Global Roundup: Hansa, OSE Nab New Funding, F-Star Links with Takeda
20 Jul 2022
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Hansa Biopharma, a Sweden-based company, focused on technology for rare immunological conditions, secured $70 million in non-dilutive financing from U.S.-based NovaQuest Capital Management.
Chief Financial Officer Donato Spota said the funding extends the company’s cash runway through 2024 and bolsters its ability to invest in developing its antibody-cleaving enzyme technology platform across multiple therapeutic areas. The financing will fully support the company’s ConfIdeS trial, which is evaluating Idefirix (imlifidase) as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney. Hansa anticipates the submission of a Biologics License Application to the U.S. Food and Drug Administration under the accelerated approval pathway in the first half of 2024.
“The funds, together with our existing cash, may also be used to complete our existing Phase II programs in antibody mediated kidney transplant rejection (AMR) and Guillain-Barré Syndrome (GBS) and to advance our next generation of enzymes (NiceR) into clinical development,” Spota said in a statement.
Hansa obtained conditional approval for Idefirix in Europe in August 2020. Additional market access procedures are currently ongoing in 11 countries, including Spain and Italy.
Elsewhere around the globe:
OSE – Oxford Science Enterprises, the independent investment company created to support the launch of businesses in partnership with the University of Oxford, secured an additional £250 million (about $300 million) in funding, giving the group a little more than $1 billion in assets. The funds are used to support the launch of university-based companies in the life sciences, health tech and other areas.
CN Bio – Also based in the U.K., CN Bio opened a new contract research facility at Cambridge Science Park. With the new site, the company’s laboratory space has doubled in response to the increasing market demand for organ-on-a-chip services as the technology gains traction within drug discovery and development programs.
F-Star Therapeutics – Also based in the United Kingdom, F-Star Therapeutics entered into a license agreement with Takeda. Under the terms of the deal, F-Star will grant Takeda a worldwide, exclusive royalty-bearing license to research, develop, and commercialize a bispecific antibody against an immuno-oncology target using F-Star’s proprietary Fcab and mAb2 platforms. Takeda will be responsible for all research, development, and commercialization activities under the agreement. F-Star will receive an upfront license fee of $1 million. F-Star is also eligible to receive future development and commercialization milestone payments up to approximately $40 million over the course of the agreement if all milestones are achieved, plus single-digit percentage royalties on annual net sales.
Byondis BV – Based in the Netherlands, Byondis secured validation of its marketing authorization application from the European Medicines Agency for its next generation anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine (SYD985) for use with patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). If granted, SYD985 will be marketed by Byondis’ commercialization partner and marketing authorization applicant medac GmbH, a privately owned pharmaceutical company based in Germany.
Nabriva Therapeutics – Ireland’s Nabriva forged an exclusive distribution agreement with Er-Kim, a leading partner for biotech companies in international markets, for the oral and intravenous formulations of Xenleta (lefamulin). Under the terms of the agreement, Er-Kim gains exclusive rights to distribute Xenleta in Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia and Slovenia. Er-Kim may also distribute Xenleta to five countries through a named patient usage program.
ForSight Robotics – Israel-based ForSight Robotics, a pioneer in ophthalmic robotic surgery, raised $55 million in a Series A financing round to advance the world’s first surgical platform for fully robotic cataract surgery, Oryom. Financing was led by the Adani Group with support from existing investors Eclipse Ventures and Mithril Capital.
Medigus Ltd. – Also based in Israel, Medigus Ltd. announced that Polyrizon Ltd., an Israeli biotech company specializing in innovative intranasal products, signed a binding collaboration agreement with NurExone Biologic Inc., which is developing biologically-guided exosome therapy for patients with traumatic spinal cord injuries. Polyrizon will use its advanced Trap and Target platform to develop formulations, conduct analytical development and produce technical batches of a tailored intranasal delivery system.
CardiNor AS – Norway’s CardiNor signed an exclusive agreement with IBL-America for sales of the CardiNor Secretoneurin ELISA test. CardiNor hopes the partnership will pave the way for future commercialization upon U.S. regulatory clearance to research institutes, clinical research organizations and pharmaceutical companies.
Ribbon Biolabs – Austria’s Ribbon Biolabs secured a U.S. patent that covers its novel method for synthesizing a double-stranded polynucleotide. Ribbon Biolabs’ novel approach to synthesizing DNA, as described in the patent, comprises a pre-built library of oligonucleotides or shorter genetic sequences that have been streamlined for efficient access. The patent is the first of the company’s submitted patent applications, which forms the foundation of its IP portfolio covering its long DNA synthesis technology.
Xortx Therapeutics – Canada-based Xortx Therapeutics submitted a request to the European Medicines Agency for a “scientific advice review” of its XRx-008 program for autosomal dominant polycystic kidney disease. The company plans to launch a Phase III registration trial and seek potential approval in Europe.
Tilray Brands, Inc. – Based in Germany, cannabis-focused Tilray Medical launched the education platform, WeCare-MedicalCannabis, which is dedicated to providing resources and educating healthcare practitioners and patients about medical cannabis. The platform is designed to serve as a one-stop, comprehensive resource on medical cannabis insights, WeCare-MedicalCannabis is now available in Germany, France, the United Kingdom, and Portugal.
Cardior Pharmaceuticals – Germany’s Cardior has dosed the first patient in a Phase I study that is assessing the efficacy and safety of CDR132L in 280 patients with reduced left ventricular ejection fraction after myocardial infarction. Cardior’s CDR132L is an oligonucleotide-based ncRNA inhibitor that targets microRNA-132, a central regulator of pathological cardiac remodeling processes.
Oryzon Genomics, SA – Spain’s Oryzon entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute to collaborate on the potential further clinical development of Oryzon’s clinical stage LSD1 inhibitor, iadademstat, in different types of solid and hematological cancers. Iadademstat is an orally active, highly potent and selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers. More than 100 cancer patients have been treated with iadademstat in several trials.
CryoPDP – Based in France, CryoPDP, a Cryoport company, acquired Spain’s Polar Express, which provides temperature-controlled shipments for lifesaving biological and pharmaceutical materials worldwide. Polar Expres’ key services include shipping samples for clinical trials, medical tests, assisted reproduction processes, infectious specimens, vaccines and more.
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