News

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!

September 25, 2015

Ten patients enrolled in GAPVAC-101 clinical trial

As of September 22, ten patients have been enrolled in the GAPVAC-101 clinical trial. So far, the biomarker-guided APVAC selection process worked well for all patients. Both APVAC1 warehouse peptides and APVAC2 mutated and over-presented peptides were selected for the final vaccine compositions for the first seven patients. All APVACs could be manufactured within or close to the planned timelines. Our GMP manufacturer (University of Tübingen) has been able to cope with the few production-related issues that emerged (as expected) during the unique formulation of each composition.

July 27, 2015

First APVAC2 successfully vaccinated!

APVAC2 selection and manufacturing for the first patient was successfully completed within the planned timelines. By showing feasibility for personalized drug development of APVAC1 and APVAC2 a major milestone of the GAPVAC project has been accomplished. The patient received the first APVAC2 vaccination seven months post enrolment. Vaccinations were well tolerated so far and are currently continued.

June 29, 2015

GAPVAC-101 clinical trial approved in five countries

After the initial approval of the GAPVAC-101 trial in August 2014 in Germany, the trial was subsequently approved in four additional European countries. Now six clinical sites in Tübingen, Heidelberg, Genève, Barcelona, Leiden and Copenhagen are fully approved by the national authorities and ethics committees and are open for recruitment.

April 30, 2015

First patient vaccinated!

Whereas APVAC1 for the first enrolled patient was successfully manufactured, APVAC2 manufacturing is currently ongoing according to plan. The patient received the first APVAC1 vaccination four months post enrolment. First vaccinations were well tolerated and are currently continued.

April 18, 2015

GAPVAC at Brain Tumor Meeting 2015

The GAPVAC project will be presented by a poster at the Brain Tumor Meeting in Berlin (May 28-29, 2015). The main focus of the meeting is to provide a platform for an interdisciplinary scientific exchange especially between scientists and clinicians.

April 16, 2015

GAPVAC at CIMT Annual Meeting 2015

The Association for Cancer Immunotherapy (CIMT) is a consortium partner and our primary dissemination platform. The GAPVAC project will be presented by a poster at the 13th CIMT Annual Meeting in Mainz (May 11-13, 2015). Additionally, a teaser page in the CIMT program will be dedicated to GAPVAC to raise the visibility of the consortium in the scientific field.