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\/ PT AIVITA Biomedika","highestDevelopmentStatusID":"8","companyTruncated":"Aivita Biomedical \/ PT AIVITA Biomedika"},{"orgOrder":0,"company":"Aivita Biomedical","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Vaccine","year":"2018","type":"Inapplicable","leadProduct":"AV-GBM-1","moa":"Undisclosed","graph1":"Oncology","graph2":"Phase III","graph3":"Aivita Biomedical","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Injection","sponsorNew":"Aivita Biomedical \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Aivita Biomedical \/ Undisclosed"},{"orgOrder":0,"company":"Aivita Biomedical","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Vaccine","year":"2021","type":"Inapplicable","leadProduct":"AV-GBM-1","moa":"Undisclosed","graph1":"Oncology","graph2":"Phase 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Financing","leadProduct":"AV-GBM-1","moa":"Undisclosed","graph1":"Oncology","graph2":"Phase III","graph3":"Aivita Biomedical","amount2":0.029999999999999999,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0.029999999999999999,"dosageForm":"Injection","sponsorNew":"Aivita Biomedical \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Aivita Biomedical \/ Undisclosed"},{"orgOrder":0,"company":"Aivita Biomedical","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Vaccine","year":"2021","type":"Inapplicable","leadProduct":"AV-GBM-1","moa":"Undisclosed","graph1":"Oncology","graph2":"Phase III","graph3":"Aivita Biomedical","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Aivita Biomedical \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Aivita Biomedical \/ Undisclosed"},{"orgOrder":0,"company":"Aivita Biomedical","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Undisclosed","year":"2018","type":"Inapplicable","leadProduct":"AV-MEL-1","moa":"Undisclosed","graph1":"Oncology","graph2":"Phase I","graph3":"Aivita Biomedical","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Injection","sponsorNew":"Aivita Biomedical \/ Undisclosed","highestDevelopmentStatusID":"6","companyTruncated":"Aivita Biomedical \/ Undisclosed"},{"orgOrder":0,"company":"Aivita Biomedical","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Cell & Gene Therapy","year":"2014","type":"Inapplicable","leadProduct":"AVOVA-1","moa":"Undisclosed","graph1":"Oncology","graph2":"Phase II","graph3":"Aivita Biomedical","amount2":0,"highestDevelopmentShortName":"Ph 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Find Clinical Drug Pipeline Developments & Deals by Aivita Biomedical

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                          Therapeutic Area by Lead Product

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                          Top Deals by Deal Size (USD bn)

                          01

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Details : AV-GBM-1 is a Vaccine drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Glioblastoma.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          October 29, 2021

                          Lead Product(s) : AV-GBM-1

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          02

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Lead Product(s) : AV-COVID-19

                          Therapeutic Area : Infections and Infectious Diseases

                          Study Phase : Phase II

                          Sponsor : PT AIVITA Biomedika | Kariadi Hospital | Central Army Hospital RSPAD Gatot Soebroto

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Details : AV-COVID-19 is a Vaccine drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of COVID-19.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          August 16, 2021

                          Lead Product(s) : AV-COVID-19

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase II

                          Sponsor : PT AIVITA Biomedika | Kariadi Hospital | Central Army Hospital RSPAD Gatot Soebroto

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          03

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Details : AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor neoantigens derived from self-renewing tumor-initiating cells isolated from tumors after routine surgical debulking.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          June 08, 2021

                          Lead Product(s) : AV-GBM-1

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          04

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Details : AV-COVID-19 is being manufactured locally by AIVITA. AIVITA is in discussions with regulatory authorities for a Phase 2 study in Indonesia, as well as clinical investigation of AV-COVID-19 in the United States in early 2021.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          February 25, 2021

                          Lead Product(s) : AV-COVID-19

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : PT AIVITA Biomedika

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          05

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Lead Product(s) : AV-COVID-19

                          Therapeutic Area : Infections and Infectious Diseases

                          Study Phase : Phase I

                          Sponsor : PT AIVITA Biomedika | Indonesia Ministry of Health | NIHRD, Ministry of Health, Indonesia

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Details : AV-COVID-19 is a Vaccine drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of COVID-19.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          December 30, 2020

                          Lead Product(s) : AV-COVID-19

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase I

                          Sponsor : PT AIVITA Biomedika | Indonesia Ministry of Health | NIHRD, Ministry of Health, Indonesia

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          06

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Details : Proceeds will support clinical development of AIVITA’s personalized immunotherapy programs, including Phase 2 studies in glioblastoma and ovarian cancer, as well as AIVITA’s application for commercial approval of its melanoma immunotherapy.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Undisclosed

                          December 29, 2020

                          Lead Product(s) : AV-GBM-1

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Undisclosed

                          Deal Size : $25.0 million

                          Deal Type : Series B Financing

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                          07

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Details : The analysis focused on 57 patients who were scheduled to receive up to eight doses of AV-GBM-1 over approximately six months. At the time of the analysis, surviving patients had completed therapy and had been followed between 7.2 and 24.2 months.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          November 17, 2020

                          Lead Product(s) : AV-GBM-1

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          08

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Details : The eight-site, single-arm study investigates AV-GBM-1, AIVITA’s novel immunotherapy for the treatment of glioblastoma that targets the autologous tumor-initiating cells responsible for the rapid growth and proliferation of the disease.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          November 02, 2020

                          Lead Product(s) : AV-GBM-1

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          09

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Details : Randomized trials have failed to confirm significant anticancer activity for monotherapy GM-CSF, but it appears to provide immune enhancing effects and survival benefit when it is admixed with dendritic cells loaded ex-vivo with autologous tumor antigens

                          Product Name : Undisclosed

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          August 03, 2020

                          Lead Product(s) : AVOVA-1,GM-CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          10

                          AAPS
                          Not Confirmed
                          AAPS
                          Not Confirmed

                          Details : AV-COVID-19 is a Vaccine drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of COVID-19.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          May 13, 2020

                          Lead Product(s) : AV-COVID-19

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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