Steven Brugger, Affinivax CEO

Watch out, Pfiz­er: Affini­vax lands $226M in fund­ing to ad­vance Pre­vnar 13 ri­val as well as the rest of its pipeline

Affini­vax CEO Steven Brug­ger hit the clin­ic a cou­ple years ago with an un­con­ven­tion­al take on a pneu­mo­coc­cal vac­cine de­signed to de­throne Pfiz­er’s Pre­vnar 13. And now that the can­di­date’s ready for Phase III, Brug­ger has reeled in a $226 mil­lion mega-round to see it through.

The Se­ries C comes sev­er­al months af­ter a $120 mil­lion raise, with Viking Glob­al In­vestors, Bain and Ziff Cap­i­tal Part­ners par­tic­i­pat­ing in both rounds. It’s quite the ac­com­plish­ment for a com­pa­ny that launched with $4 mil­lion in seed fund­ing from the Gates Foun­da­tion back in 2014.

Affini­vax is spread­ing the funds across its pipeline, which in­cludes its Astel­las-part­nered lead pro­gram for pneu­mo­coc­cal in­fec­tion. The can­di­date, which cov­ers 24 pneu­mo­coc­cal serotypes, is lin­ing up to ri­val Pfiz­er’s block­buster Pre­vnar 13, which bagged $6 bil­lion in rev­enue in 2019 — more than any oth­er ful­ly owned Pfiz­er prod­uct.

Affini­vax’s jab, dubbed ASP3772, re­cent­ly com­plet­ed a Phase II tri­al in adults 65 to 85 years old and is ready for a Phase III reg­is­tra­tional tri­al, al­though the com­pa­ny de­clined to com­ment on the time­line.

Brug­ger is af­ter what he calls a new class of vac­cines, us­ing the com­pa­ny’s MAPS tech­nol­o­gy, short 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. The plat­form fore­goes tra­di­tion­al con­ju­gate chem­istry al­to­geth­er in fa­vor of a bi­otin-rhiza­vidin bond, which Brug­ger com­pared to “the strongest Vel­cro you can imag­ine.”

“By not us­ing chem­i­cal con­ju­ga­tion, we be­lieve the im­muno­genic epi­topes on both the poly­sac­cha­rides and pro­teins are not com­pro­mised and re­tain their full im­muno­genic po­ten­tial,” Brug­ger said in an email. “The re­sult is quite dis­tinc­tive­ly dif­fer­ent than con­ju­gate vac­cines, where the poly­sac­cha­ride and the pro­teins are both rec­og­nized by the im­mune sys­tem.”

Affini­vax al­so has an on­go­ing Phase I tri­al in tod­dlers and plans to ini­ti­ate a Phase II proof-of-con­cept study in in­fants.

The Cam­bridge, MA-based biotech’s pre­clin­i­cal pipeline in­cludes can­di­dates for Staphy­lo­coc­cus au­reus, Kleb­siel­la pneu­mo­ni­ae and Pseudomonas aerug­i­nosa, Clostrid­i­um dif­fi­cile, and even Covid-19. Ac­cord­ing to Brug­ger, it’s now work­ing on a next-gen­er­a­tion pneu­mo vac­cine with broad­er cov­er­age than ASP3772.

“With the ad­di­tion­al cap­i­tal raised from the Se­ries C, we are in a po­si­tion to ad­vance these on our own to IND and clin­i­cal tri­als with­in the next few years,” Brug­ger said.

Last month, Pfiz­er got pri­or­i­ty re­view for its new pneu­mo­coc­cal vac­cine, 20vP­nC, which is de­signed to pro­tect against dif­fer­ent 20 strains of path­o­gen­ic pneu­mo­coc­cal bac­te­ria as op­posed to Pre­vnar’s 13. The FDA is set to de­liv­er a de­ci­sion by June 2021.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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