News
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.”
Company News: Merus Achieves Milestone with Novartis Option Fund
– Company Reaches Milestone in Biclonics™ Program Partnered with Novartis –
Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, today announced it has met the second milestone in its option agreement with the Novartis Option Fund (NOF). The achievement triggers an undisclosed milestone payment.
In 2010, Merus had entered into an option agreement with the Novartis Option Fund for an exclusive license to one of Merus’ oncology programs. The deal grants the Novartis Option Fund rights to a product candidate created by the Biclonics™ and Oligoclonics™ technologies of Merus. Merus is potentially entitled to milestone and license payments in excess of $200 million, as well as royalties.
Ton Logtenberg, CEO and founder of Merus, commented: “Reaching this key milestone in our program partnered with NOF underlines the power of our platform to generate antibodies addressing multiple targets simultaneously with high potency and the desired functional activity.”
Company News: Anergis Obtains U.S. Patent for Lead Product AllerT
Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, has been granted patent protection for its AllerT birch pollen allergy treatment in the U.S.
The patent No. 8,343,503 granted by the U.S. Patent Office broadly covers composition of matter and medical use of AllerT, the lead product of Anergis. AllerT is composed of a set of three contiguous overlapping peptides (COPs) derived from the allergen Bet v 1, which plays a key role in inducing birch pollen allergy.
AllerT is currently evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial enrolling about 300 patients with moderate to severe birch pollen allergy in up to 30 trial centers throughout Europe. Results are expected in Q3, 2013. In an earlier Phase I/IIa trial, a 2-month treatment with AllerT was well tolerated by patients with moderate to severe allergy to birch pollen. In these patients, AllerT elicited long-lasting immunological responses, evidenced by significantly elevated allergen-specific IgG4 antibody levels four years after completion of the 2-month treatment with AllerT.
Company News: OcellO and Merus Sign Agreement for Screening Bispecific Cancer Antibodies
OcellO B.V. and Merus B.V. have entered into a collaboration under which OcellO will provide screening services to Merus. OcellO, a biotech company providing drug discovery screening services using its proprietary high throughput 3D cell culture-based screening platform, will use its platform to profile bispecific antibodies designed by Merus for the treatment of cancer. Financial details of the collaboration have not been disclosed.
Mark Throsby, Chief Operating Officer at Merus, commented: “The strength of our approach is its ability to generate thousands of full-length, bispecific human IgG antibodies addressing combinations of targets expressed by tumor cells. OcellO is able to provide high quality data on the functional properties of large panels of bispecific antibodies. These data can’t be obtained from other in vitro screening assays and are pivotal in identifying antibody leads with unique modes of action.”