Nov 13, 2020

Nicole DeFeudis Associate Editor 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 the 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. AUTHOR Jason Mast Associate Editor At 11 am after the election, Sherlock Biosciences CEO Rahul Dhanda snuck into his office and, in the couple minutes between meetings, fired off an email to his 45 employees. Dhanda had walked in calmly at 7 am, but over the next four hours, he watched his employees slumped at their desks. The entire office had sunk under a general malaise. He asked a team member why they were so distraught. They looked up and asked: “Why are you so calm?” Keep reading Endpoints with a free subscription Unlock this story instantly and join 93,900+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE Less than four months after a $55 million raise, Seer is ready to go public. The company, run by Omid Farokhzad, filed for a $150 million IPO on Thursday as it prepares to jump onto the Nasdaq. Seer’s stock ticker will be fairly simple to remember — $SEER — and the move comes after the company has raised more than $150 million since being founded in 2017. Thursday’s news also comes less than a month after Seer’s main product, the Proteograph Product Suite, was delivered to one of its first collaborators, per the company’s S-1 . Funds from the IPO will go toward further commercializing the product and other R&D-related projects for Proteograph. Read More November 13, 2020 10:33 AM EST John Carroll Editor & Founder There will be no near-term OK for BioMarin’s hemophilia A gene therapy valrox in Europe. Already sent back by the FDA to gather more data on durability after researchers flagged a waning response over several years, the EMA had also pinned a request for extended results — though they were willing to take less than the US agency. On Friday, though, the EMA unveiled a November 4 letter from BioMarin $BMRN saying they were pulling their application — for now — because they wouldn’t have the added data within the time allowed for it. Keep reading Endpoints with a free subscription Unlock this story instantly and join 93,900+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE John Carroll Editor & Founder Once the euphoria began to wane a bit following Pfizer’s dramatic unveiling of a 90%-plus effectiveness rate from its pivotal Covid-19 vaccine study earlier this week, less affluent countries and regions around the world began to wonder if they would ever be able to get in line for it. The vaccine has to be shipped in -70 degrees celsius temps and then used within 5 days of being thawed. For distributors in China, that means building a unique distribution system to deliver the first dose and then a booster. And there are plenty of countries that say they can’t afford to go that route — adding a big obstacle in front of a huge logistical challenge. Keep reading Endpoints with a free subscription Unlock this story instantly and join 93,900+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE Assistant Editor → Co-founded by Nessan Bermingham and banking $91.5 million in Series A funding in September, RNA editing startup Korro Bio has tapped Ram Aiyar as their first CEO. Aiyar, who began as a research scientist in the immunology group at Janssen in the late 2000s, co-founded Corvidia Therapeutics in 2016 and was also their CFO and CBO along the way. Back in June, Aiyar helped steer the sale of Corvidia to Novo Nordisk for $2.1 billion, including $725 million upfront. With the deal , Novo Nordisk inserted Corvidia’s IL-6 inhibitor ziltivekimab into their pipeline. Keep reading Endpoints with a free subscription Unlock this story instantly and join 93,900+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE