Clinical Catch-Up: November 23-27

As the U.S. went into its Thanksgiving holiday week, clinical trial news was quieter than usual, although there was a lot of important news on the COVID-19 vaccine front. Here’s a look.

COVID-19-Related

AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90%. The vaccine was effective at preventing COVID-19, with no hospitalizations or severe cases in people receiving it. There were a total of 131 COVID-19 positive cases in the interim analysis group. One dosing regimen was given at a half dose and demonstrated 90% efficacy, followed by a full dose at least one month apart. Another dosing regimen demonstrated 62% efficacy when given two full doses at least one month apart. The combined analysis showed average efficacy of 70%.

Bellerophon Therapeutics announced interim analysis of the first 100 patients in its Phase III COViNOX trial of INOpulse for COVID-19. As a result, they put the trial on clinical hold. The analysis included 10 respiratory failure or death (RFD) events, which was a small size for the RF endpoint. The company plans to complete the study for the remaining patients and evaluate the full data set.

CytoDyn hit the enrollment target of 293 patients in its Phase III trial for COVID-19 patients with severe-to-critical symptoms. They are evaluating Vyrologix (leronlimab-PRO 140), a CCR5 antagonist. This hits the requested criteria for a second interim efficacy analysis.

Russia’s Gamaleya Institute reported that its Sputnik V COVID-19 vaccine had more than 95% efficacy in new preliminary data. They were reported based on 42 days of a study where 19,000 participants received two doses of the vaccine and 21,000 received a single dose.

Capricor Therapeutics dosed the first two patients in its Phase II trial of intravenous infusion of CAP-1002 for COVID-19. CAP-1002 is an allogeneic cardiosphere-derived cells (CDC) technology.

Equillium indicated that it had halted plans to initiate the EQUINOX Phase III trial of itolizumab in hospitalized COVID-19 patients. The decision was based on a thorough review of recent updates regarding new potential vaccines and other treatment options. Itolizumab is a clinical-stage, first-in-class monoclonal antibody that targets the CD6-ALCAM pathway. They plan to continue developing it for lupus/lupus nephritis and uncontrolled asthma.

Non-COVID-19

Immunocore announced that its Phase III IMCgp100-202 trial of tebentafusp compared to investigator’s choice for metastatic uveal melanoma (mUM) hit the statistical significant for overall survival (OS) in its first pre-planned interim analysis. Tebentafusp is a novel bispecific protein made up of a soluble T-cell receptor fused to an anti-CD3 immune-effector function. The drug specifically targets gp100, an antigen expressed in melanocytes and melanoma. It is the first drug coming out of Immunocore’s ImmTAC technology platform that is designed to redirect and activate T-cells to identify and kill tumor cells.

Saniona announced positive topline data from the Phase II open-label extension study of Tesomet in patients with hypothalamic obesity. Patients receiving the drug for almost one year followed by 24-week open-label extension demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control.

GemVax and KAEL Co. released more positive data from a Phase II trial in Alzheimer’s disease of GV1001. The data showed a statistically significant improvement in the Neuropsychiatric Inventory (NPI) and an improvement trend in Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).

Urovant Sciences announced topline data from the Phase IIa trial of once-daily vibegron in women with abdominal pain due to irritable bowel syndrome (IBS) with IBS-D (diarrhea) and IBS-M (mixed IBS). The trial failed to meet the primary endpoint with 40.9% of vibegron IBS-D patients achieving at least a 30% improvement in average worst abdominal pain over a 12-week period. The placebo group was 42.9%. Vibegron is an oral, once-daily small molecule beta-3 agonist.

Genmab A/S reported that it plans to halt development of enapotamab vedotin. They note that while the drug provided some evidence of clinical activity, it was not optimized by different dose schedules or predictive biomarkers. The data from the expansion cohorts failed to meet the company’s criteria for proof-of-concept. The drug is an AXL targeted Antibody-Drug Conjugate (ADC). An ADC is a monoclonal antibody attached to a cancer drug with a molecular linker. In this case, a monoclonal antibody for AXL is conjugated to the antimitotic drug monomethyl auristatin E. AXL is overexpressed in hematologic and solid malignancies.

MediciNova reported positive Optical Coherence Tomography (OCT) results from its SPRING-MS Phase IIb trial of ibudilast in multiple sclerosis. Ibudilast is a first-in-class, oral, small molecule macrophage migration inhibitory factor inhibitor, as well as a phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines.