Q32 Bio grabs $60M to kick off hu­man stud­ies for next-gen com­ple­ment drugs — with some Covid-19 tweaks along the way

For a com­pa­ny that launched in the ear­ly months of the pan­dem­ic, Q32 Bio had its fair share of run-ins with the new nor­mals un­der Covid-19.

Mike Brox­son

The orig­i­nal plan, for in­stance, was to con­duct first-in-hu­man stud­ies of the IL-7 re­cep­tor an­ti­body it li­censed from Bris­tol My­ers Squibb in the Nether­lands. But they re­al­ized short­ly af­ter that while the coun­try was be­gin­ning to open up clin­i­cal tri­als, there were ad­di­tion­al re­stric­tions on drugs that tam­pered with im­muno­log­i­cal mech­a­nisms.

“We didn’t have any sense for the tim­ing of be­ing able to get in­to the clin­ic,” CEO Mike Brox­son told End­points News. “The team de­cid­ed in June with board sup­port to piv­ot and do our Phase I work in Aus­tralia.”

So the group led by CSO She­lia Vi­o­lette re­vised its fil­ing, fig­ured out man­u­fac­tur­ing and quick­ly got a green light to move their study to the South­ern Hemi­sphere. And on Tues­day, the first health vol­un­teer was dosed with ADX-914 — set­ting them up nice­ly to take the wraps off $60 mil­lion in fresh Se­ries B cash.

Next year will be piv­otal for the biotech, said Brox­son, a Take­da vet for whom quar­ters come as a nat­ur­al way of mea­sur­ing time. Not on­ly are in­ter­im read­outs for -914 slat­ed for Q4, but the first fu­sion pro­tein gen­er­at­ed on Q32’s plat­form is ex­pect­ed to en­ter Phase I around the same time.

She­lia Vi­o­lette

By grab­bing tis­sue-spe­cif­ic tar­gets on one end and fer­ry­ing a com­ple­ment reg­u­la­tor on the oth­er, the tech­nol­o­gy promis­es to gen­er­ate next-gen com­ple­ment drugs that can be de­liv­ered to or­gans where com­ple­ment frag­ments have been de­posit­ed — and get out of cir­cu­la­tion once that’s done.

“Our goal is to pre­serve sys­temic com­ple­ment sur­veil­lance, not in­hibit­ing in a longterm way,” Brox­son said.

While the mech­a­nism is dis­tinct from IL-7R, Brox­son added that the com­ple­ment pro­gram, ADX-097, ac­tu­al­ly shares cer­tain ap­pli­ca­tions with the lead drug such as lu­pus and arthri­tis.

With -914, though, Q32 is ini­tial­ly aim­ing to start with Sjö­gren’s dis­ease, pro­vid­ed the da­ta pan out. France’s Servi­er is part­ner­ing with OSE on a clin­i­cal drug that sim­i­lar­ly tar­gets IL-7R, so they will al­so be watch­ing the field close­ly.

As for the com­ple­ment drug pipeline — there is a slew of pre­clin­i­cal pro­grams lined up af­ter -097 — the fo­cus will be on the kid­ney and the skin.

The new fi­nanc­ing should last them two and a half years while they sort it all out, Brox­son said, and grow out the team to 30 staffers. Most of Q32 Bio’s team is still work­ing re­mote­ly while lab-based staffers set­tle in­to ro­ta­tion sched­ules.

Com­pared to op­er­a­tions, though, the fundrais­ing process struck him as fun­da­men­tal­ly dif­fer­ent.

The two years he spent as the chief of Goldfinch Bio was filled with trips to New York, San Fran­cis­co and Boston, he re­called. With­out trav­el and the need to get dressed up, his talks with in­vestors this time around were less for­mal and more ef­fi­cient.

“I think it will be a hy­brid — some as­pects of it will be re­mote, per­haps first calls, sec­ond calls,” Brox­son said when asked for pre­dic­tions about the fu­ture.

Or­bimed Ad­vi­sors and Acorn Bioven­tures led the Se­ries B. At­las Ven­ture, an ear­ly backer of Q32 Bio, re­turned along­side Os­age Uni­ver­si­ty Part­ners, At­las Ven­ture, Abing­worth, Sanofi Ven­tures, Uni­ver­si­ty of Col­orado and Chil­dren’s Hos­pi­tal Col­orado Cen­ter for In­no­va­tion.

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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