Immunology | Phase II Developments

ARS Pharmaceuticals

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ARS Pharmaceuticals Announces New Patent on ARS-1 (epinephrine nasal spray)

Lead Product(s): Epinephrine

Therapeutic Area: Immunology Product Name: ARS-1

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 July 13, 2020

Details:

Patent approval covers fast-acting decreased dosage level for intranasal administration for type 1 allergic reaction.

Harbour BioMed

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Harbour BioMed Raises $102.8M in Series C Financing to Accelerate Development of Its Innovative Portfolio of Next Generation Biologics

Lead Product(s): Batoclimab

Therapeutic Area: Immunology Product Name: HBM9161

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Hudson Bay Capital

Deal Size: $102.8 million Upfront Cash: Undisclosed

Deal Type: Series C Financing July 09, 2020

Details:

The funds will support a relatively large clinical-phase pipeline spearheaded by an anti-FcRn antibody and a TNF-alpha receptor inhibitor that are on the cusp of registration trials.

Immunovant

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Immunovant Announces Plans for Phase 3 Registrational Trial of IMVT-1401 in Myasthenia Gravis

Lead Product(s): IMVT-1401

Therapeutic Area: Immunology Product Name: IMVT-1401

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:

Based on compelling proof-of-biology for anti-FcRn agents in Myasthenia Gravis (MG), Immunovant has begun preparations to initiate a Phase 3 registrational trial of IMVT-1401 in MG.

Hansa Biopharma

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Hansa Biopharma Receives Positive CHMP Opinion for IdefirixTM (imlifidase) for Kidney Transplant in EU

Lead Product(s): Imlifidase

Therapeutic Area: Immunology Product Name: Idefirix

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 25, 2020

Details:

CHMP of the EMA has adopted a positive opinion, recommending conditional approval of IdefirixTM for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

Alpine Immune Sciences

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Alpine Immune Sciences and AbbVie Announce Option and License Agreement for the Development and Commercialization of ALPN-101

Lead Product(s): ALPN-101

Therapeutic Area: Immunology Product Name: ALPN-101

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: AbbVie Inc

Deal Size: $865‬.0 million Upfront Cash: $60.0 million

Deal Type: Licensing Agreement June 18, 2020

Details:

Alpine Immune Sciences grants AbbVie option to license worldwide rights to ALPN-101, a phase 2-ready, first-in-class dual CD28/ICOS costimulation antagonist, building on AbbVie’s commitment to developing novel therapies in Immunology.

Momenta Pharmaceuticals

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Momenta Clears a PhII Hurdle on Nipo But One Big Rival Remains Well in the Lead in this Packed Field

Lead Product(s): Nipocalimab

Therapeutic Area: Immunology Product Name: Undisclosed

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 15, 2020

Details:

Phase 2 Vivacity-MG Study of Nipocalimab (M281) in Generalized Myasthenia Gravis, met primary endpoint with a strong relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit (p<0.0001).

AbbVie Inc

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Novel Antibody Drug Conjugate ABBV-3373 Shows Improvement in Disease Activity in Phase 2a Study of Patients with Rheumatoid Arthritis

Lead Product(s): ABBV-3373

Therapeutic Area: Immunology Product Name: Undisclosed

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 10, 2020

Details:

Data show the clinical activity of ABBV-3373 and support advancing the development of the platform in rheumatoid arthritis and initiating clinical studies in other immune-mediated diseases.

Kadmon

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Kadmon Raises $50 Million in Gross Proceeds Through Its at-the-Market Facility

Lead Product(s): Belumosudil

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $50.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 05, 2020

Details:

The proceeds from the offering will be used to advance belumosudil toward a NDA filing with the U.S FDA and support related pre-commercialization activities and provide additional working capital for general corporate purposes.

Biogen

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Biogen Presents Positive Phase 2 Cutaneous Lupus Erythematosus (CLE) Data at European E-Congress of Rheumatology (EULAR) 2020

Lead Product(s): BIIB059

Therapeutic Area: Immunology Product Name: Undisclosed

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 04, 2020

Details:

Full analysis of the CLE part of the LILAC study reinforces positive top-line results; participants who received BIIB059 (anti-BDCA2) demonstrated statistically significant reduction of disease activity compared to those who received placebo.

Aclaris Therapeutics

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Aclaris Therapeutics Announces Publication of the Phase 1 Clinical Trial Results for ATI-450

Lead Product(s): ATI-450,Methotrexate

Therapeutic Area: Immunology Product Name: Undisclosed

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 03, 2020

Details:

Abstract highlights data from a Phase 1 study in healthy volunteers exploring the safety, pharmacokinetics and pharmacodynamics of ATI-450, a novel oral MK2 inhibitor.

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Find Immunology Drugs in Phase II Clinical Development

Phase II

Product Type

Companies

ARS Pharmaceuticals

ARS Pharmaceuticals Announces New Patent on ARS-1 (epinephrine nasal spray)

Harbour BioMed

Harbour BioMed Raises $102.8M in Series C Financing to Accelerate Development of Its Innovative Portfolio of Next Generation Biologics

Immunovant

Immunovant Announces Plans for Phase 3 Registrational Trial of IMVT-1401 in Myasthenia Gravis

Hansa Biopharma

Hansa Biopharma Receives Positive CHMP Opinion for IdefirixTM (imlifidase) for Kidney Transplant in EU

Alpine Immune Sciences

Alpine Immune Sciences and AbbVie Announce Option and License Agreement for the Development and Commercialization of ALPN-101

Momenta Pharmaceuticals

Momenta Clears a PhII Hurdle on Nipo But One Big Rival Remains Well in the Lead in this Packed Field

AbbVie Inc

Novel Antibody Drug Conjugate ABBV-3373 Shows Improvement in Disease Activity in Phase 2a Study of Patients with Rheumatoid Arthritis

Kadmon

Kadmon Raises $50 Million in Gross Proceeds Through Its at-the-Market Facility

Biogen

Biogen Presents Positive Phase 2 Cutaneous Lupus Erythematosus (CLE) Data at European E-Congress of Rheumatology (EULAR) 2020

Aclaris Therapeutics

Aclaris Therapeutics Announces Publication of the Phase 1 Clinical Trial Results for ATI-450