CEO Frederick Beddingfield (Kira)

Ki­ra Phar­ma­ceu­ti­cals emerges from stealth with $46M and new CEO to lead com­ple­ment ther­a­py mis­sion

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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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