BioSpace Global Roundup, Nov. 21
3SBio Inc. – China-based 3sBio and Massachusetts-based Verseau Therapeutics selected VTX-0811, a monoclonal antibody targeting PSGL-1, as the first licensed program under their agreement that focuses on the development and commercialization of novel monoclonal antibodies in the field of immuno-oncology for a broad range of cancers. The asset targets PSGL-1, an adhesion molecule highly expressed on tumor-associated macrophages across most tumor types. VTX-0811 reprograms macrophages to a pro-inflammatory state, activates T cells and attracts other immune cells to generate a coordinated and powerful antitumor response. Under the terms of the agreement, 3SBio received an exclusive license to develop and commercialize a selected number of MCM antibodies for all human oncology indications in Greater China, including mainland China, Taiwan, Hong Kong and Macau. Verseau retains global rights to all MCM programs outside of Greater China. Verseau is responsible for discovery and optimization of MCM antibodies for each program.
Securecell – Sweden’s Securecell introduced Sephara, a high performance in-situ filtration membrane for applications in bioprocess sampling and perfusion processes for use in selected bioprocess laboratories. The Sephara membrane technology addresses the key problems associated with conventional filtration-based sampling procedures such as adsorption effects, fouling, clogging, unwanted and unselective separation, lack of multi-usability, the company noted. Sephara provides retention of particles with sizes greater than the pore diameter thereby addressing the issues associated with particle contamination during downstream analytics and product purification, Securecell said. In microbial or high-density mammalian cultures, Sephara acts as a pre-filtration device and assures early separation of cells from supernatant for subsequent metabolite and product analysis. Sephara is at the core of Securecell’s latest product additions to its process analytical technology solution portfolio.
Valneva – Infectious disease-focused Valneva announced positive Phase I results for its single-shot chikungunya vaccine candidate, VLA1553. France-based Valneva said the final results of the trial showed an “excellent immunogenicity profile” in all vaccinated dose groups after a single vaccination, with a 100% seroconversion achieved at the end of two weeks following a single vaccination in all dose groups. All titers were 100% sustained at Month 12, the company added. The safety profile remained consistent across all dose groups.
Isofol – Sweden-based Isofol Medical AB completed a Clinical Trial Notification submission to the Therapeutic Goods Administration in Australia, which will allow the start of the pivotal Phase III clinical study, AGENT, for patients with metastatic colorectal cancer (mCRC) at Australian sites. The AGENT study is expected to enroll 440 mCRC patients, all treated in the first-line setting, who will receive either arfolitixorin or leucovorin, both in combination with 5-FU, oxaliplatin and bevacizumab. Top-line data from the study are expected in 2021. The recruitment of patients is ongoing in North America and Europe and will now be expanded to include patients from Japan and Australia as well.
Biofourmis – Digital therapeutics company Biofourmis, based in Boston, acquired Switzerland-based Biovotion AG, a developer of a cutting-edge clinical-grade wearable biosensor platform. The acquisition includes all of Biovotion's assets, including the market-leading Everion biosensor and more than 60 global patents covering most of the wearable and sensor technology that exists for the arm or hand. The acquisition of Biovotion will enable Biofourmis to offer proprietary, clinical-grade wearables as part of its Biovitals ecosystem, the company said. Clinical-grade wearables are becoming integral across all areas of healthcare, offering continuous real-time physiological data formerly only available in clinical settings. Combining Biovotion's wearables with Biofourmis' digital therapeutics platform and its artificial intelligence-driven predictive analytics creates the most comprehensive digital therapeutics solution on the market, Biofourmis said. The lead product among Biovotion's wearables is the clinical-grade Everion device, which is a multi-sensor platform worn on the arm capable of measuring 22 parameters in real time.
CARMAT – France’s CARMAT received the go-ahead to resume the PIVOTAL study in the Czech Republic. The artificial heart implants will be performed at the Institute of Clinical and Experimental Medicine in Prague. The company is also in advanced talks with the Kazakhstani health authorities regarding the resumption of the study at the National Research Center for Cardiac Surgery in Nur-Sultan. CARMAT is aiming to intensify enrollment in the PIVOTAL study in order to finalize it as soon as possible and obtain CE marking in 2020.
Optibrium – A three-way collaboration was announced between the U.K.’s Optibrium, Ukraine-based BioSolveIT and Germany-based Enamine, all providers of software and services for drug discovery. The companies will collaborate to support Optibrium’s StarDrop software to provide the ability to search more than 11 billion readily accessible compounds and identify novel compounds that are similar to a query structure of interest. REAL Space, developed by Enamine, is a chemical space currently containing over 11 billion compounds that can be quickly synthesised with a high success rate.
Guerbet – France-based Guerbet has been granted approval for a new indication for Lipiodol Ultra Fluid in Denmark for chemoembolization of tumors in adults with known intermediate-stage hepatocellular carcinoma. Hepatocellular carcinoma is the most common primary liver cancer and is the 4th leading cause of annual cancer death worldwide. Lipiodol Ultra Fluid is used for cTACE, a minimally invasive procedure which consists of mixing Lipiodol Ultra Fluid with an anticancer drug.
TISSIUM – Also based in France, privately-owned Tissium raised €38.75 million ($42.78 million) in a Series B financing round. The funding raised in this round will be used to support the company’s global expansion of its platform of polymers across a variety of therapeutic fields, including nerve repair, cardiovascular and gastroenterology, among others. In addition to supporting the growth of the platform, the funding is expected to support the broader strategy of creating a streamlined clinical development and regulatory process across multiple geographies. While the company remains headquartered in Paris, these efforts will also be focused towards the U.S. out of its newly opened Boston affiliate office.