Date: 2016-06-06
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Vaximm (Germany)
Product: VXM01
Action
mechanism:
- immunotherapy product/therapeutic vaccine. VXM01 is designed to stimulate the patients’ own immune system to destroy tumor-associated blood vessels, which are essential for tumors growth. VXM01 is given orally and acts in the gut to induce an anti-tumor response of the immune system.
Disease: pancreatic cancer
Therapeutic
area: Cancer - Oncology
Country: Germany
Trial
details:
- This first-in-human phase I dose escalation study in patients with locally advanced, inoperable and stage IV pancreatic cancer examines safety, tolerability, and immune response to the investigational VEGFR-2 DNA vaccine VXM01. It has been also designed to examine safety and tolerability, clinical and immunogenic response to VXM01, and to define the maximum tolerated dose. (NCT01486329)
Latest
news:
- On June 6, 2016, Vaxxim announced that data on its lead product candidate VXM01 in pancreatic cancer were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. The poster, entitled, A phase 1 trial extension to assess immunologic efficacy and safety of prime- boost vaccination with VXM01, an oral T cell vaccine against VEGF-receptor 2, in patients with advanced pancreatic cancer (Abstract 3091), discussed findings from a 26-patient study extending the randomized, double-blind, placebo-controlled Phase 1 dose-escalation trial in 45 patients with advanced pancreatic cancer. The purpose of the study extension was to explore if continuous treatments with VXM01 could be safely administered and maintain the increased specific T-cell levels previously observed after VXM01 induction treatment (four administrations within one week). In the extension part of the trial, 26 patients with locally advanced, inoperable, Stage IV pancreatic cancer were treated with either VXM01 (N=18) or a placebo (N=8). Two different doses of VXM01 were tested. Patients received the induction treatment, followed by six monthly treatments beginning on Day 38. All patients were allowed to receive standard of care gemcitabine up to Day 38 and any treatment thereafter.
- In the study, VEGFR2-specific T-cell responses were detected in a large proportion of the VXM01- treated patients. After the induction period, pronounced (? grade 2) T-cell responses were observed in about half the patients who received at least one additional administration. In the VXM01 group, specific T-cell responses peaked after three months, with an average four-fold increase compared to baseline; at completion of dosing after six months, these levels were still increased.
- VXM01 was shown to be generally well tolerated, with some mild to moderate decreases in platelets and lymphocytes and an increase in diarrhea, confirming the findings of the previous studyi. The frequency of drug-related adverse events was comparable after induction treatment and further administrations, indicating that continued dosing with VXM01 did not aggravate the side effect profile of this immunotherapy.
- While there were no significant differences between placebo and VXM01-treated patients in overall survival, due to the very small number of patients in the study, VXM01-treated patients who responded to vaccination with increased T-cell reactivity towards VEGFR2 showed a significantly improved survival compared to non- or low-grade responders. Notably, all VXM01-treated patients with a grade ?2 response survived the entire vaccination and up to Month 8. In the placebo group and in the previous study with induction treatment only, no association between grade of response and significantly improved survival was found.
- Vaxxim now plans to further evaluate VXM01 in various solid tumors. A Phase 2a trial in advanced colorectal cancer is already underway.
- • On December 4, 2014, Vaxxim announced follow-on data from the first clinical trial of its investigational oral T-cell vaccine VXM01. Data of a trial extension of the randomized, placebo-controlled, double-blind Phase I dose escalation study show that the safety profile to date is manageable, and indicate that VXM01 has a potential to trigger a strong targeted T- cell-mediated immune response in pancreatic cancer patients. The study code-named VXM01-01-DE enrolled 27 additional patients with inoperable pancreatic cancer at the Heidelberg University Hospital (Heidelberg, Germany).
- • On February 7, 2013, Vaximm announced topline data from the first clinical trial of its investigational oral cancer vaccine VXM01. The randomized, placebo-controlled, double-blind Phase I/II dose escalation study met all key endpoints and demonstrated safety and tolerability. No dose-limiting toxicities were observed. Besides this primary endpoint, several important secondary endpoints, including specific T-cell response and changes in tumor perfusion, were met. After vaccination with VXM01, a quarter of the patients showed a strongly increased T-cell mediated immune response against the target (VEGFR-2). This effect was distinct from fluctuations observed in the placebo- treated patients. Immunologically responding patients occurred already in the lowest dose group. A third of the VXM01-treated patients had a strong drop in tumor perfusion following the treatment, accompanied by corresponding changes in tumor-specific and angiogenesis-related biomarkers. Tumor perfusion changes in the treatment group were correlated with the VEGFR-2 specific effector and regulatory T-cell responses. More detailed results from the trial will be submitted for presentation at upcoming scientific meetings and for publication in a peer-reviewed journal.
- • On October 22, 2012, Vaxxim announced that it completed enrollment in the first clinical trial of VXM01. The randomized, placebo-controlled, double-blind Phase I/II dose escalation study enrolled 45 patients with inoperable pancreatic cancer at the Heidelberg University Hospital (Heidelberg, Germany). In addition to standard-of-care treatment, the patients received several doses of VXM01, a therapeutic cancer vaccine targeting the tumor vasculature. The results of the first, blinded part of the study are expected in the first quarter of 2013.
- • On December 13, 2011, Vaxxim, a Merck KGaA spin-off, announced the start of the first clinical trial of its investigational oral therapeutic cancer vaccine VXM01. The placebo-controlled phase I dose escalation study intends to enroll up to 45 pancreatic cancer patients at the Heidelberg University Hospital (Heidelberg, Germany). In addition to standard-of-care treatment, the patients will receive several doses of VXM01, a therapeutic cancer vaccine that targets the tumor vasculature. The results of the initial double blind period of the study are expected in the first half of 2013.
Is
general: Yes
