BioSpace Global Roundup, Oct. 3
T3 Pharmaceuticals – Switzerland-based T3 Pharmaceuticals AG, an immuno-oncology company, closed a financing round with 12 million CHF (Swiss francs) that was led by Boehringer Ingelheim Venture Fund. The funds will be used to complete preclinical activities for its lead candidate, which originated from the T3 platform. T3 is developing a proprietary protein delivery technology based on live bacteria expressing the type 3 secretion system. The company has engineered the bacteria to grow selectively within solid tumors where they produce and deliver therapeutic proteins. T3’s lead product, called T3P-Y058-739, is expected to enter clinical testing in the middle of 2020.
GENEWIZ – Genomics service provider GENEWIZ opened its European headquarters in Leipzig, Germany. research and applications in pharmaceutical, biotechnology, agriculture, environmental, clean energy, academic, and other related areas in Europe. It includes a 1,500 square meter biomolecular high-tech laboratory equipped with state-of-the-art sequencing and automation technologies. The facility provides onsite Sanger sequencing and next-generation sequencing services, while extending additional services such as gene synthesis, molecular genetics, and CLIA- and GLP-compliant services which are available through the GENEWIZ global network of genomics laboratories, the company said.
Iksuda Therapeutics – U.K.-based Iksuda announced the first data on its lead antibody drug conjugate (ADC) IKS01, which targets the folate receptor. IKS01 has shown significant anti-tumor efficacy in pre-clinical models of ovarian and lung tumors, each of which included a broad range of folate-receptor alpha (FRA) expression. Frequent over-expression of FRA in ovarian and non-small-cell lung cancer, accounting for 80% of lung cancer cases, and relative lack of expression in normal tissue, make it an attractive therapeutic target. However, anti-tumor activity is generally limited to patients whose tumors express high levels of FRA, the company said. IKS01 is an ADC comprised of an FRA-targeting antibody conjugated via Iksuda’s PermaLink technology to Femtogenix’s highly potent FGX2-62 payload. IKS01 is target specific and these new data confirm that it is highly effective in causing tumor regression in FRA-expressing models at doses that are well-tolerated, significantly more active than a benchmark ADC and caused complete regressions in low/moderate FRA-expressing models.
Horizon Discovery -- Horizon Discovery Group plc licensed its gene-edited Glutamine Synthetase (“GS”) knockout Chinese Hamster Ovary (CHO) K1 cell line to Glenmark Pharmaceuticals. Terms of the agreement were based on stringent evaluation of the cell line by Glenmark to assess its suitability for adoption into the company’s biomanufacturing processes. Horizon licenses its CHO expression system to pharmaceutical, biotechnology, and biosimilar companies, as well as contract manufacturing organizations. The system includes the GS knockout CHO K1 cell line, a comprehensive package of supporting documentation, and an expression vector.
Hutchison China MediTech (Chi-Med) -- Hutchison China MediTech Limited (Chi-Med) has priced an offering to sell approximately 1.3% of the total outstanding share capital in Chi-Med through an underwritten public offering, which would reduce its stake in Chi-Med from 51.1% to 49.9%. The offering price was $17.65 per American depositary share (ADS). Each ADS represents five ordinary shares. CK Hutchison has previously announced that, upon completion of the offering, it has no intention of selling additional Chi-Med shares for the foreseeable future. CK Hutchison plans to maintain its shareholding in Chi-Med as a strategic investment for the long term as it continues to strive to become a global biopharmaceutical company.
Inventiva – France-based Inventiva completed a €625,000 financing round subscribed by Sofinnova Partners. Proceeds from the transaction will primarily be used for general corporate purposes including funding operations and the development of the company’s products, particularly lanifibranor and odiparcil. Results of the iMProveS Phase IIa clinical study in Europe evaluating odiparcil for the treatment of mucopolysaccharidosis type VI (MPS VI) are expected by the end of this year. Results of the NATIVE Phase IIb clinical study evaluating lanifibranor for the treatment of non-alcoholic steatohepatitis (NASH) are expected in the first half of 2020.
Mimetas – Two Sweden-based companies, Mimetas and Hubrecht Organoid Technologies entered into a strategic collaboration to market organoid models on a Chip. The agreement includes a license to MIMETAS to market HUB Organoids in an assay ready format, as well as a collaborative effort to develop disease-specific models.
ProBioGen AG – Germany-based ProBioGen and France-based Ceva Sante Animale signed a licensing agreement for the manufacture of vectorized poultry vaccines using ProBioGen’s proprietary AGE1.CR technology. ProBioGen and Ceva have a long track record of producing innovative veterinary vaccine technologies from a number of different research and development programs.
Themis Bioscience – Austria-based Themis initiated a Phase I trial for a second-generation vaccine for the mosquito-borne Zika virus. The vaccine candidate is based on Themis’ proprietary measles vector platform. The trial will evaluate the safety and immunogenicity of the candidate in healthy volunteers. The vaccine will be administered by intra-muscular injection in two different dose levels. Secondary objectives will include optimal dose-finding, immunogenicity and long-term safety evaluation, as well as cell-mediated immunity specific to the Zika antigen. This is the second Zika program based on Themis’ measles vector platform to enter the clinic. The company’s pipeline includes additional earlier-staged vaccines and immuno-oncology development programs.
Mallinckrodt – U.K.-based Mallinckrodt’s Phase III trial of its investigational StrataGraft regenerative tissue hit both primary endpoints. Results showed that a significantly smaller area of burn wounds treated with StrataGraft tissue required autografting by three months compared to the area of burn wounds treated exclusively with autograft. Additionally, results showed that the proportion of StrataGraft-treated wounds that achieved durable wound closure at three months exceeded the pre-defined threshold for statistical significance. Based on the positive Phase III data, Mallinckrodt plans to submit a Biologics License Application for StrataGraft tissue to the U.S. Food and Drug Administration in the first half of 2020.