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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.”

Company News: ISA Pharmaceuticals Secures EUR 8 Million Funding

ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, has today announced that it has raised EUR 8 million in a follow-on round from its existing investor base.

The proceeds will be used to fund a randomized Phase II clinical trial in cervical cancer with ISA’s lead program ISA-HPV, a therapeutic vaccine for pre-malignant diseases and cancers induced by human papilloma virus (HPV). Cervical cancer is the second most common cancer in women worldwide and is caused by HPV infection. The company has already demonstrated clinical efficacy of its HPV vaccine in a Phase II study in Vulvar Intraepithelial Neoplasia.

ISA’s vaccines are based on its proprietary synthetic long peptide (SLP®) vaccine platform. The company is currently advancing existing and new programs based on its SLP® vaccine platform in a number of cancers, including cervical carcinoma, as well as its groundbreaking proprietary toll-like receptor (TLR) ligand adjuvant technology.

Company News: Merus Selects Clinical Candidate for the Treatment of Acute Myeloid Leukemia (AML)

Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, today announced that it has selected MCLA-117 as lead candidate for clinical studies in patients with acute myeloid leukemia (AML). MCLA-117 is a human, full-length IgG bispecific antibody, which activates the patient’s own immune system by simultaneously binding to the CLEC12A molecule expressed by AML tumor cells and the CD3 molecule expressed by T cells. MCLA-117-mediated co-engagement of CLEC12A and CD3 results in the potent killing of cancerous AML cells and their malignant precursors. Merus intends to start phase I clinical trials with MCLA-117 in 2014.

The antibody is based on Merus’ Biclonics™ ENGAGE platform. Human bispecific antibodies from this platform can be manufactured and administered like conventional, full-length IgG molecules, thereby providing for high yield, good stability and a long serum half life. In addition, bispecific antibodies from the Biclonics™ ENGAGE platform have a modified constant region to abrogate unwanted clinical cytokine release.

Prof. Gert Ossenkoppele from the department of hematology at the Free University Medical Centre in Amsterdam, The Netherlands, will be the lead investigator of the first MCLA-117 Phase I study.

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