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.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.