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All of a mind on brain tumor vaccine
TUEBINGEN, Germany—June 2 saw the announcement that immatics biotechnologies GmbH, a clinical-stage biopharmaceutical company developing anti-cancer vaccines, has signed a clinical trial agreement with the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) in the United States. Complementing a February deal with Cancer Research UK, this gives the German company important agreements with a key oncology organization across the pond as well as one just inside it.
The NCI deal covers the clinical development of immatics' therapeutic cancer vaccine IMA950, which is to be evaluated in the field of brain cancer, specifically glioblastoma, the most aggressive form of brain cancer. CCR will sponsor and conduct a phase I trial of IMA950 to be carried out at the National Institute of Health's facility in Bethesda, Md., which will evaluate IMA950 in stable or recurrence-free glioblastoma patients following standard radiochemotherapy with temozolomide.
This is distinct from the February agreement, under which Cancer Research UK will sponsor and conduct a Phase I trial of IMA950 to be carried out at leading glioma research centers in the United Kingdom via its Drug Development Office, treating newly diagnosed patients with IMA950 in combination with radio-chemotherapy, rather than treat patients after successful radio-chemotherapy with standalone IMA950. For the deal, immatics will not only supply the drug for the trial and also undertake immunomonitoring in the treated patients.
The different protocols for these two studies should mean that they provide complementary data reflecting the different clinical situations experienced by glioblastoma patients.
"Our ability to secure two such highly regarded collaborators to advance IMA950 into the clinic demonstrates the significant interest in immatics' novel therapeutic vaccines and the need for a much improved treatment option for glioblastoma," says Paul Higham, CEO of immatics.
After the completion of the U.K. study, immatics will have an exclusive first right to take a license to the data for further development of IMA950. No financial details were disclosed with regard to that deal.
The principal investigator of the U.S. study is Dr. Howard Fine, chief of the Neuro-Oncology Branch at NCI. As with the Cancer Research UK deal, immatics will be responsible for drug supply for the study as well as undertaking immunomonitoring of the treated patients.
IMA950 is a therapeutic cancer vaccine generated through immatics' proprietary XPRESIDENT technology. It consists of 11 tumor-associated peptides that the immatics platform selected on the basis of their natural presentation by tumor tissue, overexpression in tumor versus healthy tissue, immunogenicity and their relevance to tumor function.
It is not, however, the only item in the immatics pipeline with promise. Just three days after announcing the NCI deal, immatics also announced that results from its exploratory Phase II clinical trial with IMA901 in patients with advanced renal cell carcinoma were positive enough that it plans to start a randomized, controlled pivotal clinical trial with IMA901.
The exploratory Phase II study recruited 68 patients with advanced/metastatic renal cell carcinoma who had failed previous first line therapy (either tyrosine kinase inhibitors or cytokines). Patients in the study were randomized to receive one single infusion of cyclophosphamide (CY) as immunomodulator prior to the first vaccination with the multi-peptide vaccine IMA901. The study investigated disease control rate at six months, progression-free survival, overall survival, correlation of immune response with clinical benefit and safety and tolerability.
Patients randomized to receive a single dose of CY showed a strong trend towards improved overall survival versus patients who did not receive CY, and the survival data of this study compares very favorably to previous studies of the approved tyrosine kinase inhibitors sunitinib and sorafenib.
"The fact that we have seen this potential survival benefit is important given the regulatory authorities' recognition of survival as the key efficacy endpoint for cancer vaccines," Higham says. "Additionally, we have confirmed the mechanism of action of IMA901 by demonstrating a significant association of immune response with clinical benefit in two independent trials."