Immunocore's bispecific lands speedy review with FDA, EMA; Low-profile gene therapy player grabs $30M
UK TCR-focused biotech Immunocore announced that it scored a priority review with the FDA for lead drug tebentafusp.
The bispecific already boasts a breakthrough therapy designation thanks to positive Phase III data. The priority review shaves four months off the regular 10-month process, leading to an expected PDUFA date of Feb. 23.
Across the Atlantic, the EMA agreed to accelerate its assessment of Immunocore’s marketing authorization application, which it has already accepted. That accelerated timeline reduces the assessment process from up to 210 days to 150 days, excluding clock stops.
Bahija Jallal, CEO of Immunocore, said in a release: “There is an urgent need for an approved treatment for metastatic uveal melanoma, an aggressive form of cancer for which there are very limited treatment options.” — Paul Schloesser
Xalud Therapeutics nabs $30M to push non-viral gene therapy in inflammation
Xalud Therapeutics announced that it finished a round of Series C financing with $30 million raised. According to CEO Diem Nguyen, “We are well positioned to continue advancing XT-150, our lead therapeutic candidate, through clinical development and further expand our platform.”
Nguyen, who took on the role of CEO in January, has led a company that has operated under a very low profile. Very little information about the company before Nguyen took the helm is publicly available.
The NYC-based biotech has spent a significant amount of its resources on XT-150, a locally injectable, non-viral gene therapy that targets chronic inflammation. That therapy is currently in a Phase IIb trial for osteoarthritis of the knee and a Phase I/IIa clinical study for peripheral neuropathic pain. — Paul Schloesser
FDA expands label for J&J’s Xarelto
J&J subsidiary Janssen Pharmaceuticals has the FDA’s blessing for an expanded peripheral artery disease (PAD) indication for Xarelto plus aspirin to include patients who have received recent lower-extremity revascularization (LER) due to symptomatic PAD. FDA’s approval is based on data from a Phase III study known as VOYAGER PAD.
That study showed that when Xarelto and aspirin are combined, patients with symptomatic PAD and LER had a 15% decreased risk in major adverse limb and cardiovascular events.
With this approval, Xarelto, a blood thinner, brings its number of indications to nine.
“We’re thrilled to bring Xarelto to even more patients with PAD who have been living for two decades without any new innovation in the antithrombotic space,” said James List, global therapeutic area head, cardiovascular and metabolism of Janssen R&D. — Paul Schloesser
Lux Capital leads $50M infusion into rare disease research platform
AllStripes has some new money to play around with.
The San Francisco-based company announced a new $50 million Series B round Tuesday morning, led by Lux Capital. AllStripes said the cash will support launching 100 new rare disease research programs while expanding its global operational footprint.
“Beginning research on a rare condition can feel like being dropped into a new world without a map and we are on a mission to change that with data,” CEO Nancy Yu said in a statement. “This investment will allow us to better support the rare disease community, where each person’s experience is essential to understanding disease progression.”
In addition to the research expansion, AllStripes also plans to build out its technology and data automation to improve research insights, which will further develop its platform capabilities. That will help the biotech continue to invest in growing the company’s team to support creating the playbook for rare disease research, the biotech said.
AllStripes is a public benefit corporation that advocates for more real-world evidence while treatments are being developed. It aims to build tools that make research more inclusive for the global rare disease community. Currently, the company is partnered with 30 patient advocacy groups. — Max Gelman
Catching up with giants, China’s Reistone touts PhII alopecia areata for JAK1 inhibitor
In a Phase II study, Reistone Biopharma reports, its oral JAK1 blocker SHR0302 met the primary endpoint of spurring statistically significant and clinically relevant percentage change of SALT score — a measure of hair loss — versus placebo.
Recruited across Australia, China and the US, 94 patients entered the trial with 25% or greater scalp hair loss and were randomized to one of four groups: 8mg drug, 4mg, 2 mg or placebo. The high and mid doses met the primary endpoint as well as the secondary endpoint of absolute change in SALT score at week 24.
Reistone first licensed SHR0302 from Jiangsu Hengrui.
CEO Min Irwin calls the results “encouraging” and says Phase III planning is underway.
Clearly cognizant of the safety concerns that have plagued the class, the biotech highlighted that “safety of SHR0302 was consistent with established profiles from previous studies of other JAK class of medication and was well tolerated with no major adverse cardiovascular events (MACE), deaths, or venous thromboembolic events (VTEs) reported from the study.”
But it’s far from the only one making those claims, as a slate of players clamor for a stake in this autoimmune disease. Lilly, in particular, is lining up its NDA any day now following a breakthrough therapy designation. — Amber Tong