Yingli Pharma brings small molecule research to the US in new pact with MD Anderson; UCB's psoriatic arthritis drug shows positive PhIII results
Shanghai biotech Yingli Pharma wants to bring its small molecule drug research global — and a new pact with MD Anderson will help it get there.
Yingli and MD Anderson have inked a 5-year collaboration deal that will put its cancer candidates — some of which have already generated data in China — into trials in the US. The lead program is linperlisib, a PI3Kδ inhibitor that’s in a Phase III trial in follicular lymphoma, according to Yingli’s website. In the US, MD Anderson will work with Yingli to put the candidate in a Phase II trial for peripheral T cell lymphoma (PTCL), an uncommon and aggressive type of non-Hodgkin’s lymphoma.
About a year ago, Hengrui Medicine put down a $20 million equity investment in return for joint development and commercialization rights to Yingli’s PI3kδ inhibitor in China.
“This collaboration brings a potentially effective treatment option with a favorable safety profile to the US to address an unmet need for patients with this aggressive cancer. I look forward to leading this exciting study,” principal investigator and MD Anderson professor Swaminathan Iyer said in a news release.
The duo will also launch a Phase I trial for a second program, a TGFβR1 inhibitor dubbed YL-13027, in advanced solid tumors.
In addition to the existing programs, Yingli and MD Anderson will also progress Yingli’s discovery programs, with the goal of pushing forward a steady stream of new cancer candidates.
The partners are keeping the financial terms of the deal under wraps for now. — Nicole DeFeudis
Psoriatic arthritis drug shows positive PhIII results
Belgian biopharma UCB has announced that the Phase III BE COMPLETE study for its psoriatic arthritis drug has passed all of the primary and secondary endpoints, showing significant improvement over the placebo.
Bimzelx is intended to treat adults who did not respond to anti-TNF therapies. The drug achieved 50% or greater improvement in symptoms from the baseline, and measured a 90% improvement in skin clearance.
Psoriatic arthritis is a chronic inflammatory condition that affects a person’s joints and skin. The disease can cause red patches of skin that are topped with silver scales, and usually follows a psoriasis diagnosis. It affects between .05% and .25% of the world’s population, and between 6% and 41% of those suffering from psoriasis. Those diagnosed experience joint pain and stiffness, swollen toes and fingers and inflammation.
“We believe that these consistent and robust results have the potential to elevate the standard of care for patients,” said Emmanuel Caeymaex, the US head of UCB, in a statement. “Both psoriatic arthritis studies in the program used ACR50 as the primary outcome measure. The positive findings in both studies highlight the clinical potential of bimekizumab in psoriatic arthritis for both biologic naïve and anti-TNF therapy experienced patients.”
Bimzelx is currently being reviewed for approval by the FDA. – Josh Sullivan
Mirati unveils new PhII data for adagrasib in GI tumors
While Mirati builds a case for its KRAS inhibitor adagrasib in non-small cell lung cancer — where it would challenge Amgen’s Lumakras — the biotech is also unveiling some new Phase II data it says show promise in gastrointestinal tumors.
Of 27 evaluable GI cancer patients in a cohort of the KRYSTAL-1 study (which is testing adagrasib as a monotherapy and in combinations across multiple solid tumor types), 41% saw a response, Mirati announced on Friday.
The cohort enrolled 30 patients with GI cancers harboring a KRAS G12C mutation, who had received at least two lines of prior therapy. That included patients with pancreatic ductal adenocarcinoma and other GI tumors, including cancers of the biliary tract, appendix, small bowel, gastro-esophageal junction, and esophagus. They received adagrasib monotherapy, and had a median follow-up of about 6 months.
In 10 patients with pancreatic cancer, the response rate was 50%, with a median duration response of 7 months and a median follow-up of 8.1 months. Of the 17 patients with other GI tumors, 35% saw a response, and median duration of response was 7.9 months.
The median progression-free survival in patients with pancreatic cancer was 6.6 months, compared to 7.9 months for patients with other tumors.
“We continue to aggressively evaluate adagrasib as a single agent and in combination with other cancer medicines in a broad development plan to help more people living with cancer,” head of R&D Charles Baum said in a news release. — Nicole DeFeudis