Clinical Catch-Up: May 17-21
It was another busy week for clinical trial announcement. Here’s a look.
COVID-19-Related
Sanofi and GlaxoSmithKline (GSK) reported positive data on their COVID-19 vaccine candidate in all adult age groups in its Phase II trial of 722 volunteers. They expect to launch a global pivotal Phase III trial in the coming week. The Phase II interim data demonstrated 95% to 100% seroconversion after a second injection in all age groups, ranging from 18 to 95 years of age.
Celltrion Group announced that CT-P59 confirmed neutralizing potency against emerging variants, New York (B.1.526), Nigeria (B.1.525) and India (B.1.617). CT-P59 is an anti-COVID-19 monoclonal antibody treatment candidate.
Medicago and GlaxoSmithKline announced positive interim Phase II data from its plant-derived COVID-19 vaccine candidate. It was tested in combination with GSK’s pandemic adjuvant. The vaccine induced a significant humoral immune response after two doses.
Veru enrolled the first patient in its Phase III trial of sabizabulin for COVID-19. Sabizabulin is a proprietary, oral cytoskeleton disruptor with anti-inflammatory and anti-viral properties.
Non-COVID-19-Related
Foghorn Therapeutics dosed the first patient in its first-in-human trial of FHD-286 in metastatic uveal melanoma (mUM). A separate trial of the drug in relapsed/refractory acute myelogenous leukemia (AML) is also ongoing. FHD-286 is a selective inhibitor of the BAF chromatin remodeling complex ATPases BRG1 and BRM.
AC Immune and Janssen Pharmaceutical, a Johnson & Johnson company, expanded their ongoing Phase Ib/IIa trial of their first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate, ACI-35.030, for Alzheimer’s disease. The expansion is based on encouraging interim safety, tolerability and immunogenicity data, with the second highest dose supporting continued development into Phase IIb/III trials. It is also continuing to study the highest dose.
Orchestra BioMed presented two-year data on its MODERATO II study of patients treated with BackBeat Cardiac Neuromodulation Therapy for systolic blood pressure. The data showed a clinically meaningful and statistically significant decrease in 16.6 mmHg in office Systolic Blood Pressure that was sustained out to two years. The therapy is a bioelectronic treatment that lowers blood pressure while modulating the Autonomic Nervous System.
Incyte announced positive topline data from its pivotal Phase III TRuE-V trial of ruxolitinib cream in vitiligo. Vitiligo is a chronic immune-mediated skin condition. The trial was in adolescent and adults 12 years and older. Ruxolitinib is a JAK inhibitor.
Black Diamond Therapeutics presented Phase I data of its MasterKey-01 trial of BDTX-189 in patients with advanced solid tumors. BDTX-189 is an oral, irreversible, ATP competitive small molecule inhibitor designed to block the function of a family of oncogenic epidermal growth factor receptor (EGFR) and ErbB-2 proteins.
Athenex reported that investigators from Texas Children’s Cancer Center and the Center for Cell and Gene Therapy at Baylor College of Medicine presented new clinical data from the ongoing GINAKIT2 Phase I trial of Athenex’s cell therapy candidate KUR-501 targeting GD2 in neuroblastoma. The responses in 11 evaluable, heavily pretreated patients with neuroblastoma, included one complete response and one partial response. Four additional patients have exhibited stable disease.
Galera Therapeutics dosed the first patient in its Phase IIb GRECO-2 trial of GC4711 in combination with stereotactic body radiation therapy (SBRT) in locally advanced pancreatic cancer. GC4711 is a selective small molecule dismutase mimetic being developed to increase the anti-cancer effect of radiation.
Catalyst Biosciences initiated dosing in its Phase I/II MAA-202 trial of SQ MarzAA for bleeding in FVII deficiency, Glanzmann Thrombasthenia, and Hemophilia A with inhibitor patients receiving Hemlibra prophylaxis. MarzAA is administered subcutaneously; it is a next-generation engineered FVIIa to treat bleeding in patients with rare bleeding disorders.
Amolyt Pharma presented new Phase I data on AZP-3601 for hypoparathyroidism. AZP-3601 is a parathyroid hormone (PTH) analog specifically designed to treat hypoparathyroidism.
Mustang Bio and City of Hope dosed the first patient in their Phase I trial of MB-101 in patients with leptomeningeal brain tumors, such as glioblastoma, ependymoma or medulloblastoma. MB-101 is a CAR-T cell therapy made up of autologous IL13Ralpha2-CAR T-cells.
CSL Behring presented new meta-analysis of seven interventional Phase III trials of more than 82,000 high-risk patients with recent acute coronary syndrome (ACS). The data show that 49% of the recurrent major adverse cardiovascular events (MACE) experienced in the first year after an ACS event happened within the first 90 days.
Janssen Pharmaceutical Companies of Johnson & Johnson presented new data from the Phase III VOYAGER PAD trial which demonstrated that Xarelto (rivaroxaban) in combination with aspirin consistently decreased severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone, regardless of if it was the first, second, third, or subsequent event. Xarelto plus aspirin decreased first events by 15% in patients with PAD after LER.
AstraZeneca presented new integrated analysis from the MELTEMI Phase III extension trial of Fasenra (benralizumab) demonstrating it was well-tolerated for up to five years. Its long-term safety profile was consistent to previous Phase III trials in adults with severe asthma.
R-Pharm Group, out of Russia, reported findings from the Phase III CREDO study of olokizumab in rheumatoid arthritis. The data demonstrated significant improvements in RA compared to the placebo and methotrexate group. The drug is a monoclonal antibody targeting the interleukin-6 (IL-6) cytokine.