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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): CG-806

            Therapeutic Area: Oncology Product Name: CG-806

            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 29, 2020

            Details:

            CG-806 is currently in a Phase 1 dose escalation study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to current therapies.

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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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            Lead Product(s): SBT6050

            Therapeutic Area: Oncology Product Name: SBT6050

            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 22, 2020

            Details:

            The presentation shows that TLR8 agonism potently and uniquely activates human myeloid cells, driving a broad spectrum of anti-tumor immune mechanisms, including those not dependent on T cells.

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            Lead Product(s): AMX-818

            Therapeutic Area: Oncology Product Name: AMX-818

            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 22, 2020

            Details:

            Data demonstrate potential of Amunix’s XPAT platform to significantly widen therapeutic index, and address on-target, off-tumor toxicity that has hindered application of T cell engagers to treat solid tumors.

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            Lead Product(s): BPX-603

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 June 15, 2020

            Details:

            BPX-603 is the company’s first dual-switch GoCAR-T® product candidate, which incorporates both the company’s iMC activation and CaspaCIDe® safety switch technologies.

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            Lead Product(s): GEN-011

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 June 15, 2020

            Details:

            Company announced the filing of an IND Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical study of GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy.

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            Lead Product(s): CpG-STAT3siRNA

            Therapeutic Area: Oncology Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Scopus BioPharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement June 11, 2020

            Details:

            The licensed gene therapy drug, CpG-STAT3siRNA, is a highly-selective and targeted therapy that silences the activity of the STAT3 gene by way of RNA interference while stimulating the TLR9 receptors to activate the body's immune defense to recognize and kill cancer cells.

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