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1. A couple billion for Exscientia was only part of Sanofi's AI ambitions, as the Big Pharma adds Atomwise to the table
2. Updated: Hit by another PhIII flop, Sanofi culls breast cancer drug — sounding alarm for the class
3. Former Google CEO’s VC is making a bigger push into the biotech world, hiring prominent Theranos skeptic
4. Blueprint met all its endpoints in bid for expanded Ayvakit label — but stock trends lower anyway
5. Novartis-partnered biotech nabs new cash, boosting efforts to develop 'functional cure' for chronic hepatitis B
6. Updated: EU's lending arm grants Polish biotech $22M+ in debt financing to advance pipeline
7. AbbVie calls off PhI trial for I-Mab’s CD47 days after Zai Lab shelves its own program
8. Squeezed by AstraZeneca/Daiichi Sankyo, biotech developing HER2 ADC switches CEO, launches pipeline review
9. AstraZeneca files lawsuit against former exec as he jumps to GSK
10. What’s in monkeypox names? History, traditional convention and even sitcom suggestions
more stories
 
Max Gelman
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Nominations for our fourth annual Women in Biopharma feature will remain open until August 29. Know any deserving candidates? Fill out this form here.

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Max Gelman
Senior Editor, Endpoints News
@MaxGelman
Atomwise CEO and co-founder Abraham Heifets (left) and co-founder Izhar Wallach
1
by Kyle LaHucik

Sanofi made clear its AI am­bi­tions were re­al at the be­gin­ning of this year when the Big Phar­ma took its drug dis­cov­ery col­lab­o­ra­tion with Ex­sci­en­tia to the next lev­el, ink­ing a pact that could birth 15 drugs and de­liv­er $5.3 bil­lion to the UK part­ner.

Sev­en months lat­er, the AI blue­print is far from over at the French Big Phar­ma, as an­oth­er of the much-hyped drug dis­cov­ery star­tups is com­ing to the ta­ble in a five-drug deal. Sanofi will pay Atom­wise $20 mil­lion to kick off the hunt for up to five tar­gets, which are aimed at lead­ing to the cre­ation of new small mol­e­cules. An­oth­er $1 bil­lion is on the line — as are roy­al­ties — and the com­pa­nies kept mum on the spe­cif­ic dis­eases or broad­er ther­a­peu­tic ar­eas of in­ter­est.

The deal with Ex­sci­en­tia, an­nounced in Jan­u­ary, cen­ters on small mol­e­cules in im­munol­o­gy and on­col­o­gy.

“Not all AI is cre­at­ed equal and dif­fer­ent peo­ple are fo­cused on dif­fer­ent pieces,” Atom­wise CEO and co-founder Abra­ham Heifets told End­points News.

He char­ac­ter­ized Atom­wise’s plat­form as a “sin­gle glob­al mod­el” that can ap­ply to what­ev­er pro­tein the com­pa­ny is work­ing on, as com­pared to “lo­cal mod­els” that oth­er com­pa­nies have de­ployed, mean­ing they need a new mod­el for each area, with EGFR of­fered as an ex­am­ple.

“Our fo­cus has re­al­ly al­ways been about ex­trap­o­la­tion to nov­el bi­ol­o­gy to nov­el chem­istry to nov­el scaf­folds, so we can work on pro­teins where we have no train­ing da­ta , we have no known lig­ands for that pro­tein, so ex­trap­o­la­tions of nov­el bi­o­log­i­cal space," Heifets said.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)
2
by Amber Tong, John Carroll

Sanofi is of­fi­cial­ly giv­ing up on its oral SERD.

The French drug­mak­er put out word Wednes­day morn­ing that it will dis­con­tin­ue the glob­al de­vel­op­ment pro­gram of am­cen­es­trant, the se­lec­tive es­tro­gen re­cep­tor de­grad­er once billed as a top late-stage prospect. Hav­ing al­ready failed a Phase II monother­a­py test ear­li­er this year, a com­bo with the drug al­so missed the bar in a sec­ond tri­al for breast can­cer, trig­ger­ing the de­ci­sion to drop the whole pro­gram.

Shares on Nas­daq SNY fell 6% to about $42 in pre­mar­ket trad­ing — a sig­nif­i­cant drop for a Big Phar­ma — as ob­servers pon­der what's left in the pipeline. Sanofi has al­so been see­ing tur­bu­lence of its stock af­ter an­a­lysts drew at­ten­tion to per­son­al in­jury lit­i­ga­tion re­lat­ed to Zan­tac.

“I’d have to say over­all the class has rather un­der­whelmed in terms of adding some­thing be­yond what the stan­dard of care to­day pro­vides,” Sanofi R&D chief John Reed tells End­points Wednes­day. “And I think every­one’s da­ta has been most­ly in that di­rec­tion, with pos­si­bly the ex­cep­tion of the mu­tant es­tro­gen re­cep­tors where one sees sig­nals of en­cour­age­ment. That’s ob­vi­ous­ly more of a niche op­por­tu­ni­ty, some­thing one sees in late lines of ther­a­py, and might be an op­por­tu­ni­ty for the class.

“We had high hopes for am­cen­es­trant based on the ear­ly da­ta and in­vest­ed broad­ly, but now with two ran­dom­ized tri­als un­der our belt at least our mol­e­cule is not hav­ing the ro­bust ben­e­fit we had hoped for pa­tients, we de­cid­ed to pull the plug.”

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Joel Dudley, new partner at Innovation Endeavors (Tempus Labs)
3
by Tyler Patchen

Ven­ture cap­i­tal firm In­no­va­tion En­deav­ors has main­ly had its fo­cus on in­vest­ments across the tech space, but it has been slow­ly turn­ing its at­ten­tion to the biotech world. Now, a new part­ner is com­ing in­to the fold show­ing that its in­ter­est in biotech is like­ly to grow fur­ther.

The Sil­i­con Val­ley-based com­pa­ny, which is head­ed up by for­mer Google CEO Er­ic Schmidt, has brought on Joel Dud­ley as a part­ner. Ac­cord­ing to Dud­ley’s LinkedIn page, he is join­ing In­no­va­tion En­deav­ors af­ter serv­ing as the chief sci­ence of­fi­cer of biotech start­up Tem­pus Labs from 2020.

In an in­ter­view with End­points News, Dud­ley said he has al­so been work­ing with In­no­va­tion En­deav­ors in some ca­pac­i­ty for a lit­tle while as a part-time ven­ture part­ner, but now de­cid­ed to jump on full-time.

In­no­va­tion En­deav­ors has been slow­ly creep­ing in­to biotech in­vest­ments. While the firm has in­vest­ed in well-known tech en­ti­ties such as SoFi and Uber, it made sev­er­al biotech in­vest­ments last year. This in­cludes par­tic­i­pat­ing in rounds for Geroge Chruch’s spin­out GRO Bio­sciences, the al­ler­gy biotech Ukko and BigHat Bio­sciences.

Dud­ley told End­points that bring­ing him on shows that In­no­va­tion En­deav­ors is tak­ing a hard­er look in­to the biotech world, and he feels that the re­cent de­vel­op­ments have made it an at­trac­tive land­ing spot.

“You had these trends that were go­ing to hap­pen ir­re­spec­tive of these ex­po­nen­tial tech­nolo­gies in mol­e­c­u­lar pro­fil­ing, imag­ing, da­ta sci­ence and ma­chine learn­ing, all sort of con­verg­ing, ir­re­spec­tive of their in­no­va­tion cy­cle and hit­ting these ex­po­nen­tial in­no­va­tion curves,” he said. “But then ob­vi­ous­ly you have Covid sit­ting on top of that, which was sort of this World War Two-like cy­cle of com­pressed in­no­va­tion.

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Kate Haviland, Blueprint Medicines CEO
4
by Lei Lei Wu

Blue­print Med­i­cines an­nounced this morn­ing that the sec­ond part of its study on Ay­vak­it in non-ad­vanced sys­temic mas­to­cy­to­sis (SM) — a rare dis­ease in which a type of white blood cells known as mast cells builds up — met all end­points, but the bio­phar­ma left key ques­tions unan­swered.

In 212 pa­tients, with 141 in the treat­ment arm and 71 in the con­trol arm, pa­tients who got Ay­vak­it saw an av­er­age 15.6-point de­crease in their symp­tom scores com­pared to a 9.2-point de­crease in the place­bo arm at 24 weeks. In an ex­ten­sion study, those on Ay­vak­it saw their symp­tom scores drop by 20.2 points by week 48.

Lat­er this year, the Mass­a­chu­setts biotech plans to file for a sup­ple­men­tary ap­proval for Ay­vak­it, which was green­lit for the rar­er ad­vanced form of SM back in 2021.

De­spite the ap­par­ent pos­i­tive read­out, Blue­print BPMC was trad­ing down by over 20% this morn­ing, drop­ping from around $68 to $54.

For one, an­a­lysts not­ed that the dif­fer­ence be­tween the av­er­age symp­tom scores of the treat­ment and place­bo arms in the Part 2 re­sults was just over 6 points, sub­stan­tial­ly less than the 16-point dif­fer­ence in the small­er Part 1 study. Not on­ly did the treat­ment have a small­er ef­fect in Part 2 than in Part 1, in which pa­tients saw a 19-point im­prove­ment in their symp­tom scores, but the place­bo plus stan­dard of care fared con­sid­er­ably bet­ter than in Part 1 as well, where the con­trol arm saw on­ly a 3-point im­prove­ment in symp­tom scores.

When asked about the dif­fer­ence in the con­trol arm, Blue­print COO Christy Rossi told End­points News that it was “hard to spec­u­late,” but not­ed the mul­ti-cen­ter, glob­al scale of the sec­ond part of the study.

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Keting Chu, Bluejay Therapeutics CEO
5
by Aayushi Pratap

Every year, 820,000 peo­ple die of chron­ic he­pati­tis B in­fec­tions glob­al­ly, and 1.5 mil­lion get in­fect­ed, de­spite the avail­abil­i­ty of vac­cines and treat­ments, ac­cord­ing to the CDC. Cur­rent stan­dard-of-care treat­ments can be ef­fec­tive in stop­ping virus repli­ca­tion, but they re­quire pa­tients to be on meds for life.

Blue­jay, which was found­ed in 2019, is try­ing to change that, aim­ing to de­vel­op a func­tion­al cure for he­pati­tis B in­fec­tions by mak­ing HB­sAg — vi­ral pro­tein-sur­face anti­gens — com­plete­ly un­de­tectable with­in six months of treat­ment. And it's got a new round of cash to try mak­ing it a re­al­i­ty.

The com­pa­ny closed a $41 mil­lion Se­ries B round Tues­day led by Arkin Bio Ven­tures. This round in­clud­ed par­tic­i­pa­tion from oth­er new and ex­ist­ing in­vestors, in­clud­ing Syn­er­gen­ics LLC, River­Vest Ven­ture Part­ners, Yon­jin Cap­i­tal, Oc­ta­gon Cap­i­tal and InnoPin­na­cle In­ter­na­tion­al.

“Vac­cines are avail­able but not every­one has ac­cess to it. For in­stance, the U.K. health sys­tem does not even cov­er it,” said Ket­ing Chu, founder and CEO of Blue­jay Ther­a­peu­tics. “When pa­tients stop tak­ing med­i­cine, the virus re­bounds,” Chu added. Even when pa­tients are on meds, their bod­ies con­tin­ue to make HB­sAg, which caus­es chron­ic in­flam­ma­tion that even­tu­al­ly leads to liv­er cir­rho­sis and can­cer.

These HB­sAg anti­gens, when pro­duced in the body, cause "ex­haus­tion" of the im­mune sys­tem, specif­i­cal­ly the B cell and T cell, said Chu. Blue­jay’s lead as­set is BJT-778, an an­ti­body against HB­sAg anti­gens, which the com­pa­ny has li­censed from No­var­tis.

“The goal is to re­store T cell and B cell func­tions to get im­mune con­trol and achieve a func­tion­al cure,” Chu said.

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Pawel Przewiezlikowski, Ryvu Therapeutics CEO
6
by Paul Schloesser

Many US biotechs have been tight­en­ing their pock­et­books in an ef­fort to keep them­selves run­ning. But over in Poland, one com­pa­ny is nab­bing a debt fi­nanc­ing to push it­self to­wards more clin­i­cal tri­als, with the help of one of Eu­rope's largest lenders.

Ryvu Ther­a­peu­tics put out word ear­ly Wednes­day that the Eu­ro­pean In­vest­ment Bank, the lend­ing arm of the Eu­ro­pean Union, is pro­vid­ing the biotech with $22.3 mil­lion in debt fi­nanc­ing — or €22 mil­lion. As part of the debt fi­nanc­ing, the Eu­ro­pean Fund for Strate­gic In­vest­ments is back­ing it with a "first loss guar­an­tee," en­sur­ing that the EIB can at least re­coup some of its in­vest­ment if the com­pa­ny's projects go south, al­low­ing it to in­vest in projects that could have a high­er lev­el of risk.

EIB VP Tere­sa Cz­er­wińs­ka said in a state­ment that fi­nanc­ing projects with­in R&D are a top pri­or­i­ty for the lender, not­ing, "The EIB’s in­vest­ment will strength­en Ryvu Ther­a­peu­tics’ re­search, de­vel­op­ment and in­no­va­tion ca­pac­i­ty and com­pet­i­tive­ness for the wider so­cial ben­e­fit.”

Ryvu will use the fi­nanc­ing to con­tin­ue ad­vanc­ing its pipeline of on­col­o­gy small mol­e­cule can­di­dates through the dis­cov­ery and pre­clin­i­cal phas­es and in­to clin­i­cal tri­als, CEO Pawel Przewie­z­likows­ki said in a state­ment. The biotech is go­ing af­ter such tar­gets as PRMT5 and WRN in syn­thet­ic lethal­i­ty, STING in an an­ti­body-drug con­ju­gate, STING as a stand­alone and HPK1 in I/O, ac­cord­ing to Ryvu's web­site.

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7
by Kyle LaHucik

The CD47 field ran in­to an­oth­er hur­dle Tues­day as I-Mab qui­et­ly dis­closed in an SEC fil­ing that Ab­b­Vie is say­ing good­bye to a Phase I study of the biotech’s drug.

Weeks af­ter end­ing an ex­plorato­ry tri­al of I-Mab’s CD47 an­ti­body, Ab­b­Vie has now called it quits on an­oth­er ear­ly-stage tri­al. The Phase I was test­ing the drug, lem­zopar­limab, in com­bi­na­tion with azac­i­ti­dine and vene­to­clax in pa­tients with acute myeloid leukemia and myelodys­plas­tic syn­drome.

“This de­ci­sion was not based on any spe­cif­ic or un­ex­pect­ed safe­ty con­cerns,” I-Mab dis­closed in the pa­per­work filed with the SEC.

The study arose from the pact Ab­b­Vie and I-Mab inked in au­tumn 2020 with $200 mil­lion up­front and more than a bil­lion dol­lars in back-end pay­ments.

The part­ner­ship will con­tin­ue with “cer­tain new an­ti-CD47 an­ti­bod­ies” or “oth­er li­censed prod­ucts,” I-Mab dis­closed. I-Mab stands to re­ceive up to $1.295 bil­lion in pay­ments and tiered roy­al­ties un­der the amend­ed deal, the com­pa­ny said.

The move comes days af­ter Zai Lab shelved a Phase I pro­gram of its CD47 in­hibitor ZL-1201 af­ter scop­ing out the com­pet­i­tive land­scape.

Mul­ti­ple set­backs have oc­curred to the CD47 space since Gilead’s ma­grolimab, for­mer­ly of the biotech Forty Sev­en and one of the lead pro­grams in the in­dus­try, was placed on par­tial clin­i­cal holds last year. All study paus­es have since been lift­ed, and the Cal­i­for­nia bio­phar­ma has re­it­er­at­ed its “un­wa­ver­ing” con­fi­dence in the pro­gram, which aims to block the “don’t eat me” sig­nal loved by some can­cer cells.

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Kate Hermans and Feng Tian
8
by Amber Tong

When Am­brx Bio­phar­ma went pub­lic in the sum­mer of 2021 — join­ing in on the go-go times in biotech — ex­ecs cel­e­brat­ed it as the cul­mi­na­tion of a wind­ing jour­ney that took them from a failed IPO bid in 2014 to a sale to Chi­nese in­vestors and phar­ma com­pa­nies and, thanks to a new vi­sion and strat­e­gy, a $200 mil­lion crossover round from mar­quee VCs be­fore jump­ing on Nas­daq.

But it now ap­pears that an­oth­er piv­ot is due.

Am­brx, which has been ap­ply­ing its pro­tein en­gi­neer­ing tech to make an­ti­body-drug con­ju­gates, is bring­ing in a new CEO, Kate Her­mans, to tem­porar­i­ly re­place Feng Tian, who’s been with the biotech for 17 years, pre­vi­ous­ly as CSO.

As in­ter­im chief, Her­mans will over­see a strate­gic pipeline re­view “to max­i­mize our com­mer­cial op­por­tu­ni­ties and fur­ther ex­tend the cash run­way,” the com­pa­ny not­ed. In the mean­time, it will pri­or­i­tize part­ner­ships such as the one with Chi­na’s NovoCodex while search­ing for a per­ma­nent CEO.

Am­brx shares AMAM have plunged 85% since it first list­ed, now trad­ing at $2.56.

Cur­rent­ly, Am­brx’s most ad­vanced pro­gram is an ADC tar­get­ing HER2 called ARX788. While the orig­i­nal plan was to seek ac­cel­er­at­ed ap­proval at the FDA based on Phase II re­sults, Am­brx ad­mit­ted in an April SEC fil­ing that it may no longer be vi­able giv­en the crowd­ed space:

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Chris Sheldon, AstraZeneca's former VP and head of investor relations
9
by Nicole DeFeudis

As­traZeneca and GSK are once again wran­gling over tal­ent.

The British phar­ma gi­ant has filed suit against for­mer VP and head of in­vestor re­la­tions Chris Shel­don as he pre­pares to start a new job at its ri­val next month. As­traZeneca ar­gued in a Lon­don court fil­ing that Shel­don would be vi­o­lat­ing a non-com­pete agree­ment, which he was paid more than $774,000 in shares to sign back in 2021, Bloomberg re­port­ed.

Shel­don worked at As­traZeneca for more than 18 years, start­ing as a re­search sci­en­tist back in 2004 and climb­ing to glob­al head of busi­ness de­vel­op­ment and li­cens­ing for on­col­o­gy R&D, and even­tu­al­ly, head of IR. He re­signed ear­li­er this month, ef­fec­tive im­me­di­ate­ly, ac­cord­ing to Law360. 

A GSK spokesper­son con­firmed to End­points News on Tues­day that Shel­don’s head­ed there to be­come the next se­nior VP of its com­mer­cial port­fo­lio. While the com­pa­ny de­clined to com­ment on the As­traZeneca case, the spokesper­son added that GSK “com­mit­ted to lever­ag­ing busi­ness de­vel­op­ment as a tool to se­cure ac­cess to ex­ter­nal in­no­va­tion, help shape the port­fo­lio and fur­ther strength­en our late-stage pipeline.”

Shel­don al­so de­clined to com­ment, though he added: “I de­ny what is al­leged or any wrong do­ing.”

As­traZeneca was not im­me­di­ate­ly avail­able for an in­ter­view.

This isn’t the first time As­traZeneca has tak­en a mat­ter like this to court. Back in 2017, the phar­ma gi­ant sued for­mer ex­ec Luke Miels, who was poached by GSK ear­li­er that year to head up its glob­al phar­ma­ceu­ti­cals busi­ness. Miels had worked with As­traZeneca CEO Pas­cal So­ri­ot for more than a decade at Aven­tis, Roche and As­traZeneca. He served as an ex­ec­u­tive VP at As­traZeneca for just over three years be­fore jump­ing to GSK, where he’s now chief com­mer­cial of­fi­cer.

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10
by Beth Snyder Bulik

The Covid-19 pan­dem­ic and rush to vac­cines cre­at­ed a stir with a raft of un­usu­al and me­dia-de­bat­ed names in­clud­ing Mod­er­na’s Spike­vax, Pfiz­er’s Comir­naty and As­traZeneca’s Vaxzevria.

Now mon­key­pox drug names are in the news — al­though both the lead­ing vac­cine Jyn­neos and the spe­cial use treat­ment Tpoxx have been around for years. Jyn­neos was ap­proved as pro­tec­tion against small­pox and mon­key­pox in 2019, while Tpoxx was ap­proved as an an­tivi­ral to treat small­pox in 2018.

How­ev­er, un­like the Covid vac­cine Big Phar­ma com­pa­nies and close­ly watched de­vel­op­ments, the mon­key­pox drugs aren't close to the mar­ket main­stream. Both Jyn­neos and Tpoxx are na­tion­al stock­pile prod­ucts and are on­ly sup­plied and sold to gov­ern­ment agen­cies. Of course, that could change if mon­key­pox con­tin­ues to spread in the US and be­comes en­dem­ic.

Siga’s chief sci­en­tif­ic of­fi­cer and long­time pox vi­rol­o­gist Den­nis Hru­by said Tpoxx com­mer­cial­iza­tion is a “fu­ture con­ver­sa­tion” de­pen­dent on whether the out­break fades or stays in cir­cu­la­tion.

“We nev­er an­tic­i­pat­ed mon­key­pox, of course. With small­pox, the av­er­age cit­i­zen is not go­ing to go down to the gro­cery store to get it. Now that’s go­ing to change with mon­key­pox. And cer­tain­ly, we’re look­ing at per­haps launch­ing it through tra­di­tion­al com­mer­cial chan­nels, but that will re­quire a bit with ap­proval, prob­a­bly se­ri­al­iza­tion, etc. So we’ve been too busy re­al­ly to have those con­ver­sa­tions with the FDA, but that could be down the road,” he said.

Still, the brand names of both are now crop­ping up in me­dia men­tions, so­cial me­dia chan­nels and ca­su­al con­ver­sa­tions every­where.

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