Affini­vax CEO Steven Brug­ger has al­ways looked for un­con­ven­tion­al ways to go about the busi­ness of vac­cine R&D. The Gates Foun­da­tion put up a lot of the ini­tial seed cash in 2014 and an ear­ly al­liance with Astel­las paid the bills — which now cov­ers a staff of about 70 in Cam­bridge, MA.

When the pan­dem­ic hit, Brug­ger’s team kept the lab go­ing by re­duc­ing and dis­tanc­ing the num­bers in­side while mov­ing to a 7-day sched­ule.

“We’re try­ing to keep the com­pa­ny to­geth­er so­cial­ly” as well, adds the CEO, which calls for a vir­tu­al town hall every Fri­day at 4 pm.

About the most con­ven­tion­al thing they’ve done is to­day’s $120 mil­lion mega-round, de­signed to take them through a make-or-break stage of de­vel­op­ment over the next sev­er­al years. But even here they turned to a small, off­beat syn­di­cate of deep-pock­et play­ers in­ter­est­ed in the longterm suc­cess of the com­pa­ny.

Viking Glob­al In­vestors joined up with Bain and Ziff Cap­i­tal Part­ners, adding Bain’s An­drew Hack (ex-Ed­i­tas) and Steven Altschuler from Ziff to the board.

As the syn­di­cate in­di­cates, the plan is to keep an IPO on the ta­ble, con­sid­er­ing when it might make sense. The mon­ey, though, is enough to stay flex­i­ble — for awhile. No one likes to try and go pub­lic when funds are low and pub­lic in­vestors are tapped to keep the lights on in the lab.

That Astel­las al­liance in­volves a big pro­gram for pneu­mo­coc­cal in­fec­tion. Affini­vax set out to beat Pfiz­er’s Pre­vnar 13 block­buster with a ri­val that ups the num­ber of cov­ered pneu­mo­coc­cal serotypes to 24 — which they say should al­so out­strip any­one in the clin­ic with an­oth­er pro­gram in the field.

The Phase II da­ta on that are ev­i­dent­ly around the cor­ner, in biotech terms. The Phase I set the stage on im­muno­genic­i­ty and safe­ty. In the lab now is a new ap­proach to us­ing a vac­cine to re­duce the risk of hos­pi­tal-ac­quired in­fec­tions, a pre­emp­tive ap­proach to jump ahead of an­tibi­otics, where R&D has cratered even as the need for new prod­ucts to ad­dress drug-re­sis­tant bac­te­ria grows high­er.

Brug­ger is mighty proud of Affini­vax’s plat­form tech, dubbed MAPS, 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. And they say they can prove it can be cal­i­brat­ed to fight the tar­get.

They now have plen­ty of mon­ey to prove it. And along the way there’s al­so an ear­ly-stage pro­gram to see how that could work against Covid-19. The main R&D strat­e­gy, though, will re­main the same. For small play­ers like Affini­vax, dis­ci­pline is a must.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.