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.

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the “New Biohaven” post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.