MorphoSys AG has provided an update on the clinical development outlook for its proprietary drug pipeline. Over the last several years, MorphoSys has built one of the broadest and most differentiated biopharmaceutical pipelines in the biotechnology sector.
With the first partnered programs approaching the market and the Company's proprietary portfolio gaining momentum, MorphoSys intends to commit additional resources to advance its programs through approval-enabling studies and become a commercial organization.
Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG commented: "MorphoSys has successfully transitioned from a technology provider to a drug development organization. With a robust set of proprietary drug candidates, now is the time to scale our investment to ensure that we capture the full value of our portfolio. We aspire to become a fully-integrated and commercial biopharmaceutical organization with our own products on the market. Our lead cancer compound MOR208, for which we have a comprehensive development plan, will be at the forefront of this process."
MorphoSys's proprietary activities are currently focused on three clinical candidates: the hemato-oncology programs MOR208 and MOR202, for which MorphoSys holds worldwide commercial rights, and the prostate cancer program MOR209/ES414, which is being co-developed with Emergent BioSolutions. MorphoSys is also planning to commence clinical studies of MOR106 and MOR107 in inflammatory and fibrotic indications respectively in 2016.
MOR208 - addressing current treatment challenges in leukemia and lymphoma
MOR208 is an Fc-enhanced antibody targeting CD19, a more widely and earlier expressed target across multiple lymphomas and leukemias than CD20, the therapeutic target of the most commonly used lymphoma and leukemia treatments. By targeting CD19 and being Fc-enhanced, MOR208 could become an important and attractive alternative to multiple current treatment options for some of the sickest cancer patients. Based on promising results presented at the 2015 annual meeting of the American Society of Clinical Oncology (ASCO 2015), MorphoSys will commence two phase 2 trials of MOR208 in diffuse large B cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL) in the near future. In addition, MorphoSys aims to start a pivotal study of MOR208 in DLBCL in 2017.
In DLBCL, MOR208 will be tested in combination with lenalidomide in up to 80 patients with relapsed/refractory DLBCL. The trial will be designed as an open label, single arm study with the primary endpoint of objective response rate (ORR) and multiple secondary endpoints, including progression-free survival (PFS), overall survival (OS) and time to progression (TTP).
The CLL study will combine MOR208 with idelalisib and shall include 120 patients previously treated with Bruton tyrosine kinase (BTK) inhibitor therapy. This study will also be designed as an open label, single arm trial with the primary endpoint of overall response rate (ORR) and multiple secondary endpoints, including progression-free survival (PFS), overall survival (OS) and time to progression (TTP).
In addition, MorphoSys aims to start a pivotal phase 3 trial in DLBCL in 2017, which will test MOR208 plus bendamustine in a head-to-head setting against the combination of rituximab and bendamustine in approximately 320 patients with relapsed/refractory DLBCL, who are ineligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).
MOR208 is also being studied in two investigator-initiated trials (IIT). The first is an ongoing phase 2 trial in CLL, which is being conducted by MorphoSys's academic partner Dr. John Byrd, Director, Division of Hematology, Department of Internal Medicine at Ohio State University and Dr. Jennifer Woyach as co-investigator. This study is exploring a combination of MOR208 and lenalidomide in treatment-naïve, older CLL patients, and relapsed/refractory CLL patients. The second IIT is a pediatric study in ALL to be conducted in collaboration with St. Jude Children's Research Hospital, Memphis, USA. This IIT will test MOR208 in combination with NK-cell transplantation. Patient recruitment for this study is anticipated to start in the first half of 2016.
Based on the positive clinical results of MOR208 in NHL which were presented at ASCO 2015, the Company is also evaluating the possibility of commencing other studies in B cell malignancies.
"MOR208 is an innovative, Fc-enhanced antibody which has shown great promise in the clinic. It is one of a number of important assets for MorphoSys which we believe can bring significant benefit to patients in need," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "Our goal is to establish MOR208 as a new backbone therapy and as an ideal combination agent for several other drugs used in a broad range of lymphomas and leukemias. Encouraged by the promising clinical data generated so far with MOR208 and other drug candidates, we plan to broaden our development activities."
The significantly expanded breadth of the planned and ongoing studies of MOR208 including the anticipated pivotal study in DLBCL is likely to result in significantly higher proprietary R&D expenditure in 2016 and thereafter as compared to previous years. MorphoSys will provide its financial guidance for next year in early 2016.
MOR202 - generating promising data in multiple myeloma
MOR202 targets CD38, which is one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. Because of this expression pattern, anti-CD38 antibodies are expected to have clinical utility as a new therapeutic approach to multiple myeloma treatment. Initial promising efficacy data for MOR202 was presented at ASCO 2015. A phase 1/2a study of MOR202 in combination with dexamethasone in relapsed or refractory multiple myeloma patients is nearing completion. Additional cohorts in which patients receive MOR202 up to 16 mg/kg weekly in combination with pomalidomide or lenalidomide plus dexamethasone have also commenced. Clinical data from those cohorts will be presented at an upcoming medical conference.
MOR209/ES414 - co-development program with Emergent Biosolutions
MOR209/ES414 is a bi-specific anti-PSMA/anti-CD3 antibody being developed for the treatment of prostate cancer. This immunotherapeutic protein activates the patients' T-cell immunity specifically against prostate cancer cells expressing Prostate Specific Membrane Antigen (PSMA), an antigen commonly over-expressed in this tumor. A phase 1 study of MOR209/ES414 is ongoing, and will be conducted in two stages. The primary objective of stage 1 of the study is to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered to patients with metastatic castration-resistant prostate cancer (mCRPC). The primary objective of stage 2 of the study is to evaluate the clinical activity of MOR209/ES414 in patients who have received prior chemotherapy as well as those who are chemotherapy-naïve. The study will enroll up to 130 patients and run through 2018. First clinical data are expected in 2016.
Continued investment in technology leadership aimed at producing additional clinical development programs
In addition to MorphoSys's ongoing clinical studies, the Company is continuing to progress its earlier programs including: i) the immuno-oncology focused collaborations with Merck Serono and Immatics, ii) alliances with Heptares and G7 Therapeutics to support development of a portfolio of therapeutic programs targeting unique G protein-coupled receptors (GPCRs) and other transmembrane proteins, iii) a co-development alliance with Galapagos, which, in MOR106, has produced a first pre-clinical candidate in inflammatory diseases, iv) further development of the lanthipeptide portfolio including MOR107 in fibrotic diseases, and v) a growing target sourcing network with leading academic organizations such as Temple University in Philadelphia, USA. As a result of these efforts, MorphoSys expects to further expand its portfolio of discovery programs and to proceed with at least two of these, namely MOR106 in inflammation and MOR107 in fibrosis, into clinical development in 2016.
Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG added: "MorphoSys has established a broad network of relationships with big pharma, biopharma companies of various sizes and academia that could generate a stream of attractive product opportunities. We intend to expand this network even further. The Company's technology platforms continue to play an important role in developing the pipeline and hence we are committed to investing in technology development both through internal efforts and by seeking access to technology innovations from the outside. The impact of Ylanthia, the latest antibody library of MorphoSys, keeps increasing with 17 programs in MorphoSys's pipeline now based on this platform. In addition, MorphoSys has established and continues to refine platforms to generate alternative biomolecular formats including bi-specific antibodies and constrained therapeutic peptides."