News

March 07, 2019

EU honors GAPVAC project as success story

The European Union rates the GAPVAC project and Consortium as one of the recent EU research success stories! The online article highlights the results of the GAPVAC-101 phase 1 study that were recently published in Nature. Furthermore, the project is recognized as a blueprint for future personalized cancer treatments.

See the full article here.

December 19, 2018

NATURE PUBLICATION REPORTS FIRST-IN-HUMAN TRIAL OF A NOVEL ACTIVELY PERSONALIZED THERAPEUTIC VACCINE FOR BRAIN CANCER

Clinical study demonstrates proof-of-concept of the Glioma Actively Personalized Vaccine Consortium (GAPVAC) approach in a pioneering multi-center, multi-national study co-funded by the European Union

Heidelberg, Tuebingen and Mainz, December 19, 2018 – The prospect of an actively personalized approach to the treatment of glioblastoma has moved a step closer with the recent publication in Nature of favorable data from the phase 1 study GAPVAC-101, testing a novel therapeutic concept tailored to specific characteristics of patients’ individual tumors and immune systems. For the first time, the feasibility of such a highly personalized form of immunotherapy has been exemplified in a multi-center, multi-national clinical setting.

Glioblastoma, an aggressive form of brain tumor with poor prognosis, has a high unmet need and the limited treatments available today have minimal effect on overall survival. To date, patients with glioblastoma have not sufficiently benefited from recent breakthroughs with checkpoint inhibitors – to a great part, because this tumor type is characterized by a low mutational load and thus only few neoantigens are targetable by the immune system.

The Glioma Actively Personalized Vaccine Consortium (GAPVAC) approach is a highly personalized method being progressed through the GAPVAC-101 first-in-human clinical trial by a European Union-funded consortium, led by Immatics Biotechnologies GmbH (Tuebingen, Germany) and BioNTech AG (Mainz, Germany).

Fifteen newly diagnosed glioblastoma patients received two therapeutic vaccines in succession; the first being actively personalized vaccine 1 (APVAC1) targeted at non-mutated antigens, followed by APVAC2 preferentially targeted at neo-antigens. Vaccine compositions were personalized for each patient based on analysis of the transcriptome, immunopeptidome and mutanome of the individuals’ tumors and, for APVAC1, also based on the capability of each patient to mount an immune response. Both vaccine types displayed favorable safety and immunogenicity. Non-mutated APVAC1 antigens induced sustained central memory CD8+ T-cell responses, whilst APVAC2 induced T helper cell type 1 (TH1) CD4+ as well as CD8+ T-cell responses against predicted neo-epitopes.

Patients in this study were treated at six European centers: The University Hospital of Heidelberg (Germany), the University Hospital of Tuebingen (Germany), the Geneva University Hospital (Switzerland), the Leiden University Medical Center (The Netherlands), the Rigshospitalet (Copenhagen, Denmark), and the Vall d’Hebron University Hospital (Barcelona, Spain). Furthermore, the Department of Immunology, University of Tuebingen (led by Prof. Hans-Georg Rammensee), BCN Peptides (Barcelona, Spain), the Association of Cancer Immunotherapy (CIMT), the University of California San Francisco (US), the University Southampton (UK), and the Technion-Israel Institute of Technology (Haifa, Israel) participated in the study involving a pioneering concept, complex manufacturing, logistics and various biomarker analyses.

The trial was led by the Principal Investigator (PI) Prof. Dr. Wolfgang Wick, University of Heidelberg and German Cancer Consortium (DKTK). Prof. Dr. Pierre-Yves Dietrich, University of Geneva, also an internationally recognized expert in the treatment and immunology of brain cancer, served as Co-PI.

“The ability to exploit the full repertoire of tumor antigens, including non-mutated and neo-antigens, may offer more effective immunotherapies, especially for tumors with low mutational load”, said Prof. Dr. Wolfgang Wick, Chair of the Neurology Clinic at the Heidelberg University Hospital.

He added: “The trial approach combines exceptional science and a rigorous protocol for a disease for which over-simplified strategies have failed in the past. In addition, the insights gained will contribute to future immunotherapy efforts to bridge the precision of genomic medicine and immunotherapy for the benefit of patients. We believe that it provides a blueprint for future trials in personalized medicine.”

Dr. Harpreet Singh, Chief Scientific Officer of Immatics Biotechnologies GmbH and Coordinator of the GAPVAC consortium, said: “We are at a very exciting stage in the evolution of personalized cancer treatments, building on the scientific advances in immuno-oncology and checkpoint inhibitors. The protocol used in GAPVAC-101 is an entirely new, personalized approach to treating cancer that combines the innovative science of all of the consortium members. We are excited that we have been able to achieve such a high degree of treatment personalization due to our ability to perform mass spectrometry, next generation sequencing, mRNA microarray, immune repertoire analysis and drug manufacturing for every patient.”

Prof. Dr. Ugur Sahin, Chief Executive Officer of BioNTech AG and Vice Coordinator of the GAPVAC consortium, noted: “The GAPVAC consortium is one of the first groups in the world that aim to target mutations in glioblastoma to optimize drugs for each individual patient. The high immunogenicity rate of vaccine targets detected in this collaborative study indicates that even tumors with low mutational load such as glioblastomas are amenable for individualized immunotherapy approaches.”

Publication reference:

Hilf et al., Actively personalized vaccination trial for newly diagnosed glioblastoma, Nature 2018 Electronic publication date: 19th December, 2018 (DOI 10.1038/s41586-018-0810-y)

 Nature Publication Reports First-In-Human Trial Of A Novel Actively Personalized Therapeutic Vaccine For Brain Cancer

November 05, 2018

GAPVAC at SITC (Nov 7-11) in Washington, DC

We’re happy to announce, that GAPVAC will be part of the SITC Conference in Washington, DC (Nov 7-11). If you’re there, stop by and discuss with our experts newest trial results and scientific insights:

November 9th, 3:00pm-3:15pm

Talk: “The GAPVAC approach of actively personalized peptide vaccination for patients with newly diagnosed glioblastoma

Speaker: Hideho Okada (University of California, San Francisco, USA and Parker Institute for Cancer Immunotherapy)

Session: Early Phase 1 Clinical Trials

 

November 10th, 12:20pm-1:50pm and 7:00pm-8:30pm

Poster: “The GAPVAC approach of actively personalized peptide vaccination for patients with newly diagnosed glioblastoma” (Abstract #O8)

Presenter: Norbert Hilf (Vice President Translational Development, Immatics Biotechnologies GmbH, Germany)

 

We’re looking forward to interesting and exciting discussions.

Further information about SITC here.

October 31, 2018

GAPVAC at the 5th USP Workshop on Therapeutic Peptides (Nov 5-6) in Rockville, MD

Meet Norbert Hilf, VP Translational Development at Immatics, at the 5th USP Workshop on Therapeutic Peptides in Rockville, MD (Nov 5-6) and join his talk:

November 6th, 1:25pm-1:45pm

“The GAPVAC Project: Active Personalization of Peptide Vaccines for Patients with Newly Diagnosed Glioblastoma”

Speaker: Norbert Hilf (VP Translational Development, Immatics)

Session VI: Peptide Vaccines

 

We’re looking forward to interesting and exciting discussions.

You can find further information on the USP Workshop here.

October 10, 2018

GAPVAC at the EANO conference (Oct 10-14) in Stockholm, Sweden

Prof. Pierre-Yves Dietrich, Co-lead Investigator of the GAPVAC-101 trial and Director of the Centre of Oncology at the Geneva University Hospital, to present results from the GAPVAC trial at EANO conference (Oct 10-14) in Stockholm:

October 12, 11:27am-11:39am 

Oral Session 2: Non-surgical treatment (Room: A2)

“Highly personalized peptide vaccination for patients with newly diagnosed glioblastoma:  the GAPVAC trial”

We’re looking forward to interesting and exciting discussions.

Further information on EANO here.

April 30, 2018

GAPVAC results presentation at ASCO 2018 (June 1-5) in Chicago, IL

Results from the GAPVAC clinical trial will be presented at ASCO 2018!

The oral presentation “GAPVAC-101: First-in-human trial of a highly personalized peptide vaccination approach for patients with newly diagnosed glioblastoma” by Lead Investigator Prof. Dr. Wolfgang Wick (University Hospital Heidelberg, Germany) will take place on June 1st during the Central Nervous System Tumors session (starting 2:45 pm CDT).

Visit www.asco.org for more information.

March 24, 2017

EU-funded consortium led by Immatics and BioNTech announces completion of regular study treatment in the GAPVAC-101 trial

Study is assessing fully personalized therapeutic cancer vaccines for patients with brain cancer

 Tuebingen/ Mainz, March 24, 2017 – Immatics Biotechnologies GmbH and BioNTech AG announce today the completion of regular study treatment in the GAPVAC-101 clinical trial. The phase 1/2 trial assesses for the first time therapeutic cancer vaccines designed and manufactured for each glioblastoma patient individually based on the specific characteristics of their tumor and immune system.

The clinical trial is being led by chief investigator Prof. Dr. Wolfgang Wick, University of Heidelberg, and co-led by Prof. Dr. Pierre-Yves Dietrich, University of Geneva, both internationally recognized experts in the treatment and immunology of brain cancer.

The Glioma Actively Personalized VAccine Consortium (GAPVAC) is the first EU-funded initiative aimed at clinically developing biomarker-guided actively personalized vaccines (APVACs) to treat patients with glioblastoma. The GAPVAC consortium includes 13 organizations in Europe and the United States and is led by Immatics Biotechnologies GmbH (coordinator) and BioNTech AG (vice coordinator).

Until completion of patient recruitment in July 2016, the phase 1/2 clinical trial has recruited 16 newly diagnosed glioblastoma patients. To-date the trial has shown that the consortium’s highly personalized, complex multi-peptide APVACs can be designed and manufactured within the European regulatory environment and within acceptable time lines for physicians and patients. Moreover, APVACs are well tolerated and show an acceptable safety profile. Results from the trial including immune data analysis are expected in the second half of 2017. Some patients are still continuing APVAC vaccinations beyond the last regular study visit under the discretion of their treating physicians to fully exploit the potential benefit from the APVACs specifically tailored to their disease.

Prof. Dr. Wolfgang Wick, Chair of the Neurology Clinic at the University of Heidelberg, said: “I’m excited to announce that we have completed regular study treatment in the GAPVAC-101 trial. I am pleased to report that we have successfully managed the highly complex process of sample collection, analysis, vaccine design and manufacturing. This enabled us to offer personalized APVACs to all patients in the study, showing that a truly personalized vaccine approach is feasible. We believe that it provides a blueprint for future trials in personalized medicine. Congratulations to the Consortium for the achievements.”

Dr. Carsten Reinhardt, Chief Medical Officer of Immatics, said: “This is a key milestone for the GAPVAC consortium as we look to assess the potential of biomarker-guided personalized vaccines to deliver improved outcomes for patients with glioblastoma. We look forward to having a full picture of the data later in 2017.”

Prof. Dr. Ugur Sahin, Chief Executive Officer of BioNTech AG and Vice Coordinator of the GAPVAC consortium, said: “The GAPVAC consortium used individual tumor mutations in glioblastoma as targets for cancer immunotherapy. With the GAPVAC clinical trial, the consortium proved that this approach of truly individualized treatments is feasible and furthermore promising to significantly extent the treatment options for cancer patients.”

 GAPVAC announcement: Completion of regular study treatment

 

September 07, 2016

End of GAPVAC patient recruitment (July 2016)

With 16 patients enrolled in the GAPVAC trial, patient recruitment was closed in July 2016. Patients have been recruited by the six clinical sites Tübingen, Heidelberg, Genève, Barcelona, Leiden and Copenhagen. The individual targets have already been selected for all enrolled patients and the biomarker-guided APVAC selection process worked very well. Out of the 16 enrolled patients, 13 received APVAC1 and/or APVAC2 vaccinations by now. Patient treatment will presumably be completed in Q2 2017.

April 25, 2016

GAPVAC at CIMT Annual Meeting 2016 (May 10 – May 12) in Mainz, Germany

Meet people from the GAPVAC EU consortium at the Annual Meeting of the Association of Cancer Immunotherapy (CIMT), the largest cancer immunotherapy meeting in Europe! GAPVAC will also be presenting:

Wednesday, May 11
4.45pm – 5.05pm
GAPVAC: first results from a personalized peptide vaccination study in glioblastoma
Harpreet Singh, Immatics Biotechnologies Tuebingen, Germany
Session: EU Consortia Session
Type: Talk
Location: Rheingoldhalle Congress Center Mainz, Gutenberg A

For further information please contact us!
For more information on CIMT 2016: click

April 04, 2016

GAPVAC at AACR Annual Meeting 2016 (April 16 – April 20) in New Orleans, Louisiana, USA

Meet people from the GAPVAC EU consortium at the AACR Annual Meeting 2016! GAPVAC will also be presenting:

Monday, April 18
4.35pm – 4.50pm
GAPVAC-101 phase I trial: First data of an innovative actively personalized peptide vaccination trial in patients with newly diagnosed glioblastoma
Harpreet Singh, Immatics Biotechnologies Tuebingen, Germany
Session: Minisymposium Immunotherapy Trial Results and Correlates
Type: Talk [abstract no. 2654]
Location: Morial Convention Center, New Orleans Theater B

For further information please contact us!