BioSpace Global Roundup, May 28
CARMAT – French artificial heart maker CARMAT announced the first implantation of its bioprosthetic artificial heart in Denmark. The implant procedure was performed at the Heart Center of Rigshospitalet in Copenhagen. It is the first Danish hospital to implant the CARMAT total artificial heart and the third international medical center contributing to the PIVOTAL study, together with the Institute for Clinical and Experimental Medicine in Prague, Czech Republic, and the National Research Center for Cardiac Surgery in Nur-Sultan, Kazakhstan.
Inventiva – Also based in France, Inventiva announced that the China National Intellectual Property Administration (CNIPA) granted a new patent directed at the use of lanifibranor for the treatment of several fibrotic diseases in China until June 2035. This new patent covers, among others, the use of the company’s lead product candidate lanifibranor for the treatment of NASH, hepatic fibrosis, chronic renal failure and fibrotic pulmonary disorder.
Novasep – France’s Novasep and Lysogene forged an agreement for the development and manufacturing of LYS-GM101, an AAVrh10-based gene therapy drug candidate for the treatment of GM1 Gangliosidosis, a rare neuronopathic lysosomal storage disorder. With this collaboration, the two companies consolidate their long-lasting partnership initiated with the development and manufacturing of Lysogene’s lead gene therapy product, LYS-SAF302, currently in clinical Phase II/III.
AbCellera – Vancouver-based AbCellera closed a $105 million Series B financing round led by OrbiMed and current investor DCVC Bio. AbCellera intends to use the proceeds from the funding to expand its capacity and invest in technologies that complement and extend its proprietary antibody discovery engine. AbCellera will use the funds to deepen its technology stack, creating and aggregating new technology to propel the development of new biological modalities, from monoclonal, multi-specific, and single-domain antibodies, to bioconjugates, gene-encoded biologics, and cell therapies. AbCellera said funds will also be used to support the expansion of its workforce and open a new 48,000-square-foot R&D facility in 2021
SeraNovo – Netherlands-based SeraNovo B.V. signed a second license agreement with Carna Biosciences that expands the existing collaboration between the companies. SeraNovo is formulating one of Carna’s proprietary drugs to increase its oral bioavailability. The DES formulation platform is based on GRAS excipients that are used for oral administration and broadly used in the industry.
Accure Therapeutics – CNS-focused Accure Therapeutics, based in Spain, launched with $8.1 million in a Series A financing round. The funding round was led by Alta Life Sciences and supported by the Centre for Technological and Industrial Development (CDTI). The company will develop a portfolio of new drug candidates to treat CNS diseases.
Poxel – France-based Poxel announced the successful private placement of 2,358,483 new ordinary shares, each with a nominal value of €0.02 per share. The gross proceeds of the Reserved Offering are €17,688,622.50, about $19.4 million.
Hutchison China MediTech -- Hutchison China MediTech Limited, better known as Chi-Med, and BeiGene, forged a clinical collaboration to evaluate the safety, tolerability and efficacy of two of Chi-Med’s drug candidates, surufatinib and fruquintinib combined with BeiGene’s anti-PD-1 antibody tislelizumab, for the treatment of various solid tumor cancers. Under the terms of the agreement, Chi-Med and BeiGene each plan to explore development of the combination of surufatinib with tislelizumab or fruquintinib with tislelizumab in different indications and regions. Each of these three compounds are currently in late-stage global clinical development across many countries outside of China. Tislelizumab and fruquintinib have both been approved by the China National Medical Products Administration, which is also currently reviewing the New Drug Application for surufatinib that was submitted late last year.
Cambridge Cognition Holdings – U.K.-based Cambridge Cognition Holdings won new contracts to support pharmaceutical clients in delivering virtual clinical trials. CCC has been supporting virtual clinical trials since the launch of its cloud-based platform in 2017. With pharmaceutical companies searching for options to continue trials outside of the clinic, the company has seen increased interest in virtual or part-virtual assessments since COVID-19 driven lockdowns began.
MiNA Therapeutics – MiNA Therapeutics, located in London, published data from its Phase I liver cancer trial dubbed OUTREACH, in Clinical Cancer Research. It is the first publication in which a small activating RNA treatment demonstrated clinical benefit in advanced hepatocellular carcinoma, MiNA said. In addition, the company provided an update on its ongoing clinical trials for lead program MTL-CEBPA and its drug discovery programs. The framework for a subsequent Phase II clinical trial is currently being designed with the objective of initiating this next stage of clinical development in the second half of 2020.
Dermavant Sciences – Switzerland-based Dermavant published secondary efficacy and patient-reported outcomes from the Phase IIb randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis in The Journal of the American Academy of Dermatology. The latest analyses of the mid-stage study include significant improvements on the Psoriasis Area and Severity Index of greater than 50%, 75% and 90%. Patient-reported outcomes include change over time in daily Psoriasis Symptom Diary scores and patient global impression of change in overall severity of psoriasis symptoms and pruritus symptoms from baseline to Week 12. Tapinarof cream is a potential first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of plaque psoriasis and atopic dermatitis.