Licensing News: NinePoint Medical Receives FDA 510(k) Clearance
NinePoint Medical, an in vivo pathology device maker and RVL licensee, recently received 510(k) clearance from the U.S. Food and Drug Administration to market its Nvision VLE Imaging System, a next-generation, high resolution optical imaging technology. The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization. The Nvision VLE Imaging System is designed to enable physicians and pathologists, for the first time, to view high-resolution, volumetric images of organs and tissues in real-time. Clinicians can then analyze and immediately act on these images, thus providing patients with streamlined care and a significantly shortened timeline between detection, diagnosis and treatment of disease. In 2010, Ninepoint Medical exclusively licensed over 188 patents for technologies related to endoscopic optical frequency domain imaging and confocal microscopy products developed in the laboratory of Dr. Gary Tearney and Brett Bouma at the MGH’s Wellman Center for Photomedicine.
Licensing News: FDA Clearance for Presage® ST2
Critical Diagnostics, a biomarker company focused on cardiovascular disease, announced FDA clearance for the Presage® ST2 Assay for use as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The Presage® ST2 Assay quantitatively measures the level of ST2 in blood. ST2 has been shown to be a significant predictor of mortality as well as all-cause hospitalization, mortality due to cardiovascular disease, and hospitalization due to cardiovascular disease. ST2 is prognostic for clinically important outcomes in addition to all-cause mortality. The Presage® ST2 Assay is based on the ST2 biomarker technology developed by Dr. Richard Lee of the Cardiovascular Division at BWH. In 2004, BWH exclusively licensed the technology to Critical Diagnostics for further clinical testing and commercialization.
Editorial: Developing Centers of Excellence within Technology Transfer Offices by Frances Toneguzzo
Technology transfer offices, such as Research Ventures & Licensing, have traditionally worked on a service and income generating model, with services by and large having the greatest emphasis. There is good reason for this as income generation is largely a happenstance situation that the technology transfer office ultimately does not control (control being in the hands of a licensee/partner company). As a result, these offices have been historically funded quite leanly and have limited access to expertise relating to markets, clinical need, technology requirements for competitiveness, and regulatory and reimbursement issues. However, some offices, due to success, volume of inventions and/or institutional focus, have developed quite specific areas of expertise which could be shared with other offices.
Leveraging a model which incentivizes offices to share expertise relating to market and technical issues could increase the ability to move technologies to market. The Kauffman Foundation explored this issue and concluded that investigators should be allowed to work with whatever office best suits their needs and the needs of the instant technology. While there are a number of problems with this simplistic approach, the concept of accessing technology transfer offices with specific expertise deserves some consideration. As these technology transfer centers of excellence do exist in different fields, the federal government could fund an initiative to identify these centers and then support a limited effort to explore mechanism of expertise sharing and/or consulting on the development of specific technologies identified as having superior clinical potential.
Licensing News: RNA therapeutic license signed with Santaris
RVL completed a significant license with Santaris Pharma A/S for intellectual property related to the regulation of miR 33 for treatment of cardiovascular disorders. The technology, invented by Dr. Anders Naar of the MGH Cancer Center, represents a promising new class of therapeutics, RNA targeted drugs which will enable scientists to develop drugs to work through targets thought to be inaccessible to small molecules and monoclonal antibodies. Santaris Pharma will use its Locked Nucleic Acid (LNA) drug platform to develop a LNA-based drug targeting miR 33, an important regulator of high density lipoprotein (HDL) levels. The RVL relationship with Santaris includes a development investment by Partners Innovation Fund (PIF) to demonstrate proof of concept in non-human primates. Upon success, the study will generate a sizeable milestone payment to continue to advance different aspects of the technology at MGH.
Licensing News: Ninepoint Medical licenses major patent portfolio
Ninepoint Medical licensed MGH's portfolio of over 200 patent filings that claim endoscopic optical frequency domain imaging and confocal microscopy technologies. The company is developing novel in vivo imaging technology. More specifically, the company is developing endoscopic optical frequency domain imaging and confocal microscopy products invented in the laboratory of Drs. Gary Tearney and Brett Bouma at the MGH’s Wellman Center for Photomedicine. Initially, Ninepoint Medical will develop the devices for examining the gastrointestinal tract and pulmonary airways. The company has an aggressive timeline and expects to file their first regulatory application in Q4 2012 and make a first commercial sale in Q1 2013. In addition, the company is sponsoring research at MGH's Wellman Center for Photomedicine in an approximate sum of $2.5 million for advanced development of the same technologies. The company has raised $33 million in a Series A round of funding from Third Rock Ventures of Boston and Prospect Venture Partners of Palo Alto, CA
Licensing News: Ventana Medical Systems, Inc. to develop a Companion Diagnostic for Non-small Cell Lung Cancer
RVL signed an exclusive worldwide licensing agreement, with the right to sub-license, with Ventana Medical Systems, Inc (Ventana), a member of the Roche Group, and developer of tissue-based cancer diagnostic solutions, to develop a companion diagnostic test for non-small cell lung cancer (NSCLC) as part of a commitment to personalized healthcare. Dr. Charles Lee of BWH’s Department of Pathology, in collaboration with Dr. Pasi Janne of the Dana Farber Cancer Institute, developed a test for the presence of an inversion on Chromosome 2 that places two genes in close proximity with each other and affects roughly 7% of all patients with non-small cell lung cancer (NSCLC). This test could be offered as a companion diagnostic to drugs in development by several pharmaceutical companies targeting NSCLC, aiding in the targeted treatment of patients, and thereby increasing the efficacy of treatment and improving outcomes worldwide.
Collaboration Agreement: Partners HealthCare and Pfizer’s Centers for Therapeutic Innovation
Partners HealthCare signed an agreement to participate in Pfizer’s Centers for Therapeutic Innovation. The collaboration is designed to jointly engage in research programs that create Clinical Probes (therapeutic, preventive, prognostic, or diagnostic candidates) directed at targets/pathways of interest that culminate in clinical trials that demonstrate Proof-of-Mechanism. The agreement also lays out the terms of an exclusive option for Pfizer to license from Partners rights in the Clinical Probe and certain other intellectual property. If an option is exercised, Partners will be compensated via milestones and royalty payments consistent with industry standards.
Licensing News: OvaScience
RVL signed an exclusive worldwide license, with the right to sublicense, with OvaScience, Inc., an MGH start-up focused on increasing the safety and success of in vitro fertilization (IVF) through innovative science. OvaScience is founded on the patent portfolio based on Dr. Jonathan Tilly’s published research on ovarian stem cells conducted in the Vincent Center for Reproductive Biology (VCRB). The company expects to initiate a clinical proof of concept study in 2012.
Update: Invention Liaison Program Update
Research Ventures & Licensing recently expanded the Invention Liaison Program to support innovation across the MGH and BWH communities. This educational initiative was originally launched at MGH, and now expands to include six liaisons offering expertise in many technology areas, including software, medicinal chemistry, medical devices, diagnostics and therapeutics, and medicine and biology. The liaisons serve as a peer-to-peer resource to investigators, regardless of institutional lines, on aspects of intellectual property and technology commercialization. RVL staff work closely with the Program Liaisons to connect investigators to the appropriate liaison and work as a team to proactively help investigators find the right path for commercialization of their ideas and inventions. For additional information about this program, please contact Seema Basu.
Update: PCPGM launched Gene Insight Suite™
Partners HealthCare Center for Personalized Genetic Medicine (PCPGM), Partners IS, and RVL continued to collaborate in the genetics space. The long running collaboration, initially established to build the IT environment used by the PCPGM and other researchers within Partners, recently expanded its focus to the development and marketing of the GeneInsight Suite™. This suite of IT assets was specifically designed to address the data management challenges associated with genetic testing at both the laboratory (GeneInsight LabSM) and clinician (GeneInsight ClinicSM) levels, and will be instrumental in supporting the Laboratory for Molecular Medicine’s proposed Whole Genome Interpretation Service slated to launch in 2012. Advances in these areas continue to differentiate Partners HealthCare and its affiliates as leaders in clinical genetics and are a key step towards the promise of personalized medicine.
GeneInsight continues to be deployed commercially at diagnostic labs and provider organizations. The Fred A. Litwin and Family Center for Clinical Genetics & Genomic Medicine, a Canadian provider of genetic counseling, testing & education across a range of clinical specialties, became the 2nd external provider group to adopt GeneInsight Clinic. Also, ARUP Laboratories, a national reference laboratory in Utah and the first external laboratory customer of GeneInsight Lab, agreed to extend the term of their initial agreement with Partners. ARUP has successfully transitioned a number of complex genetic tests to GeneInsight Lab and continues to drive increased utilization of the system.