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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.