CSBio CSBio

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Completes Pre-IND Meeting with U.S. FDA for Development Program as a Potential Cure for Type 1 Diabetes Without the Need for Life-long Immunosuppression","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"iTolerance"},{"orgOrder":0,"company":"Lygenesis","sponsor":"Imagine Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"LyGenesis and Imagine Pharma Announce Joint Research Collaboration to Develop Novel Cell Therapies for Patients with Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Lygenesis"},{"orgOrder":0,"company":"Tiziana Life Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tiziana Life Sciences Initiates Program to Develop Intranasal Foralumab in Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Tiziana Life Sciences"},{"orgOrder":0,"company":"iTolerance","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"iTolerance, Inc. Announces Issuance of U.S. Patent Covering Proprietary Regenerative SA-FasL Microgel Technology, iTOL-100","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"iTolerance"},{"orgOrder":0,"company":"Sernova","sponsor":"AstraZeneca","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sernova Announces Research Collaboration with AstraZeneca to Evaluate Novel Potential Therapeutic Cell Applications","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"CANADA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Sernova"},{"orgOrder":0,"company":"DiogenX","sponsor":"Boehringer Ingelheim Venture Fund","pharmaFlowCategory":"D","amount":"$30.0 million","upfrontCash":"Undisclosed","newsHeadline":"DiogenX Raises \u20ac27.5M Series A Financing To Advance its First-in-class Regenerative Treatment For Type 1 Diabetes into Clinical Trial","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"DiogenX"},{"orgOrder":0,"company":"iTolerance","sponsor":"Kadimastem","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"iTolerance, Inc. and Kadimastem Enter into Collaboration Agreement for Development of a Potential Cure for Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"iTolerance"},{"orgOrder":0,"company":"iTolerance","sponsor":"BIRD Foundation","pharmaFlowCategory":"D","amount":"$1.0 million","upfrontCash":"Undisclosed","newsHeadline":"iTolerance, Inc. 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Submit Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) Meeting Request with FDA for Potential Cure for Type 1 Diabetes","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"iTolerance"},{"orgOrder":0,"company":"Porosome Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Porosome Therapeutics Announces Groundbreaking Approach to Advance Diabetes Treatment","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Porosome Therapeutics"},{"orgOrder":0,"company":"Encellin","sponsor":"Khosla Ventures","pharmaFlowCategory":"D","amount":"$9.9 million","upfrontCash":"Undisclosed","newsHeadline":"Encellin Closes $9.9M Financing Led by Khosla Ventures to Advance Cell Encapsulation Platform for Endocrine Disorders","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Encellin"},{"orgOrder":0,"company":"Fractyl Health","sponsor":"BofA Securities","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Hoping its GLP-1 gene therapy can beat Wegovy, Fractyl plans IPO","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Fractyl Health"},{"orgOrder":0,"company":"Fractyl Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fractyl Health Announces Nomination of RJVA-001 as First Clinical Candidate in Its Rejuva\u00ae GLP-1 Gene Therapy Platform","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Fractyl Health"}]

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            RJVA-001 is the first GLP-1 pancreatic gene therapy (GLP1 PGTx) candidate, which is being evaluated in preclinical studies for the treatment of Type 2 Diabetes (T2D).

            Lead Product(s): AAV-Delivered Pancreatic Gene Therapy

            Therapeutic Area: Endocrinology Product Name: RJVA-001

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 05, 2024

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            The net proceeds will be used to fund the continued preclinical development of our Rejuva, a GLP-1-based pancreatic gene therapy candidate, for treatment across the spectrum of type 2 diabetes and obesity.

            Lead Product(s): AAV-based Pancreatic Gene Therapy

            Therapeutic Area: Endocrinology Product Name: Rejuva

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: BofA Securities

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Public Offering December 15, 2023

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            The financing will advance a Phase 1 clinical trial evaluating subcutaneous transplantation of primary islets within Encellin’s encapsulated cell replacement therapy, ENC-201, in Type 1 Diabetes (T1D).

            Lead Product(s): ENC-201

            Therapeutic Area: Endocrinology Product Name: ENC-201

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Khosla Ventures

            Deal Size: $9.9 million Upfront Cash: Undisclosed

            Deal Type: Financing December 13, 2023

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            iTOL-102 is our lead program that is developed Using our proprietary SA-FasL biotin-PEG microgel platform, which being developed as a potential cure for Type 1 Diabetes without the need for chronic immunosuppression.

            Lead Product(s): Allogeneic Stem Cell-derived Pancreatic Islets

            Therapeutic Area: Endocrinology Product Name: iTOL-102

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Kadimastem

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 07, 2023

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            Porosome Therapeutics' has a proprietary approach of porosome-reconstitution therapy, T1D-PT101, where insulin-secreting porosomes are introduced into the cell plasma membrane of stem cell-derived beta cells.

            Lead Product(s): T1D-PT101

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 30, 2023

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            Under the terms of the agreement, Meitheal, through its parent company, will receive exclusive rights to commercialize biosimilar versions of insulin aspart, insulin lispro, and insulin glargine in the U.S. upon approval by the FDA.

            Lead Product(s): Insulin aspart

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Peptide

            Partner/Sponsor/Collaborator: Meitheal Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement September 21, 2023

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            ABA-201 is Abata’s autologous Treg therapy in development for the treatment of T1D. It targets T1D patients who have remaining beta cell function and a specific HLA genetic haplotype.

            Lead Product(s): ABA-201

            Therapeutic Area: Endocrinology Product Name: ABA-201

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 24, 2023

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            Through the acquisition, Lilly gains control of the partnered encapsulated cell therapies, including SIG-002 (human insulin), for the treatment of type 1 diabetes.

            Lead Product(s): SIG-002

            Therapeutic Area: Endocrinology Product Name: SIG-002

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Eli Lilly

            Deal Size: $344.2 million Upfront Cash: $344.2 million

            Deal Type: Acquisition August 14, 2023

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            The funding will support the development of the Prometheus™ dose-adjustable gene therapy platform technology for the advancement of RMD1202 for the treatment of Type 2 Diabetes and Obesity.

            Lead Product(s): RMD1202

            Therapeutic Area: Endocrinology Product Name: RMD1202

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: National Science Foundation

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Funding August 01, 2023

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            The agreement aims for the commercialising of Folotyn (Pralatrexate), a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, in the People's Republic of China.

            Lead Product(s): iTOL-102

            Therapeutic Area: Endocrinology Product Name: iTOL-102

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: iTolerance

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership August 01, 2023

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