Frederick Beddingfield, Kira CEO

Ki­ra and its com­ple­ment-tar­get in­hibitors plot run to the clin­ic with new in­vestor cash just months af­ter un­cloak­ing

A cou­ple months af­ter emerg­ing from stealth, Ki­ra Phar­ma­ceu­ti­cals has reeled in its largest ven­ture round yet to fund a dash to the clin­ic.

The start­up, co-found­ed back in 2017 by Uni­ver­si­ty of Penn­syl­va­nia pro­fes­sor Wen­chao Song, hooked $53.5 mil­lion in what it calls a “Se­ries B+” fi­nanc­ing. It burst on­to the scene in No­vem­ber, with $18 mil­lion in Se­ries A win­nings and $28 mil­lion from a Se­ries B raised in stealth. With for­mer Si­en­na Bio­phar­ma­ceu­ti­cals CEO Fred­er­ick Bed­ding­field at the helm, the team is on a mis­sion to put three com­ple­ment-tar­get­ed ther­a­pies in the clin­ic over the next 18 months.

“While the com­ple­ment sys­tem has his­tor­i­cal­ly been dif­fi­cult to tar­get giv­en its com­plex­i­ty, we be­lieve our LOG­IC drug dis­cov­ery plat­form en­ables us to ap­proach com­ple­ment me­di­a­tion in new and dif­fer­ent ways, un­lock­ing trans­for­ma­tive ther­a­pies for pa­tients,” Bed­ding­field said in a state­ment.

The com­ple­ment cas­cade, a part of the in­nate im­mune sys­tem, is “great when it’s work­ing well,” the CEO told End­points News in No­vem­ber. 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, he added.

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 the team is look­ing to im­prove on the stan­dard of care in some dis­eases, Bed­ding­field told End­points in No­vem­ber that they’re more in­ter­est­ed in treat­ing dis­eases for which there are no com­ple­ment drugs cur­rent­ly ap­proved.

“Our big­ger goal is to treat dis­eases where there’s re­al­ly a com­plete­ly un­met need,” he said.

The com­pa­ny is keep­ing mum about its oth­er pro­grams, which are “in de­vel­op­ment to treat a range of im­mune-in­flam­ma­to­ry dis­eases and can­cers in the US, Asia and oth­er glob­al mar­kets,” ac­cord­ing to its web­site. In ad­di­tion to its Cam­bridge, MA head­quar­ters, Ki­ra boasts a Suzhou, Chi­na R&D cen­ter.

Pri­or to join­ing Ki­ra, Bed­ding­field left his perch at Si­en­na in De­cem­ber 2019 — a few months af­ter the biotech filed for bank­rupt­cy. Si­en­na’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 CEO was plan­ning to take some time off when he got a call from Song — and the rest is his­to­ry.

Once it lands in the clin­ic, Ki­ra may have some catch­ing up to do. Alex­ion snagged its sec­ond ap­proval for the com­ple­ment ther­a­py Ul­tomiris last year, which is now OK’d to treat atyp­i­cal he­molyt­ic ure­mic syn­drome and parox­ys­mal noc­tur­nal he­mo­glo­bin­uria.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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