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.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Take­da earns win for its TKI in­hibitor in tiny lung can­cer group — but GI side ef­fects could be an ear­ly red flag

Japanese drugmaker Takeda has made a big push in recent years to build a hand in oncology, particularly in the next-gen cancer space. One of those candidates, tyrosine kinase inhibitor (TKI) mobocertinib, recently earned the FDA’s interest in a small section of untreated lung cancer patients, but will severe GI side effects be a roadblock?

Takeda’s oral mobocertinib posted clinically significant objective response rates in a Phase I/II adaptive trial drugging metastatic non-small cell lung cancer patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, according to data presented Thursday at the virtual World Conference on Lung Cancer.

Vas Narasimhan (AP Images)

BeiGene's PD-1 scores PhI­II win in esophageal can­cer — a 'key in­di­ca­tion' tapped by No­var­tis in $650M deal

Days after bringing BeiGene’s PD-1 into its portfolio, Novartis is adding a feather to its tislelizumab cap.

BeiGene reported that in the second-line setting, the checkpoint inhibitor extended overall survival for patients with esophageal squamous cell carcinoma, a key indication identified by Novartis. It was the primary endpoint in this Phase III trial.

“This is our fourth positive Phase 3 readout for tislelizumab and the first from our large Phase 3 program in gastrointestinal cancers that also include liver, stomach cancers as well as esophageal cancer,” BeiGene’s CMO in immuno-oncology, Yong Ben, said in a statement.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.

Covid-19 roundup: Con­tro­ver­sy around colchicine per­co­lates af­ter study fail­ure; As­traZeneca's meet­ing with EU was 'con­struc­tive,' but did­n't solve much

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

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