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

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            Lead Product(s): PC14586

            Therapeutic Area: Oncology Product Name: PC14586

            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 October 13, 2020

            Details:

            PC14586 is a first-in-class small molecule designed to structurally correct the p53 Y220C mutant protein. There are currently no FDA-approved medicines that target the p53 Y220C mutation.

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            Lead Product(s): APR-548

            Therapeutic Area: Oncology Product Name: APR-548

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Karolinska Development AB

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 07, 2020

            Details:

            Aprea Therapeutics intends to initiate a Phase 1 clinical trial of APR-548 in MDS to expand its leadership in the development of therapeutic options for patients with p53 mutated cancers.

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            Lead Product(s): CypCaps,Ifosfamide

            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 October 02, 2020

            Details:

            The trial will be a prospective, multicenter, randomized, open-label Phase 2b study to evaluate the efficacy and safety of CypCapsTM in combination with low-dose ifosfamide as compared to chemoradiation therapy with capecitabine plus EBRT or SBRT alone.

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            Lead Product(s): TNB-486

            Therapeutic Area: Oncology Product Name: TNB-486

            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 October 01, 2020

            Details:

            TNB-486 is a fully human bispecific antibody that binds CD19 with one arm and incorporates unique anti-CD3 on the other. In preclinical studies, TNB-486 induced T-cell dependent killing of CD19-positive B-cell leukemia and lymphoma cells while inducing less cytokine secretion.

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            Lead Product(s): ADXS-504

            Therapeutic Area: Oncology Product Name: ADXS-504

            Highest Development Status: IND Enabling Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 24, 2020

            Details:

            Advaxis intends to first advance the clinical evaluation of ADXS-504 through an Investigator Sponsored Phase 1 study in prostate cancer patients with biochemical recurrence which remains on-track for initiation in the fourth quarter this year.

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            Lead Product(s): TCRT-ESO-A2

            Therapeutic Area: Oncology Product Name: TCRT-ESO-A2

            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 23, 2020

            Details:

            TCRT-ESO-A2 is being developed by Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences Limited (“XLifeSc"), a subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147).

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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: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2020

            Details:

            The IND allows Genocea to initiate a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy. The trial will evaluate safety, T cell proliferation and persistence as well as clinical activity.

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            Lead Product(s): PC14586

            Therapeutic Area: Oncology Product Name: PC14586

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Goldman Sachs

            Deal Size: $125.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 21, 2020

            Details:

            The company's lead candidate, PC14586, is designed to potently and selectively correct p53 misfolding caused by a specific p53 mutation while sparing wild-type p53.

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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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