Find FDA Investigational New Drug (IND) Submissions for Oncology

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            Virtual BoothGlobal Pharmaceutical Dosage Solutions Company

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            Lead Product(s): TAC01-HER2

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Triumvira Immunologics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration March 24, 2020

            Details:

            Collaboration, aimed at developing Triumvira’s TAC01-HER2 T-cell therapy for solid tumors, will leverage Lonza’s expertise in process development and the usage of its proprietary Cocoon® Platform.

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            Lead Product(s): KP1237,NK Cell Therapy

            Therapeutic Area: Oncology Product Name: KP1237

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            KP1237 is an antibody-redirecting molecule (ARMä) that targets CD38, a clinically validated target for multiple myeloma.

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            Lead Product(s): CB-010

            Therapeutic Area: Oncology Product Name: CB-010

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            Upon initiation of the ANTLER Phase 1 trial, CB-010 will be Caribou’s first clinical-stage product candidate. CB-010 is manufactured from healthy donor T cells using Caribou’s next-generation CRISPR genome editing technology.

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            Lead Product(s): ATA2271

            Therapeutic Area: Oncology Product Name: ATA2271

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Memorial Sloan Kettering Cancer Center

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            UFDA has Provided clearance to Atara Biotherapeutics' IND application to initiate an open-label, single-arm Phase 1 study of ATA2271, a next-generation autologous CAR T therapy targeting mesothelin under development in collaboration with Memorial Sloan Kettering Cancer Center.

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            Lead Product(s): Natural killer cells

            Therapeutic Area: Oncology Product Name: INKmune

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            United States Patent & Trademark Office (USPTO) has issued US Pat. No. 10,758,567 B2, titled “IN VIVO PRIMING OF NATURAL KILLER CELLS,” which covers a method for treating cancer using INKmune™, a natural killer (NK) cell priming technology. The patent expires in 2036.

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            Lead Product(s): Efineptakin alfa,Tisagenlecleucel

            Therapeutic Area: Oncology Product Name: NT-I7

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 24, 2020

            Details:

            This IND clearance allows NeoImmuneTech (NIT) to initiate a multicenter Phase 1b study evaluating the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard-of-care Kymriah CAR T-cell therapy.

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            Lead Product(s): MVC-101

            Therapeutic Area: Oncology Product Name: MVC-101

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 19, 2020

            Details:

            The preclinical data demonstrate that MVC-280 regresses established solid tumors in mice and increases tolerability relative to inherently active T cell engagers.

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            Lead Product(s): MVC-101

            Therapeutic Area: Oncology Product Name: MVC-101

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 06, 2020

            Details:

            The article establishes Maverick’s core platform in the context of the current T cell engager landscape as applied to solid tumors, and highlights its technological advances in developing the next generation of conditionally active T cell engaging therapies for solid tumors.

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            Lead Product(s): CYT-101

            Therapeutic Area: Oncology Product Name: CYT-101

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Cytovia Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition August 03, 2020

            Details:

            Cytovia will conduct and finance all future development and will apply the EGFR Dual-targeting CAR to its iPSC CAR NK technology. CytoImmune will receive an upfront equity grant in Cytovia, future development milestones, and royalties.

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            Lead Product(s): IL-2 conjugates

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Ridgeline Therapeutics Discovery

            Deal Size: $35.0 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing July 28, 2020

            Details:

            Bright Peak’s technology platform allows a wide range of proteins to be chemically assembled de novo. The company has validated the platform by creating a portfolio of designer cytokines with the potential to be advanced as novel immune-oncology therapeutics.

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