publication date: Jan. 13, 2017
Drugs & Targets
Merck joins ORIEN
M2Gen said Merck has joined the Oncology Research Information Exchange Network (ORIEN) Avatar Research Program.
Launched in April 2016, the ORIEN Avatar Research Program fosters collaboration among key stakeholders in cancer research, including patients themselves, with the shared goal of discovering and developing novel therapies and ultimately matching patients to the best treatment options.
ORIEN Avatar is a collaboration between leading U.S. cancer hospitals, pharmaceutical companies and M2Gen, which manages the program. Patients donate clinical and molecular data through their consent to the Total Cancer Care Protocol; that data is then utilized by the ORIEN cancer center members and pharmaceutical partners to speed discoveries and match eligible patients to cutting-edge trials.
The program represents an unprecedented, pre-competitive approach to fighting cancer, designed to accelerate the discovery and development of novel therapies for millions of patients. Merck’s participation in the program builds on a history of collaboration dating back to the founding of M2Gen in 2006, to operationalize a multi-year agreement based on the Total Cancer Care Protocol.
The ORIEN Avatar Research Program links pharmaceutical companies and prominent cancer centers.
Participating cancer researchers contribute samples and disease information from patients who provide consent to be studied via the Total Cancer Care Protocol, and receive rich molecular data plus access to a rich network of potential collaborators.
Pharmaceutical companies contribute financial support and receive access to de-identified genetic and disease information that can be used to inform the discovery and clinical development of novel cancer therapeutics.
Scripps to collaborate with Pfizer to advance DNA-encoded library technology
The Scripps Research Institute announced a research collaboration and license agreement with Pfizer Inc. to pioneer new DNA-encoded library technology, including new synthetic chemistry for the creation of next-generation DELs, a potentially transformative technology for early stage drug discovery research.
Under the collaboration, Pfizer will pay a technology access fee and thereby gain access to innovative chemical synthesis technology developed at TSRI.
Members of the TSRI chemistry department—Professors Phil Baran, Dale Boger, Jin-Quan Yu, K. Barry Sharpless, and others—will work alongside Pfizer scientists to adapt these chemical methods for use in creating DELs, which require stringent processes that are tolerant of the delicate DNA backbone.
TSRI and Pfizer may choose to expand the scope of the joint research to include other technologies relevant for enabling DEL-based drug discovery. Financial terms of the agreement are not disclosed.
In contrast to conventional drug screening where a few million small molecules are evaluated in biological systems, DEL screening uses DNA-based “barcodes” to survey billions of small molecules, potentially increasing the ability of researchers to identify promising chemical leads.
While this technology was originally conceived at TSRI by Richard Lerner and Sydney Brenner in the early 1990s, the reduction to practice has taken decades and required technological advances in DNA sequencing and informatics in order to be more fully realized.
AbbVie announces four new global research collaborations
AbbVie announced four collaborations and investments with leading healthcare innovators to advance early-stage research in key therapeutic areas such as oncology and immunology.
AbbVie and Pure MHC, a privately-held target discovery company, will embark on a research and license agreement to discover and validate peptide targets for use with T-cell receptor therapeutics in several types of cancers.
The collaboration between AbbVie and Pure MHC will seek to identify a library of peptide targets for further research across multiple tumor types and advance AbbVie’s ongoing development of next-generation immuno-oncology therapies.
AbbVie entered into an exclusive license with Dong-A-ST, a leading specialty healthcare company in South Korea, for MerTK inhibitors in pre-clinical development for use in conjunction with immuno-oncology therapies.
MerTK is a protein that is believed to contribute to the promotion of immunosuppressive tumor microenvironment.
Inhibition of this activity may help promote an inflammatory state, alerting the immune system to attack tumors and augmenting the efficacy of targeted cancer therapies such as checkpoint inhibitors (anti-PD1/PD-L1) and pro-apoptotic agents.
The collaboration will explore the combination of MerTK inhibitors in conjunction with AbbVie’s portfolio of anti-cancer agents across multiple types of solid tumors.
The addition of this mechanism will advance AbbVie’s existing research into immuno-oncology therapies and complement its oncology pipeline under development for nearly 20 cancers and tumor types.
AbbVie and Zebra Biologics, Inc., a discovery stage biotechnology company, entered into a partnership to discover agonist antibody therapeutics for inflammatory diseases. Zebra will utilize its novel and patented function-based antibody discovery platform to generate antibodies that activate biological pathways associated with targets designated by AbbVie. Zebra and AbbVie will collaborate closely on the identification and pre-clinical validation of emerging candidates. The targets were not disclosed.
Zebra will lead the discovery of candidate agonist antibodies for designated targets and will collaborate with AbbVie in pre-clinical validation of select clinical candidates. Upon advancement of clinical candidates, AbbVie would be responsible for clinical development, manufacturing, regulatory approval and world-wide commercialization.
AbbVie and Genomics Medicine Ireland, a life sciences startup company, partnered to conduct population genomics research in Ireland. The alliance will sequence the genomes of 45,000 volunteers across Ireland. The data to be included will originate from people with several types of immune-mediated diseases, neurological disorders and cancer, as well as people unaffected by these diseases. By incorporating the genotypic and phenotypic data across a wide sample population, the partnership aims to better understand human biology and disease etiology to discover new therapeutic targets and identify biomarkers.
AbbVie will utilize the research to select targets for drug development, as well as potential development of companion diagnostics for selected conditions.
GMI is backed by investors ARCH Venture Partners, Polaris Partners, GV (formerly Google Ventures) and the Ireland Strategic Investment Fund.
Lilly and Merck expand immuno-oncology collaboration
Eli Lilly and Co. announced the expansion of an existing immuno-oncology collaboration with to add a new study of Lilly’s Lartruvo (olaratumab) with Keytruda (pembrolizumab) in patients with previously treated advanced or metastatic soft tissue sarcoma.
FDA recently granted accelerated approval for Lartruvo (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with STS with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
Lartruvo (olaratumab injection, 10 mg/mL), in combination with doxorubicin, also recently received conditional marketing authorization from the European Medicines Agency for the treatment of adults with advanced STS not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin.
Lilly is the sponsor of the phase 1 study and enrollment is expected to begin mid-2017. Other ongoing trials between Lilly and Merck, through a subsidiary, include:
Studies of pemetrexed (plus carboplatin) and pembrolizumab in first-line nonsquamous non-small cell lung cancer, including a phase III study that is currently enrolling patients;
A phase I study examining the combination of ramucirumab with pembrolizumab in NSCLC, gastric cancer and bladder cancer;
A phase I study examining the combination of necitumumab with pembrolizumab in NSCLC; and
A phase I study examining the combination of abemaciclib, a CDK 4 and 6 inhibitor, with pembrolizumab. Based on the phase I trial results, the collaboration has the potential to progress top Phase II trials in patients who have been diagnosed with either metastatic breast cancer or NSCLC.
Amgen and Immatics collaborate to develop cancer immunotherapies
Amgen and Immatics Biotechnologies GmbH announced a research collaboration and exclusive license agreement to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancers.
The collaboration will combine Immatics’ XPRESIDENT target discovery and T-cell receptor capabilities with Amgen’s validated Bispecific T-cell Engager technology, with the aim of creating novel oncology drugs. Amgen will be responsible for clinical development, manufacturing, and commercialization worldwide.
Under the agreement, Immatics will receive an upfront fee of $30 million and is eligible to receive over $500 million in development, regulatory and commercial milestone payments for each program and tiered royalties up to a double-digit percentage of net sales.
Philips and Illumina to co-develop integrated genomics solutions for oncology
Royal Philips and Illumin Inc. announced a strategic collaboration that aims to integrate Illumina’s sequencing systems for large-scale analysis of genetic variation and function and Philips’ IntelliSpace Genomics clinical informatics platform, and to coordinate marketing and sales of the resulting solutions. Philips and Illumina will also seek to engage in clinical research collaborations with health systems in the U.S. that want to develop precision medicine programs in oncology.
Profiling tumors using genomic information is critical for complex cancer cases, and next-generation DNA sequencing—the process of rapidly profiling large sections of the genome in parallel to find mutations—is increasingly being used for this. However, challenges remain in developing ways to rapidly and accurately interpret genomic findings in the context of a patient’s condition.
While cancer patients can have hundreds of gene variants in their tumors, only a small number may actually drive the individual’s specific cancer or may have actionable therapeutic implications for a particular patient. The patient’s history, related lab tests and cancer type are needed for a meaningful interpretation of the genomic data.
Philips and Illumina will collaborate to provide new solutions aimed at the acquisition, analysis, annotation, and interpretation of genomics data in oncology cases. The data will be acquired by Illumina’s BaseSpace Sequence Hub connected to its instruments and will be processed through Philips’ IntelliSpace Genomics solution for oncology. This solution will combine data from multiple sources—radiology, immunohistochemistry, digital pathology, medical records and lab tests—and will deliver a consolidated dashboard view. This system will support researchers to develop insights more efficiently and will ultimately support lowering the cost of health care delivery and improved health outcomes.
The two companies intend to collaborate on system integration, cohort analysis and health economics applications, and future research programs. Laboratories adopting the solution will be able to integrate sequencing data with information from multiple data sources (e.g., imaging, pathology and laboratory). The Illumina-Philips solution will also give them ready access to advanced analytics, deep learning technologies and available reference literature, guidelines, and evidence in a single view.
Tecentriq receives priority review for treatment of urothelial carcinoma
Genentech said FDA accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy, and are either previously untreated or have disease progression at least 12 months after receiving chemotherapy before surgery or after surgery.
Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.
“In May 2016, Tecentriq became the first treatment approved by the FDA for people with previously treated advanced bladder cancer in more than 30 years,” said Sandra Horning, chief medical officer and head of Global Product Development. “We are committed to continue working with the FDA to make Tecentriq available to more people with this type of advanced bladder cancer, specifically those who are unable to tolerate cisplatin-based chemotherapy as an initial treatment.”
This sBLA submission for Tecentriq is based on results from the Phase II IMvigor210 study, and the FDA will make a decision on approval by April 30, 2017. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Tecentriq is currently approved by the FDA to treat people with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy or whose disease has worsened within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy.
Tecentriq is approved under accelerated approval for this indication based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Tecentriq is also approved for the treatment of people with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
IMvigor210 is an open-label, multicenter, single-arm phase II study that evaluated the safety and efficacy of Tecentriq in people with locally advanced or mUC, regardless of PD-L1 expression. People in the study were enrolled into one of two cohorts. Cohort 1, upon which this sBLA submission is based, consisted of people who were ineligible for first-line cisplatin-based chemotherapy, and who had received no prior chemotherapies for locally advanced or mUC (i.e., first-line) or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy.
Cohort 2, which served as the basis for the FDA’s accelerated approval of Tecentriq in May 2016, included people whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen, or who had disease progression within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regimen. The primary endpoint of the study was objective response rate. Secondary endpoints included duration of response, overall survival, progression-free survival and safety.
EMD Serono and MD Anderson enter three-year collaboration
EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, and MD Anderson Cancer Center announced a three-year strategic collaboration, with the aim of more quickly advancing the development of investigational cancer therapies in four cancers–breast, colorectal, glioblastoma and leukemia.
EMD Serono will be the first company to gain access to the Adaptive Patient-Oriented Longitudinal Learning and Optimization Platform (APOLLO)—MD Anderson’s research platform that standardizes the long-term collection of patients’ medical history and data derived from tissue samples to better understand the biology of cancer and accelerate research-driven patient care.
The collaboration will encompass both biomarker-focused pre-clinical research and clinical trials in specific tumor types aimed at identifying biomarkers of response and resistance and developing a better understanding of the disease biology.
The collaboration will enhance the value of EMD Serono’s future oncology/immuno-oncology pipeline, with a goal of multiple registrational studies in novel indications in the next two to three years. Data from APOLLO will be used to match a number of investigational compounds to select tumor types for potential development and collaboratively design biomarker-driven pre-clinical and clinical studies at MD Anderson evaluating the potential therapeutic effect of the compounds—alone or in combination.
APOLLO was developed by MD Anderson as part of its Moon Shots Program, an ambitious effort to reduce cancer deaths by more rapidly developing and implementing advances in prevention, early detection and treatment based on scientific discoveries.
MD Anderson and Deerfield Management create company to inhibit autophagy
Vescor LLC, a new company focused on discovery and development of autophagy targeted therapeutics for cancer treatment, was formed by MD Anderson Cancer Center, Deerfield Management and two autophagy experts, Eileen White, deputy director and associate director for Basic Science, Rutgers Cancer Institute of New Jersey, and Alec Kimmelman, chairman, Department of Radiation Oncology at NYU Langone Medical Center and a member of the Perlmutter Cancer Center at NYU Langone.
Vescor, advised by its scientific founders White and Kimmelman, will develop small molecule inhibitors of a number of protein targets at critical nodes of the autophagy cascade, perform investigational new drug enabling studies, and move these into clinical development.
MD Anderson’s Institute for Applied Cancer Science, in combination with Deerfield, will provide drug discovery and development expertise, together with translational research focused at advancing autophagy therapeutics into trials in melanoma, lung and pancreatic cancers.
Vescor’s core activities will be performed at IACS, while managerial and operational expertise will be provided by both IACS and Deerfield.
Cologuard earns positive review from Blue Cross Blue Shield Association
Exact Sciences Corp. announced that the Blue Cross Blue Shield Association’s Center for Clinical Effectiveness “Evidence Street” recently released a positive review of Cologuard to its members.
This continues the positive momentum for Cologuard, as coverage increased by 67 percent in 2016 and nearly 163 million Americans are now in health plans that cover the non-invasive colorectal cancer screening option.
“Nearly two thirds of the Blue Cross and Blue Shield companies already cover Cologuard,” said Kevin Conroy, Exact Sciences’ chairman and CEO. “This review affirms that Cologuard has a positive impact on health outcomes and provides additional support for the remaining plans to offer their members our patient-friendly, non-invasive colon cancer screening option.”
The BCBSA’s Center for Clinical Effectiveness is an organization that assesses the effectiveness of medical devices, procedures, and biological products through comprehensive reviews and clinical evidence. The Evidence Street assessment follows other positive reviews of Cologuard, which is now included in the recommendations of the U.S. Preventive Services Task Force, and the colorectal cancer screening guidelines of the American Cancer Society and the National Comprehensive Cancer Network.
More than 70 percent of Cologuard’s addressable population is now in a health plan that covers the test, the company said. Coverage expanded by 62 million lives since June 2016, when Cologuard was included as an A-graded test in the U.S. Preventive Services Task Force’s final colorectal cancer screening recommendations.
FDA accepts BLA for Mylan and Biocon’s biosimilar Trastuzumab
Mylan N.V. and Biocon Ltd. said FDA has accepted Mylan’s biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway.
This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept 3.
Mylan and Biocon’s proposed biosimilar trastuzumab is also under review by the European Medicines Agency.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.
Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
FDA releases guidance on nonproprietary naming of biologics
FDA released the final guidance for industry “Nonproprietary Naming of Biological Products.”
The guidance describes the agency’s thinking on the need for biological products previously and newly licensed under the Public Health Service Act (PHS Act) to bear nonproprietary names that include an FDA-designated suffix.
Under this naming convention, FDA will designate a distinguishing suffix that is devoid of meaning and composed of four lowercase letters in the nonproprietary names for originator biological products, related biological products, and biosimilar products. The suffix will be attached to each product’s core name with a hyphen.
FDA is continuing to consider the appropriate suffix format for interchangeable products.