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Enteris BioPharma and Nordic BioScience’s KeyBioScience Enter Strategic Licensing Agreement to Develop Metabolic Peptides Using Enteris’ Proprietary Oral Drug Delivery and Manufacturing Platform

Enteris BioPharma, Inc., an industry leader in innovative oral dosage formulations, and KeyBioScience, a wholly-owned subsidiary of Nordic Bioscience, recently announced a strategic licensing agreement for Enteris’ oral drug delivery and recombinant manufacturing technologies to advance the development of KeyBioScience’s recently acquired family of proprietary metabolic peptides for various indications, including the treatment of Type 2 diabetes, obesity and other inflammatory conditions with high unmet medical and socioeconomic needs.

Nuclea Bio Acquires Oncogene Science, Extends Deal with Wilex

Just a few months after announcing several new partnerships and landing venture capital dollars, Nuclea Biotechnologies Inc. has snapped up Oncogene Science, an Cambridge, Mass.-based subsidiary of Wilex AG in Germany.

BioTime’s Subsidiary OncoCyte Corporation Publishes Data on the Gene FSIP1 as a Breast Cancer-Specific Marker

BioTime, Inc. (NYSE MKT: BTX) and BioTime’s subsidiary OncoCyte Corporation recently announced the publication of a scientific report on the gene FSIP1 and its potential as a marker for breast cancer. The paper, published in the peer-reviewed journal Biomarkers in Medicine and available online today, describes the microarray-based approach used to identify FSIP1 as a breast cancer biomarker with significantly elevated expression in breast tumors expressing the estrogen receptor, which represents 70-80% of all breast cancers. In addition to elevated gene expression, FSIP1 protein was also expressed within tumors at significant levels whereas little to no expression was found in most normal tissues, including healthy breast tissue. Combined, these findings lay the foundation for novel diagnostic and therapeutic strategies, including the measurement of FSIP1 in the blood as a screen for the presence of cancer, as well as targeting of FSIP1 as an antigen in cancer immunotherapy approaches.

Based on large unmet need, market size, and data generated thus far from patient sample screening, OncoCyte is initially focusing its efforts on identifying biomarkers that may be used to detect and monitor breast and bladder cancers. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies for use in detecting breast cancer, in preparation for the initiation of the first clinical study of PanC-DxTM and is currently working with a select group of cancer researchers to finalize a study protocol for submission to the institutional review boards of the study sites. If clinical trials are successful, OncoCyte intends to launch PanC-DxTM as an in vitro diagnostic (IVD) in Europe before seeking FDA approval required to market PanC-DxTM in the United States.

EMD Serono Establishes Immuno-Oncology Research and Early Development Platform to Advance Innovation in Cancer Therapies

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, recently announced its commitment to the field of cancer immunotherapy by creating a fully dedicated immuno-oncology innovation platform integrating research, early development and biomarker strategies. In addition to the company’s existing oncology platform, this new immuno-oncology platform will focus on developing therapies that leverage the immune system’s natural ability to fight tumors, and work in combination with existing and future therapies.

“We are pleased to announce our commitment to immuno-oncology, recognizing that the complexity of cancer requires diverse approaches that will enable alternative therapeutic interventions,” said Bernhard Kirschbaum, Head of Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “In order to spur research and early development in this specialized area, we have created an innovative environment where researchers and clinicians work side-by-side to advance potential new cancer immunotherapies.”

The new immuno-oncology platform includes three innovation clusters, each of which is focused on discovery research and the advancement of molecules into the clinic through proof of confidence:

  • Therapeutic cancer vaccines: targeting tumor antigens to elicit a tumor-specific immune response
  • Cancer stem cells: targeting cancer stem cells to prevent or reduce tumor formation and inhibit metastases
  • Immunotolerance: eliminating or circumventing inhibitory mechanisms in the immune system that prevent cancer cells from being recognized and attacked by the body

To ensure a broad immuno-oncology research and early development platform, EMD Serono has assembled an in-house team of preeminent researchers and clinicians who will focus resources and technologies to build a portfolio of investigational immunotherapies, while collaborating with premier academia, research and industry organizations to complement internal capabilities.

The current immuno-oncology portfolio comprises therapeutic candidates in early clinical development and a robust pipeline of pre-clinical molecules. Leading therapeutic concepts in the clinic are:

  • A monoclonal antibody targeting PD-L1 (programmed cell death ligand) expressed by various tumors, currently in Phase I in solid tumors
  • NHS-IL12, a cancer immunotherapy targeting IL-12 to the necrotic regions of tumors, sponsored by the United States National Cancer Institute (NCI), currently in Phase I in solid tumors
  • NHS-IL2, targeting IL-2 to the necrotic regions of tumors, completed Phase I and currently preparing for Phase II in solid tumors

“Our goal is to develop leading immunotherapies that work in combination with other therapeutic modalities, understanding that attacking multiple cancer targets simultaneously increases the possibility of therapeutic success,” said Helen Sabzevari, Head of Immuno-Oncology, Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “We are committed to delivering on the promise of immuno-oncology by combining creative thinking with strong research and clinical excellence, and, more importantly, by keeping patient needs at the heart of our efforts.”

Source: EMD Serono

DaVita Labs and Myriad RBM Announce Biomarker Research Collaboration

DaVita Labs, a unit of DaVita HealthCare Partners Inc. (NYSE:DVA) and Myriad RBM, a wholly-owned subsidiary of Myriad Genetics (Nasdaq:MYGN) announced today a research collaboration to conduct protein biomarker discovery research with the goal of developing and commercializing diagnostic tests that could benefit in the treatment of dialysis patients.

DaVita and Myriad have identified potential opportunities where novel diagnostic tests utilizing blood-based protein biomarkers could improve the quality of life for patients and potentially lower overall healthcare costs. The primary area of focus will include the prediction of vascular access failure.

“This collaboration uses DaVita’s proprietary biorepository that is intended to facilitate innovative research across renal disease,” said Chris Rucker, president of DaVita Labs and DaVita Clinical Research. “Myriad recognizes the value that the biorepository can bring to research and development activities, and we look forward to collaborating with Myriad on the research and development of novel diagnostics that could transform our industry.”

“We are enthusiastic to collaborate with a company of the caliber of DaVita in the field of dialysis, one of the largest health care service markets,” said Craig Benson, president Myriad RBM. “We have extensive experience with research in kidney disease and inflammatory markers that we believe could increase the quality of care for dialysis patients.”

Specimens from the DaVita biorepository will be processed on the Myriad RBM DiscoveryMAP® platform for the quantification of more than 300 important proteins. DiscoveryMAP analyzes protein biomarkers correlated with inflammatory, metabolic and renal disease conditions that could have meaningful utility as diagnostic criteria for dialysis patients. Myriad is expected to begin processing specimens associated with this collaboration in fiscal year 2014.

Source: Myriad Genetics