On March 28, 2017 Medical Prognosis Institute A/S (MPI.ST) (Denmark and Phoenix, AZ, USA) reported that Oncology Venture a spinout from MPI and 2-BBB Medicines BV have entered into an exclusive global license agreement on 2-BBB’s Phase 2 lead product 2B3-101 – now called 2X-111 (Press release, 2X Oncology, MAR 28, 2017, View Source [SID1234526107]). 2X-111 has demonstrated clinical activity in a phase 2 study in metastatic Breast Cancer patients and in patients with Glioblastoma (primary brain cancer) both hard to treat cancers with a huge unmet medical need. 2X-111 will be combined with its Drug Response Predictor (DRP) as a companion diagnostic in DRP(TM) focused Phase 2 trials for selected, high-likelihood responder patients. The drug will be developed as a 2X Oncology Inc. pipeline drug. 2X Oncology Inc. is a spinout of Oncology Venture developing Precision medicine for Women’s cancers. MPI has a 10% ownership in 2X Oncology.
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The active anticancer drug in 2X-111, doxorubicin, is an almost identical molecule to epirubicin, for which it was recently announced that the DRP(TM) biomarker from MPI can, with certainty, identify those patients who benefit from treatment with the drug. A retrospective-prospective validation (i.e. the highest validation level) has been achieved for the epirubicin DRP(TM), and 2X-111 therefore has a similar risk reduced profile (like LiPlaCis in the Oncology Venture pipeline).
Under the terms of the agreement, Oncology Venture will be responsible for the development and commercialization of 2X-111 in oncology. Oncology Venture will, through 2X Oncology, fund and execute the mutually agreed clinical development plan, which includes an initial phase 2 clinical study in metastatic Breast Cancer through screening of approximately 250 patients in Denmark and potentially other countries with its DRP biomarker as a predictive/companion diagnostic. MPI will on behalf of OV handle the screening.
"It is great to see OV’s ability to identify proven active drugs to in-license and develop using MPI’s technology. I believe that the cutting-edge science and compelling clinical data behind the drug (now called 2X-111) in combination with our unique Drug Response Predictor (DRP(TM)) biomarker from MPI technology gives an exceptional risk reduced opportunity to develop effective treatments for hard to treat cancers," says Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "MPI has ownership of 10% of spinouts from Oncology Venture and development of drugs through OV is considered as an important validation of the technology as well as an important potential income stream," Peter Buhl Jensen further commented.
About MPI’s multiple biomarker called Drug Response Predictor – DRP(TM)
MPI’s DRP(TM) is a tool for developing tumor-derived genetic signatures to predict which cancer patients are high likely to respond to a given anti-cancer product. The DRP(TM) has been tested in 37 trials, where 29 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients responded well to the treatment. The DRP(TM) platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP(TM) method can be used to design the Clinical Development Plan, i.e. to select which indications are relevant for a given anti-cancer drug. In addition to this, the individual genetic patterns of patients can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of patients with a high likelihood of response to the drug. DRP(TM) builds on comparison between sensitive and resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. The DRP(TM) is a Big Data tool based on messenger RNA.
The DRP(TM) platform can be used in all cancer types, and has been patented for more than 70 anti-cancer drugs in the US.
More about tumor biopsies
The pathologist evaluates biopsies to see if it is cancer. At the operational theatre, the surgeon places the biopsy in formalin and submits the specimen to the pathology department. Here a technician embeds the tumor biopsy in a paraffin block to allow the cutting of very fine slices of the specimen. The slices are put on glass slides and stained with various dyes and finally evaluated by the pathologist. The tumor in formalin and paraffin are stored. The biopsy block belongs to the patient and follows her or him if she or he changes hospital. In Scandinavia, hospitals are mostly public and patients usually stick to their local hospital. The patient and her or his clinical data can be followed over years as well as CT scans and blood tests. Biopsy blocks can be reclaimed for tests.
In MPIs and Oncology Ventures LiPlaCis study more than 1,100 patients have agreed to allow the two companies to attain material from the paraffin embedded biopsies and to measure the gene expression on the material and relate it to treatment outcome. Gene expression is a measurement of the activity of the genes. Some are very active some are not active. There are 20,000 (twenty thousand) genes in normal tissue and in cancer and modern gene expression technology allows the measurement all the genes in one step on a single chip. MPI uses the commercially available Affymetrix chip for this purpose. MPI has developed and validated a link between gene expression and the efficacy of a range of anticancer drugs. This press release informs about a validation of the method by use of biopsy material and clinical data on four anticancer agents used in daily practice for breast cancer treatment. The companies have worked together with the Danish Cooperative Group for Breast Cancer and breast cancer experts on 10 hospitals to attain the data. The study encompasses data from more than 800 patients with metastatic Breast Cancer receiving almost 2800 treatment lines or an average of 3.5 treatments per patient. Biopsies were from the original diagnosis of Breast Cancer i.e. at a time where the patient was evaluated as curable and most of the patients at then received so-called adjuvant therapy with chemotherapy, irradiation and antihormone therapy after surgery. On average the biopsies were 10 years old.