In the last week, there were many good news from the high-impact hemotology conference ASH, but also in other areas, Munich biotech SMEs show good progress.
Martinsried-based MorphoSys reported positive clinical data of two proprietary projects, MOR 208 and MOR 202. MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion that is being developed to treat B cell malignancies. The data, which were presented at the 2015 American Society of Hematology (ASH) Annual Meeting, are from a phase 2a monotherapy study of patients with different subtypes of relapsed or refractory Non-Hodgkin's Lymphoma (NHL) and another phase 2 study where MOR208 is tested in chronic lymphocytic leukemia (CLL) in combination with lenalidomide. "Encouraging single-agent activity together with a long duration of response as a single agent in patients with relapsed/refractory NHL bodes well for additional combination trials in DLBCL and CLL", commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. Clinical trials of the combination of MOR208 with other anti-lymphoma therapies (e.g. lenalidomide and bendamustine) will commence shortly. MorphoSys also presented interim safety, pharmacokinetic and efficacy data for MOR202 in Multiple Myeloma. MOR202 is a fully human HuCAL antibody targeting CD38, a highly expressed and validated target in multiple myeloma (MM). The data are from a phase 1/2a clinical study in 52 heavily pretreated patients with relapsed/refractory multiple myeloma. The clinically relevant dose regimens show encouraging clinical efficacy combined with a very good safety profile," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "The clinical study will continue as planned, focusing on combination cohorts, as we see the highest potential for MOR202 in combination therapy."
Also on the ASH conference, Medigene (Martinsried) presented early results from two independent clinical programmes in patient groups with acute myeloid leukaemia (AML) receiving dendritic cell (DC) vaccines. The CD vaccines were prepared according to technologies licensed and developed by Medigene and showed an excellent safety profile. Moreover, they showed the capacity to induce T cell responses in elderly patients unable to undergo stem cell transplantation. The clinical data on AML included data from an ongoing Phase I/II investigator initiated trial (IIT) under the direction of Prof. Marion Subklewe of the Ludwig-Maximilians-Universität (LMU) in Munich. The second presentation reported about an ongoing Compassionate Use Programme under the direction of Prof. Gunnar Kvalheim at Oslo University Hospital (OUH) in Norway. Prof. Dolores J. Schendel, Chief Scientific Officer of Medigene AG, summarizes the findings from the two ASH reports: "We are pleased with the new information that could be derived from the preliminary assessments of the ten AML patients receiving next-generation DC vaccines in these ongoing independent studies. It was feasible to manufacture high quality DCs according to our technology that led to detectable immune responses in different patients to one or both leukaemia-associated antigens. The rapidity with which T cell responses were detected in some patients speaks to the good immunizing capacity of the DCs."
And Freising-based Pieris, listed on the NASDAQ for several months, has announced a research collaboration and license agreement with Roche in cancer immunotherapy. Under the terms of the agreement, Pieris will discover, characterize and optimize Anticalin®-based drug candidates against an undisclosed target. Pieris will receive an upfront payment of CHF 6.5 million (~$6.4 million USD) and committed research funding. If all milestones and other conditions are met, the total payments to Pieris could surpass CHF 415 million (~$409.3 million USD), excluding royalties.
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