Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
European life sciences venture capital firm Sofinnova Partners closed the oversubscribed $540 million (€445 million) Sofinnova Crossover Fund. This capital raise positions Paris-based Sofinnova Partners as the largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.
The fund will maintain its focus on European clinical-stage companies needing scale-up capital and will also support best-in-class companies in the U.S. and elsewhere. The fund has, to date, invested in 10 high-profile companies developing unique products that address major unmet clinical needs. The initial portfolio has demonstrated outstanding progress since inception, with the majority of investments reaching positive clinical trial milestones and raising large financings, including two NASDAQ IPOs of European companies.
“European biopharma and medtech companies have matured tremendously in the last decade. Sofinnova Partners was the first European VC to seize the opportunity to unlock the potential of these high-growth start-ups by providing late-stage capital, building on our decades of experience funding innovative life science companies,” Antoine Papiernik, chairman and Managing Partner of Sofinnova Partners, said in a statement. “With over €2 billion of assets under management dedicated to life science investing and an outstanding international team, Sofinnova Partners continues its expansion to partner with ambitious entrepreneurs across Europe, from company creation to late-stage developments.”
Elsewhere around the globe:
EG 427 – Paris-based EG 427 announced the closing of a €12 million Series A round. Funds will be used to move the company’s leading vector construct forward to clinical trials in neurogenic bladder. EG 427 focuses on creating a step-change in the gene therapy field by exploiting the natural properties of Herpes Simplex Virus 1 (HSV-1) and in particular its ability to establish lifelong latency in peripheral neurons. EG 427 has already built its proprietary HSV-1 vector platform and achieved the preclinical proof of its concept in the most common type of neurogenic bladder: urinary bladder dysfunction due to supra-sacral spinal cord injury. The financing round was led by David Lamond in association with San Francisco-based large family offices.
Evotec SE – Germany’s Evotec SE and Chinook Therapeutics announced a strategic collaboration focused on the discovery and development of novel precision medicine therapies for patients with chronic kidney diseases. Based on Evotec’s proprietary comprehensive molecular datasets from thousands of patients across chronic kidney diseases of multiple underlying etiologies, Chinook and Evotec will jointly identify, characterize and validate novel mechanisms and discover precision medicines for PKD, lupus nephritis, IgA nephropathy and other primary glomerular diseases. The collaboration will also involve further characterization of pathways and patient stratification strategies for programs currently in Chinook’s clinical and preclinical pipeline. Under the terms of the agreement, Chinook and Evotec will share drug discovery and preclinical development responsibilities. Chinook will be responsible for clinical development and commercialization of product candidates developed under the collaboration. Financial details were not disclosed.
Genomics PLC -- Genomics plc, which is based in the United Kingdom, completed a $30 million financing round. Genomics plc will use the funding to expand its work building a patient-centric, population health platform that unlocks a more proactive, precise and personalized form of healthcare. The fund was led by leading life science investors Foresite Capital and F-Prime Capital and was supported by existing backers such as Oxford Sciences Innovation and Lansdowne Partners.
Additionally, the company announce the successful results of a study in predicting coronary artery disease (CAD). Using an integrated risk tool (IRT) which combines polygenic risk scores (PRS) with external factors such as age, sex and BMI, Genomics can more accurately predict CAD. This presents a particular opportunity for identifying high-risk individuals much earlier to target lifestyle changes and potentially interventions. The study, published in the journal Circulation: Genomic and Precision Medicine, demonstrates that the risk of developing CAD is more accurately predicted if existing risk prediction tools used by clinicians are adjusted to include PRS.
Memic – Medtech company Memic, based in Israel, was granted De Novo marketing authorization for its Hominis robot-assisted surgical platform by the U.S. Food and Drug Administration. The platform is used in single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures including benign hysterectomy. The Hominis system features miniature humanoid-shaped robotic arms that provide human level dexterity, multi-planar flexibility and 360 degrees of articulation. Multiple instruments can be introduced to the body through a single portal and the 360-degree articulation offers obstacle avoidance as well as optimal access and working angles. The company plans to pursue general surgery and transluminal indications for the Hominis platform and is developing artificial intelligence (AI)-enabled features to support all its surgical indications.
IM Cannabis Corp. – Israel-based IM Cannabis is now trading on the Nasdaq under the ticker symbol “IMCC.” IMC will be the first Israeli medical cannabis operator to list its shares on exchange.
CN Bio – CN Bio received a grant from Innovate UK, the UK’s innovation agency, to develop human-relevant MPS to advance investigations into SARS-CoV-2 infection. The funding will be used to develop and test advanced cell culture models that represent different regions of the lung and subsequently linking these models to other organ systems, such as liver and gut, to inform the rapid development of novel therapeutics. CN Bio is developing single and multi-organ COVID-19 models to investigate virology and immunology throughout the body, with a prolonged viable cell culture time for extended studies. The single and multi-organ COVID-19 lung and lung-liver models will be developed specifically for use with the PhysioMimix lab-benchtop microphysiological system. These features will enable the models to be rapidly shared with collaborators, to allow them to be further validated and incorporated into current research streams working to develop the next generation of therapeutics to treat and prevent COVID-19.
Avadel Pharmaceuticals – Ireland’s Avadel announced the FDA accepted the company’s New Drug Application for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA assigned the NDA a Prescription Drug User Fee Act target action date of Oct. 15. The NDA submission is supported by positive data from the pivotal Phase III REST-ON study, which was completed under a Special Protocol Assessment (SPA) agreement with the FDA.
HKBU – A Hong Kong Baptist University-led (HKBU) research team has developed a novel drug which has the potential to become a next-generation treatment for cancers associated with Epstein–Barr virus (EBV). The peptide-linked drug, which is responsive to the acidic environment found in tumors, is the first known agent to have successfully targeted two viral proteins that are simultaneously produced by EBV, the team announced. It also offers a new strategy by increasing the uptake of anti-cancer drugs in tumor cells, thus allowing the application of lower drug dosages which helps reduce treatment side effects and health risks, the researchers added. The research results were published in the international academic journal Advanced Science.
ERS Genomics – Ireland’s ERS Genomics signed a license agreement with Otsuka Pharmaceutical Co. Ltd. giving that company access to CRISPR/Cas9 genome editing technology for its internal research and development initiatives to address areas of unmet medical need.
Dotmatics – Based in the U.K., Dotmatics Ltd. entered a licensing agreement with Compugen. The multi-year agreement will provide Compugen scientists access to Dotmatics’ SaaS technology, including Bioregister, Inventory, Studies Notebook and Platform applications. The tools enable gathering, analyzing and visualizing project data and will facilitate project teams to become more efficient and make better informed decisions faster.
Saniona – Rare disease company Saniona, which is based in Denmark, received Orphan Drug designation from the FDA for Tesomet in Prader-Willi Syndrome. Saniona is preparing to initiate a Phase IIb study of Tesomet in PWS in the first half of this year. Saniona previously evaluated Tesomet in a randomized, double-blind, placebo-controlled Phase IIa trial in adults and adolescents with PWS. Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a clinically meaningful reduction in body weight at a dose of 0.5 mg per day.
Novasep – France’s Novasep and Bonumose, a start-up technology company with a patented enzymatic technology platform for continuous production of high-purity rare sugars, announce a collaboration for the development, design, fabrication, installation and start-up of a complete process line to produce High Purity Rare Sugars, including Tagatose and Allulose, in Virginia. The collaboration covers the design, engineering and commissioning of a complete process line to produce High Purity Rare Sugars such as Tagatose and Allulose.
