Neurology | Phase I Developments | UNITED STATES

Pfizer Inc

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Biogen to buy early-stage potential Alzheimer's, Parkinson's treatment from Pfizer

Lead Product(s): PF-05251749

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Biogen

Deal Size: $710.0 million Upfront Cash: $75.0 million

Deal Type: Acquisition January 13, 2020

Details:

With this purchase, Biogen plans to develop the Phase 1 asset for the treatment of Sundowning in Alzheimer’s disease (AD) and Irregular Sleep Wake Rhythm Disorder in Parkinson’s disease.

Biogen

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First Patient Enrolled in Phase 1 Gene Therapy Study in Ireland

Lead Product(s): BIIB078

Therapeutic Area: Neurology Product Name: BIIB078

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 September 04, 2020

Details:

Sponsored by Biogen, the trial involves a new gene therapy, called BIIB078, that targets a mutation in the ALS-associated gene C90rf72. Known as an expansion, this mutation occurs when a sequence of DNA “letters” is repeated within the gene.

Atara Biotherapeutics

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Atara Biotherapeutics to Present 12-Month Data from All Four Cohorts in the Phase 1a Study of ATA188 in Progressive MS at MSVirtual2020

Lead Product(s): ATA188

Therapeutic Area: Neurology Product Name: ATA188

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 September 01, 2020

Details:

Company will present for the first time 12-month data from all four cohorts in the Phase 1a study of ATA188 for the treatment of progressive forms of multiple sclerosis (MS) at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting, held September 11-13, 2020.

Yumanity Therapeutics

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Yumanity Therapeutics and Proteostasis Therapeutics Announce Merger Agreement

Lead Product(s): YTX-7739

Therapeutic Area: Neurology Product Name: YTX-7739

Highest Development Status: Phase I Product Type: Undisclosed

Partner/Sponsor/Collaborator: Proteostasis Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Merger August 24, 2020

Details:

The combined company will leverage their common scientific expertise in protein misfolding, and will work to advance Yumanity’s lead candidate YTX-7739, currently in Phase 1 clinical development for the treatment and disease modification of Parkinson’s disease.

INmune Bio

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European Patent Granted Covering INmune Bio’s XPro1595

Lead Product(s): XPro1595

Therapeutic Area: Neurology Product Name: XPro1595

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 August 13, 2020

Details:

European Patent Office granted patent covers XPro1595 and Algernon's peripheral administration for treating Alzheimer’s Disease and other diseases of the CNS.

Kineta

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Kineta Receives Regulatory Approval for Initiation of Phase 1 Clinical Trials of KCP506

Lead Product(s): KCP506

Therapeutic Area: Neurology Product Name: KCP506

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 August 12, 2020

Details:

A double-blind, placebo-controlled, single ascending dose and multiple ascending dose study will be conducted in healthy subjects to evaluate the safety, tolerability, and pharmacokinetics of KCP506.

Denali Therapeutics

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Biogen and Denali to Collaborate on LRRK2 Program for Parkinson’s Disease and TV Platform-Enabled Programs for Neurodegenerative Diseases

Lead Product(s): DNL151

Therapeutic Area: Neurology Product Name: DNL151

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Biogen

Deal Size: $2,150.0 million Upfront Cash: $560.0 million

Deal Type: Collaboration August 06, 2020

Details:

Biogen will collaborate with Denali to co-develop and co-commercialize Denali’s small molecule inhibitors of LRRK2 for Parkinson’s disease. Biogen and Denali will co-commercialize the LRRK2 product in the U.S. and China, and Biogen will commercialize in all other markets.

Denali Therapeutics

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Denali Therapeutics Announces Decision to Advance DNL151 into Late Stage Clinical Studies in Parkinson’s Patients

Lead Product(s): DNL151

Therapeutic Area: Neurology Product Name: DNL151

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 August 06, 2020

Details:

DNL151 selected to advance into two late stage studies in Parkinson’s disease in patients with a kinase activating mutation in LRRK2 and in patients with sporadic disease.

IMAC Holdings

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IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the T...

Lead Product(s): Allogeneic mesenchymal stem cells

Therapeutic Area: Neurology Product Name: MSCTC-0010

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 August 05, 2020

Details:

FDA approved its investigational new drug application for the use of umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual loss and slowing down of spontaneous body movement, due to Parkinson’s disease.

Sonnet BioTherapeutics

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Sonnet BioTherapeutics Signs Letter of Intent for Potential Licensing of Neuropathies Asset to New Life Therapeutics

Lead Product(s): SON-081

Therapeutic Area: Neurology Product Name: SON-081

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: New Life Therapeutics

Deal Size: $40.5 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 04, 2020

Details:

Sonnet BioTherapeutics executed a letter of intent to license its SON-081 and SON-080 assets, both low-dose formulations of Interleukin 6 (IL-6), for diabetic peripheral neuropathy (DPN) and chemotherapy-induced peripheral neuropathy (CIPN) to New Life Therapeutics.

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Pfizer Inc

Biogen to buy early-stage potential Alzheimer's, Parkinson's treatment from Pfizer

Biogen

First Patient Enrolled in Phase 1 Gene Therapy Study in Ireland

Atara Biotherapeutics

Atara Biotherapeutics to Present 12-Month Data from All Four Cohorts in the Phase 1a Study of ATA188 in Progressive MS at MSVirtual2020

Yumanity Therapeutics

Yumanity Therapeutics and Proteostasis Therapeutics Announce Merger Agreement

INmune Bio

European Patent Granted Covering INmune Bio’s XPro1595

Kineta

Kineta Receives Regulatory Approval for Initiation of Phase 1 Clinical Trials of KCP506

Denali Therapeutics

Biogen and Denali to Collaborate on LRRK2 Program for Parkinson’s Disease and TV Platform-Enabled Programs for Neurodegenerative Diseases

Denali Therapeutics

Denali Therapeutics Announces Decision to Advance DNL151 into Late Stage Clinical Studies in Parkinson’s Patients

IMAC Holdings

IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the T...

Sonnet BioTherapeutics

Sonnet BioTherapeutics Signs Letter of Intent for Potential Licensing of Neuropathies Asset to New Life Therapeutics