Steven Brugger, CEO (Affinivax)

Bain helps push Affini­vax to next stage with $120M round, as PhII da­ta loom on a lead ef­fort to do some­thing new in vac­cines

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 Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,700+ biopharma pros reading Endpoints daily — and it's free.

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,700+ biopharma pros reading Endpoints daily — and it's free.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,700+ biopharma pros reading Endpoints daily — and it's free.

Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.

Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,700+ biopharma pros reading Endpoints daily — and it's free.

Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.