Archive: Company News
Company News: ISA Pharmaceuticals Announces Start of First Phase I/II Clinical Trial of its SLP®-AMPLIVANT® Conjugates
– Leiden University Medical Center to study novel immunotherapeutic in HPV-positive head & neck cancer patients
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, has announced the start of an investigator-initiated Phase I/II clinical trial of a novel immunotherapeutic based on ISA Pharmaceuticals´ platform technology. The trial will be conducted by the Department of Clinical Oncology at Leiden University Medical Center in The Netherlands. The study will investigate the biological activity and safety of the compound in head and neck cancer patients who tested positive for human papilloma virus type 16 (HPV16). HPV infections, in particular HPV16, are one of the major causes of this type of cancer. The immunotherapeutic is a conjugate of two HPV16 E6 Synthetic Long Peptides (SLP®s) covalently linked to AMPLIVANT®, a synthetic Toll-like receptor (TLR) 1/2 ligand. The investigators have assigned the acronym HESPECTA to the conjugate (HPV E-Six Peptide Conjugated To AMPLIVANT®).
In the single-center, open-label dose escalation study, 24 HPV16-positive head and neck cancer patients will be grouped into four dose escalation groups. In each group, every patient will receive three intradermal doses of the immunotherapeutic. The primary endpoint is to assess its ability to induce HPV16 E6-specific T-cell immunity. The secondary endpoint is to evaluate the safety of the intervention.
The human papillomavirus is associated with several types of cancer, of which HPV16 is by far the most common high-risk HPV type detected. It encodes the two tumor-specific oncoproteins E6 and E7 which are known to also induce and maintain the malignant state of the transformed cells. This SLP®-AMPLIVANT® conjugate aims to induce a strong, lasting immune response against the tumor.
AMPLIVANT®, developed by ISA Pharmaceuticals, is based on a Toll-like receptor ligand (TLR1/2 ligand), one of the most powerful natural stimulants of the immune system. SLP®-AMPLIVANT® conjugates have demonstrated to be 100- to 1000-fold more potent in inducing an immune response compared to unconjugated SLP®s in preclinical and mouse tumor models.
Company News: Anergis Presents Sustained Efficacy Data from its AllerT Phase IIb Trial at the AAAAI Annual Meeting
– Contiguous Overlapping Peptide allergy immunotherapeutic AllerT confirms sustained efficacy in the second year following treatment
Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, presented detailed data from the Phase IIb trial of its birch pollen allergy immunotherapeutic AllerT in two separate scientific posters at the AAAAI (American Academy of Allergy, Asthma and Immunology) Annual Meeting in Houston, Texas. The findings were presented on February 22, 2015. Abstracts can be found at www.anergis.ch. AllerT is Anergis´ most advanced long-peptide immunotherapeutic and based on the company´s proprietary Contiguous Overlapping Peptide (COP) platform.
In 2013, the clinical efficacy of AllerT was demonstrated in a field-based, randomized, placebo-controlled, double-blind trial in 239 patients with birch pollen allergy, who received either AllerT (at 50μg or 100μg doses) or a placebo during a 2-month immunotherapy regimen. All main efficacy and safety endpoints were met in this study.
In 2014, the sustained efficacy of AllerT was assessed in the same group of patients during a second follow-up season without additional treatment. In both years, efficacy was evaluated using combined Rhinoconjunctivitis Symptom and Medication Scores (RSMS) as the primary endpoint as well as quality of life (Mini RQLQ) and Night-time Nasal Symptom Score (NNSS) as the main secondary endpoints. The study also measured the levels of allergen-specific immunoglobulins (Bet v 1 specific IgG4) in patients.
The data collected during the second post-treatment season (N=196 patients) proved the sustained efficacy of AllerT, as demonstrated by improvements in the primary endpoint, RSMS, and in the main secondary endpoints, Mini RQLQ and NNSS. The trial also confirmed that AllerT had induced a persistent elevation of anti-Bet v 1 IgG4 antibodies, i.e. measured after one year without treatment.
Company News: Lead Pharma to Partner with Sanofi on Development of Treatments for Autoimmune Diseases
– R&D collaboration and license agreement may yield potential first-in-class oral anti-ROR gamma (t) therapies
Lead Pharma, a pharmaceutical company developing innovative medicines for the treatment of autoimmune diseases and cancer, today announced that it has entered into a research collaboration and license agreement with Sanofi to discover, develop and commercialize small molecule therapies directed against the nuclear hormone receptor ROR gamma (t) to treat a broad range of autoimmune disorders, including common diseases such as rheumatoid arthritis and inflammatory bowel disease.
Researchers have identified 80 to 100 different autoimmune disorders and suspect at least an additional 40 diseases of being driven by immune function. These diseases are chronic and can be life-threatening.
Under the terms of the agreement, Lead Pharma will receive an upfront payment and is eligible to receive research, development, regulatory and commercial milestone payments. Further details of the financial terms have not been disclosed. Sanofi is responsible for clinical development and will have worldwide marketing and commercialization rights to any products that may be developed as a result of the collaboration. Lead Pharma is entitled to receive royalty payments on global sales from any such products.
Company News: Curetis Presents Product Updates at Intensive Care Conference
– Multiple Unyvero product launches planned for 2015
– Clinical trial aimed at US FDA clearance of Unyvero adapted to reflect most recent FDA guideline issued in Q3-2014
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the presentation of its product range at Germany’s biggest congress on intensive medicine and intensive care, Symposium Intensivmedizin + Intensivpflege, in Bremen from February 18-20, 2015. Curetis will be exhibiting the Unyvero Solution at booth #N27, hall 4 at Messe & Congress Centrum Bremen. Curetis is also providing an update on its pipeline of new products to be launched in 2015.
By the end of 2014, the installed base of Curetis´ Unyvero Solution has grown to more than 60 systems world-wide. Unyvero is a versatile hardware platform for the detection of a broad panel of bacteria, fungi and antibiotic resistances from a single sample in one run. At present, cartridges for pneumonia testing (Unyvero P50) and for implant & tissue infections (Unyvero i60 ITI) are available in Europe. The company is expecting the European launch of its enhanced and expanded Unyvero P55 Pneumonia application in the spring of 2015.
By mid 2015, Curetis also anticipates data from an updated i60 ITI application Cartridge. Moreover, the company is planning the launch of a comprehensive blood culture panel combining Gram-positive and Gram-negative pathogen markers as well as resistance markers by the end of 2015 in Europe.
The company also announced an update on its US trial of the Unyvero LRT lower respiratory tract infection application. Curetis has adapted its FDA trial design to reflect the new guidelines issued by the FDA for multiplexed infectious diseases tests and will re-initiate prospective sample measurement once the enhanced and expanded P55 Pneumonia Cartridge is available as LRT-labeled test cartridges for the US FDA trial. Patient sample collection with the updated LRT application based on the P55 assay is expected to start mid-2015.
Curetis has decided to un-blind all data generated in its FDA trial to date and has engaged its network of US trial sites to continue collecting retrospective specimen. Data from the previous LRT study based on the P50 panel will be analyzed and published in a peer-reviewed format.
The new FDA guideline reduces the minimum number of required prospective patient samples to 1,500, limits requirements for prospective samples to only specificity endpoints, allows testing of retrospectively collected patient samples for sensitivity endpoints, and provides clarity on positive and negative control samples. Based on the adapted design and a start of patient sample collection with the new LRT55 application, which is anticipated by mid-2015, Curetis is expecting completion of patient enrolment in the first half of 2016, with subsequent filing with the FDA.