Synovial sarcoma

Medigene AG reports Financial Results and Business Update for Q1 2024

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星期五, 四月 26, 2024

Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial results for the first quarter of 2024.

Key Points: 
  • Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial results for the first quarter of 2024.
  • The full Quarterly Statement Q1 2024 can be downloaded here: https://medigene.com/investors-media/reports-presentations/ .
  • The financial performance in Q1 2024 was in line with the Executive Management Board’s expectations.
  • The subscription period for the new shares commenced on April 24, 2024 and ends on May 7, 2024 at 24:00 hours (CEST).

Medigene presents streamlined 6-day, high stemness TCR-T therapy production process

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星期四, 四月 25, 2024

Medigene tackles these challenges with a comprehensive approach, which starts with the development of a potential best-in-class, 3S (sensitive, specific, and safe) TCR.

Key Points: 
  • Medigene tackles these challenges with a comprehensive approach, which starts with the development of a potential best-in-class, 3S (sensitive, specific, and safe) TCR.
  • This process is vital for producing effective, safe, and durable TCR-T therapies," stated Kirsty Crame, MD, VP Clinical Strategy & Development.
  • Medigene has developed a streamlined 6-day manufacturing process that focuses on the enrichment of CD8+ T cells whilst simultaneously maintaining a high degree of stemness.
  • Clinical indications for MDG1015 were primarily chosen based on the high unmet medical need, expression of the target antigen and/or PD-L1.

Medigene Presents Favorable Safety Profile of TCR-T Cells with Costimulatory Switch Protein at AACR Annual Meeting 2024

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星期一, 四月 8, 2024

Impaired T cell functionality and T cell exhaustion are driven by several factors within the hostile solid tumor microenvironment (TME).

Key Points: 
  • Impaired T cell functionality and T cell exhaustion are driven by several factors within the hostile solid tumor microenvironment (TME).
  • This is one major factor that allows cancer cells to proliferate and metastasize without being recognized by the host immune system.
  • Enhanced, gated T cell functionality of CSP-armored rTCR-T cells increased secretion of interferon-γ (IFNγ) only when tumor cells simultaneously expressed the pHLA target antigen and PD-L1.
  • Rapid and sustained killing of 3D tumor cell-derived spheroids only occurred when PD-L1-positive tumor cells simultaneously expressed the specific pHLA target antigen.

Medigene AG Reports Full-Year 2023 Financial Results and Provides Corporate Update

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星期四, 三月 28, 2024

Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial results for the fiscal year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial results for the fiscal year ended December 31, 2023, and provided a corporate update.
  • General and administrative (G&A) expenses were EUR 9.3 million in 2023 compared to EUR 7.7 million in the year prior.
  • First pre-clinical data on MDG2011 was presented at the ESMO Congress 2023 and the SITC Annual Meeting 2023.
  • As of Dec 31, 2023, Medigene’s IP portfolio consisted of 112 issued and 131 pending patents across 28 patent families.

Medigene to Present Favorable Safety Profile of TCR-T Cells upon Addition of Costimulatory Switch Protein with a Poster Presentation at AACR 2024 Annual Meeting

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星期三, 三月 6, 2024

Details on the poster presentation are as follows:

Key Points: 
  • Details on the poster presentation are as follows:
    Session details: PO.IM01.13 - Adoptive Cell Therapies 1: Tumor Antigen-Specific T-cells and TCR-T, Sunday, April 7, 1:30 PM - 5:00 PM local time
    The work to be presented shows that recombinant T cell receptor engineered T cells (rTCR-T cells), when armored and enhanced by the PD1-41BB CSP, exhibit superior TCR-T cell functionality and safety as well as a favorable safety profile, revealing the strong potential for improving treatment of cancer patients suffering from advanced solid tumor malignancies.
  • The Company is planning a first-in-human trial for MDG1015, a TCR-T therapy incorporating the CSP in gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma with IND/CTA filing targeted for 2H 2024.
  • MDG1015 is a first-in-class, third generation TCR-T therapy targeting NY-ESO-1/ LAGE-1a, armored and enhanced by the PD1-41BB CSP.

Medigene Announces Indication Selection for the Clinical Development of its Lead 3rd Generation TCR-T Therapy Program in Solid Tumors

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星期一, 二月 12, 2024

MDG1015 is a first-in-class, third generation TCR-T therapy targeting NY-ESO-1/ LAGE-1a, armored and enhanced by costimulatory switch protein PD1-41BB

Key Points: 
  • MDG1015 is a first-in-class, third generation TCR-T therapy targeting NY-ESO-1/ LAGE-1a, armored and enhanced by costimulatory switch protein PD1-41BB
    Planegg/Martinsried, February 12, 2024.
  • Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today announced the selection of gastric cancer, ovarian cancer and two types of soft tissue sarcomas, myxoid/round cell liposarcoma and synovial sarcoma, as the initial clinical indications for its lead candidate MDG1015.
  • Preclinical data presented in 2023 at the AACR and ESMO conferences demonstrated the clear potential of MDG1015 to improve clinical outcomes in solid tumors.
  • “The selection of these cancers as targets for MDG1015 is an important step as we advance towards the first-in-human trial.

Replay’s oncology-focused product company Syena and Miltenyi Biotec enter into exclusive licensing and GMP manufacturing agreement for PRAME TCR-NK cell therapy based on CliniMACS Prodigy®

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星期一, 十二月 18, 2023

Under the terms of the agreement, Syena, the oncology-focused engineered cell therapy product company launched jointly by Replay and The University of Texas MD Anderson Cancer Center in February 2023, has secured an exclusive license to Miltenyi Biotec’s PRAME (PReferentially expressed Antigen in MElanoma) TCR.

Key Points: 
  • Under the terms of the agreement, Syena, the oncology-focused engineered cell therapy product company launched jointly by Replay and The University of Texas MD Anderson Cancer Center in February 2023, has secured an exclusive license to Miltenyi Biotec’s PRAME (PReferentially expressed Antigen in MElanoma) TCR.
  • Miltenyi Biotec will use its CliniMACS Prodigy® closed and automated cell processing platform to manufacture a scalable, GMP-compliant, PRAME-targeted, TCR-NK cell therapy product for clinical development and provision of future commercial supply.
  • The Company’s first target, NY-ESO-1, is being investigated in relapsed or refractory multiple myeloma, synovial sarcoma, and myxoid/round cell liposarcoma.
  • In line with our mission to advance cell therapies to treat patients with cancer and other serious diseases, we’re excited to collaborate with Replay and the Syena team on their GMP-compliant PRAME TCR-NK cell therapy product.”

Leiomyosarcoma Drug Pipeline Report 2023 - ResearchAndMarkets.com

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星期五, 十一月 10, 2023

The report offers comprehensive insights into the pipeline landscape for Leiomyosarcoma, a type of cancer.

Key Points: 
  • The report offers comprehensive insights into the pipeline landscape for Leiomyosarcoma, a type of cancer.
  • It covers information about more than 10 companies and over 10 pipeline drugs related to Leiomyosarcoma.
  • Furthermore, the report offers a comprehensive overview of the current status and growth prospects within the Leiomyosarcoma pipeline landscape.
  • The assessment section of the report delves into both commercial and clinical aspects of the pipeline products in development.

C4 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

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星期三, 十一月 1, 2023

WATERTOWN, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today reported financial results for the third quarter ended September 30, 2023, as well as recent business highlights.

Key Points: 
  • Revenue: Total revenue for the third quarter of 2023 was $11.1 million, compared to $6.8 million for the third quarter of 2022.
  • Research and Development (R&D) Expense: R&D expense for the third quarter of 2023 was $28.3 million, compared to $29.7 million for the third quarter of 2022.
  • Net Loss and Net Loss per Share: Net loss for the third quarter of 2023 was $27.0 million, compared to $32.0 million for the third quarter of 2022.
  • Net loss per share for the third quarter of 2023 was $0.55 compared to $0.65 for the third quarter of 2022.

Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine® IMA203 TCR-T Monotherapy

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星期二, 十月 24, 2023

IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.

Key Points: 
  • IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.
  • “The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients.
  • This is an important regulatory milestone and a recognition of our clinical development progress for this program,” said Cedrik Britten, Chief Medical Officer of Immatics.
  • As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 922.