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Find FDA Investigational New Drug (IND) Submissions for Oncology in UNITED STATES

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            Lead Product(s): SBT6050

            Therapeutic Area: Oncology

            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 May 15, 2020

            Details:

            Data highlights systemically delivered, tissue-directed, localized activation of myeloid cells and inducement of immune response in tumors lacking T cells.

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            Lead Product(s): HFB301001

            Therapeutic Area: Oncology

            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 May 15, 2020

            Details:

            HiFiBiO Therapeutics will take a pioneering approach to clinical development of its pipeline of antibody candidates by using patient stratification biomarkers identified by the company’s proprietary Drug Intelligent Science (DIS™).

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            Lead Product(s): EDIT-201

            Therapeutic Area: Oncology

            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 May 15, 2020

            Details:

            The iNKs derived from the edited iPSC clones had enhanced tumor killing activity relative to iNKs from unedited iPSCs, demonstrating the utility of an edited iPSC platform.

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            Lead Product(s): KP1237,NK Cell Therapy

            Therapeutic Area: Oncology

            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 May 15, 2020

            Details:

            Data support the initiation of an upcoming first-in-human trial for first-line, MRD+ multiple myeloma patients post-ASCT.

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            Lead Product(s): iNKT cell

            Therapeutic Area: Oncology

            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 May 13, 2020

            Details:

            FDA has accepted the IND application for an allogeneic iNKT therapy, agenT-797, submitted by AgenTus Therapeutics. AgenTus has also submitted a separate IND for the treatment of COVID-19.

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            Lead Product(s): MB-104

            Therapeutic Area: Oncology

            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 May 12, 2020

            Details:

            Presentation will highlight the results of CS1 Targeted CAR-T cells (MB-104) for multiple myeloma treatment that showed antitumor activity sparing normal T-cells despite common CS1 expression.

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            Lead Product(s): ST101

            Therapeutic Area: Oncology

            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 May 07, 2020

            Details:

            MHRA UK has accepted Sapience's Clinical Trial Authorization application for ST101, a peptide therapy being evaluated for the treatment of adults with unresectable and metastatic solid tumors.

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            Lead Product(s): ZN-d5

            Therapeutic Area: Oncology

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 30, 2020

            Details:

            U.S. FDA has cleared the Zentalis's IND application for ZN-d5, an oral selective inhibitor of B-cell lymphoma 2 initially in development for the treatment of hematologic malignancies.

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            Lead Product(s): EDIT-201

            Therapeutic Area: Oncology

            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 April 29, 2020

            Details:

            The company believes that EDIT-201, which uses innate immune cells, specifically NK cells, has the potential to be a transformational therapy.

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            Lead Product(s): Natural killer cells

            Therapeutic Area: Oncology

            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 April 22, 2020

            Details:

            The patent covers a method of cancer treatment by delivering a patented preparation of inactivated cellular material and accessing the patient's own natural killer cells within the body.

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