BioSpace' s Global Biopharma Roundup: April 18
Vetter – Germany-based Vetter, a contract development and manufacturing organization, has expanded in the United States. The company is nearing completion of its U.S. clinical manufacturing facility located at the Illinois Science & Technology Park in suburban Chicago. The ongoing growth of the facility will help satisfy existing and ever-increasing future customer requirements as well enable meet the complex needs of newer drug molecules like peptides or antibodies, many which need refrigeration or freezing. Since beginning full operations in late 2011, Vetter’s U.S. early-stage development site has been expanding to help meet growing customer demands. As recently as 2016, the site expanded its storage capacity by 150 percent to 3,700 square feet. The new addition will increase the facility’s storage capacity by an additional 3,100 square feet.
Atomwise – Geneva-based Drugs for Neglected Diseases initiative and the Bay Area’s Atomwise Inc. announced their partnership has unveiled drug-like substances that could be used to develop a treatment for Chagas disease. DNDi scientists selected three verified but challenging therapeutic protein targets that would inhibit the action of the parasite that causes Chagas disease. For each disease protein, Atomwise screened millions of compounds using its AI-powered screening technology to predict those that bind and potentially inhibit protein function. This research has delivered drug-like compounds that will now go on to further optimization and then potential drug development, the companies said. The Centers for Disease Control and Prevention estimates that nearly seven million people in the world have Chagas disease. Approximately 30percent of those with Chagas disease develop life-threatening cardiac, digestive, or neurological disorders. The research collaboration is part of Atomwise’s Artificial Intelligence Molecular Screen Awards program.
AMO Pharma – London-based AMO Pharma launched the first ever clinician-completed rating scale as a new tool to support clinical research in congenital myotonic dystrophy type 1(CDM1). The new scale identifies 11 observable characteristics associated with CDM1 and rates each on a four-point Likert scale incorporating information from natural history studies and consultation with therapeutic area experts, the company said. The scale was approved following discussions with the FDA as a resource to capture and assess characteristic symptoms of CDM1 in clinical research, a genetic disease caused by a large tri-nucleotide expansion repeat adjacent to the DMPK gene, AMO noted. This clinician-completed rating scale will serve as the primary outcome measure in a Phase II/III registration-caliber study in children and adolescents with CDM1 being planned by AMO Pharma. It is also being validated in an ongoing natural history study in children and adolescents with CDM1.
Synaptive Medical – Toronto-based Synaptive launched its new surgical tool. The company unveiled an automated white matter segmentation feature that was designed to augment the company’s Modus Plan. Synaptive’s Modus Plan is named to align with the next generation of Synaptive products, including Modus V, and will be available for purchase this year, the company said.
Kitov Pharmaceuticals – Israel-based Kitov announced a key milestone in the acquisition of FameWave Ltd., following signature of a clinical collaboration agreement between FameWave and Bristol Myers Squibb for planned Phase I/II clinical trials to evaluate the combination of CM-24, a monoclonal antibody targeting the novel immune checkpoint carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1) with nivolumab (Opdivo), a PD-1 inhibitor, in patients with non-small cell lung cancer (NSCLC). Preclinical studies have shown a strong synergetic anti-cancer effect using CM-24 in combination with a PD-1 antibody. Based on Kitov’s review of the initial Phase I dose-ranging study of CM24 as a single agent, Kitov plans to explore higher doses in order to reach receptor saturation, the company said.
Tessa Therapeutics – Tessa Therapeutics, based in Singapore, entered into an agreement with pharma giant Merck to evaluate the company’s armored human papillomavirus-specific T cell (HPVST) therapy, or TT12, in combination with Keytruda, Merck’s vaunted checkpoint inhibitor in patients with recurrent or metastatic HPV 16 and 18-positive cervical cancer. Tessa will conduct a multi-center Phase Ib/II trial to evaluate the safety and efficacy of the combination. Tessa’s TT12 is an autologous cell therapy product composed of HPVSTs that have been trained to target HPV 16/18 antigens and genetically modified with a decoy TGF-β receptor to overcome the suppressive tumor microenvironment. The safety and optimal dose selection of armored HPVSTs in combination with another anti-PD-1 antibody is currently being evaluated in a separate, ongoing investigator-sponsored Phase I trial in patients with relapsed HPV-associated cancers. Preliminary results from this trial show that armored HPVSTs and its combination with anti-PD-1 are well-tolerated, have minimal toxicities and early signs of efficacy.
GenSight – France-based GenSight Biologics announced results from a Phase III trial that showed eyes treated with its asset showed continuous recovery of visual functions from nadir (worst vision post-treatment) in both best-corrected visual acuity (BCVA) and contrast sensitivity. Patients treated with GS010 suffered vision loss due to Leber Hereditary Optic Neuropathy six months prior to the procedure. Trial subjects received GS010 in one eye and a sham injection in the other eye, with drug treatment randomized between best- and worst-affected eyes. At 72 weeks, GS010-treated eyes recovered 21 ETDRS letters, the company said. Also, mean BCVA in both GS010- and sham-treated eyes improved from off-chart values at Week 48 to on-chart values at Week 72. Also at week 72, 40 percent of eyes achieved a clinically meaningful BCVA improvement from nadir.