CSBio CSBio

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I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Aquestive Therapeutics"},{"orgOrder":0,"company":"Inimmune","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Inimmune Corporation announces First Subject Dosed in First-in-Human Phase 1 Clinical Trial of its novel intranasal TLR4 agonist, INI-2004, for the Treatment of Allergic Rhinitis and FDA Clearance of IND application for INI-2004","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Inimmune"},{"orgOrder":0,"company":"Kyverna Therapeutics","sponsor":"Bain Capital Life Sciences","pharmaFlowCategory":"D","amount":"$145.0 million","upfrontCash":"Undisclosed","newsHeadline":"Kyverna Therapeutics Extends Series B Financing Round to $145 Million and Brings in New Investors","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Kyverna Therapeutics"},{"orgOrder":0,"company":"Tonix Pharmaceuticals Holding Corp","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tonix Pharmaceuticals Initiates Phase 1 Trial of TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Tonix Pharmaceuticals Holding Corp"},{"orgOrder":0,"company":"InflaRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InflaRx Announces Positive Topline Results from the Single Ascending Dose (SAD) Phase I Study with C5aR Inhibitor INF904","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"InflaRx"},{"orgOrder":0,"company":"Kyverna Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyverna Therapeutics Announces Achievement of 28-Day Post-Infusion Milestone for First U.S. Patient Dosed in Phase 1 Clinical Trial of CD19 CAR T-Cell Therapy for Lupus Nephritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Kyverna Therapeutics"},{"orgOrder":0,"company":"Oxford Biomedica","sponsor":"Kyverna Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Kyverna Therapeutics and Oxford Biomedica Sign License and Supply Agreement for LentiVector\u00ae Platform","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"UNITED KINGDOM","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Oxford Biomedica"},{"orgOrder":0,"company":"Immunovant","sponsor":"Leerink Partners","pharmaFlowCategory":"D","amount":"$450.0 million","upfrontCash":"Undisclosed","newsHeadline":"Immunovant Announces Pricing of $450 Million Common Stock Financing","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Immunovant"},{"orgOrder":0,"company":"Immunovant","sponsor":"Leerink Partners","pharmaFlowCategory":"D","amount":"$300.0 million","upfrontCash":"Undisclosed","newsHeadline":"Immunovant Announces Proposed Offering of $300 Million of Common Stock","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Immunovant"},{"orgOrder":0,"company":"Immunovant","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Immunovant Announces Positive Initial IMVT-1402 Phase 1 SAD and 300 mg Subcutaneous MAD Results","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Immunovant"},{"orgOrder":0,"company":"Immunovant","sponsor":"Leerink Partners","pharmaFlowCategory":"D","amount":"$492.1 million","upfrontCash":"Undisclosed","newsHeadline":"Immunovant Announces Closing of Upsized Common Stock Financing and Full Exercise of Underwriters' Option to Purchase Additional Shares","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Immunovant"},{"orgOrder":0,"company":"Hansa Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Hansa Biopharma Announces Encouraging High-Level Results for First-In-Human Trial of HNSA-5487","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Hansa Biopharma"},{"orgOrder":0,"company":"Kyverna Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyverna Therapeutics Announces FDA Clearance of Phase 2 IND for KYV-101, a Fully Human CD19 CAR T-Cell Therapy to Treat Myasthenia Gravis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Kyverna Therapeutics"},{"orgOrder":0,"company":"Lipella Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Orphan Designation for Lipella's LP-310 Drug Candidate for Oral Graft-versus-Host Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Lipella Pharmaceuticals"},{"orgOrder":0,"company":"InflaRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InflaRx Announces Positive Topline Results from the Multiple Ascending Dose (MAD) Phase I Study with C5aR Inhibitor INF904","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"InflaRx"},{"orgOrder":0,"company":"Intrommune Therapeutics","sponsor":"Inimmune","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Inimmune Corporation and Intrommune Therapeutics Announce a Collaboration to Advance a Revolutionary Rapid, Long-acting Oral Mucosal Allergy Immunotherapy for the Treatment of Peanut Allergy","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Intrommune Therapeutics"},{"orgOrder":0,"company":"Ventus Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ventus Therapeutics Initiates Clinical Testing of VENT-03, a First-in-Class, Orally Administered cGAS Inhibitor","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Ventus Therapeutics"},{"orgOrder":0,"company":"Evommune","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Evommune Announces Initiation of a Phase 1 Trial of its MRGPRX2 Antagonist for the Treatment of Chronic Spontaneous Urticaria","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Evommune"},{"orgOrder":0,"company":"Rise Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Enrolled in Rise Therapeutics' Rheumatoid Arthritis Clinical Trial","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Rise Therapeutics"},{"orgOrder":0,"company":"Angany","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ANGANY\u2019s First Clinical Trial Concludes on Time and with Positive Results","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"CANADA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Vaccine","graph2":"Angany"},{"orgOrder":0,"company":"Dianthus Therapeutics","sponsor":"Jefferies","pharmaFlowCategory":"D","amount":"$230.0 million","upfrontCash":"Undisclosed","newsHeadline":"Dianthus Therapeutics Announces $230 Million Private Placement","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Dianthus Therapeutics"},{"orgOrder":0,"company":"ALK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ALK Completes First Part of Phase 1 Trial with Peanut SLIT-tablet","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"ALK"},{"orgOrder":0,"company":"Graviton Bioscience","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Graviton Bioscience Announces Strategic Investment from Sanofi to Advance Development of the Next Generation of Selective ROCK2 Inhibitors","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Graviton Bioscience"},{"orgOrder":0,"company":"AnaMar","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AnaMar Announces US and EU Orphan Drug Designation for AM1476 for Treating Systemic Sclerosis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"AnaMar"},{"orgOrder":0,"company":"Immunovant","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Roivant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Immunovant"}]

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            Details:

            Tocilizumab Biosimilar is a recombinant humanized monoclonal antibody targeting IL-6R, which specifically binds to sIL-6R and mIL-6R and inhibits signaling mediated by sIL-6R or mIL-6R. It is approved for the treatment of RA, sJIA, and CRS.

            Lead Product(s): Tocilizumab

            Therapeutic Area: Immunology Product Name: DRL_TC

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 05, 2023

            Details:

            Tocilizumab is an important anti-rheumatic agent used in the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

            Lead Product(s): Tocilizumab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 19, 2022

            Details:

            Provention Bio plans to begin a Phase 2a trial of PRV-3279 in systemic lupus erythematosus (SLE) in the second half of 2021 and expects a portion of such trial to be conducted in China.

            Lead Product(s): PRV-3279

            Therapeutic Area: Immunology Product Name: PRV-3279

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Huadong Pharmaceutical

            Deal Size: $293.0 million Upfront Cash: $6.0 million

            Deal Type: Collaboration February 17, 2021

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            AM1476 is a selective peripheral-acting 5-HT2B receptor small molecule antagonist. It is being evaluated in phase 1 clinical trials for the treatment of Systemic Sclerosis.

            Lead Product(s): AM1476

            Therapeutic Area: Immunology Product Name: AM1476

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 05, 2024

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            Details:

            Through the financing, Sanofi receives a right of first negotiation to license compounds, including GV101, across various indications, including immunological and metabolic syndrome indications, driving the momentum behind ROCK2 inhibitor treatments.

            Lead Product(s): GV101

            Therapeutic Area: Immunology Product Name: GV101

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing February 01, 2024

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            The net proceeds will be used for the clinical development of DNTH103. It is a selective inhibitor of the active C1s protein for the treatment of neuromuscular & autoimmune disorders.

            Lead Product(s): DNTH103

            Therapeutic Area: Immunology Product Name: DNTH103

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Jefferies

            Deal Size: $230.0 million Upfront Cash: Undisclosed

            Deal Type: Private Placement January 22, 2024

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            EVO756 is a potent, highly selective small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2). It is under phase 1 clinical development for the treatment of chronic spontaneous urticaria.

            Lead Product(s): EVO756

            Therapeutic Area: Immunology Product Name: EVO756

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 18, 2024

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            ALK

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            ALK Abello AS is developing sublingual immunotherapy (‘SLIT’) tablets and it is under phase 1 clinical development for the treatment of Peanut Allergy.

            Lead Product(s): Peanut Sublingual Immunotherapy

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 18, 2024

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            Intrommune's clinical stage oral mucosal therapy, INT301, for food allergies will combine its disease-modifying treatment through its peanut oral mucosal immunotherapy, with the rapid desensitization to allergens provided by Inimmune’s clinical stage proprietary immunotherapy.

            Lead Product(s): INT301

            Therapeutic Area: Immunology Product Name: INT301

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Inimmune

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration January 08, 2024

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            VENT-03 is a first-in-class, orally administered cGAS inhibitor. it is under phase 1 clinical development for the treatment of systemic lupus erythematosus (SLE) and other inflammatory disorders.

            Lead Product(s): VENT-03

            Therapeutic Area: Immunology Product Name: VENT-03

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 03, 2024

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