Archive: Company News

Company News: Anergis Appoints Kim Simonsen as Chief Development Officer

– Senior Biotech Executive brings over 25 years of drug development expertise

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced the appointment of Kim Simonsen, MD, as Chief Development Officer. Mr. Simonsen will head Anergis´ global product development from preclinical development to registration, including CMC, clinical development, regulatory affairs and global project management.

Kim Simonsen joins Anergis from Ablynx NV, where he was Chief Operations Officer. Prior to that, he was Senior Director, Global Clinical Development, at ALK Abello A/S, where he led the clinical development of Grazax®, the first marketed grass pollen allergy immunotherapy tablet. From 2000 to 2005, Mr. Simonsen was Chief Executive Officer of the CRO Medicon A/S after having held various clinical development roles at big pharmaceutical companies, e.g. as Medical Director of Novartis Healthcare A/S, Director of Clinical Operations at Novo Nordisk A/S, and as Medical Director and Clinical Expert at Sandoz A/S.

Prior to joining the biopharmaceutical industry in 1986, Mr. Simonsen trained as an MD at Copenhagen University and worked for five years at two different clinics in the Copenhagen area, focusing on internal medicine (gastroenterology, respiratory, cardiology). During his career, Mr. Simonsen has gained extensive experience in clinical drug development, including regulatory affairs, clinical pharmacology, and the design and management of clinical trials and pharmacovigilance. His expertise covers an extensive range of disease indications, incl. allergy immunotherapy, immunology, oncology, rheumatology, and cardiovascular and pulmonary diseases.

Company News: Merus appoints Mark Iwicki as President of the Supervisory Board

Merus B.V., a leader in developing best-in-class bispecific antibody therapeutics to treat cancer patients, today announced that Mark Iwicki has been appointed as President of its Supervisory Board.

Mr. Iwicki most recently served as President and Chief Executive Officer of biotechnology company Civitas Therapeutics until it was acquired by Acorda Therapeutics in 2014.  Previously, Mr. Iwicki was the CEO of Blend Therapeutics and Sunovion Pharmaceuticals.

Mark will replace Gerard van Odijk who has been the company’s President of the Board for the last 7 years.

Company News: Merus and Selexis receive a € 2.1 million grant for single cell line manufacturing of a bispecific antibody combination to treat colorectal cancer

Merus B.V., a leader in developing best-in-class bispecific antibody therapeutics to treat cancer patients and Selexis SA a serial innovation company with proven technologies for biologics drug discovery and Research Cell Bank (RCB) development today announced the award of the EUREKA Eurostars grant “BiSECT” with a total budget of €2.1 million to develop bispecific antibody combination products for the treatment of colorectal cancer.

In the program, Merus and Selexis will combine their unique and proprietary Oligoclonics® and SUREtechnology™ platforms respectively to develop a product combining two bispecific full length IgG antibodies that simultaneously targets and potently inhibits three receptor tyrosine kinases. The lead Oligoclonics® candidate was discovered as part of a previous EUREKA program and will be produced from a single manufacturing cell line developed by Selexis.

 

Company News: New Peer-Reviewed Publication Provides Further Insights into Mechanism of ISA Pharmaceuticals’ SLP® Immunotherapeutics

SLP®s modulate intratumoral macrophages required for tumor regression

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced the publication of a new peer-reviewed paper* demonstrating a beneficial effect of Synthetic Long Peptide (SLP®s) immunotherapeutics on intratumoral macrophages in cancers induced by human papilloma virus 16 (HPV16). ISA’s proprietary SLP® immunotherapeutics are rationally designed, off-the-shelf, synthetic peptides which ISA is developing as cancer immunotherapeutics. The company’s SLP® lead compound ISA101 is in clinical development for the treatment of early-stage, advanced and recurrent cancers induced by HPV16 infections.

Macrophages, a type of white blood cell, play a critical role in immunity by recruiting other immune cells and exerting effector functions, such as phagocytosis and cell or bacterial killing. They exist in two major and opposing types: The so-called M1 macrophages inhibit cell proliferation and cause tissue damage, while M2 macrophages promote cell proliferation and tissue repair. Cancer is often characterized by M2 activity, which facilitates tumor growth via angiogenesis, metastasis formation and suppression of Th1-type immune responses, among others. As a result, M2 macrophage infiltration of tumors commonly correlates with poor prognosis.

Based on these observations, the targeting of macrophages or inhibition of macrophage infiltration is considered a promising therapeutic option in cancer therapy. However, as part of an ongoing investigation into tumor immunotherapy, the authors of the paper cited below were able to demonstrate that skewing the macrophages towards M1 antitumor activity might be the optimal strategy instead. In animal studies, this skewing can be accomplished with ISA’s Synthetic Long Peptide (SLP®) immunotherapeutics.

The team of researchers used a mouse tumor model of HPV-induced cancers, such as cervical cancer, and HPV-positive head and neck cancer. Administration of an SLP® compound, among others, resulted in an influx of cytokine-producing CD8 T cells that strongly altered the numbers and phenotype of intratumoral macrophages from M2 to M1 activity. It was also demonstrated that complete regressions of large established tumors are dependent on the tumor-infiltrating macrophages induced by this immunotherapy: when a small molecule drug inhibitor diminished the number of intratumoral macrophages after SLP® administration, the complete remissions were abrogated and survival rates deteriorated.

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* van der Sluis TC et al. (2015), Therapeutic peptide vaccine-induced CD8 T cells strongly modulate intratumoral macrophages required for tumor regression. Cancer Immunol Res. 2015 Apr 17. pii: canimm.0052.2015

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