BioSpace Global Roundup, Nov. 12
NanoMab – London-based NanoMab Technology Limited received CTA Acceptance from the Medicines Healthcare products Regulatory Agency to conduct a Phase II clinical Study for its NM-01 product. The PELICAN study will assess programmed death ligand 1 (PD-L1) expression using 99mTc-NM-01 as a SPECT/CT radiotracer and its correlation to PD-L1 expression results based on routine immunohistochemical (IHC) testing in biopsy diagnostic specimens. It is anticipated that the first study patients will be enrolled in early 2021. The company said it will also continue to make strong progress with NM-02, a therapeutic product for the treatment of HER2 positive cancers and anticipated an FIH study over the coming months with the aim of commencing a Clinical Study Protocol in the next 12 months.
Memo Therapeutics – Switzerland-based Memo Therapeutics AG raised 14 million Swiss francs in a Series B financing round. The proceeds will primarily be used to advance development of MTX-COVAB, Memo Therapeutic AG’s lead antibody candidate for the treatment of COVID-19 through to Phase II clinical studies, including production of GMP material. MTX-COVAB is a fully human, highly potent antibody isolated from clinically selected convalescent COVID-19 donors that also neutralizes all major known mutants. Memo Therapeutics AG has agreed a fast-track development plan for MTX-COVAB with regulatory authorities and plans to begin clinical studies in 2021. The financing was led by Swisscanto Invest by Zürcher Kantonalbank and included BERNINA BioInvest, as well as new private investors and existing investors Investiere, Schroder Adveq, Jaquet Partners and Redalpine.
PhoreMost– PhoreMost Limited and Oxford Biomedica plc, both based in the U.K., entered into a discovery collaboration to develop next-generation CAR-T cell therapies. Financial details of the agreement are not disclosed. PhoreMost will deploy its next-generation phenotypic screening platform, SITESEEKER, to identify therapeutic candidates for Oxford Biomedica’s LentiVector gene therapy delivery system. The program will initially focus on CAR-T therapy and aims to develop next-generation cell therapies with significantly improved efficacy and durability. SITESEEKER exploits protein shape diversity to find functionally active peptides linked to any chosen disease setting, significantly enhancing the power of phenotypic screening and translation into therapeutic modalities. Oxford Biomedica’s LentiVector platform enables the development of breakthrough gene and cell-based medicines, and through collaborations with pharmaceutical partners, has delivered the first FDA and EMA approved CAR-T cell therapy.
APEIRON – Austria-based APEIRON Biologics partnered with U.K.-based Domainex Ltd. to provide integrated lead optimization services in order to advance the development of inhibitors for the E3 ubiquitin ligase Cbl-b through small molecule drug discovery. Under the terms of the agreement, Domainex, a leading integrated drug discovery research service partner, will provide its expertise in medicinal and computational chemistry, screening, structural biology and ADME/PK to advance APEIRON’s promising Cbl-b targeting compound series APN431 towards pre-clinical development.
MercachemSyncom – Netherlands-based MercachemSyncom acquired Finland-based Admescope Ltd. The acquisition will provide MercachemSyncom expanded capabilities for tailor-made in vitro and in vivo ADME-Tox studies for pre-clinical and early clinical R&D projects and seamless integration with the existing medicinal, synthetic and development chemistry capabilities of MercachemSyncom. Admescope brings world-class expertise in drug metabolism, drug interactions, pharmacokinetics and quantitative bioanalysis. Financial terms were not disclosed.
BioMed X – Germany-based BioMed X and Janssen expanded their collaboration in immunology. The new project will focus on the development of novel methodologies to systematically profile and dissect complex tissue microenvironments. The goal is to identify components that induce pro-resolution responses in tissue-resident innate immune cells to restore homeostasis in auto-inflammatory diseases such as psoriasis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), or inflammatory bowel disease (IBD).
Cell Guidance Systems – U.K.-based Cell Guidance Systems launched a new product for the purification of exosomes from blood and other samples. The Exo-spin 96 exosome purification kit allows researchers to purify exosome samples in the standard 96 well plate format, the company said. The Exo-spin 96 kit is based on the increasingly popular size exclusion chromatography (SEC) method of exosome purification which is now used by most exosome research labs. It is a development of Cell Guidance Systems’ Exo-spin range of SEC single columns, which have been enabling exosome research since 2014, providing a rapid, reliable, and cost-effective way to purify exosomes without specialist equipment.
Fujirebio Europe -- Belgium-based Fujirebio Europe and Centogene N.V. entered into a partnership to leverage LUMIPULSE G technology for large-scale COVID-19 antigen testing with further deployment in German airports. Fujirebio will provide a steady supply of Lumipulse G SARS-CoV-2 Ag assays running on fully automated CLEIA-based LUMIPULSE G1200 instruments. Sample collection is to be performed by CENTOGENE via the usual oropharyngeal swabs, with the analysis of the samples performed at CENTOGENE test laboratories, and the LUMIPULSE G1200 then supporting by delivering high quality results in up to only 40 minutes from sample receipt in the laboratory. These instruments will be an integrated part of the existing sophisticated automated Centogene workflow that ensures fast and direct delivery of results to customers on their smartphones or digital devices.
CatalYm – Germany’s CatalYm GmbH closed a €50 million Series B financing round. CatalYm develops monoclonal antibodies that enhance the effective infiltration of immune cells into the microenvironment of cold tumors, addressing a high unmet medical need in immuno-oncology. CatalYm’s lead molecule CTL-002 was specifically designed to neutralize a tumor-produced protein called GDF-15. High concentrations of GDF-15 in the serum and tumor-microenvironment help the tumor to evade the immune system and are associated with resistance to current therapies. The financing was led by Vesalius Biocapital III and joined by Novartis Venture Fund (NVF), Wachstumsfonds Bayern, coparion and founding investors Forbion and BioGeneration Ventures. Representatives from Vesalius Biocapital III, NVF and Wachstumsfonds Bayern will join the Board.
Oplibrium – Based in the U.K., software developer Oplibrium and Merck forged a collaboration to use the company’s StarDrop software as a central component of their cheminformatics infrastructure to improve cycle times, efficiency and productivity of the drug discovery process. StarDrop is a package of fully integrated, elegant software for small molecule design, optimization and data analysis. It supports researchers by quickly targeting high-quality chemistry in hit-to-lead and lead optimization.
HRA Pharma – Based in Paris, HRA Pharma tapped OTC Medical for over-the-counter products including medicine, as its exclusive distributor in the Netherlands. This comes after recent growth and restructuring of HRA Pharma alongside plans to expand its business further in the Dutch market. OTC Medical will take full responsibility of retail customers for the sales and distribution of HRA Pharma’s consumer healthcare brands ellaOne, NorLevo and Compeed in the Netherlands.
Affibody – Sweden’s Affibody AB initiated a year-long trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with psoriatic arthritis (PsA). The primary objective of the trial is to evaluate efficacy of different dose regimens of ABY-035 as compared to placebo.
Medicago – Medicago, based in Quebec City, reported interim results of its Phase I clinical study for its plant-derived vaccine for COVID-19. The results of the trial demonstrated that 100% of subjects developed a promising antibody response after two doses of Medicago’s COVID-19 adjuvanted vaccine candidate, the company said. There were no severe adverse events reported and reactogenicity events were generally mild to moderate and short in duration. Based on the Phase I data, Medicago plans to proceed with the Phase II/III clinical trial for its COVID-19 vaccine candidate, subject to regulatory approval.
CEVEC Pharmaceuticals – Germany-based CEVEC Pharmaceuticals GmbH signed an agreement with Roche for the use of its ELEVECTA Technology for large scale manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Under the terms of the agreement, CEVEC will grant Roche and Spark Therapeutics an option for a non-exclusive license for the development of AAV producer cell lines based on CEVEC’s ELEVECTA Technology. The partnership will provide Roche the rights to use CEVEC’s technology for their portfolio of gene therapy products.
Immatics NV – Germany’s Immatics presented Phase I results from the ACTolog program IMA101 at the 35th Annual SITC Meeting. ACTolog is a pilot study for a personalized multi-TCR-T approach that aims to address current challenges for effective cancer immunotherapy, such as tumor heterogeneity and tumor immune escape. The data demonstrates the feasibility of the approach while also showing the therapy is well tolerated. In addition, case studies within the treated patient population support further exploration of a personalized ACT approach using potent high-affinity TCRs.
Oxford – The University of Oxford and Thermo Fisher Scientific joined forces to bolster the university’s capacity to deliver COVID-19 testing data. The new rapid testing laboratory and jointly developed Thermo Scientific Omnipath Combi SARS-CoV-2 IgG ELISA test detects and quantifies antibodies against the coronavirus and increases the University of Oxford’s testing capacity to up to 50,000 tests per day.
Inventiva – France’s Inventiva announced the U.S. Food and Drug Administration said the company’s clinical strategy to conduct a single pivotal Phase III trial may be sufficient to support the filing of a New Drug Application for its lead drug candidate lanifibranor for the treatment of non-alcoholic steatohepatitis (NASH).
SOTIO – Based in the Czech Republic, Sotio announced interim data from its Phase I/Ib study of SO-C101, an IL-15 superagonist, as a monotherapy and in combination with pembrolizumab in patients with advanced/metastatic solid tumors. SO-C101 has demonstrated a favorable safety profile and Sotio observed significant, dose dependent activation of NK and T cells and a first confirmed partial response in the SO-C101 monotherapy arm in a patient with skin squamous cell carcinoma refractory to anti-PD-1 therapy.
Capitainer AB – Sweden’s Capitainer received the International Organization for Standards certification for its quality management system. The certification comes as Capitainer enters a period of rapid expansion following the signing of key distribution agreements in the US and Europe for its highly accurate qDBS dried blood spot sampling system.