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Flipping the vaccine script
MAINZ, Germany—Two German companies that are dedicated to a biomarker-guided approach in fighting cancer, immatics biotechnologies GmbH and BioNTech AG, are leading the new Glioma Actively Personalized Vaccine Consortium (GAPVAC) with their eyes toward treating glioblastoma patients with "fully personalized" therapeutic vaccines.
The two companies, with immatics as coordinator and BioNTech as vice coordinator—and more than a dozen European, American and Israeli partners in GAPVAC—intend to conduct a multinational clinical trial treating glioblastoma patients with such vaccines beginning in 2014. Giving them a leg up is support from the European Union, to the tune of $8 million through the European Union Framework 7 program grant fund.
GAPVAC is reportedly the first EU-funded initiative aimed at clinically developing biomarker-guided actively personalized vaccines (APVACs) to treat cancer patients. The consortium consists of organizations from the biotech industry and academia with cutting-edge expertise in cancer vaccine development, and it is designed to create and develop APVACs tailored for each patient based on the individual aspects of the patient's tumor and immune system.
"Some 97 percent of all mutations in a given tumor are individual-specific; there is much heterogeneity even in what is technically the same cancer from one patient to the next," Prof. Ugur Sahin, CEO of BioNTech AG, tells DDNEWS. "BioNTech and immatics last years for the first time published proof of concept that you can use mutations identified through next-generation sequencing to create vaccines against tumors."
"There is a lot of work that has been done at the University of Mainz and University of Tuebingen, which our two companies came out of, in the area of immunotherapy for cancer," adds Dr. Harpreet Singh, chief scientific officer of immatics. "People are interested in vaccines for cancers, but much of the focus has been to create a vaccine for the cancer specifically. We have a vision that one should adapt the vaccine to the patient, and not the patient to the vaccine."
According to GAPVAC's July news release about the creation of the consortium, "The latest technologies, including next-generation sequencing, high-sensitivity mass spectrometry and innovative immunomonitoring approaches, will be combined to generate an optimal therapy for the individual patient."
The project aims to show that APVACs are well tolerated and induce a strong and specific immune response against cancer—in this case, glioblastoma, an aggressive form of brain cancer with poor prognosis.
At the core of the GAPVAC project is a Phase I clinical trial that will enroll as many as 30 newly diagnosed glioblastoma patients and is expected to start in 2014. Glioblastoma patients will be repetitively immunized with a vaccine specifically prepared for them. This actively personalized vaccine will be administered in addition to standard chemotherapy after surgery and initial radiochemotherapy are completed. The clinical trial will be led by Dr. Wolfgang Wick of the University of Heidelberg and Dr. Pierre-Yves Dietrich of the University of Geneva.
BioNTech AG will add proprietary glioblastoma-expressed tumor-associated antigens to the peptide warehouse. BioNTech and immatics will use their next-generation sequencing and mass spectrometry expertise, respectively, to identify immunogenic tumor mutations and generate a blueprint for the personalized vaccine that will include patient-specific tumor mutated peptides.
The APVAC "on-demand" manufacturing will be performed by the GMP unit at the Department of Immunology led by Prof. Hans- Georg Rammensee of the University of Tuebingen. The complex peptide warehouse will be manufactured by BCN Peptides in Spain, a company focused on peptide synthesis for clinical use.
In addition, 10 academic partners have joined the consortium to apply the APVACs to their patients as well as contributing to the project with their own research. They are Eberhard Karls University of Tuebingen, Beatson West of Scotland Cancer Centre, Universities Hospital Geneva, Universities Hospital Heidelberg, Herlev Hospital, Leiden University Medical Centre, University of Pittsburgh Cancer Institute, University of Southampton, Technion and Vall d'Hebron University Hospital.
The clinical trial will be accompanied by an extensive biomarker program led by the Association of Cancer Immunotherapy (CIMT), a non-profit organization dedicated to the advancement of cancer vaccines, and immatics to confirm the mechanism of action and to identify biomarker signature candidates predicting which patients are most likely to benefit from treatment with APVACs. CIMT will also act as the dissemination platform and will contribute to the biomarker program and regulatory approach through its working parties.
"The GAPVAC consortium is dedicated to take patient care to the next level. This novel approach marks a fundamental paradigm shift in the therapeutic management of cancer patients since the approach is suited to provide a truly individualized and targeted drug development at unprecedented speed," says Sahin. "In fact, currently we are able to provide ready-to- administer personalized drugs within three months, whereas average time from target-to-hit to first-in-human testing is about 5.5 years."
Echoing Sahin's enthusiasm, Singh adds, "GAPVAC represents an exciting step forward as the first project exploring actively personalized therapeutic cancer vaccines at a European level. Unlike other approaches, this consortium is looking at the specific characteristics of each patient's disease. If successful, this novel approach could create a completely new way to treat cancer. Such a unique approach is only possible by combining a variety of the latest technological innovations and by joining forces with superb biotechnology companies and academic institutions—by partners who share a dedication for the personalization of therapy for the benefit of cancer patients."