Affini­vax CEO Steven Brug­ger hit the clin­ic a cou­ple years ago with an un­con­ven­tion­al take on a pneu­mo­coc­cal vac­cine de­signed to de­throne Pfiz­er’s Pre­vnar 13. And now that the can­di­date’s ready for Phase III, Brug­ger has reeled in a $226 mil­lion mega-round to see it through.

The Se­ries C comes sev­er­al months af­ter a $120 mil­lion raise, with Viking Glob­al In­vestors, Bain and Ziff Cap­i­tal Part­ners par­tic­i­pat­ing in both rounds. It’s quite the ac­com­plish­ment for a com­pa­ny that launched with $4 mil­lion in seed fund­ing from the Gates Foun­da­tion back in 2014.

Affini­vax is spread­ing the funds across its pipeline, which in­cludes its Astel­las-part­nered lead pro­gram for pneu­mo­coc­cal in­fec­tion. The can­di­date, which cov­ers 24 pneu­mo­coc­cal serotypes, is lin­ing up to ri­val Pfiz­er’s block­buster Pre­vnar 13, which bagged $6 bil­lion in rev­enue in 2019 — more than any oth­er ful­ly owned Pfiz­er prod­uct.

Affini­vax’s jab, dubbed ASP3772, re­cent­ly com­plet­ed a Phase II tri­al in adults 65 to 85 years old and is ready for a Phase III reg­is­tra­tional tri­al, al­though the com­pa­ny de­clined to com­ment on the time­line.

Brug­ger is af­ter what he calls a new class of vac­cines, us­ing the com­pa­ny’s MAPS tech­nol­o­gy, short for Mul­ti­ple Anti­gen Pre­sent­ing Sys­tem. It presents poly­sac­cha­ride and pro­tein anti­gens to the im­mune sys­tem to kick up both a B cell and T cell re­sponse. The plat­form fore­goes tra­di­tion­al con­ju­gate chem­istry al­to­geth­er in fa­vor of a bi­otin-rhiza­vidin bond, which Brug­ger com­pared to “the strongest Vel­cro you can imag­ine.”

“By not us­ing chem­i­cal con­ju­ga­tion, we be­lieve the im­muno­genic epi­topes on both the poly­sac­cha­rides and pro­teins are not com­pro­mised and re­tain their full im­muno­genic po­ten­tial,” Brug­ger said in an email. “The re­sult is quite dis­tinc­tive­ly dif­fer­ent than con­ju­gate vac­cines, where the poly­sac­cha­ride and the pro­teins are both rec­og­nized by the im­mune sys­tem.”

Affini­vax al­so has an on­go­ing Phase I tri­al in tod­dlers and plans to ini­ti­ate a Phase II proof-of-con­cept study in in­fants.

The Cam­bridge, MA-based biotech’s pre­clin­i­cal pipeline in­cludes can­di­dates for Staphy­lo­coc­cus au­reus, Kleb­siel­la pneu­mo­ni­ae and Pseudomonas aerug­i­nosa, Clostrid­i­um dif­fi­cile, and even Covid-19. Ac­cord­ing to Brug­ger, it’s now work­ing on a next-gen­er­a­tion pneu­mo vac­cine with broad­er cov­er­age than ASP3772.

“With the ad­di­tion­al cap­i­tal raised from the Se­ries C, we are in a po­si­tion to ad­vance these on our own to IND and clin­i­cal tri­als with­in the next few years,” Brug­ger said.

Last month, Pfiz­er got pri­or­i­ty re­view for its new pneu­mo­coc­cal vac­cine, 20vP­nC, which is de­signed to pro­tect against dif­fer­ent 20 strains of path­o­gen­ic pneu­mo­coc­cal bac­te­ria as op­posed to Pre­vnar’s 13. The FDA is set to de­liv­er a de­ci­sion by June 2021.

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.

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

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.

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.

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.