Frederick Beddingfield left Sienna Biopharmaceuticals last December, a few months after the struggling biotech filed for bankruptcy. The former CEO was planning to take some time off, until he received a call from University of Pennsylvania professor Wenchao Song.
Song was looking for someone to helm Kira Pharmaceuticals, a startup he co-founded to develop a “new generation” of complement-targeted therapies for immune-mediated diseases. The two got talking, one thing led to another, and “it just turned out to be a great fit,” Beddingfield said.
On Thursday, Kira emerged from stealth mode with Beddingfield as CEO, $46 million from the venture well, and a lead candidate expected to hit the clinic in the next three months.
“It’s the tip of the iceberg for complement diseases,” Beddingfield said.
While the company is interested in improving on the standard of care for some diseases, “our bigger goal is to treat diseases where there’s really … a completely unmet need, and there are no complement drugs approved,” he said.
The complement cascade, a part of the innate immune system, is “great when it’s working well,” Beddingfield said. But dysregulation can lead to autoimmune disorders. Depending on that dysregulation, blocking certain parts of the pathways that activate the complement system can be “quite effective” in controlling disease, the CEO said.
“Sometimes patients have a genetic predisposition, some mutation in … part of this complement cascade that makes them have this abnormal response. Other times, we don’t know exactly why it’s exaggerated, but it is. And interestingly, if you look at Covid patients, many of them have (an) exaggerated complement cascade response,” he said.
Kira’s lead candidate, P014, is designed to inhibit both upstream and downstream complement targets. It’s engineered with an extended half-life and potency, and has the potential to be self-administered at home. While Kira has yet to announce which indications it’s going after, Beddingfield said the candidate should enter the clinic within the next three months. The pipeline also includes two other candidates in IND-enabling stages.
Cambridge, MA-based Kira was founded in 2017. While in stealth, it bagged an $18 million Series A and $28 million Series B from a slate of investors including Quan Capital, 6 Dimensions Capital, Qiming Venture Partners, and Sinopharm Capital. While its headquarters is in the US, the company also boasts a Suzhou, China office.
“I think we’re the only complement company that from the get-go has a cross-border strategy to bring therapies … globally to the US to China,” Beddingfield said. This will allow the company to easily conduct clinical trials in both countries.
Even so, the biotech may have some catching up to do. Alexion, which made waves with the introduction of its first anti-C5 antibody, snagged its second approval for the complement therapy Ultomiris last year. The drug, which blocks the C5 pathway, has the FDA’s OK to treat atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria. It raked in $338.9 million in net sales last year.
Last August, Alexion was hit with a surprise inter partes review. The US Patent Trials Appeal Board action was stoked by Amgen, which pushed to overturn patents on the complement inhibitor Soliris to create a biosimilar.
While Beddingfield once served as CMO of both Kythera and Allergan, his latest gig was at Sienna, which filed for a Chapter 11 last September. The biotech’s stock never quite recovered from the failure of its experimental acne drug SNA-001, which flopped in two separate trials testing its efficacy when managed by laser tech. The company cut 20 jobs in a restructuring to refocus on psoriasis and associated pruritus, and 7 more in connection with the bankruptcy filing.