Tag: oncology
Thermosome Initiates Final Dose Level in Phase I Trial of Lead Compound THE001
— Independent Data Safety Monitoring Board declared dose level 2 as safe and recommended escalation to final dose level 3
Thermosome, a drug development company focused on targeted tumor therapies, today announced its ongoing Phase I trial has progressed to dose level 3 (DL3) after the independent Data Safety Monitoring Board (DSMB) declared dose level 2 (DL2) as safe and recommended escalation to the final dose level (DL3). In the trial, the Company’s lead compound THE001is tested in patients with heavily pre-treated, locally advanced unresectable or metastatic soft tissue sarcoma (STS) in combination with regional hyperthermia. Read more…
Thermosome Presents Encouraging Initial Clinical Data from Phase I Trial of Lead Compound THE001
— THE001 safe and well tolerated in first two dose level, demonstrating encouraging signs of clinical activity
— Data presented at The Connective Tissue Oncology Society (CTOS) Annual Meeting 2024
Thermosome, a drug development company focused on targeted tumor therapies, today announced encouraging initial clinical data from the ongoing Phase I study of its lead compound THE001 in patients with heavily pre-treated, locally advanced unresectable or metastatic soft tissue sarcoma (STS). The data were presented as a poster (#P410) titled “Phase I study of THE001 (DPPG2-TSL-DOX) combined with regional hyperthermia in patients with locally advanced or metastatic soft tissue sarcoma” at The Connective Tissue Oncology Society (CTOS) Annual Meeting 2024 in San Diego, USA. Read more…
ImmunOs Therapeutics Appoints Michael A. Curran, PhD, as Chairman of its Scientific Advisory Board
– Renowned immunology expert from MD Anderson Cancer Center to lead seasoned group of scientific advisors
ImmunOs Therapeutics AG, a biopharmaceutical company leveraging its HLA-based technology platform to develop first-in-class therapeutics for the treatment of cancer and autoimmune diseases, today announced that Michael A. Curran, PhD, has been appointed Chairman of the Company´s Scientific Advisory Board. In addition to Dr. Curran, Taha Merghoub, PhD, Ulf Petrausch, MD, and Paul Bowness, MD, PhD, currently serve as Scientific Advisors to ImmunOs.
Company News: VAXIMM Reports Positive Topline Data from First Oral Cancer Vaccine Trial
– Study meets endpoints and demonstrates safety and tolerability of VXM01 –
VAXIMM AG, a Swiss-German biotech company focusing on oral cancer vaccines, announced today 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.
The study code-named VXM01-01-DE 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 vaccine targeting the tumor vasculature, or placebo.
The results of the study indicate that the vaccine was safe and well tolerated. 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.
“We are delighted to see that VXM01 was safe and well tolerated in the patients we treated,” said PD Dr. Hubertus Schmitz-Winnenthal, principal investigator of the study. “We are especially excited about the encouraging data observed in the two key secondary endpoints. The vaccine seems to be able to induce and enhance the VEGFR-2 specific T-cell response and to impact tumor perfusion in a good proportion of treated patients.”
“We are very encouraged by these data,” added Dr. Heinz Lubenau, General Manager of VAXIMM GmbH, a fully owned subsidiary of VAXIMM AG in Germany. “It provides a strong basis for continuing the development of VXM01 for the treatment of solid tumor diseases. Following regulatory approval, we plan to re-open the study VXM01-01-DE for further recruitment of pancreatic cancer patients.”
Dr. Klaus Breiner, Executive Chairman of VAXIMM AG commented: “We are very pleased with this outcome. This first-in-man study was already designed as a placebo-controlled trial, providing us with a high level of confidence in the validity of the results.”