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Diseases","graph2":"IND Enabling","graph3":"Caring Cross","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Injection","sponsorNew":"Caring Cross \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"Caring Cross \/ Undisclosed"},{"orgOrder":0,"company":"Lion TCR","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"SINGAPORE","productType":"Cell & Gene Therapy","year":"2025","type":"Inapplicable","leadProduct":"LioCyx-M004","moa":"Undisclosed","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling","graph3":"Lion TCR","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Lion TCR \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"Lion TCR \/ Undisclosed"},{"orgOrder":0,"company":"GC Biopharma","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"SOUTH KOREA","productType":"Vaccine","year":"2025","type":"Inapplicable","leadProduct":"GC4006A","moa":"Undisclosed","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling","graph3":"GC Biopharma","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"GC Biopharma \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"GC Biopharma \/ Undisclosed"}]

Find FDA Investigational New Drug (IND) Submissions for Infections and Infectious Diseases

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                          Top Deals by Deal Size (USD bn)

                          01

                          Lead Product(s) : MRT5500

                          Therapeutic Area : Infections and Infectious Diseases

                          Study Phase : IND Enabling

                          Sponsor : Sanofi

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Details : Preclinical evaluation of MRT5500, importantly, demonstrated a favorable immune response profile against SARS-CoV-2. These data support the selection of MRT5500 for clinical development.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          October 15, 2020

                          Lead Product(s) : MRT5500

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : Sanofi

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Sanofi Company Banner

                          02

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : GC4006A is an mRNA (messenger RNA) vaccine candidate, which is being evaluated for the treatment of COVID-19.

                          Product Name : GC4006A

                          Product Type : Vaccine

                          Upfront Cash : Inapplicable

                          September 22, 2025

                          Lead Product(s) : GC4006A

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          03

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : LioCyx-M004 represents an innovative autologous cell therapy engineered using mRNA to encode T-cell receptors that specifically target hepatitis B virus antigens.

                          Product Name : LioCyx-M004

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          September 15, 2025

                          Lead Product(s) : LioCyx-M004

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          04

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : The proceeds will be used to begin the first-ever human clinical trial of phage therapy in Korea.

                          Product Name : Undisclosed

                          Product Type : Microorganism

                          Upfront Cash : Undisclosed

                          September 03, 2025

                          Lead Product(s) : Undisclosed

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : Paratus Investment

                          Deal Size : $14.5 million

                          Deal Type : Series B Financing

                          blank

                          05

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : The agreement aims to sponsor a Phase 1 clinical trial of FZ002, a live yeast genetically modified to express a tetraspecific anti-toxin for C. difficile treatment.

                          Product Name : Undisclosed

                          Product Type : Microorganism

                          Upfront Cash : Undisclosed

                          March 11, 2025

                          Lead Product(s) : FZ002

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : National Institutes of Health

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          06

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : ABX-01 is an immunotherapeutic drug candidate, which is currently being evaluated for the patients suffering with gram-negative bacterial lung infections.

                          Product Name : Undisclosed

                          Product Type : Peptide-drug Conjugate

                          Upfront Cash : Inapplicable

                          March 04, 2025

                          Lead Product(s) : ABX-01

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : The agreement authorizes Venus Remedies to spearhead the clinical development, registration, and commercialization of MET-X, an innovative metallo-beta-lactamase (MBL) inhibitor.

                          Product Name : MET-X

                          Product Type : Antibiotic

                          Upfront Cash : Undisclosed

                          February 27, 2025

                          Lead Product(s) : MET-X,Meropenem

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : Venus Remedies

                          Deal Size : Undisclosed

                          Deal Type : Licensing Agreement

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                          08

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : The grant comes as the company will move forward to accelerated the clinical trials for its lead candidate, SPVX02, a fridge-free tetanus and diphtheria vaccine.

                          Product Name : Undisclosed

                          Product Type : Vaccine

                          Upfront Cash : Undisclosed

                          February 19, 2025

                          Lead Product(s) : SPVX02

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : EIC Accelerator

                          Deal Size : $2.6 million

                          Deal Type : Funding

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                          09

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : GB05 (human interferon alpha-1b) is an inhalation solution, which is being evaluated for the treatment of respiratory syncytial virus infections in children..

                          Product Name : Undisclosed

                          Product Type : Protein

                          Upfront Cash : Inapplicable

                          February 14, 2025

                          Lead Product(s) : Human Interferon Alpha

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          blank

                          10

                          FNCE
                          Not Confirmed
                          FNCE
                          Not Confirmed

                          Details : AIM’s Ampligen (rintatolimod) is being evaluated in combination with AstraZeneca’s FluMist for the treatment of avian influenza.

                          Product Name : Ampligen

                          Product Type : Oligonucleotide

                          Upfront Cash : Inapplicable

                          February 07, 2025

                          Lead Product(s) : Rintatolimod,Influenza Vaccine Live, Intranasal

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : IND Enabling

                          Sponsor : AstraZeneca

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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