BioSpace Global Roundup, Feb. 13


Hutchison China MediTech – London-based Hutchison China MediTech Limited, better known as Chi-Med, announced the availability of updated results from the Phase II CALYPSO study of the savolitinib / Imfinz (durvalumab) combination in a cohort of patients with metastatic papillary renal cell carcinoma. Full data from the PRCC cohort of the CALYPSO study will be presented on Feb. 2020, in oral and poster presentations at the annual American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. PRCC is a subtype of kidney cancer that is unusually difficult to treat, with low response rates from current treatment options and no treatments approved for this specific indication. The CALYPSO study is an independently sponsored open-label Phase II study of Imfinzi in combination with several drug candidates in the treatment of renal cell carcinoma in the U.K. and Spain.

Stilla Technologies – Digital PCR solutions provider Stilla Technologies, based in Paris, raised €20 million ($22 million) in a Series B funding round that brought in a new investor, the Chinese group TUS-Holdings, alongside the participation of existing investors Illumina Ventures, Kurma Partners, LBO France, Paris Saclay Seed Funds, BNP Paribas Développement and Idinvest Partners. The funds will be used to support development of the company’s next-generation solution that will feature superior analytical performance including 6-color detection capabilities.

Elypta -- Swedish molecular diagnostics company Elypta AB announced that it has enrolled the first patient in the multi-center AURORAX-087A study involving its novel liquid biopsy platform. The study is the largest ever prospective multi-center diagnostic test study for the detection of recurrence after surgery in clear cell renal cell carcinoma (ccRCC), the most common form of kidney cancer. Elypta’s liquid biopsy is anticipated to detect tumor progression more rapidly than imaging: an earlier detection has the possibility to save or prolong the lives of those suffering a recurrence. Elypta’s novel liquid biopsy platform quantifies blood and urine-based metabolic glycosaminoglycan (GAG) markers and then uses cloud-based software to compute a cancer-specific score. The platform has the potential to be used in the diagnosis or monitoring of a range of cancers, of which ccRCC is the first cancer type to be evaluated, the company said.

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BD -- Germany-based BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the completion of a 50-subject human clinical trial with the BD Libertas Wearable Injector. The study was designed to evaluate the performance of the 5 mL BD Libertas device in human subjects, including tissue effects, skin reactivity and patient acceptance. The results are expected to be announced early 2020. The injector is subcutaneous drug delivery system currently under development. The study represents the most recent in a series of over 50 BD conducted pre-clinical and clinical studies intended to measure the performance of the BD Libertas Wearable Injector.

ERS Genomics – Ireland’s ERS Genomics Limited announced the signing of a license agreement granting Aelian access to ERS Genomics' CRISPR/Cas9 patent portfolio, to support Aelian's commercial functional genomic screening platform. Aelian Biotechnology combines CRISPR/Cas9 screening techniques with single-cell sequencing to identify and investigate disease targets and drug mechanisms of action. Aelian’s novel platform is applicable across a wide range of cell types, including primary cells, and broadens access to a wider range of complex phenotypes. Under the terms of the license from ERS Genomics, Aelian is now able to offer its technology worldwide to pharmaceutical and biotech companies seeking more effective therapies, the companies said in a joint statement. Financial details of the agreement are not disclosed.

TISSIUM – France-based TISSIUM, a privately-owned life sciences company developing fully synthetic, biomorphic programmable polymers, announced they have received funding from the Crohn's & Colitis Foundation's IBD Ventures, a funding mechanism intended to accelerate the discovery and development of novel research-based products with the potential to alleviate suffering caused by inflammatory bowel disease (IBD). The funding will support TISSIUM’s development of solutions that address the unmet medical needs of Crohn’s patients. Perianal disease, including anal fistulas, is one of the most debilitating manifestations of inflammatory bowel disease, including Crohn’s disease. A fistulectomy, the current gold standard of care, is associated with chronic side effects such as postoperative fecal incontinence due to damage to the sphincter. TISSIUM will be evaluating a novel biomaterial-based solution to promote fistula healing without diminishing continence or damaging the sphincter. This technology will be based on TISSIUM’s biomorphic programmable polymers.

Azafaros B.V. – Azafaros B.V., based in The Netherlands, closed its Series A financing round of €25 million, or about $28 million. The round was led by Forbion, with participation from BioMedPartners and founding investor BioGeneration Ventures (BGV). Azafaros was established in 2018 to translate innovative science from Leiden University and Amsterdam University Medical Center into novel disease-modifying treatment modalities for rare genetic metabolic disorders such as lysosomal storage diseases (LSDs). The funds will be used to develop Azafaros’ lead oral small molecule, which the company believes holds the “promise of becoming an innovative approach to treating these conditions.”

Pivotal – Spain’s Pivotal announced it had been contracted by New York City-based Lucid Diagnostics to provide expert clinical research services for its upcoming clinical studies of its GI in-vitro diagnostics EsoGuard and EsoCheck in the U.S. and Europe. The aim of these two studies is to determine the operating characteristics (sensitivity, specificity, positive and negative predictive value, and accuracy) of the EsoGuard diagnostic assay for the detection of BE on samples collected using EsoCheck, using EGD findings plus histopathologic examination of biopsies as the reference method, in an at-risk BE population. The FDA 510(k)-cleared EsoCheck Cell Collection Device with Collect+Protect technology is a non-invasive device designed to sample cells from a targeted region of the esophagus in a five-minute office-based procedure, without the need for endoscopy.

NAC – The Native Antigen Company of the United Kingdom announced the commercial introduction of its Novel Coronavirus antigens, derived from the emerging Wuhan strain. These recombinant proteins offer scientists high-quality reagents to support ongoing infectious disease research, and the development of diagnostics and vaccines, the company said. These antigens have been derived specifically from the newly identified Novel Coronavirus (2019-nCoV) using The Native Antigen Company’s proprietary mammalian, VirtuE expression system. This system is able to introduce proper protein folding and post-translational modifications to recombinant proteins, which are essential for full biological and antigenic activity.

MirrorWeb – U.K.-based MirrorWeb is now listed in the Financial Industry Regulatory Authority (FINRA) Compliance Vendor Directory (CVD), a resource which enables firms to search for vendors that offer compliance-related services. FINRA is an independent agency dedicated to protecting investors and safeguarding market integrity in a manner that facilitates vibrant capital markets. It works under the supervision of the SEC and actively engages with and provides essential tools for investors, member firms and policymakers.

OSE Immunotherapeutics – France-based OSE announced a collaboration with start-up MAbSilico, to use artificial intelligence (AI)-based solutions for therapeutic antibody drug development. OSE Immunotherapeutics plans to incorporate innovative problem-solving solutions like AI for the development of new monoclonal antibodies. MAbSilico solutions have already been tested and validated by OSE Immunotherapeutics and will be used for six antibody programs, including novel bispecific antibodies. AI and numerical simulation can guide therapeutic antibody discovery, help reduce the risk of failure and accelerate the pre-clinical development process of these drug candidates before clinical tests.

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