Sesen Bio tri­al marred by mis­con­duct — re­port; Bris­tol My­ers picks up de­vel­op­ment of AI out­fit's im­munol­o­gy drug

Sesen Bio said that it was not ex­pect­ing a CRL from the FDA for its blad­der can­cer can­di­date Vicineum. But the re­ject­ed fil­ing in­clud­ed thou­sands of vi­o­la­tions and in­ves­ti­ga­tor mis­con­duct, STAT News re­port­ed Wednes­day.

Thomas Can­nell

The 130-pa­tient study had more than 2,000 vi­o­la­tions, 215 of which were clas­si­fied as ma­jor, STAT said. In­de­pen­dent mon­i­tors al­so re­port­ed three in­ves­ti­ga­tors to the FDA for a “se­ri­ous non­com­pli­ance” that “placed sub­jects at risk of harm.” A pa­tient died in 2016 of liv­er fail­ure re­lat­ed to the drug, and two years lat­er, the com­pa­ny said that there were no drug-re­lat­ed deaths at a urol­o­gy con­fer­ence.

The com­pa­ny saw its stock crash, as it en­tered a halt at $6 per share last Fri­day and emerged bat­tered with a $0.86 price.

In June CEO Thomas Can­nell said that the drug was on its way to gen­er­at­ing be­tween $1 bil­lion and $3 bil­lion. Then Mon­day, he blamed “tox­ic” and crit­i­cal me­dia cov­er­age of the FDA’s ap­proval of Bio­gen’s Alzheimer’s treat­ment Aduhelm for the CRL. — Josh Sul­li­van

Bris­tol My­ers picks up de­vel­op­ment of AI out­fit’s im­munol­o­gy drug

Ru­pert Vessey

Bris­tol My­ers Squibb has opt­ed to pick up the de­vel­op­ment of an im­mune-mod­u­lat­ing drug as part of a re­search col­lab­o­ra­tion with UK-based AI dis­cov­ery out­fit Ex­sci­en­tia, the part­ners said Wednes­day.

Ex­sci­en­tia will re­ceive a $20 mil­lion mile­stone pay­ment as part of the pick up with ad­di­tion­al mile­stones and tiered roy­al­ties pos­si­ble. De­tails on the drug were scarce, but the part­ners said it tar­gets “a crit­i­cal im­muno­log­i­cal ki­nase.”

“We are pleased to in-li­cense our first drug can­di­date re­sult­ing from our strate­gic col­lab­o­ra­tion with Ex­sci­en­tia,” Ru­pert Vessey, Bris­tol My­ers’ pres­i­dent of ear­ly R&D said in a re­lease. “Ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing con­tin­ue to play im­por­tant roles in drug dis­cov­ery and Ex­sci­en­tia has de­liv­ered a promis­ing de­vel­op­ment can­di­date in the field of im­munol­o­gy. We look for­ward to our con­tin­ued col­lab­o­ra­tion and fur­ther ad­vanc­ing this can­di­date for the po­ten­tial ben­e­fit of pa­tients with un­met med­ical need.” — Kyle Blanken­ship

Were­wolf hops aboard the Keytru­da train with Mer­ck tri­al col­lab­o­ra­tion

Were­wolf Ther­a­peu­tics and Mer­ck are team­ing up for a new clin­i­cal tri­al.

Ran­di Isaacs

Look­ing at Were­wolf’s WTX-124 can­di­date tar­get­ing IL-2, the pair will col­lab­o­rate on a Phase I study eval­u­at­ing the pro­gram’s safe­ty and ef­fi­ca­cy in sol­id tu­mors, the com­pa­nies an­nounced Wednes­day. Re­searchers will ex­am­ine WTX-124 both as a monother­a­py and in com­bi­na­tion with Mer­ck’s Keytru­da.

“The clin­i­cal ben­e­fit of tar­get­ing IL-2 as a treat­ment for can­cer has long been es­tab­lished; how­ev­er, its util­i­ty has been lim­it­ed by chal­leng­ing tox­i­c­i­ties,” Were­wolf CMO Ran­di Isaacs said in a state­ment. “We be­lieve WTX-124 has the po­ten­tial to en­hance ther­a­peu­tic op­tions for can­cer pa­tients as a monother­a­py and when com­bined with check­point in­hibitors like Keytru­da.”

Were­wolf says it plans to sub­mit an IND for the WTX-124 pro­gram in the first half of 2022. Should the IND be cleared, the Phase I study will start “prompt­ly,” though no time­line was spec­i­fied. — Max Gel­man

Pen­ny stock sees shares jump at Phase II topline da­ta

Pen­ny stock play­er Azur­Rx got a sig­nif­i­cant bump Wednes­day af­ter it re­port­ed topline da­ta for a Phase II study.

James Sapirstein

Eval­u­at­ing the com­pa­ny’s MS1819 pro­gram for the treat­ment of se­vere ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy in pa­tients with cys­tic fi­bro­sis, Azur­Rx said the can­di­date in com­bi­na­tion with stan­dard of care re­sult­ed in an av­er­age 6.57-per­cent­age point gain from base­line in the Co­ef­fi­cient of Fat Ab­sorp­tion, which the com­pa­ny says is a clin­i­cal­ly mean­ing­ful re­sult.

Pre­vi­ous lit­er­a­ture had said any­thing above a five-per­cent­age point im­prove­ment is clin­i­cal­ly mean­ing­ful. Da­ta from Wednes­day’s re­sults come from 20 pa­tients.

“Topline da­ta clear­ly show that com­bin­ing MS1819 to the dai­ly dose of PERT [stan­dard of care] had clin­i­cal ben­e­fits for all pa­tients and im­proved qual­i­ty of life,” CEO James Sapirstein said in a state­ment. “Our next step with the MS1819 pro­gram is to fi­nal­ize de­vel­op­ment of a new en­teric-coat­ed mi­crobead for­mu­la­tion, which we be­lieve will en­able more of the med­ica­tion to reach the small in­tes­tine there­by en­hanc­ing its ther­a­peu­tic po­ten­tial.”

Azur­Rx shares $AZRX sky­rock­et­ed 46% in pre-mar­ket trad­ing Wednes­day, set­tling in the 35% to 40% range af­ter the open­ing bell.

The for­mu­la­tion work for the new en­teric-coat­ed mi­crobead tech is ex­pect­ed to be com­plet­ed by the end of the year. Azur­Rx plans to launch a bridg­ing study in 2022 eval­u­at­ing the for­mu­la­tion as a monother­a­py. — Max Gel­man

So­ma­Log­ic does the Twist

Emi­ly Lep­roust

So­ma­Log­ic and Twist Bio­science have agreed to a new col­lab­o­ra­tion, an­nounced Wednes­day morn­ing. The deal will al­low Twist ac­cess to So­ma­Log­ic’s plat­form to dis­cov­er new an­ti­bod­ies and drug tar­gets.

No fi­nan­cial terms were dis­closed for the deal.

“We in­tend to use the an­ti­bod­ies dis­cov­ered for our in­ter­nal pipeline, mov­ing the most promis­ing can­di­dates through pre­clin­i­cal de­vel­op­ment and then po­ten­tial­ly out­li­cens­ing to a part­ner,” Twist CEO Emi­ly Lep­roust said in a state­ment. — Max Gel­man

Biotech de­vel­op­ing an­ti-in­flam­ma­to­ry COPD treat­ment lands €20M Se­ries A

An Ice­landic biotech that fo­cus­es on treat­ing chron­ic ob­struc­tive pul­monary dis­ease has se­cured a Eu­ro­pean Se­ries A fi­nanc­ing round, the com­pa­ny an­nounced Wednes­day.

Maria Bech

Epi­En­do raised €20 mil­lion, or $23.4 mil­lion. The round was led by Flerie In­vest and Iðunn Ven­ture Fund. Ex­ist­ing in­vestor ABC Ven­tures par­tic­i­pat­ed, as well as the Eu­ro­pean In­no­va­tion Coun­cil Fund.

Funds will go to­ward mov­ing EP395 through clin­i­cal tri­als through Phase IIa. The drug en­tered Phase I tri­als in April.

“This fi­nanc­ing is a ma­jor step for Epi­En­do, not on­ly fund­ing our lead com­pound through clin­i­cal de­vel­op­ment in pa­tients with COPD, but al­so en­abling ex­plo­ration of oth­er im­por­tant po­ten­tial ther­a­peu­tic ap­pli­ca­tion ar­eas such as der­ma­tol­ogy and gas­troin­testi­nal dis­or­ders, where com­pro­mised ep­ithe­lial in­tegri­ty is known to con­tribute to dis­ease patho­phys­i­ol­o­gy,” CEO Maria Bech said in a press re­lease.

Sci­en­tists seek to make EP395 the first dis­ease mod­i­fy­ing non-an­tibi­ot­ic macrolide that can be used as a long-term treat­ment for COPD. It works by re­duc­ing in­flam­ma­tion in the ep­ithe­lial bar­ri­er, and in the fu­ture, the com­pa­ny will try the can­di­date on pa­tients with asth­ma, bronchiec­ta­sis and dif­fuse pan-bron­chi­oli­tis. — Josh Sul­li­van

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Mi­to­chon­dria biotech re­ceives Morn­ing­side buy­out of­fer af­ter PhII fail; On­col­o­gy mi­cro­cap with­draws IPO plans

Not even two months after reporting a Phase II fail for its lead drug candidate, Stealth BioTherapeutics is now being eyed for a potential acquisition, with one firm wanting to take it private.

Stealth reported Monday that Morningside Venture Investments sent Stealth’s board of directors a non-binding preliminary proposal to acquire all outstanding shares not yet owned by Morningside for 2.6 cents per share and 31.3 cents per ADS.