Notizia - Recent Pharma, Healthcare and Biotech Happenings
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May 18, 2021
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InnoCare, a biopharma firm developing novel therapies for the treatment of cancer and autoimmune diseases, today announced the approval of Phase I clinical trial of its novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-332, by the China National Medical Products Administration.
TYK2 (Tyrosine Kinase 2) inhibitor is a member of the JAK kinase family, which is an important kinase on the JAK-STAT signaling pathway, playing an important role in the pathogenesis of inflammatory diseases.
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The company developed oral ICP-332, a potent and selective TYK2 inhibitor with 400 folds of selectivity against JAK2 to prevent the adverse events associated with non-selective JAK inhibitors. At present, there is no selective TYK2 inhibitor in the pharma market and if approved, the drug will help lower down the burden due to autoimmune diseases such as psoriasis and atopic dermatitis.
Sanofi and GSK have been leveraging the traditional approach when it comes to the development of vaccines for COVID-19. Earlier, the decision looked a bit unfruitful owing to delays due to failure in demonstrating effectiveness in older individuals.
However, it looks like there is still hope. The duo presented the results from the Phase II trials of 722 volunteers investigating their COVID-19 vaccine candidate in all adult age groups. The Phase II interim data demonstrated 95% to 100% seroconversion after the second injection in all age groups, ranging from 18 to 95. There were no safety concerns, and tolerability was acceptable. Moreover, the vaccine provided strong neutralizing antibody levels similar to that in people who recovered from COVID-19, with higher levels in younger adults ages 18 to 59.
The duo, although, failed to have an early-mover advantage as its rivals such as Pfizer-BioNTech, Moderna, AstraZeneca-Oxford, and Johnson & Johnson are distributing their doses on a large scale in several western markets, however, the demand is clearly exceeding the supply, there is still a place for Sanofi/GSK COVID-19 vaccine in the market.
Apellis recently announced the U.S. FDA approval to its drug, Empaveli, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Empaveli (pegcetacoplan) is the first and only targeted C3 therapy for the treatment of adults with PNH and is approved for use in PNH patients who are treatment naïve as well as patients switching from the C5 inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab). The approval was based on the results from the Phase III PEGASUS study.
As per DelveInsiht’s PNH epidemiological analysis, the diagnosed prevalence in 2020 was 8,385 in the 7MM (the US, EU5 and Japan), out of which the USA accounted for maximum cases. At present, the only disease-modifying therapeutic strategies for PNH are complement inhibition therapy (eculizumab and ravulizumab) and bone marrow transplantation; however, the approval of Empaveli marks a significant step ahead in the first new class of complementary medicine in almost 15 years. Other companies working in the PNH market include Hoffmann-La Roche, Novartis, Alexion Pharmaceutical, Regeneron Pharmaceuticals, RA Pharmaceuticals, and others.
US-based Landos Biopharma announced a partnership with China-based LianBio to manufacture and market omilancor and NX-13 in Greater China and select Asian markets.
Omilancor is an oral, gut-restrict LANCL2 agonist under development for Ulcerative Colitis (UC), Crohn’s disease (CD), and Eosinophilic Esophagitis (EoE). Similarly, NX-13 is an oral, gut-restricted compound that targets NLRX1 and is being developed for UC and CD.
As per the terms of the agreement, LianBio will have exclusive rights to develop and commercialize omilancor and NX-13 in Greater China, South Korea, Singapore, Thailand, Vietnam, Myanmar, Cambodia, Indonesia, and the Philippines; while paying Landos upfront cash of $18 million and up to $200 million in various development and commercial milestones, and tiered low double-digit royalties on net sales in the select areas.
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