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Find Immunology Drugs in Phase I Clinical Development in UNITED STATES

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            Lead Product(s): MGTA-145

            Therapeutic Area: Immunology Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2020

            Details:

            MGTA-145 first-line mobilization program to move into Phase 2 studies in autologous and allogeneic patients in 2020, including allogeneic study in newly announced collaboration with National Marrow Donor Program® (NMDP)/Be The Match®.

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            Lead Product(s): CDX-0159

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 06, 2020

            Details:

            CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, consistent with systemic mast cell suppression.

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            Lead Product(s): BX-U001

            Therapeutic Area: Immunology Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 05, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has cleared Baylx's Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with Rheumatoid Arthritis (RA).

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            Lead Product(s): NKTR-358

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 04, 2020

            Details:

            The data, presented during the EULAR 2020, show that NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent expansion of regulatory T cells (Tregs) that was maintained over multiple administrations.

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            Lead Product(s): Ibafloxacin

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 03, 2020

            Details:

            Data related to R835, the company's investigational IRAK1/4 inhibitor, will be presented in two oral and two poster presentations at the European League Against Rheumatism (EULAR) 2020 E-Congress.

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            Lead Product(s): NKTR-358

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 29, 2020

            Details:

            Data from a Phase 1b multiple ascending dose study of NKTR-358, a first-in-class investigational regulatory T cell stimulator, in patients with systemic lupus erythematosus will be presented.

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            Lead Product(s): ADX-914

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Atlas Venture

            Deal Size: $46.0 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing May 27, 2020

            Details:

            With this financing, Q32 Bio is planning to advance a portfolio of biologics targeting the body’s innate and adaptive immune systems and also plans to enter the clinic this year with its lead candidate, ADX-914.

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            Lead Product(s): VIB7734

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 14, 2020

            Details:

            The interim findings indicated safety and tolerability comparable to placebo control across all cohorts, potent depletion of pDC both in peripheral blood and in inflamed CLE skin lesion biopsies in cohort 2, and dose-dependent reduction in CLASI after treatment with VIB7734.

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            Lead Product(s): ADX- 629

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 14, 2020

            Details:

            ADX-629 was well-tolerated, and no treatment-related adverse events were observed in the trial.

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            Lead Product(s): Epinephrine

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 06, 2020

            Details:

            Intranasal (IN) delivery of epinephrine from Bryn's needle-free Bi-dose Epinephrine Nasal Spray was comparable to intramuscular (IM) injection in pharmacokinetics, pharmacodynamics, and safety.

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