Research and Development
During the third quarter, MorphoSys's partners continued to advance their antibody programs and published various development steps. Newly launched and planned clinical trials with HuCAL antibodies during the third quarter included:
- A planned Boehringer Ingelheim phase 1 trial with the HuCAL antibody BI 836845 will test the antibody in combination with the compound Enzalutamide in up to 160 prostate cancer patients.
- A further phase 1 trial with the HuCAL antibody BI 836845 planned by Boehringer Ingelheim will test the antibody in combination with the compound Afatinib in up to 60 patients with non-small cell lung carcinoma.
- The publication of three phase 3 trials planned by Janssen with the HuCAL antibody guselkumab for testing the antibody in up to 2,550 patients with psoriasis. Shortly after the end of the third quarter 2014, the first phase 3 trial with guselkumab was started.
- A phase 1b trial with the HuCAL antibody PF-05082566 in combination with the anti-CCR4 antibody mogamulizumab for testing the safety and tolerability of the combination in patients with solid tumors. This trial has been planned by Pfizer and Kyowa Hakko Kirin and is scheduled to start in 2015.
MorphoSys's partner OncoMed is allowed to continue the temporarily stopped phase 1 trial of the antibody drug vantictumab using a modified trial protocol. This decision, made by the U.S. Food and Drug Administration, was announced in August. Changes in the trial protocol stipulate, among others, an altered dosage regimen, a change in inclusion criteria, the closer monitoring of patients, and measures to counteract the effects occurring on bone metabolism.
At the end of September, OncoMed presented additional clinical data on the second HuCAL antibody in their portfolio, tarextumab, at the Congress of the European Society for Medical Oncology (ESMO) in Madrid. The results of the current ALPINE and PINNACLE studies support the promising potential of this antibody.
During the first nine months of 2014, the number of active partnered therapeutic antibody programs grew to a total of 84 (31 December 2013: 75 partner-operated programs). Of these, 18 programs were in clinical development, 26 in preclinical development, and 40 in the discovery phase.
MorphoSys’s portfolio within the Proprietary Development segment comprises three projects in clinical trials: the HuCAL antibody MOR103 (anti-GM-CSF) in the areas of rheumatoid arthritis (RA) and multiple sclerosis (MS), the HuCAL antibody MOR202 (anti- CD38) in the area of multiple myeloma, and MOR208, an Fc-optimized and humanized antibody targeting CD19 in the area of B-cell malignancies.
With MOR209/ES414, a further compound was in-licensed during the third quarter. MorphoSys and its partner Emergent plan to start a phase 1 clinical trial for MOR209/ES414 with patients having metastatic, castration-resistant prostate cancer (mCRPC) within six months after the contract's signature. The first phase of the trial will be conducted in the USA and Australia. The trial will be sponsored by Emergent.
MOR209/ES414 steers cytotoxic T cells to prostate cancer cells expressing the prostate specific membrane antigen (PSMA). PSMA is an antigen often found on these cancer cells. The mechanism of action is similar to the immune system's natural processes and leads to both a target molecule-dependent killing of the cancer cells and to an activation and proliferation of T cells.
In preclinical trials, MorphoSys's partner Emergent showed in animal models that treatment with MOR209/ES414 successfully led to the disappearance of prostate tumors. The compound also greatly prolonged the overall survival rate compared to that of the control group. These effects even occurred at low doses of 3 to 30 µg. Emergent presented these results amongst other events at the annual conference of the American Association for Cancer Research (AACR) in 2013. Additional studies suggest a longer serum half-life of the molecule compared to antibody fragments and similar bi-specific compounds. The compound was tested in toxicity studies in non-human primates and was generally well tolerated, both in single-dose and repeated- dose administration.
In addition to MOR103, MOR202, MOR208, and MOR209/ES414, MorphoSys is also pursuing various programs in earlier stages. These include the co-development program with Galapagos N.V., which is in preclinical development, as well as the immuno-oncology programs initiated under the alliance agreement which was signed in the second quarter with Merck Serono. The early development portfolio is now based completely on the Ylanthia technology, MorphoSys’s latest antibody library.
At the end of the third quarter, the entire proprietary portfolio consisted of three antibody compounds in clinical development and seven compounds in drug discovery or preclinical development.