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Bio-Pharma","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"SWITZERLAND","productType":"Undisclosed","year":"2021","type":"Collaboration","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"Bright Peak Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Bright Peak Therapeutics \/ Ajinomoto Bio-Pharma","highestDevelopmentStatusID":"5","companyTruncated":"Bright Peak Therapeutics \/ Ajinomoto Bio-Pharma"},{"orgOrder":0,"company":"University of Michigan","sponsor":"Ascentage Pharma","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Undisclosed","year":"2020","type":"Licensing Agreement","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"University of 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Medicine \/ Immatics","highestDevelopmentStatusID":"5","companyTruncated":"Editas Medicine \/ Immatics"},{"orgOrder":0,"company":"Alterome Therapeutics","sponsor":"Goldman Sachs & Co","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Undisclosed","year":"2024","type":"Series B Financing","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"Alterome Therapeutics","amount2":0.13,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0.13,"dosageForm":"Undisclosed","sponsorNew":"Alterome Therapeutics \/ Goldman Sachs & Co","highestDevelopmentStatusID":"5","companyTruncated":"Alterome Therapeutics \/ Goldman Sachs & Co"},{"orgOrder":0,"company":"Ideaya 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Research","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Scripps Research \/ AbbVie Inc","highestDevelopmentStatusID":"5","companyTruncated":"Scripps Research \/ AbbVie Inc"},{"orgOrder":0,"company":"Affini-T Therapeutics","sponsor":"Vida Ventures LLC","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Undisclosed","year":"2022","type":"Financing","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"Affini-T Therapeutics","amount2":0.17999999999999999,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0.17999999999999999,"dosageForm":"Undisclosed","sponsorNew":"Affini-T Therapeutics \/ Vida Ventures LLC","highestDevelopmentStatusID":"5","companyTruncated":"Affini-T Therapeutics \/ Vida Ventures LLC"},{"orgOrder":0,"company":"Affini-T Therapeutics","sponsor":"ElevateBio","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Undisclosed","year":"2022","type":"Partnership","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"Affini-T Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Affini-T Therapeutics \/ ElevateBio","highestDevelopmentStatusID":"5","companyTruncated":"Affini-T Therapeutics \/ ElevateBio"},{"orgOrder":0,"company":"RayzeBio","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Undisclosed","year":"2023","type":"Inapplicable","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND 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Therapeutics","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Undisclosed","year":"2022","type":"Inapplicable","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"Virtuoso Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Virtuoso Therapeutics \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"Virtuoso Therapeutics \/ Undisclosed"},{"orgOrder":0,"company":"Replay Bio","sponsor":"The University of Texas MD Anderson Cancer Center","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Undisclosed","year":"2023","type":"Inapplicable","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"Replay 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Biotechnologies","sponsor":"Genentech","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Cell & Gene Therapy","year":"2025","type":"Termination","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"Adaptive Biotechnologies","amount2":2.2999999999999998,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":2.2999999999999998,"dosageForm":"Undisclosed","sponsorNew":"Adaptive Biotechnologies \/ Genentech","highestDevelopmentStatusID":"5","companyTruncated":"Adaptive Biotechnologies \/ Genentech"},{"orgOrder":0,"company":"HCW Biologics","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Antibody, Unconjugated","year":"2025","type":"Inapplicable","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"HCW Biologics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"HCW Biologics \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"HCW Biologics \/ Undisclosed"},{"orgOrder":0,"company":"Carina Biotech","sponsor":"Tenmile","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"AUSTRALIA","productType":"Undisclosed","year":"2022","type":"Financing","leadProduct":"Undisclosed","moa":"Undisclosed","graph1":"Oncology","graph2":"IND Enabling","graph3":"Carina Biotech","amount2":0.01,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0.01,"dosageForm":"Undisclosed","sponsorNew":"Carina Biotech \/ Tenmile","highestDevelopmentStatusID":"5","companyTruncated":"Carina Biotech \/ Tenmile"},{"orgOrder":0,"company":"Neogap","sponsor":"Karolinska University 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Cellectar"},{"orgOrder":0,"company":"ARTBIO","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"NORWAY","productType":"Radiolabeled Compound","year":"2025","type":"Inapplicable","leadProduct":"AB001","moa":"ACE2 receptor","graph1":"Oncology","graph2":"IND Enabling","graph3":"ARTBIO","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"ARTBIO \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"ARTBIO \/ Undisclosed"}]

    Find FDA Investigational New Drug (IND) Submissions for Oncology in UNITED STATES

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                            01

                            Sanofi

                            France
                            CPhI WW Frankfurt
                            Attending
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Sanofi

                            Deal Size : Undisclosed

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            Sanofi Completes Acquisition of Amunix

                            Details : The acquisition also provides access to Amunix Pro-XTEN, XPAT, and XPAC technology to deliver next generation Conditionally Activated Biologics. The technology platform is highly complementary to Sanofi’s existing R&D platforms.

                            Product Name : Undisclosed

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Undisclosed

                            February 08, 2022

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Sanofi

                            Deal Size : Undisclosed

                            Deal Type : Acquisition

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                            02

                            Sanofi

                            France
                            CPhI WW Frankfurt
                            Attending
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Sanofi

                            Deal Size : $1,225.0 million

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            Sanofi to Acquire Amunix Immuno-Oncology Pipeline with Next Generation Conditionally Activated Biologics

                            Details : Under the terms of the agreement, Sanofi will acquire Amunix with it's pipeline including it's lead candidate, AMX-818, a masked HER2-directed TCE, offers a strong strategic fit with Sanofi’s focus on developing potentially transformative cancer therap...

                            Product Name : Undisclosed

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : $1,000.0 million

                            December 21, 2021

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Sanofi

                            Deal Size : $1,225.0 million

                            Deal Type : Acquisition

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                            03

                            Sanofi

                            France
                            CPhI WW Frankfurt
                            Attending
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Amunix Presents Preclinical Data on Its XPAT T Cell Engager Platform at the AACR-NCI-EORTC Conference on Molec...

                            Details : AMX-818, a protease-activated T cell engager targeting HER2 with potent T Cell activation, proteolytic cleavage and efficacy in Xenograft tumors.

                            Product Name : Undisclosed

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            October 07, 2021

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            04

                            Sanofi

                            France
                            CPhI WW Frankfurt
                            Attending
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Amunix to Present Preclinical Data on HER2- and EGFR-Targeted T Cell Engagers at AACR Virtual Annual Meeting I...

                            Details : Data demonstrate potential of Amunix’s XPAT platform to significantly widen therapeutic index, and address on-target, off-tumor toxicity that has hindered application of T cell engagers to treat solid tumors.

                            Product Name : Undisclosed

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            June 22, 2020

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            Sanofi

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                            CPhI WW Frankfurt
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                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Omega Funds

                            Deal Size : $73.0 million

                            Deal Type : Series A Financing

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                            Amunix Raises $73 Million in Series A Financing Led by Omega Funds

                            Details : Amunix plans to utilize the Series A proceeds to advance its lead development candidate, AMX-818, to progress earlier discovery stage XPAT programs and to initiate XPAC discovery work.

                            Product Name : Undisclosed

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Undisclosed

                            March 04, 2020

                            Lead Product(s) : AMX-818

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Omega Funds

                            Deal Size : $73.0 million

                            Deal Type : Series A Financing

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                            06

                            Evestia

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                            Evestia

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                            Aus. Peptide Conference
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                            • fda
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                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : CLR 125

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Cellectar

                            Deal Size : Undisclosed

                            Deal Type : Agreement

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                            Cellectar, Evestia Partner for Auger-Emitting Radiopharmaceutical Trial in TNBC

                            Details : Evestia will provide Cellectar with full CRO services for their upcoming Phase 1b study evaluating CLR 125 for the treatment of triple-negative breast cancer (TNBC).

                            Product Name : CLR 125

                            Product Type : Radiolabeled Compound

                            Upfront Cash : Undisclosed

                            September 24, 2025

                            Lead Product(s) : CLR 125

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Cellectar

                            Deal Size : Undisclosed

                            Deal Type : Agreement

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                            07

                            Radiopharm Theranostics

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                            Aus. Peptide Conference
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                            Radiopharm Theranostics

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                            Aus. Peptide Conference
                            Not Confirmed
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                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Betabart

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            FDA Clears Radiopharm IND For Betabart (RV-01) Phase I Targeting B7H3

                            Details : RV-01 (betabart), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues.

                            Product Name : RV-01

                            Product Type : Radiolabeled Compound

                            Upfront Cash : Inapplicable

                            July 28, 2025

                            Lead Product(s) : Betabart

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            08

                            InnoCare Pharma

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                            InnoCare Pharma

                            China arrow
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                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : ICP-B794

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            InnoCare Announces Approval of Clinical Trial of a Novel ADC ICP-B794 in China

                            Details : ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated, being investigated for treatment of solid tumors.

                            Product Name : Undisclosed

                            Product Type : Undisclosed

                            Upfront Cash : Inapplicable

                            July 03, 2025

                            Lead Product(s) : ICP-B794

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            09

                            NovalGen

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                            NovalGen

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                            Lead Product(s) : NVG-222

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Mabion SA

                            Deal Size : Undisclosed

                            Deal Type : Partnership

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                            Mabion, NovalGen Partner to Bring NVG-222 to Market

                            Details : The partnership aims to bring the proprietary T-cell engager, NVG-222 targeting ROR1 and CD3, to market for phase one of in-human clinical trials.

                            Product Name : NVG-222

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Undisclosed

                            June 30, 2025

                            Lead Product(s) : NVG-222

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Mabion SA

                            Deal Size : Undisclosed

                            Deal Type : Partnership

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                            10

                            Radiopharm Theranostics

                            Australia arrow
                            Aus. Peptide Conference
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                            Radiopharm Theranostics

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                            Aus. Peptide Conference
                            Not Confirmed
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                            Lead Product(s) : 177-Lu BetaBart

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : The University of Texas MD Anderson Cancer Center

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            Radiopharm Shows Lu177-B7H3-mAb with Favourable Biodistribution, High Tumour Uptake

                            Details : RV01 is the Company’s B7-H3-targeted radiopharmaceutical therapy designed with strong affinity for the 4Ig isoform of B7H3.

                            Product Name : RV01

                            Product Type : Radiolabeled Compound

                            Upfront Cash : Inapplicable

                            June 02, 2025

                            Lead Product(s) : 177-Lu BetaBart

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : The University of Texas MD Anderson Cancer Center

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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