On November 13, 2019 Medigene AG (Medigene, FSE: MDG1), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported on its business performance and financial results for the first nine months of 2019 and confirms the financial guidance (Press release, MediGene, NOV 13, 2019, View Source [SID1234551163]).
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The full version of the quarterly statement 9M-2019 can be downloaded here: View Source
Prof. Dolores Schendel, CEO/CSO of Medigene AG commented: "In the past nine months, we have continued to work intensively on the progress of our immunotherapies. Preparations are ongoing for our next clinical trial with the T cell receptor (TCR) immunotherapy MDG1021 in cancer patients suffering from a disease relapse after hematopoietic stem cell transplantation. This trial will start next year and will be conducted in cooperation with the Leiden University Medical Center.
Our first-in-human clinical phase I/II trial with MDG1011 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM) continues to recruit patients. While recruitment has been below desired levels we have adapted the study protocol and successively expanded the study centers. We expect data from the first three dose cohorts to be available in Q4 2020. We plan to further expand our pipeline of potential TCR candidates and are continuously researching the innovation potential of our technologies. We aim to increase the number of possible targets for our TCRs and are developing innovative next-generation TCR therapies, especially for difficult conditions such as the immunosuppressive environments in solid tumors. After promising interim data for our dendritic cell (DC) vaccine, we expect the topline results to be reported at the beginning of next year. Our partnerships as well as our finances are on track and we look forward to the coming months."
Major events since the beginning of 2019
– Medigene enters a clinical trial agreement for its second TCR immunotherapy MDG1021 with Leiden University Medical Center. Phase I clinical trial with the HA-1-specific TCR therapy scheduled to start in 2020
– Medigene publishes interim analysis from ongoing Phase I/II clinical trial with DC vaccines in acute myeloid leukemia (AML) patients at the Congress of the European Hematology Association (EHA) (Free EHA Whitepaper)
– bluebird bio presents preclinical data of the first TCR candidate from the Medigene collaboration and announces that clinical development of the TCR candidate targeting the MAGE-A4 tumor antigen, which is expressed on a variety of solid tumor types, will start in 2020
– Medigene doses the first patient in Phase I/II clinical trial of Medigene’s first T cell immunotherapy MDG1011 to treat the blood cancers: AML, MDS, and MM, and opens additional clinical trial centers
– Medigene and Roivant/Cytovant enter into a strategic partnership for the research and discovery of cell therapies in Asia. Medigene receives upfront payment of USUSD10 m and reimbursement of future R&D expenditure, potential milestone payments and royalties
– Medigene licenses a co-stimulatory receptor to enhance TCR therapies for solid tumors
– Medigene presents the results from in vitro tests to assess the potential TCR-mediated off-target toxicity for neuronal cells at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper)
– Medigene presents preclinical data on the selective killing of tumor cells by PRAME TCR-transduced T cells at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference
– Medigene presents its new ‘inducible Medigene (iM)-TCR’ which enables controllable cytotoxicity of tumor-specific TCR-T cells to potentially tune safety and efficacy according to clinical needs at the CAR-TCR Summit 2019
– Medigene obtains two European patents for its DC vaccine platform and for a TCR building block library to develop neoantigen-specific TCRs
– Medigene sells the remaining rights and stocks of Veregen to Aresus Pharma and thereby completes its transformation into a pure-play immunotherapy company
Key figures in the first three quarters of 2019
– Revenue from the core business of immunotherapies increased by 32% to Eur 6.2 m (9M 2018: Eur 4.7 m)
– Research and development expenses increased as expected by 24% to Eur 16.5 m (9M 2018: Eur 13.3 m) due to more intense activities in the development and production activities for Medigene’s immunotherapy programs
– EBITDA loss increased as anticipated by 48% to Eur 18.6 m (9M 2018: Eur 12.6 m*) (without taking the non-core business Veregen effect into account: increase of EBITDA loss by 11% to Eur 13.9 m)
– Net loss for the period increased as expected by 52% to Eur 20.0 m (9M 2018: Eur 13.2 m*)
– Cash and cash equivalents and time deposits of Eur 60.5 m as at September 30, 2019 (December 31, 2018: Eur 71.4 m)
– Confirmation of financial guidance 2019
* IAS 8 correction – see note (3) to the consolidated financial statements
Outlook
Financial guidance 2019
Medigene confirms the financial guidance issued in the 6M-2019 financial statement.
– The company is expecting to generate total revenue of Eur 10 – 11 m in 2019.
– Due to progress in the development projects, Medigene is projecting research and development expenses of Eur 24 – 29 m and forecasts an EBITDA loss of Eur 23 – 28 m.
– This assessment does not include potential future milestone payments or cash flows from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene.
– Based on its current planning, the Company has sufficient financial resources to fund business operations beyond the planning horizon of two years.
Immunotherapy Outlook
Current Phase I/II clinical trial with Medigene’s first TCR therapy MDG1011
Medigene commenced the Phase I/II clinical trial of its TCR-based T cell therapy MDG1011 and began treating patients in the first quarter of 2019. In 2019, the focus of the trial is the recruitment for the first dose cohorts to assess the safety and tolerability of the treatment with MDG1011.
Planned Phase I/II clinical trial with Medigene’s second TCR therapy MDG1021
Based on the Clinical Trial Agreement entered into with the Leiden University Medical Center in May 2019, Medigene plans to conduct a Phase I clinical trial with its TCR therapy MDG1021, targeting the HA-1 antigen. Medigene will assess the safety, feasibility and preliminary efficacy of MDG1021 in patients with relapsed or persistent hematologic malignancies after allogeneic hematological stem cell transplantation. The study is scheduled to start in 2020 as Medigene’s second company-sponsored clinical TCR-T trial. In preparation for the trial, Medigene first needs to establish the manufacturing process, develop the design of the trial and then obtain the official trial approval.
Development of additional TCR candidates
Now that a robust platform for the discovery and characterization of new TCR candidates has been fully established, building a solid pipeline of potential TCR development candidates is an important goal to secure future clinical programs for both internal and existing or future partners.
In 2019, in addition to the MDG1011 clinical trial, Medigene will therefore continue to work on characterizing new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collecting preclinical data to prepare further clinical TCR trials.
Optimization of future TCR therapies for solid tumors
The new inducible Medigene (iM)-TCR approach as well as the chimeric co-stimulator receptor (the PD-1/4-1BB molecule) licensed from HMGU will be assessed in combination with Medigene’s tumor-specific TCR-Ts in preclinical models in order to optimize future TCR therapies for solid tumors.
TCR partnerships
Medigene continues its successful collaboration with bluebird bio and expects to make further progress on TCR candidate discovery. Within the framework of the partnership entered into with Roivant/Cytovant, Medigene will now, together with the collaboration partner, undertake the preparations to generate TCR constructs tailored specifically to Asian patient populations using its proprietary TCR discovery and isolation platform.
Dendritic cell vaccines (DCs)
Conclusion of the Phase I/II clinical trial at the end of 2019
Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of AML as planned and bring it to a conclusion at the end of 2019. Topline data will be reported in the beginning of 2020.
Conference call and webcast
A telephone conference in English will be held today at 2:00 pm CET (Munich/Frankfurt) / 8:00 am EST (New York) and transmitted live via webcast. Access and transmission of the synchronized presentation slides and a recording of the presentation will be available on the Medigene website at View Sourcewebcasts/