Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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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. 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            Through the collaboration, Repertoire will lead all activities through to the development candidate nomination, while BMS will lead the commercialization of the tolerizing vaccines under an exclusive worldwide license for the treatment of type 1 diabetes.

            Lead Product(s): Undisclosed

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Vaccine

            Partner/Sponsor/Collaborator: Bristol Myers Squibb

            Deal Size: $1865 million Upfront Cash: $65.0 million

            Deal Type: Collaboration April 29, 2024

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            Under the collaboration, companies will combine proprietary technologies to formulate an oral semaglutide (GLP-1 receptor agonist) with enhanced bioavailability, using a novel lipid technology to provide a more convenient treatment for patients with diabetes and obesity.

            Lead Product(s): Semaglutide

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Peptide

            Partner/Sponsor/Collaborator: TRx BIOSCIENCES

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration March 12, 2024

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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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            UP421 is an allogeneic, primary islet cell therapy engineered with Sana’s hypoimmune (HIP) technology, which is being evaluated for the treatment of patients with type 1 diabetes.

            Lead Product(s): UP421

            Therapeutic Area: Endocrinology Product Name: UP421

            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 November 17, 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