BioSpace Global Roundup, Oct. 17
Cellink – Days after winning a Merck innovation award for its Holograph X bioprinter, Cellink and its cofounders won the Entrepreneur of the Year award in Sweden for 2019. Each year, the trade organization Företagarna chooses a winner in the award ceremony "Entrepreneur of the Year." The criteria to win the award are, among other things, to show creativity and innovation, to be leaders and role models, and to show profitability and growth. CELLINK has expanded dramatically during the four years since its inception, and today the company has 170 employees at offices in Gothenburg, Kyoto, Stuttgart and Boston.
Guerbet – France-based Guerbet signed an exclusive agreement with icometrix for the distribution in France, Italy and Brazil of icobrain, their Saas (Software as a Service) artificial intelligence-based medical imaging solution. Icobrain is designed to help radiologists and neurologists diagnose and monitor patients with neurological disorders. The Artificial Intelligence software extracts clinically meaningful information from brain CT or MRIs scans of patients with multiple sclerosis, dementia or brain injury. Icobrain can be used to automate the currently manual process of identifying, marking and quantifying volumes of brain structures identified, the company said.
Clinigen – England-based Clinigen Group launched a Managed Access Program for Progenics Pharmaceuticals, Inc. to provide Azedra (iobenguane I 131) outside the United States. Azedra, a high-specific-activity radiotherapeutic agent, is approved in the United States for the treatment of adult and pediatric patients 12 years and older with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. It is currently not approved for use outside of the United States.
Innovent – China-based Innovent and U.K.-based Chi-Med (Hutchison China MediTech Limited) expanded their agreement to evaluate the safety and efficacy of Innovent’s Tyvyt (sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody, in combination with Chi-Med’s surufatinib, a novel inhibitor of vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor 1 (FGFR1) and colony-stimulating factor-1 receptor (CSF-1R), in patients with advanced solid tumors. The expansion builds on the existing global collaboration agreement between the two companies on sintilimab in combination with Chi-Med’s highly selective VEGFR inhibitor, fruquintinib.
MGB Biopharma – MGB Biopharma, a Scotland-based company developing a novel class of anti-infectives, is developing MGB-BP-3 for the treatment of Clostridium difficile-associated disease (CDAD). The drug is in an ongoing Phase IIa trial. The first cohort of patients has now completed treatment with the lowest dose and results indicate high efficacy and good tolerability of MGB-BP-3. A Safety Committee review of the first cohort reported no concerns and recruitment of patients in the next cohort is progressing at sites in both Canada and the US. Headline results from all three cohorts are anticipated in early 2020. The company said MGB-BP-3 is the only antibiotic that has the killing power, combined with the speed of action, to eradicate C. difficile within the first few hours of exposure. Also, MGB-BP-3 has very strong bactericidal activity against the BI/NAP1/027 strain, the most virulent strain of C. difficile, which is largely resistant to current therapy, the company said.
Avacta Group – Avacta Group plc entered into a collaboration and option agreement with ADC Therapeutics to develop Affimer-drug conjugates combining Avacta’s Affimer technology with ADC Therapeutics’ pyrrolobenzodiazepine (PBD)-based warhead and linker technologies. As part of the multi-target collaboration, Avacta will generate and optimize Affimer binders against three undisclosed cancer targets and provide these to ADC Therapeutics to target its proprietary cytotoxic warheads (PBDs) to the site of the tumor. ADC Therapeutics will carry out pre-clinical research and development programs to evaluate each of the Affimer-drug conjugates with a view to generating clinical candidates.
Optibrium – U.K.-based software company Optibrium introduced its Augmented Chemistry services. The software provides collaborators with novel artificial intelligence technologies to supplement their skills and experience, enabling them to make more effective decisions and advance their drug discovery projects.
BIA Separations – Slovenia-based BIA Separations, a bio-chromatography development and manufacturing company, announced the introduction of its CORNERSTONE Exosome Process Development Solution, designed to help drug-developers overcome critical development bottlenecks in the preparation of exosomes for clinical use.
RedHill Biopharma – At 52 weeks, Israel-based RedHill Biopharma’s RHB-104 in Crohn’s disease maintained consistent positive outcomes in a Phase III trial that it has shown in previous studies. The study met its primary endpoint of clinical remission at 26 weeks, with 36.7% of patients responding against 22.4% for placebo. It also hit its secondary endpoints of maintaining remission through 52 weeks, the company said. RHB-104 was found to be generally safe and well-tolerated.
CombiGene – Sweden-based CombiGene signed an agreement with Cobra Biologics to produce CG01 for early clinical trials, as well as potential commercial production.
Mogrify – U.K.-based Mogrify raised $16 million in a Series A funding round to support its internal cell therapy programs and the development of out-license intellectual property related to cell conversions. Mogrify has developed a proprietary direct cellular conversion technology, which makes it possible to transform any mature human cell type into any other without going through a pluripotent stem cell- or progenitor cell-state. The company is deploying this platform to develop novel cell therapies addressing musculoskeletal, auto-immune, cancer immunotherapy, ocular and respiratory diseases as well as generating a broad IP position relating to cell conversions that exhibit safety, efficacy and scalable manufacturing profiles suitable for development as cell therapies.
Femtogenix – Also based in the United Kingdom, Femtogenix announced data verifying the favorable toxicity profile and potent efficacy of its Pyridinobenzodiazepine (PDD) ADC payload platform in tumor cell models. When attached to antibodies or other targeting moieties, Femtogenix’s novel PDD platform allows reversible/irreversible DNA minor groove binding, in a sequence-interactive manner, leading to highly targeted cytoxicity towards tumor cells, the company said. The payloads are designed to have a novel mechanism of action and IP space compared to existing DNA-interactive payloads, to have minimal hydrophobicity, and to be resistant to P-Glycoprotein pumps in tumor cells.
PPF – Czech Republic-based PPF Group invested $6.5 million into California-based MaveriX Oncology Inc. The proceeds will enable MaveriX to advance the company’s lead program MVX-5005 through IND-enabling studies, and complete first-in-human Phase Ia/Ib clinical trials for the treatment of solid tumors in support of clinical proof-of-concept. The company will also advance further platform programs to drug candidate selection.
Horizon Therapeutics – Ireland’s Horizon announced data from its Phase III clinical trial that showed teprotumumab provided significant benefit on several devastating effects of active thyroid eye disease (TED) compared with placebo, including diplopia, quality of life and clinical activity score. Teprotumumab is an investigational medicine for the treatment of active TED and is currently under review by the U.S. Food and Drug Administration. The teprotumumab Biologics License Application (BLA) was recently granted Priority Review by the FDA and if approved, teprotumumab would be the first FDA-approved medicine for the treatment of active TED. The Prescription Drug User Fee Act goal date is March 8, 2020.
Enterprise Therapeutics – U.K.-based Enterprise snagged $7 million in funding from the Cystic Fibrosis Foundation to support clinical development up to the end of Phase 2 for ETD002 – a first-in-class TMEM16A potentiator that has the potential to treat all persons with cystic fibrosis, independent of their cystic fibrosis transmembrane conductance regulator mutation type.
Amarna Therapeutics – Privately-held Amarna, based in the Netherlands, raised €10 million in a private equity placement to progress development of its SVac platform towards a first-in-man clinical study to commence in two to three years from now.
Nonacus – U.K.-based Nonacus Ltd. launched ExomeCG, a new product to simplify the generation and interpretation of molecular and cytogenomic data. ExomeCG is an exome capture kit which will enable the genomics community to perform confident and robust whole-exome sequencing and targeted copy number analysis in a single assay.