BioSpace Global Roundup, Oct. 8
Zai Lab Limited – Shanghai-based Zai Lab dosed the first patient in China as part of its global MAHOGANY study evaluating margetuximab, an investigational, Fc-optimized monoclonal antibody targeting HER2, in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. Gastroesophageal adenocarcinoma is the fifth and second most common tumor type worldwide and in China, respectively. MAHOGANY is a Phase II/III clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GC/GEJ.
Biocartis – Belgium-based Biocartis Group NV announced the market release of SeptiCyte RAPID on Idylla as a CE-marked IVD test. SeptiCyte RAPID is a host-response test1 that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about one hour. The test was developed by Biocartis’ partner Immunexpress Pty Ltd., a Seattle-based molecular diagnostics company. Current diagnostic tests to aid in the diagnosis of sepsis are often unreliable and slow. A scientific publication by The Lancet estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths.
KAEL–GemVax – Korea’s GemVax applied for an expanded access IND for its lead candidate GV1001 to include additional investigational groups in Alzheimer’s. The application is based on an encouraging recent analysis of results from a Phase II trial completed last year in Korea and if granted would apply to a second Phase IIb trial in the U.S. now planned for early 2021. GemVax had already registered a second Phase II clinical trial last year to be conducted in the US for moderate and severe Alzheimer's disease, but this has been delayed due to COVID-19. Recruitment is now back on track for early 2021 and will be expanded to include patients with mild cognitive impairment and mild symptoms.
Oculis – Based in Switzerland, Oculis announced positive results from the Phase II clinical trial investigating OCS-01 for the treatment of Diabetic Macular Edema. OCS-01 is a novel, high concentration, topical formulation of dexamethasone (ophthalmic suspension 1.5%) developed using Oculis’ proprietary Soluble NanoParticle technology (SNP). The SNP technology was developed to overcome the main barriers for the topical delivery of drugs to the eye. The Phase II trial met its pre-specified efficacy endpoints and showed that OCS-01 eye drops were more effective than vehicle in reducing central macular thickness and improving visual acuity in patients with DME. No significant or unanticipated ocular adverse events were observed.
Derm-Biome – Privately-owned Derm-Biome Pharmaceuticals, Inc., based in Vancouver, said one of its topical drugs produced significant, and dose dependent inhibitory effects in a well-established mouse model of psoriasis, a chronic inflammatory skin disease often linked to depression and a decreased quality of life. The treatment demonstrated significant inhibitory effects in a dose dependent manner in all concentration ranges tested. Derm-Biome’s
SIRION Biotech – Germany’s SIRION Biotech GmbH and Mustang Bio entered into a licensing agreement. Mustang Bio acquired rights to SIRION’s LentiBOOST technology for the development of MB-207, Mustang’s lentiviral gene therapy for the treatment of patients with X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. LentiBOOST is SIRION’s proprietary non-cytotoxic transduction enhancer for lentiviral vectors. Under the terms of the agreement, SIRION will receive an undisclosed upfront payment and development and sales milestones, as well as royalties on future product sales.
Molecular Partners – Based in Switzerland, announced supportive preclinical data from in vivo assessments of its DARPin candidates targeting SARS-CoV-2. These candidates show robust activity in an aggressive viral challenge hamster model, supporting potential efficacy as therapeutic options in patients with late-stage disease. Hamsters were first infected with SARS-CoV-2 and then administered either select doses of the anti-COVID-19 DARPin candidates, MP0420 or MP0423, or placebo. In the five-day experiment, all animals treated with DARPin molecules recovered and survived, while 83% of animals in the placebo group had to be euthanized due to severe disease progression. First-in-human studies for MP0420 are anticipated to begin in November 2020, and clinical studies for the second antiviral candidate, MP0423, are expected to initiate in 2021.
The Native Antigen Company – U.K.-based Native Antigen Company introduced 10 new monoclonal antibodies recognizing SARS-CoV-2, the virus that causes COVID-19. These antibodies recognize different epitopes of the SARS-CoV-2 Spike glycoprotein, nine of which are SARS-CoV-2-specific and do not cross-react with other human coronaviruses. Three of the antibodies have been shown to be specific for the receptor-binding domain (RBD) of Spike, the region responsible for binding to the cellular ACE2 receptor.
Arch Biopartners – Toronto’s Arch Biopartners Inc. has received approval in Turkey to begin a Phase II study of its lead drug LSALT peptide (Metablok), targeting acute lung injury and acute kidney injury caused by inflammation in patients with moderate to severe cases of COVID-19. Activation of clinical sites in Istanbul and Ankara and patient enrollment into the trial will begin imminently in Turkey, where COVID-19 infection rates continue to be in the range of 1,500 new cases per day.
RedHill Biopharma –Israel-based RedHill announced its Phase II study with opaganib in patients hospitalized with severe COVID-19 pneumonia has passed its second pre-scheduled safety review. The Safety Monitoring Committee unanimously supported the decision based on an unblinded analysis of safety data from the first 24 patients treated in the study for at least seven days.
Ilya Pharma – Sweden’s Ilya Pharma completed recruitment for its Phase I study of its lead candidate ILP100-Topical. ILP100 represents both a novel drug delivery technology and a novel investigational new product (IMP) and is classified as an advanced therapy medicinal product by the EMA and as a low-risk candidate under the gene therapy umbrella by the FDA. ILP100 is the first drug based on genetically engineered Lactobacillus to be approved to enter trials. Upon successful completion, the company plans to initiate Phase II studies in mid-2021.