Drozitumab

GSK’s experimental drug depemokimab met the primary endpoint of a pair of Phase III studies in people with severe asthma, setting up marketing applications for the ultra-long-acting biologic. Kaivan Khavandi, the company’s global head of respiratory/immunology R&D, said the anti-IL-5 monoclonal antibody “could offer…a dosing schedule of just two injections per year.”The SWIFT-1 and SWIFT-2 trials evaluated depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterised by blood eosinophil count. GSK noted that the studies hit their main goals of a reduction in the annualised rate of clinically significant exacerbations over 52 weeks.Depemokimab, also known as GSK3511294, is also currently being evaluated in late-stage studies for eosinophilic granulomatosis with polyangiitis, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.  More to follow.

MELBOURNE, Australia and ADELAIDE, Australia, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announces it has extended its previously announced partnership with AusHealth Corporate Pty Ltd (‘AusHealth’) relating to APOMAB®, a novel therapeutic and diagnostic (‘theranostic’) technology platform being investigated in lung and ovarian cancers.1 Specifically, Telix has exercised an option granted in 2019 to in-licence the antibody, based on encouraging preliminary clinical data from a Phase I imaging study that forms part of the current academic collaboration. APOMAB is an antibody targeting the La/SSB protein, which is specifically expressed by cancer cells that have been treated with chemotherapy and/or radiation. This investigational asset is the subject of an ongoing clinical study being conducted by the Central Adelaide Local Health Network (‘CALHN’)2, led by Royal Adelaide Hospital (‘RAH’) Cancer Clinical Trials Unit Head, Professor Michael Brown.3 This Phase I proof-of-concept study is initially using zirconium-89 labelled antibody (89Zr-APOMAB) to evaluate the biological properties and safety of the agent using positron emission tomography (PET) imaging. With early results demonstrating the potential suitability of APOMAB to safely deliver targeted radiation to advanced lung and ovarian cancers, a follow-on study is currently in planning to accelerate the development of a next generation version of APOMAB labelled with a therapeutic isotope such as lutetium-177 (177Lu). The trial’s Principal Investigator Professor Michael Brown said, “After years of research at RAH exploring the unique mechanism and potential of APOMAB to diagnose and treat cancer in preclinical models, it is highly pleasing to see this technology demonstrate targeted delivery of radiation to tumours in clinical settings.” Telix CEO Dr Christian Behrenbruch stated, “Having established a clinical proof-of-concept, we are motivated to progress the licence for this promising technology platform, which has potential as a targeting agent for both imaging and therapy in multiple cancer indications. The next stage in this academic-industry partnership is to take APOMAB into therapeutic studies, with the ultimate aim of commercialisation. We would like to thank Professor Brown and his clinical team at RAH, and most importantly the patients who have contributed to this ground-breaking study.” AusHealth Managing Director and CEO Greg Johansen added, “Our early research demonstrated that APOMAB binds cancer cells after cytotoxic anticancer treatment. It’s brilliant to see the same binding effect taking place in APOMAB-dosed cancer patients. The APOMAB clinical trial conducted at the Royal Adelaide Hospital shows what can take place when an innovative medical concept is developed into a ‘results driven’ partnership led by AusHealth and by vital industry partners such as Telix. This clinical proof-of-concept strengthens our confidence that APOMAB® will become a vital tool, useful in both theranostic and therapeutic applications in clinical settings.” About AusHealth® AusHealth® is a national Profit-for-Purpose company that supports the commercialisation of innovative medical technologies, improving the health of all through its three divisions: AusHealth® Research, AusHealth® Work and AusHealth® Hospitals. All profits fund medical research and development of products and services that look to improve healthcare, wellbeing, and medical practice. Since 1985, AusHealth® has helped people with diabetes, arthritis, cardiovascular disease, and cancer; as well as improved burn & scar, and foetal health diagnostics. Other commercial success stories by AusHealth® include Mesoblast, LBT Innovations and Firefly Health. Visit . About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit and follow Telix on Twitter (@TelixPharma) and LinkedIn. Telix’s lead investigational product, illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,4 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).5 Telix is also progressing marketing authorisation applications for illuccix® in the European Union6 and Canada.7 None of Telix’s products have received a marketing authorisation in any jurisdiction. Telix Media Contact Dr. Stewart HolmstromTelix Pharmaceuticals LimitedDirector Corporate CommunicationsEmail: stewart.holmstrom@telixpharma.com 1 ASX disclosure 30/10/19.2 ASX disclosure 21/09/20.3 Australian New Zealand Clinical Trials Registry registration number: ACTRN12620000622909.4 ASX disclosure 24/11/20.5 ASX disclosure 14/04/21.6 ASX disclosure 1/05/20.7 ASX disclosure 16/12/20.