated, cancer antigens as well as associations with response to treatment. Dr. Fox explained how these findings from leading groups offer good news and hope for patients whose cancers have low tumor mutational burden (TMB). Dr. Fox explained how UbiVac’s DRibble Platform Vaccine (DPV) technology enriches for proteins that make up the dominant cancer antigens presented on the surface of cancer cells. He showed results from UbiVac’s phase I/II study of vaccination as adjuvant treatment for definitively treated non-small cell lung cancer (NSCLC) where vaccination with UbiVac’s DPV-001 induced immune responses to a wide spectrum of shared cancer antigens. He also showed that many cancer antigens recognized by two or more vaccinated patients were against genes whose expression was associated with reduced survival. The association of these genes with reduced survival, he noted, underscores the importance of targeting these shared antigens with UbiVac's vaccine. Dr. Fox also noted the failure of clinical trials for advanced cancer that relied on vaccines as the only treatment and presented data from Dr. Hong-Ming Hu, UbiVac’s co-Founder and CSO, showing how combining UbiVac’s vaccine technology with anti-OX40 significantly increased survival in a difficult to treat model of breast cancer. These data led to the development of a first-in-human combination immunotherapy trial that is now open at three sites in the USA and combines UbiVac’s DPV-001 off-the-shelf cancer vaccine, with anti-OX40 and anti-PD-1 as treatment for women with advanced triple negative breast cancer. Award Number R44CA121612 from the National Cancer Institute, NIH, supported the research and clinical trial of DPV-001 as adjuvant treatment for patients with NSCLC. That trial characterized DPV-001’s safety profile, drug formulation and ability to induce immune responses to a broad spectrum of shared cancer antigens, thus providing the proof of concept for additional trials. This content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. UbiVac is a privately held, clinical stage immunotherapy company engaged in the research and development of therapeutic vaccines to combat cancer. With innovative, first-in-class platform technology that couples an off-the-shelf DC-targeted cancer vaccine with more than 100 cancer antigens for most adenocarcinomas and squamous cell cancers, plus multiple TLR/NOD agonists and DAMPs that are effective at inducing anti-cancer immune responses. UbiVac believes that DPV-001 is highly complementary to current and developing immunotherapy, chemotherapy and small molecule drug portfolios. UbiVac also has a pipeline of vaccines under development to prevent cancer in patients at high risk of developing disease and for those that have failed to respond to anti-PD-1/anti-PD-L1. Founded by Dr. Bernard A. Fox, Dr. Hong-Ming Hu and Mr. Bernard A. Fox, III, in Portland, Oregon in 2005, UbiVac is a spinout of the Robert W. Franz Cancer Center, Earle A. Chiles Research Institute at Providence Portland Medical Center. UbiVac is currently raising equity funding from accredited investors to advance combination immunotherapy strategies. This includes innovative trials for men with advanced prostate cancer and other diseases where standard immunotherapy combinations have failed. More information about the offering can be found at www.ubivac.com/investors. UbiVac Press@UbiVac.com Visit us on social media: Facebook Twitter LinkedIn There is a new paradigm for combating cancer at https://www.youtube.com/watch?v=7GTKYbP5fEA

ImmunotherapyVaccineClinical Study

100 Deals associated with Autophagosome vaccine(UbiVac LLC)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 2	US	UbiVac, Inc.	25 Jul 2013
Prostatic Cancer	Phase 2	US	UbiVac, Inc.	-
Squamous Cell Carcinoma of Head and Neck	Phase 1	US	UbiVac, Inc.	09 Apr 2022
Breast Cancer	Phase 1	US	UbiVac, Inc.	31 May 2020
Adenocarcinoma of prostate	Phase 1	US	UbiVac, Inc.	24 Oct 2014
Advanced Prostate Carcinoma	Phase 1	US	UbiVac, Inc.	24 Oct 2014
Colonic Cancer	Phase 1	-	UbiVac, Inc.	-
Esophageal Carcinoma	Phase 1	-	UbiVac, Inc.	-
Ovarian Cancer	Phase 1	-	UbiVac, Inc.	-
Stomach Cancer	Phase 1	-	UbiVac, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04470024 (GITRVax, AACR2024) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck	18	DPV-001+ PD-1 + GITR	tyfxlnlsbs(yucyelvsvp) = G3 irAE's included: hypothyroidism & mucositis (Arm 1, same pt); pneumonitis and adrenal insufficiency (Arm 2, separate pts). No G4 toxicity was observed. tgzotrbhnn (sicezvikxc ) View more	Positive	05 Apr 2024

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