Calliditas Therapeutics AB, of Stockholm, said it will acquire 7.2 million ordinary shares, representing 62.7% of the share capital and voting rights, of Saint-Julien-en-Genevois, France-based Genkyotex SA. Calliditas said it closed the off-market block trade for a total consideration of €19.8 million (US$23.22 million) in cash or about €2.73 ($US3.20) per ordinary share plus contingent rights payable upon regulatory approvals of setanaxib, a NOX1/4 inhibitor, which is Genkyotex's lead asset. Calliditas specializes in developing treatments for renal and hepatic diseases.
CEPI, the Coalition for Epidemic Preparedness Innovations, said it will fund development of a protein-based S-Trimer COVID-19 vaccine candidate developed by China’s Sichuan Clover Biopharmaceuticals Inc. through a global pivotal phase II/III efficacy trial. CEPI’s total investment in Clover’s vaccine candidate will be up to $328 million, including previously announced commitments of $69.5 million, which funded preclinical studies and phase I trials, preparations for the global pivotal phase II/III efficacy study and initial manufacturing scale-up activities.
Hoth Therapeutics Inc., of New York, reported statistically significant proof-of-concept preclinical data on its therapeutic, HT-005, for the treatment of cutaneous lupus erythematosus (CLE), a chronic autoimmune skin disease. The study, conducted by Jackson Laboratory in partnership with Zylö Therapeutics Inc., of Greenville, S.C., using a CLE mouse model demonstrated a significant reduction in skin plaque severity after treatment with HT-005-loaded topical Z-pods compared to untreated control mice. The skin severity scoring was based on a semi-quantitative measurement scale of erythema, thickness, scaling and alopecia measured on the scapula, head and overall composite score. The study was conducted over the period of 10 weeks, and significant reduction of plaque severity in the overall composite score was observed within three weeks of treatment and maintained through the entire 10-week treatment cycle, supporting that the therapeutic response is sustained.
Humanigen Inc., of Burlingame, Calif., said it executed its first licensing transaction in the Asia-Pacific Region with Telcon RF Pharmaceutical Inc. and KPM Tech Co. Ltd. for development and commercialization rights to lenzilumab for treating COVID-19 in South Korea and the Philippines. The licensing agreement includes payments of up to $20 million, with $6 million as an up-front payment upon execution of the licensing agreement and the balance of $14 million in two payments based on achievement by Humanigen of specified milestones in the U.S. Telcon and KPM Tech will be responsible for gaining regulatory approval and subsequent commercialization of lenzilumab in its territories. Humanigen will earn double-digit royalties following receipt of those approvals on net sales subsequent to commercialization. Lenzilumab is a GM-CSF ligand inhibitor.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, said it entered a research partnership with Mila, a research institute dedicated to artificial intelligence (AI) development and focused on deep learning optimization for AI and machine language learning. The collaboration will leverage data and AI to transform how novel therapeutics are discovered and developed. Terms were not disclosed.
New data from Inventiva SA, of Daix, France, showed that peroxisome proliferator-activated receptors (PPARs) are attractive therapeutic targets for treating nonalcoholic steatohepatitis (NASH), producing beneficial effects on the liver, improving features of the metabolic syndrome and mitigating the risk of related extrahepatic diseases. PPARs regulate metabolism, inflammation and fibrosis, which determine NASH progression, the company said.
Minoryx Therapeutics SL, of Barcelona, Spain, said the European Investment Bank approved a €25 million (US$29.3 million) financing to support development of leriglitazone, a differentiated, disease-modifying PPAR-gamma agonist currently being evaluated in three late-stage clinical trials. The studies are a phase II/III in adrenomyeloneuropathy, a phase II in cerebral adrenoleukodystrophy and a phase II in Friedreich's ataxia.
Pivotal SL, of Madrid, Spain, said it was contracted by New York-based Checkpoint Therapeutics Inc. to provide clinical research services in Europe for the upcoming study of PD-L1 inhibitor cosibelimab (CK-301) in cutaneous squamous cell carcinoma.
Taiwan Liposome Co. (TLC), of Taipei, Taiwan, said research describing how inhalable liposomal hydroxychloroquine (TLC-19) may provide clinical benefit and serve as a potential treatment for COVID-19 has been peer-reviewed and accepted by Clinical and Translational Science. Phase I studies of TLC-19 are ongoing.
Xoma Corp., of Emeryville, Calif., said it acquired the rights to future milestone and royalty revenue due to Bioasis Technologies Inc., of Guildford, Conn., associated with the advancement of the enzymes being investigated for treating four different lysosomal storage disorders under Bioasis’ strategic alliance with Chiesi Group, of Parma, Italy. In exchange for a $1.2 million up-front payment, Xoma will receive a low single-digit royalty on future net sales of each of the four Chiesi-Bioasis enzymes and an undisclosed share of the up to $138 million in potential milestones due to Bioasis under its agreement with Chiesi.