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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.