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    Amphera Announces a Positive Opinion of the European Medicines Agency on the Granting of Orphan Medicinal Product Designation for MesoPher in Pancreatic...

    Details:

    MesoPher (Autologous Tumor Lysate-Loaded Dendritic Cell) is comprised of autologous patient DCs loaded with “PheraLys” – Amphera’s allogeneic lysate of mesothelioma cell lines and being developed for pancreatic cancer.


    Lead Product(s): Autologous Dendritic Cells Loaded PheraLys

    Therapeutic Area: Oncology Product Name: MesoPher

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

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 06, 2023

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    Amphera Announces Clinical Updates of MesoPher Cell Therapy

    Details:

    The DENIM trial confirmed MesoPher’s excellent safety profile and MesoPher induced a robust T-cell response. The immune response did not translate into clinical benefit, and consequently the primary endpoint of an improvement of Overall Survival (OS) was not met.


    Lead Product(s): Autologous DCs Loaded With PheraLys

    Therapeutic Area: Oncology Product Name: MesoPher

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

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 12, 2022

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    Last patient completed follow-up period in Phase II/III study of Amphera’s MesoPher cell therapy in mesothelioma

    Details:

    Patients received 3 bi-weekly injections of MesoPher, plus two further injections of MesoPher after 4 and 7 months. Patients in the control arm received best supportive care alone. The primary endpoint of the study is overall survival.


    Lead Product(s): MesoPher

    Therapeutic Area: Oncology Product Name: MesoPher

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

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 01, 2022

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    Amphera’s MesoPher Cell Therapy Demonstrates Favourable Safety and Promising Survival in a Phase II Clinical Trial in Resected Pancreatic Cancer

    Details:

    The latest REACtiVe data for MesoPher showed an average Overall Survival after surgery of approximately 36 months, with 8 of 10 patients alive, which is far beyond expected survival.


    Lead Product(s): MesoPher Dendritic Cell Therapy,Undisclosed

    Therapeutic Area: Oncology Product Name: MesoPher

    Highest Development Status: Phase IIProduct Type: Vaccine

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 04, 2022

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