Neurology | Phase I/ Phase II Developments

Stoke Therapeutics

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United States

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Stoke Therapeutics Announces Publication of Preclinical Data on STK-001 in the Journal Science Translational Medicine

Lead Product(s): STK-001

Therapeutic Area: Neurology Product Name: STK-001

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 26, 2020

Details:

Data published in the journal Science Translational Medicine showed that STK-001 achieved target engagement, pharmacologic activity and efficacy by selectively increasing Scn1a gene and Nav1.1 protein expression.

Kadimastem

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ISRAEL Israel

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Kadimastem Reports Positive Interim Results of Cohort B of its AstroRx® Phase 1/2a Clinical Trial in ALS

Lead Product(s): Human astrocytes

Therapeutic Area: Neurology Product Name: AstroRx

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

Details:

Kadimastem's lead product, AstroRx®, showed a positive efficacy signal and a good safety profile in Cohort B of the Company’s Phase 1/2a clinical trial in ALS.

Oxford Biomedica

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United Kingdom

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Axovant Signs Three-Year Clinical Supply Agreement With Oxford Biomedica for Manufacturing and Supply of AXO-Lenti-PD

Lead Product(s): AXO-Lenti-PD

Therapeutic Area: Neurology Product Name: OXB-102

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

Partner/Sponsor/Collaborator: Axovant Gene Therapies

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 31, 2020

Details:

Oxford Biomedica will manufacture GMP batches for Axovant to support the ongoing and future clinical development of AXO-Lenti-PD, a clinical-stage gene therapy product to treat moderate to severe Parkinson’s Disease based on Oxford Biomedica’s LentiVector® platform.

Prevail Therapeutics

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Prevail Therapeutics Granted Composition of Matter Patent for Experimental Gene Therapy Program PR006

Lead Product(s): PR006

Therapeutic Area: Neurology Product Name: PR006

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2020

Details:

PR006 is being developed as a potential one-time gene therapy for FTD-GRN, a progressive neurodegenerative disease caused by mutations in the GRN gene that reduce production of progranulin.

AC Immune

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Switzerland

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AC Immune Advances Phospho-Tau Alzheimer’s Vaccine in Phase 1b/2a Study

Lead Product(s): ACI-35.030

Therapeutic Area: Neurology Product Name: ACI-35.030

Highest Development Status: Phase I/ Phase II Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 16, 2020

Details:

The ACI-35.030 anti-pTau vaccine is the second vaccine under investigation generated from AC Immune’s SupraAntigen™ platform, along with ACI-24, a proprietary anti-amyloid beta (Abeta) vaccine currently in Phase 1b/Phase 2 clinical development in two separate indications.

Axovant Gene Therapies

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United States

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Four Patients Given Higher AXO-Lenti-PD Dose in Gene Therapy Trial

Lead Product(s): AXO-Lenti-PD

Therapeutic Area: Neurology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 2020

Details:

A Phase 1/2 clinical trial testing AXO-Lenti-PD (OXB102), Axovant‘s experimental gene therapy for Parkinson’s disease, has completed dosing of all four adults in a second group in its dose-escalation part of the study.

Aim ImmunoTech

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AIM ImmunoTech files provisional patent application for Ampligen as treatment for COVID-19 induced fatigue

Lead Product(s): Rintatolimod,Interferon Alfa-2B

Therapeutic Area: Neurology Product Name: Ampligen

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

Company has filed a provisional patent application for, among other discoveries, the use of its experimental drug Ampligen® as a potential early-onset therapy for the treatment of COVID-19 induced chronic fatigue, which shows similarities to ME/CFS.

Heron Therapeutics

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United States

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Heron Therapeutics Begins Phase 1b/2 Study of HTX-034 to Treat Postoperative Pain

Lead Product(s): Bupivacaine,Meloxicam

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2020

Details:

The study initiation follows clearance from the US Food and Drug Administration (FDA) of Heron's Investigational New Drug (IND) application for HTX-034 for the treatment of postoperative pain.

Alpha Cognition

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CANADA Canada

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Alpha Cognition, Inc. Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy

Lead Product(s): Alpha-1062

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 30, 2020

Details:

U.S. FDA agreed upon a clinical and regulatory pathway for the approval of Alpha-1062 and has suggested that a single pivotal trial, scheduled for mid-2021.

Harbour BioMed

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Harbour BioMed Announces First Patient Dosed in Phase 1b/2a Study of Anti-FcRn Batoclimab to Treat Neuromyelitis Optica Spectrum Disorder

Lead Product(s): Batoclimab

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2020

Details:

The study aims to assess the safety, tolerability, pharmacodynamics, and efficacy of batoclimab in patients with NMOSD in China. It is the first anti-FcRn PoC study for the treatment of NMOSD.

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Phase I/ Phase II

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Companies

Stoke Therapeutics

Stoke Therapeutics Announces Publication of Preclinical Data on STK-001 in the Journal Science Translational Medicine

Kadimastem

Kadimastem Reports Positive Interim Results of Cohort B of its AstroRx® Phase 1/2a Clinical Trial in ALS

Oxford Biomedica

Axovant Signs Three-Year Clinical Supply Agreement With Oxford Biomedica for Manufacturing and Supply of AXO-Lenti-PD

Prevail Therapeutics

Prevail Therapeutics Granted Composition of Matter Patent for Experimental Gene Therapy Program PR006

AC Immune

AC Immune Advances Phospho-Tau Alzheimer’s Vaccine in Phase 1b/2a Study

Axovant Gene Therapies

Four Patients Given Higher AXO-Lenti-PD Dose in Gene Therapy Trial

Aim ImmunoTech

AIM ImmunoTech files provisional patent application for Ampligen as treatment for COVID-19 induced fatigue

Heron Therapeutics

Heron Therapeutics Begins Phase 1b/2 Study of HTX-034 to Treat Postoperative Pain

Alpha Cognition

Alpha Cognition, Inc. Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy

Harbour BioMed

Harbour BioMed Announces First Patient Dosed in Phase 1b/2a Study of Anti-FcRn Batoclimab to Treat Neuromyelitis Optica Spectrum Disorder