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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.