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Logo Made in Germany BIO 2018

Medigene AG

Booth number: 1401-3

www.medigene.com
business.development@medigene.com

About us

Medigene AG is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

Clinical Highlight:
In March 2018 the Company announced the start of the Phase I/II clinical trial with its TCR therapy MDG1011 for the treatment of various types of blood cancers. It is planned to include approximately 92 blood cancer patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM). MDG1011 is Medigene's first clinical TCR immunotherapy product candidate.

In November 2017, Medigene completed patient recruitment for the clinical trial with DC vaccines in acute myeloid leukemia (AML). All 20 planned patients have been enrolled in the Phase I/II study. The completion of the study is expected in 2019 after a treatment period of two years for all patients



Products and services

Medigene is developing Living Immunotherapies, with the goal of providing revolutionizing cancer treatments that offer a higher quality of life for patients.

We aim to enter strategic partnerships with interested parties to share the transformative potential of cancer immunotherapies with partners who truly believe in innovation.

Please contact our business development team if you are interested in discussing our clinical programs or want to develop new innovative immunotherapies based on our technologies to optimally tackle specific tumor types.
TCR-based immunotherapies

TCR-based immunotherapies

Medigene's TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient's tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient's T cells outside the body (ex vivo)

www.medigene.com/technologies/

Starting Phase I/II clinical trial with TCR immune cell therapy -  MDG1011

Starting Phase I/II clinical trial with TCR immune cell therapy - MDG1011

In March 2018, Medigene announced the start of the Phase I/II clinical trial with its TCR therapy MDG1011 for the treatment of various types of blood cancers.
It is planned to include approximately 92 blood cancer patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM).
MDG1011 is Medigene's first clinical TCR immunotherapy product candidate.

www.medigene.com/technologies/platforms/tcr-platform/

News & Innovations

Start of clinical trial with TCR immunotherapy MDG1011  Target:
PRAME (Preferentially Expressed Antigen in Melanoma) is a well characterized tumor antigen overexpressed in multiple hematological and solid tumor indications

The drug, MDG1011:
T cells expressing a HLA-A*02:01-restricted T cell receptor (TCR) specific for PRAME

Trial outline:
1) Combined Phase I/II safety, feasibility and early efficacy clinical trial
2) Disease indications for Phase I, all in advanced stages:
- acute myeloid leukemia (AML)
- myelodysplastic syndrome (MDS)
- multiple myeloma (MM)
3) Two of the three indications will be carried over into Phase II

Phase I:
Primary endpoint:
1) Safety (incidence, severity of adverse events (AEs) at 3 months, maximum tolerated dose (MTD) based on dose limiting toxicities up to 28 days)
2) Feasibility (percent of patients receiving the planned dose) at 3 months

Secondary endpoints:
1) Safety (incidence, severity of AEs at 6 and 12 months)
2) Overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), overall survival (OS), quality of life (QoL) and the correlation of PRAME expression with the antitumor response, measured at 3, 6 and 12 months

Phase II:
Co-primary endpoints:
1) Safety (incidence, severity of AEs) at 3 months
2) Efficacy (ORR) at 3 months

Secondary endpoints:
1) Safety (incidence, severity of AEs) at 6 and 12 months
2) ORR at 6 and 12 months, DoR, TTP, PFS, OS, QoL and the correlation of PRAME expression with the antitumor response at 3, 6 and 12 months

Contacts

Address
Medigene AG
Lochhamer Str. 11
82152 Martinsried
Germany

Phone: +49 89 200033-0
Fax: +49 89 200033-2920

Dr. Rolf Kalhammer
Vice President, Head of Business Development
Phone: +49-89-20 00 33-33 06
business.development@medigene.com


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