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Company News: Anergis Starts Phase II Dose Ranging Trial with Birch Pollen Allergy Vaccine AllerT
– Dose assessment for upcoming Phase III trial
Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the start of a Phase II trial designed to finalize the dose selection for the Phase III study of AllerT. AllerT is Anergis´ lead vaccine against birch pollen allergy that originated from the company´s proprietary Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceutical-grade, long-peptide immunotherapeutics designed for an ultra-fast, safe and long-lasting treatment of allergy patients.
The randomized, double-blind, placebo-controlled, 4-parallel-group trial will assess the dose response efficacy of AllerT across doses of 50 µg, 25 µg, 10 µg compared to a placebo in an environmental exposure chamber (EEC). Approximately 180 birch pollen allergy patients will receive 5 subcutaneous injections over 2 months. All enrolled patients will be challenged with birch pollen prior to receiving AllerT or the placebo, and 4 weeks after the last injection.
The primary endpoint is the change in Total Rhinoconjunctivitis Symptom Scores (TRSS) from the baseline EEC challenge to the post-treatment EEC challenge.
Secondary endpoints are the mean Total Nasal Symptom Scores (TNSS), Total Ocular Symptom Score (TOSS), Individual Nasal Symptom Scores (NSS) and Asthma Symptom Score (ASS), which will also be evaluated from the baseline EEC challenge to the post-treatment EEC challenge. The trial is being conducted in Canada, with results expected in the third quarter of 2015.
Company News: Heraeus Medical GmbH Signs Exclusive License and Development Agreement with Locate Therapeutics for Orthopaedic Applications
Heraeus Medical GmbH announced today an agreement with Locate Therapeutics to license the intellectual property surrounding the use of TAOS® in orthopaedic applications and the inception of the first development program in this field. The agreement gives Heraeus Medical GmbH the rights to the future co-developed orthopaedic products as well as the processes involved in manufacturing the final product. Locate Therapeutics has the full capabilities to carry out such development work. The agreement takes the form of a standard upfront and milestone payment structure.
Locate is a specialist regenerative medicine and device company which has been incubated by University of Nottingham. With grant funding and financial assistance from Wellcome Trust and the Technology Strategy Board (now Innovate UK) the company has developed TAOS™ a patented platform polymer technology with multiple medical applications. The TAOS (Targeted, Orchestrated Signaling) technology is a world first in tissue repair. It enables the precision focus of therapeutic signals and provides an optimal structure to support tissue repair. Uniquely, TAOS can accommodate and promote the actions of receptor-binding moieties, locally-applied drugs, and emergent biological & cell-based therapies.
Company News: Anergis Closes Series B Financing Round Totaling CHF 14.5 Million
– Two U.S.-based family offices join as new investors
– All Series A investors participate in the round
Anergis, a company developing proprietary ultra-fast allergy vaccines, today announced the closing of a Series B financing round totaling CHF 14.5 million (€ 12.1 million, US$ 15 million). All Series A investors participated in the round together with new private European and U.S.-based investors. The financing was jointly led by existing investors Sunstone Capital, BioMedInvest and Renaissance PME as well as new investor WJFS, Inc. Anergis has so far raised a total of CHF 44 million in private equity, which includes the latest Series B financing round.
The funds will be used to advance Anergis´ birch allergy vaccine AllerT closer to market. The company is currently preparing the Phase III clinical trial program of AllerT. Anergis has already demonstrated the rapid and long-lasting clinical efficacy of AllerT in two subsequent field-based clinical Phase II trials. The funds will also be used to advance the AllerR ragweed allergy program towards clinical testing, as well as to research and discover undisclosed new Contiguous Overlapping Peptide (COP) allergy vaccines.
Company News: Publication in Nature Supports ISA Pharmaceuticals´ Synthetic Long Peptide Immunotherapeutic Approach to Treat Cancer
– Synthetic Long Peptide (SLP®) immunotherapy achieves targeted tumor eradication comparable to checkpoint-blocking immunotherapy
– New findings on antigens relevant for checkpoint blocking pave the way for personalized cancer vaccines
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced that a recent scientific paper in Nature supports the company´s therapeutic approach to using synthetic long peptides in cancer therapy. It could be shown that personalized SLP® immunotherapy is as capable of inducing efficient tumor eradication as are T cell checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 monoclonal antibodies. The research was conducted by a consortium led by Prof. Robert D. Schreiber from Washington University St. Louis. Prof. Cornelis Melief, Willem-Jan Krebber, and Gwenn E. Mulder from ISA Pharmaceuticals also participated in the project.
It is well known that checkpoint immune regulators on the surface of T cells act as deactivators. While they are useful in preventing T cells from attacking healthy tissues, in cancer they prevent the T cells from destroying tumor cells. Checkpoint blockers, such as anti-PD-1 and anti-CTLA-4 monoclonal antibodies, that target these proteins are very effective in restoring the T cell’s ability to eradicate tumor cells. In the Nature publication, Matthew M. Gubin and co-workers – among them three ISA researchers – report about their identification of the antigens recognized by these tumor-infiltrating T cells once their activity has been restored. The researchers used a mouse model of carcinogen-induced cancer, which – like human lung cancer from smokers – bears many mutations (e.g. caused by tar).
The researchers demonstrated that the T cells previously blocked by checkpoint immune regulators were directed against two mutant antigens on the cancer cell surface. These T cells had already infiltrated the tumor prior to checkpoint blocking, but were subsequently deactivated by the tumor microenvironment. Moreover, the team showed that an immunotherapy consisting of two synthetic long peptides, each incorporating one of the mutant amino acid sequence admixed with the adjuvant poly I:C, was able to eradicate the tumor as effectively as checkpoint immunotherapy.
Personalized synthetic long peptides against tumor-unique mutant sequences are a promising treatment approach for cancers with many mutations, such as smoking-induced lung cancer and UV-induced skin cancer. Compared to checkpoint blocking, personalized immunotherapy is likely to achieve anti-tumor effects with less toxicity because they do not activate T cells that are able to attack healthy tissue.