Roche builds long-term case for Evrysdi with 2-year SMA data; ExeVir nets $50M Series A for llama-derived Covid antibody

16 Mar 2021
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At the two-year mark, Roche’s Evrysdi (risdiplam) either maintained or improved motor function from a one-year check-up in patients aged 2 to 25 with Types 2 or 3 spinal muscular atrophy, the Swiss drugmaker said Tuesday. Even better, Evrysdi showed no new long-term safety signals, and patients in the second year of treatment actually posted fewer severe side effects than in the first year, Roche said. The SUNFISH Part 2 study continues an initial one-year study for Types 2 and 3 SMA for Evrysdi, which snared an FDA approval back in August. In addition to studies in that setting, Roche is looking at Evrysdi follow-ups in Type 1 SMA as well as in patients who have received a prior SMA therapy prior to Evrysdi and in infants. “These encouraging results confirm that the efficacy and safety of Evrysdi in people with Type 2 and Type 3 SMA can be sustained over time,” Roche’s CMO Levi Garraway said in a statement. “Therefore, these findings further highlight the potential longer-term benefit this first-of-its-kind medicine can have for people of varying ages and levels of SMA disease severity.” — Kyle Blankenship What a year it’s been for llama researchers. The Belgium-based biotech ExeVir has closed a $50 million Series A round to advance development of its llama-derived antibodies for the treatment and prevention of Covid-19. ExeVir will use the financing to launch a global Phase Ib/II clinical trial of lead compound XVR011 that is scheduled to start “shortly,” the company said. “In only 9 months from set up, ExeVir has made fantastic progress in the development of lead compound XVR011 which is now ready to move into clinical development,” ExeVir chairman Philippe Monteyne said in a statement. “We are proud that Belgium is at the forefront of international efforts in cutting-edge research, innovation and science.” The Series A comes after the research team, in collaboration with the NIH, engineered a llama antibody to block the novel coronavirus last May. Some animals, like llamas, produce smaller antibodies called nanobodies that can potentially provide the foundation for inhaled Covid-19 therapeutics. Tuesday’s financing was led by Fund+ with VIB, UCB Ventures, SFPI-FPIM, V-Bio Ventures, and new investors SRIW, Noshaq, Vives IUF, SambrInvest also participated, as well as several Belgian family offices. — Max Gelman Israel-based Intec Pharma is dipping its toes in immuno-oncology through a reverse merger with the preclinical startup Decoy Biosystems. $NTEC shares surged 87% in premarket trading after the companies announced the merger on Monday. On Tuesday morning, they were down 10.9%, pricing around $5.31 apiece. Decoy brings with it a “robust” immunotherapy pipeline, CEO Jeffrey Meckler said in a statement. The company says it will advance its platform to battle “a variety of tumor types and chronic viral infections.” It plans to file an IND in the second half of this year, and initiate a Phase I trial in 2022 targeting solid tumors and lymphomas. “Decoy’s bacteria-based platform is a novel modality which has the potential to dramatically change how we treat cancer and chronic viral diseases,” said Roger Pomerantz, who will become the combined company’s board chair. Former Decoy stockholders are expected to own about 75% of the combined company, while Intec shareholders will take about 25%. — Nicole DeFeudis
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