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

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            Lead Product(s): Efineptakin alfa,Undisclosed

            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 July 27, 2020

            Details:

            NT-I7 has demonstrated clinically to help overcome lymphopenia in cancer patients by expanding lymphocyte counts in the peripheral blood as well as in the tumor microenvironment.

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            Lead Product(s): CypCaps

            Therapeutic Area: Oncology Product Name: CypCaps

            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 July 27, 2020

            Details:

            The DMF provides all confidential and detailed information covering the production of the CypCaps™ final product, which was produced by Austrianova and will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

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            Lead Product(s): GEN-011

            Therapeutic Area: Oncology Product Name: GEN-011

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

            Partner/Sponsor/Collaborator: Brookline Capital Markets

            Deal Size: $80.0 million Upfront Cash: Undisclosed

            Deal Type: Financing July 22, 2020

            Details:

            Genocea intends to use the net proceeds from this private placement to fund continued clinical and program development of its neoantigen vaccine GEN-009 and its neoantigen cell therapy GEN-011, as well as for working capital and other general corporate purposes.

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            Lead Product(s): TTX-080

            Therapeutic Area: Oncology Product Name: TTX-080

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Gilead Sciences

            Deal Size: $1,150.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition July 21, 2020

            Details:

            Gilead can exercise its option to acquire the remainder of Tizona following the readout of a Phase 1b study of Tizona’s investigational antibody, TTX-080, or earlier if Gilead decides to do so.

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            Lead Product(s): Efineptakin alfa,Nivolumab

            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 July 20, 2020

            Details:

            This IND clearance allows NeoImmuneTech (NIT) to initiate a randomized Phase 2 study comparing NT-I7 + nivolumab versus nivolumab to evaluate preliminary anti-tumor activity and to establish safety and tolerability of the combination in these patients.

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            Lead Product(s): Envafolimab,Ipilimumab

            Therapeutic Area: Oncology Product Name: KN035

            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 July 16, 2020

            Details:

            The application cross references the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology.

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            Lead Product(s): FT819

            Therapeutic Area: Oncology Product Name: FT819

            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 July 09, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT819, an off-the-shelf allogeneic chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies.

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            Lead Product(s): AB-101,Anti-CD20 monoclonal antibody

            Therapeutic Area: Oncology Product Name: AB-101

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

            Partner/Sponsor/Collaborator: 5AM Ventures

            Deal Size: $78.0 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing June 26, 2020

            Details:

            The company plans to enter the clinic this year with AB-101 in combination with an anti-CD20 monoclonal antibody for the treatment of relapsed refractory B-cell lymphoma.

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            Lead Product(s): TTX-080

            Therapeutic Area: Oncology Product Name: TTX-080

            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 June 25, 2020

            Details:

            TTX-080 prevents the suppression of both innate and adaptive immune activity and has the potential to enhance anti-tumor responses. Tizona plans to evaluate TTX-080 as both a monotherapy and in combination therapy in advanced cancers in a Phase 1 clinical trial.

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            Lead Product(s): JBI-802

            Therapeutic Area: Oncology Product Name: JBI-802

            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 June 22, 2020

            Details:

            Preclinical data demonstrated that JBI-802 has strong efficacy in multiple in vivo cancer models mediated by LSD1 and HDAC6 inhibition, it has excellent selectivity against other HDACs and superior in vivo efficacy compared to single agents targeting LSD1 or HDAC6.

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