News brief­ing: Ex­elix­is rolls the dice with 2 ADC deals tied to $35M cash up­fronts; A rare an­tibi­ot­ic win for promi­nent­ly-backed Spero

Pe­ter Lamb

Catal­ent’s Red­wood Bio­science sub­sidiary is tak­ing the lead role in de­vel­op­ing AD­Cs for Ex­elix­is $EX­EL. In one of 2 deals an­nounced this morn­ing, Ex­elix­is is turn­ing to Catal­ent to do the dis­cov­ery work on the AD­Cs, which will em­ploy their SMARTag site-spe­cif­ic bio­con­ju­ga­tion plat­form tech­nol­o­gy us­ing an­ti­bod­ies out of the biotech’s pipeline.

Catal­ent gets $10 mil­lion up­front to trig­ger the deal, with Ex­elix­is hold­ing world­wide de­vel­op­ment rights on any­thing it choos­es.

In a sep­a­rate ADC de­vel­op­ment deal, Ex­elix­is is turn­ing to NBE-Ther­a­peu­tics for an­oth­er pact that could steer more prod­uct can­di­dates its way. In this deal Ex­elix­is is pay­ing $25 mil­lion up­front to get a 2-year al­liance un­der­way.

“Ex­elix­is is pur­su­ing both in­ter­nal drug dis­cov­ery and ex­ter­nal busi­ness de­vel­op­ment ap­proach­es to build a pipeline with the po­ten­tial to make a dif­fer­ence for pa­tients with can­cer,” said Pe­ter Lamb, the CSO at Ex­elix­is. – John Car­roll

Spero her­alds Phase III an­tibi­ot­ic suc­cess

Back in the days when in­vestors thought there was still good busi­ness to be made in an­tibi­otics, Spero raised a fair bit of cap­i­tal: a $30 mil­lion Se­ries A and B led by At­las Ven­tures, a $51.7 mil­lion Se­ries C led by GV, and a $77 mil­lion IPO. In 2018, they re­ceived an up to $54 mil­lion con­tract with BAR­DA too.

The mar­ket for an­tibi­otics has since soured, but that cash has al­lowed Spero to get through Phase III with its lead drug. And on Tues­day they an­nounced pos­i­tive re­sults, show­ing in a 1,372-per­son study that their oral an­tibi­ot­ic tebipen­em was non-in­fe­ri­or to the ap­proved IV an­tibi­ot­ic er­tapen­em in treat­ing pa­tients with com­pli­cat­ed uri­nary tract in­fec­tions and acute pyelonephri­tis.

Ankit Ma­hade­via

The drug, said tri­al in­ves­ti­ga­tor Kei­th Kaye, will give cU­TI pa­tients a new oral op­tion af­ter evolv­ing mi­cro­bi­ot­ic re­sis­tance had left them with on­ly the IV drug.

“Due to the in­creas­ing preva­lence of an­tibi­ot­ic-re­sis­tant bac­te­ria, many pa­tients with cU­TI now re­ceive in­tra­venous an­tibi­otics as their on­ly avail­able treat­ment op­tion,” Kaye, who is al­so di­rec­tor of re­search in the di­vi­sion of in­fec­tious dis­eases at the Uni­ver­si­ty of Michi­gan Med­ical School, said in a state­ment. “The much-an­tic­i­pat­ed da­ta from this head-to-head com­par­i­son against an IV stan­dard-of-care car­bapen­em an­tibi­ot­ic sug­gest that in many in­stances oral, out­pa­tient treat­ment of these com­pli­cat­ed bac­te­r­i­al in­fec­tions is a vi­able op­tion.”

Spero CEO Ankit Ma­hade­via said it would be the first oral cU­TI drug ap­proved in 26 years. The com­pa­ny said it plans to start a rolling NDA and com­plete it by the sec­ond quar­ter of 2021.

An ap­proval would be a ma­jor boon to any biotech, but when it comes to an­tibi­otics, reg­u­la­to­ry suc­cess doesn’t nec­es­sar­i­ly trans­late in­to com­mer­cial suc­cess. Melin­ta and Achaoe­gen are well proof of that.  — Ja­son Mast

A UK biotech bro­kers an in­ter­con­ti­nen­tal AI deal

A UK-based biotech is buy­ing out­right a soft­ware de­vel­op­er in Brook­lyn, NY, in or­der to bring ar­ti­fi­cial in­tel­li­gence to its di­ag­nos­tics tools.

APIS As­say Tech­nolo­gies an­nounced the ac­qui­si­tion of Beoge­nomics on Fri­day, hop­ing to use da­ta-min­ing process­es to iden­ti­fy bio­mark­er tar­gets in on­col­o­gy, as well as in­flam­ma­to­ry, au­toim­mune and in­fec­tious dis­eases. The tech­nol­o­gy from Beoge­nomics, which has been de­vel­op­ing both on-prem and se­cure cloud-based da­ta analy­sis so­lu­tions, will help sup­port the launch of a new pro­pri­etary ser­vice line. APIS main­ly works in R&D and di­ag­nos­tics, de­vel­op­ing new tests for the pre­dic­tion, pre­ven­tion, and di­ag­no­sis of dis­ease from dis­cov­ery to reg­u­la­to­ry ap­proval.

The com­pa­ny’s busi­ness mod­el fo­cus­es on three as­pects: bio­mark­er di­ag­nos­tics de­vel­op­ment, mol­e­c­u­lar di­ag­nos­tic con­tract de­vel­op­ment, and ap­plied bioin­for­mat­ics. — Max Gel­man

NIH hands out $9.4. M con­tract for re­search on dif­fer­ent virus

In­travacc, a Dutch vac­cines com­pa­ny, land­ed an up to $9.4 mil­lion con­tract from NI­AID to de­vel­op a vac­cine for en­terovirus D68, a res­pi­ra­to­ry virus that can cause paral­y­sis and has be­come in­creas­ing­ly com­mon in Amer­i­ca, Eu­rope and Asia over the last few years.

The small biotech, which al­so has pro­grams for RSV, gon­or­rhea and of course Covid-19, will de­vel­op an in­ac­ti­vat­ed virus vac­cine in Vero cells. The con­tract is for ear­ly prod­uct se­lec­tion through Phase I. — Ja­son Mast

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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News brief­ing: Eli Lil­ly com­pletes $1B+ Pre­vail buy­out; El­zon­ris ap­proved in Eu­rope for adults

Eli Lilly’s $1.04 billion takeover of Prevail Therapeutics is officially complete, the company announced Friday.

The sides had entered into the buyout agreement last month with Lilly focusing on Prevail’s pipeline of gene therapies, highlighting two AAV9 programs in Parkinson’s disease and frontotemporal dementia as potential winners. Lilly paid $22.50 per share, which amounted to an 82% premium over the previous day’s closing price and a 117% premium over Prevail’s 60-day average.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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