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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

Covid-19 roundup: Rus­sia prices vac­cine 't­wo or more times cheap­er' than mR­NA shots; Sino­vac PhI­II da­ta ex­pect­ed in ear­ly De­cem­ber

The world can now purchase its first registered vaccine — at less than $10 per dose.

RDIF, the Russian sovereign wealth fund and an avid backer of Sputnik V, said the vaccine will be available internationally starting from March 2021. A two-dose regimen of the adenovirus-based vaccine, which it has said is more than 90% effective, will cost less than $20.

And they are not shy about inserting themselves right into a rivalry with Western frontrunners, namely Pfizer/BioNTech and Moderna.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Peter Thiel (Riccardo Savi/Sipa via AP Images)

Tech bil­lion­aire Pe­ter Thiel backs a lead­ing psy­che­del­ic drug de­vel­op­er

Right on the heels of investing in antibody drug developer AbCellera, Facebook billionaire Peter Thiel has jumped into a syndicate putting up $125 million for a company with a portfolio of psychedelic drugs in the clinic for mental health.

The C round — which includes a $32 million conversion of notes to equity — will fuel the development programs at ATAI Life Sciences, a Berlin-based biotech that has assembled a portfolio of companies with psychedelic and non-psychedilc approaches to depression, anxiety and addiction.

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