Immunology | Phase III Developments | UNITED STATES

X4 Pharmaceuticals

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X4 Pharmaceuticals Announces Publication of Mavorixafor Phase 2 Clinical Data for Treatment of WHIM Syndrome in ‘Blood’

Lead Product(s): Mavorixafor

Therapeutic Area: Immunology Product Name: AMD11070

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 02, 2020

Details:

Publication infoms about a comprehensive safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy data of mavorixafor from an ongoing Phase 2, dose-escalation study in adult patients with genetically confirmed WHIM syndrome.

AbbVie Inc

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AbbVie Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis

Lead Product(s): Upadacitinib

Therapeutic Area: Immunology Product Name: Rinvoq

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 25, 2020

Details:

The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.

Momenta Pharmaceuticals

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Momenta Enters Definitive Agreement with Johnson & Johnson

Lead Product(s): Nipocalimab

Therapeutic Area: Immunology Product Name: M281

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Johnson & Johnson

Deal Size: $6,500.0 million Upfront Cash: $6,500.0 million

Deal Type: Acquisition August 19, 2020

Details:

This acquisition gives Johnson & Johnson a major entry point into a new class of drugs. Momenta’s FcRn inhibitor, nipocalimab, has the potential to transform treatment of autoantibody-driven autoimmune diseases.

Gilead Sciences

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Gilead Receives Complete Response Letter for Filgotinib for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

Lead Product(s): Filgotinib

Therapeutic Area: Immunology Product Name: GS-6034

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 18, 2020

Details:

U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA).

Principia Biopharma

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Sanofi to acquire Principia Biopharma

Lead Product(s): SAR442168

Therapeutic Area: Immunology Product Name: SAR442168

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Sanofi

Deal Size: $3,680.0 million Upfront Cash: $3,680

Deal Type: Acquisition August 17, 2020

Details:

The acquisition expands and accelerates development of Sanofi's BTK inhibitors consisting ‘168, rilzabrutinib and PRN473 Topical, across multiple indications.

Gilead Sciences

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Gilead and Galapagos Gets Positive EU CHMP Opinion For Jyseleca® For The Treatment Of Adults With Moderate To Severe Rheumatoid Arthritis

Lead Product(s): Filgotinib

Therapeutic Area: Immunology Product Name: Jyseleca

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Galapagos

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 24, 2020

Details:

The CHMP positive opinion is supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs, which included 4,544 RA patient-years of experience with filgotinib.

Incyte Corporation

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Incyte Announces REACH3 Trial of Ruxolitinib in Patients with Chronic Graft-Versus-Host Disease Met Primary and Both Key Secondary Endpoints

Lead Product(s): Ruxolitinib

Therapeutic Area: Immunology Product Name: Jakafi

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 23, 2020

Details:

Jakafi® demonstrated superior overall response rate in patients with steroid-refractory chronic graft-versus-host disease (GVHD) at Week 24 compared to best available therapy.

Talaris Therapeutics

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Talaris Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients

Lead Product(s): FCR001

Therapeutic Area: Immunology Product Name: FCR001

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 22, 2020

Details:

The trial will evaluate the safety and efficacy of a single dose of FCR001, the company’s investigational cell therapy designed to durably free LDKT recipients from immunosuppression without rejection of their transplanted organ.

ChemoCentryx

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ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis

Lead Product(s): Avacopan,Rituximab,Cyclophosphamide

Therapeutic Area: Immunology Product Name: CCX168

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 09, 2020

Details:

The Company’s NDA submission is supported by the results of its pivotal Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group.

Janssen Pharmaceutical

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Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus

Lead Product(s): Ustekinumab

Therapeutic Area: Immunology Product Name: Stelara

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 26, 2020

Details:

The decision is based on data from a pre-planned interim efficacy analysis. Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified.

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Find Immunology Drugs in Phase III Clinical Development in UNITED STATES

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Companies

X4 Pharmaceuticals

X4 Pharmaceuticals Announces Publication of Mavorixafor Phase 2 Clinical Data for Treatment of WHIM Syndrome in ‘Blood’

AbbVie Inc

AbbVie Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis

Momenta Pharmaceuticals

Momenta Enters Definitive Agreement with Johnson & Johnson

Gilead Sciences

Gilead Receives Complete Response Letter for Filgotinib for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

Principia Biopharma

Sanofi to acquire Principia Biopharma

Gilead Sciences

Gilead and Galapagos Gets Positive EU CHMP Opinion For Jyseleca® For The Treatment Of Adults With Moderate To Severe Rheumatoid Arthritis

Incyte Corporation

Incyte Announces REACH3 Trial of Ruxolitinib in Patients with Chronic Graft-Versus-Host Disease Met Primary and Both Key Secondary Endpoints

Talaris Therapeutics

Talaris Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients

ChemoCentryx

ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis

Janssen Pharmaceutical

Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus