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Find Drugs for Infections and Infectious Diseases in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): CYTO-201

            Therapeutic Area: Infections and Infectious Diseases Product Name: CYTO-201

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            Based on the FDA's feedback, Cytocom plans to revise the protocol of Company's planned Phase 2 clinical trial of CYTO-201 for the treatment of SARS-CoV-2 and quickly initiate enrollment.

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            Lead Product(s): Interleukin-7

            Therapeutic Area: Infections and Infectious Diseases Product Name: CYT107

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            CYT107 is a therapeutic form of the master growth factor for human T cells: Interleukin-7 (IL-7). CYT107 has been administered to over 440 patients in clinical trials and is known to substantially increase the number and diversity of T cells, including in patients in the ICU.

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            Lead Product(s): Autologous adipose-derived stem cells

            Therapeutic Area: Infections and Infectious Diseases Product Name: AdMSCs

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 26, 2020

            Details:

            This is a Phase 2 multi-center, randomized, double-blind, placebo-controlled study that will evaluate the safety and prophylactic efficacy of AdMSCs against COVID-19.

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            Lead Product(s): mRNA-1273

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Vaccine

            Partner/Sponsor/Collaborator: Moderna Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration June 25, 2020

            Details:

            Both Companies have collaborated for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Indiana.

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            Lead Product(s): M5049

            Therapeutic Area: Infections and Infectious Diseases Product Name: M5049

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 25, 2020

            Details:

            The Phase 1 segment of this trial will generate important data about the safety and tolerability of GT103, which targets complement factor H, a protein that protects tumor cells from complement lysis.

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            Lead Product(s): TD-0903

            Therapeutic Area: Infections and Infectious Diseases Product Name: TD-0903

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 25, 2020

            Details:

            First COVID-19 patient has been dosed in a Phase 2 study of TD-0903. TD-0903 is a lung-selective, nebulized Janus kinase inhibitor (JAKi) in development for the potential treatment of hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19.

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            Lead Product(s): ABI-H2158,Entecavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H2158

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 25, 2020

            Details:

            The international multi-center, randomized, placebo-controlled trial will evaluate 2158 with entecavir versus placebo with entecavir in treatment-naïve patients with HBeAg positive chronic hepatitis B infection without cirrhosis.

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            Lead Product(s): Stannous protoporphyrin

            Therapeutic Area: Infections and Infectious Diseases Product Name: RBT-9

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Renibus Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration June 24, 2020

            Details:

            RBT-9 is being developed by Renibus Therapeutics as an antiviral agent with organ-protective attributes. With the advent of the coronavirus pandemic, Renibus scientists moved quickly to plan and initiate a clinical trial of RBT-9 in COVID-19 patients.

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            Lead Product(s): Pamrevlumab

            Therapeutic Area: Infections and Infectious Diseases Product Name: FG-3019

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 23, 2020

            Details:

            The primary objective of this study is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 infection, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio.

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            Lead Product(s): Stannous protoporphyrin

            Therapeutic Area: Infections and Infectious Diseases Product Name: RBT-9

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 23, 2020

            Details:

            Preclinical studies have shown that RBT-9 protects various organs, including the lung, heart, kidney, and liver. Importantly, RBT-9 has demonstrated antiviral activity in several enveloped viruses and inhibits a key mediator of viral replication in coronaviruses.

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