Immunology | Phase I Developments | UNITED STATES

Magenta Therapeutics

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Magenta Reports Stem Cell Mobilization and Conditioning Programs Prioritized and Advancing Toward Clinical Milestones

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®.

Celldex Therapeutics

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Celldex’s KIT Inhibitor CDX-0159 Demonstrates Profound, Sustained Dose-dependent Reductions in Plasma Tryptase

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.

Baylx

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BAYLX,INC. Received US FDA Clearance of IND Application for Cord Tissue Mesenchymal Stem Cells

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).

Nektar Therapeutics

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Data Presented from Phase 1b Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at Annual European Congress of Rheumatology

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.

Rigel Pharmaceuticals

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Rigel to Present Four Posters Highlighting IRAK1/4 Inhibitor at the EULAR 2020 E-Congress

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.

Nektar Therapeutics

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Nektar Therapeutics to Host Webcast Conference Call for Analysts & Investors During 2020 Virtual European Congress of Rheumatology

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.

Q32 Bio

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Q32 Bio Launches to Develop Novel Therapeutics Targeting Regulators of Innate and Adaptive Immunity

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.

Viela Bio

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Viela Bio Announces Positive Interim Results from a Phase 1b Study of VIB7734 in Patients with Cutaneous Lupus Erythematosus

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.

Aldeyra Therapeutics

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Aldeyra Announces Positive Top-Line Phase 1 Clinical Trial Results and Clinical Development Plans for ADX-629

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.

Bryn Pharma

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Bryn Pharma Presents Data Demonstrating Comparable Pharmacokinetic and Pharmacodynamic Effects of Intranasal Epinephrine

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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Magenta Therapeutics

Magenta Reports Stem Cell Mobilization and Conditioning Programs Prioritized and Advancing Toward Clinical Milestones

Celldex Therapeutics

Celldex’s KIT Inhibitor CDX-0159 Demonstrates Profound, Sustained Dose-dependent Reductions in Plasma Tryptase

Baylx

BAYLX,INC. Received US FDA Clearance of IND Application for Cord Tissue Mesenchymal Stem Cells

Nektar Therapeutics

Data Presented from Phase 1b Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at Annual European Congress of Rheumatology

Rigel Pharmaceuticals

Rigel to Present Four Posters Highlighting IRAK1/4 Inhibitor at the EULAR 2020 E-Congress

Nektar Therapeutics

Nektar Therapeutics to Host Webcast Conference Call for Analysts & Investors During 2020 Virtual European Congress of Rheumatology

Q32 Bio

Q32 Bio Launches to Develop Novel Therapeutics Targeting Regulators of Innate and Adaptive Immunity

Viela Bio

Viela Bio Announces Positive Interim Results from a Phase 1b Study of VIB7734 in Patients with Cutaneous Lupus Erythematosus

Aldeyra Therapeutics

Aldeyra Announces Positive Top-Line Phase 1 Clinical Trial Results and Clinical Development Plans for ADX-629

Bryn Pharma

Bryn Pharma Presents Data Demonstrating Comparable Pharmacokinetic and Pharmacodynamic Effects of Intranasal Epinephrine