Global Roundup: Clover Progresses Universal COVID-19 Booster, TikoMed Proves Platform in ALS

Clover’s SCB-2019 showed a robust immune response to the Omicron BA.5 sub-variant, while BrainsWay, TikoMed and more provide updates on their businesses and pipelines.

Clover Biopharmaceutical made progress with a booster against Omicron BA.5, the European Commission authorized a biosimilar for wet age-related macular degeneration and TikoMed‘s platform demonstrated potential in Amyotrophic lateral sclerosis (ALS). For that and more global news, see below.

Clover posted positive Phase II/III data for its lead COVID-19 vaccine candidate, SCB-2019. The China-based company announced that SCB-2019 prompted a robust immune response to Omicron BA.5 sub-variant, the dominant strain of COVID-19 circulating the globe.

Clover reported that the data from the Phase II/III study adds to the growing evidence supporting the potential use of SCB-2019 as a universal COVID-19 booster vaccine. As a booster dose, SCB-2019 (CpG 1018/Alum) in individuals who previously received two doses of SCB-2019 sparked a “robust and rapid neutralizing antibody immune response,” the company noted.

Data showed that trial participants who had a prior COVID-19 infection and received two doses of the Clover vaccine three weeks apart saw a 61-fold increase in neutralizing antibodies against BA.5. Additionally, the vaccine also generated a 37-fold boost in neutralizing antibodies against the Omicron BA.2 sub-variant and a 20-fold boost in neutralizing antibodies against Omicron BA.1.

These results indicate that Omicron BA.5 neutralizing antibody levels were approximately two to four-fold higher than Omicron BA.1 neutralizing antibody levels induced by SCB-2019.

Nicholas Jackson, president of global research and development at Clover, said the new data provides evidence that supports the potential for SCB-2019 to be used across the globe to halt the continued spread of COVID.

Clover is focused on completing regulatory submissions to the China National Medical Products Administration, the European Medicines Agency, and the World Health Organization for SCB-2019 in the second half of 2022.

Elsewhere around the globe:

Santhera Pharmaceuticals: Santhera and ReveraGen published research in JAMA Neurology that included positive data from the VISION-DMD study evaluating vamorolone, an investigational drug for the treatment of Duchenne muscular dystrophy (DMD). The drug met its primary endpoint by improving the time it took to stand from the floor compared to placebo, which is the first milestone to begin to deteriorate in young children with the disease. The study was conducted across 24 weeks, and the most commonly reported adverse events were cushingoid features, vomiting and vitamin D deficiency.

TikoMed: Sweden’s TikoMed published research in Frontiers in Pharmacology supporting the mechanism of action of its ILB neuroprotective drug platform. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases, including ALS, the low molecular weight dextran sulfate compound mobilized and modulated naturally occurring tissue repair mechanisms, the company noted. TikoMed added that the compound restored cellular homeostasis and function by releasing heparin-binding growth factors. TikoMed stated its belief that this approach has the potential to transform current cell and gene therapy paradigms.

PolPharma Biologics Group BV: PolPharma, along with Formycon AG and Bioeg AG, jointly announced that the European Commission granted marketing authorization to Ranivisio, a biosimilar to Lucentis used to treat renal diseases. Ranivisio is indicated for the treatment of wet age-related macular degeneration, the treatment of visual impairment due to diabetic macular edema or choroidal neovascularization and the treatment of proliferative diabetic retinopathy. It is also indicated for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion.

BrainsWay Ltd.: Israel’s BrainsWay received 510(k) clearance from the U.S. FDA for the Deep TMS H7 Coil to treat adults suffering from major depressive disorder and depression, including those with comorbid anxiety symptoms commonly known as anxious depression. The FDA’s clearance was based on the review of successful results from a multicenter trial designed to better understand the H7 Coil’s efficacy in addressing treatment-resistant depression. The study found overall efficacy rates for the H7 Coil comparable to those achieved with BrainsWay’s H1 Coil.

Aeterna Zentaris Inc.: Toronto-based Aeterna Zentaris announced that Novo Nordisk exercised its right to terminate an agreement for Macrilen (macimorelin), an oral test for diagnosing adult growth hormone deficiency approved in the United States and Europe. Aeterna will regain full U.S. and Canadian rights to the test. In light of Novo’s decision, Aeterna said it plans to engage in robust business development efforts to identify and secure a new development and commercialization partner.

Immutep Limited: Based in Australia, Immutep secured a new patent from Japan that covers its lead active immunotherapy candidate, eftilagimod alpha, a LAG-3 fusion protein and an anti-PD-(L)1 antibody.

Medtronic: Ireland’s Medtronic completed its acquisition of Affera, Inc. The company noted that the acquisition expands its cardiac ablation portfolio to include cardiac mapping and navigation. Affera’s investigational technology is designed to provide solutions for patients with cardiac arrhythmias such as atrial fibrillation. The acquisition brings the Affera Prism-1 cardiac mapping and navigation platform into the company, which will complement Medtron’s therapeutic catheters and technologies. It also brings the Spere-0 cardiac diagnostic ablation catheter that rapidly creates detailed electro-anatomical maps and delivers radio frequency and pulsed field cardiac ablation therapies.

Laverock Therapeutics: Based in the United Kingdom, Laverock was launched with the mission of developing a gene silencing platform for the creation of programmable, allogeneic cell therapies. With financing from its seed funding round, Laverock has opened labs in the Stevenage Bioscience Catalyst. It is conducting experiments to demonstrate cell type and condition-specific programmability, generating data to support allogeneic programs in Type 1 diabetes and solid tumor-directed immune therapy.

Futura Medical plc: Also based in England, Futura Medical announced results from the Phase III study of MED3000, an investigational therapy for the treatment of erectile dysfunction. The company announced that the study met coprimary endpoints. MED3000 demonstrated a statistically significant improvement in erectile function compared to baseline. Also, the study achieved a clinically meaningful improvement in erectile function at 24 weeks. Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate and severe ED sufferers. The company remains on track for potential filing with the FDA and other regulatory agencies.

Volta Medical: France’s Volta Medical, a health tech company developing AI software solutions, announced that the Journal of Cardiovascular Electrophysiology published peer-reviewed results from its successful Ev-AIFib-Proof-of-Concept-Study with VX1, an expertise-based AI software solution. The study was the first large-scale clinical validation of a companion AI-based software solution that reproduces expert-physician electrogram analysis. Results demonstrated that VX1 allowed for the building of standardized “Volta VX1 maps”, used as a reference for operators to conduct EGM-guided ablation.