Im­muno­bi­ol­o­gy biotech Equi­l­li­um an­nounced a “mu­tu­al ter­mi­na­tion” of an an­tic­i­pat­ed merg­er with Rich Hey­man-chaired Metacrine a lit­tle over three months af­ter the ini­tial an­nounce­ment of the all-stock agree­ment.

Ac­cord­ing to SEC fil­ings, nei­ther Equi­l­li­um nor Metacrine will pay a ter­mi­na­tion fee.

Bruce Steel

Equi­l­li­um CEO Bruce Steel said in a state­ment on Dec. 23 that Equi­l­li­um start­ed look­ing in­to ac­quir­ing Metacrine in ear­ly 2022 in an at­tempt to add cash run­way “in a very dif­fi­cult fi­nanc­ing mar­ket.” Back in Sep­tem­ber, the com­pa­nies an­nounced that a merg­er would add $33 mil­lion to Equi­l­li­um’s bal­ance sheet and ex­tend the run­way through 2024. But the com­pa­ny has since found a dif­fer­ent part­ner in Ono Phar­ma­ceu­ti­cal.

“How­ev­er, our re­cent strate­gic part­ner­ship with Ono Phar­ma­ceu­ti­cal is ex­pect­ed to ex­tend our cash run­way in­to 2025, and pos­si­bly fur­ther with po­ten­tial op­tion ex­er­cise and mile­stone pay­ments,” Steel said.

Ear­li­er this month, Equi­l­li­um en­tered in­to an agree­ment with Ono that in­clud­ed a $26 mil­lion up­front pay­ment. Ono will have the ex­clu­sive op­tion to pur­chase the rights, in­clud­ing com­mer­cial­iza­tion, to mon­o­clon­al an­ti­body itolizum­ab in the Unit­ed States, Cana­da, Aus­tralia and New Zealand.

There is a po­ten­tial for up to an­oth­er $138.5 mil­lion in mile­stone pay­ments while Equi­l­li­um con­tin­ues R&D with itolizum­ab, in­clud­ing two stud­ies of the drug’s im­pact on acute graft-ver­sus-host dis­ease and lu­pus nephri­tis.

— Kather­ine Lewin

Mer­ck KGaA and Am­gen dish cash for biotech AD­Cs

Mer­ck KGaA is hedg­ing its bets on the STING path­way. It has tapped Mer­sana Ther­a­peu­tics for a two-tar­get deal for STING ag­o­nist an­ti­body drug con­ju­gates, or AD­Cs, a type of treat­ment that arms an an­ti­body, which acts as an in­ter­nal com­pass, with a cell-killing drug.

Mer­sana will get $30 mil­lion up­front, and will be el­i­gi­ble for up to $800 mil­lion in po­ten­tial down­stream mile­stones plus roy­al­ties.

GSK al­so has a pact with Mer­sana on STING ag­o­nist AD­Cs. Last year, As­traZeneca signed a STING deal with F-star, and re­cent­ly BioN­Tech signed a deal with Ryvu Ther­a­peu­tics. But these deals come af­ter oth­ers left the field. No­var­tis walked away from its STING pro­gram in 2019 and Nim­bus al­so culled its ef­forts.

Sep­a­rate­ly, Am­gen has en­list­ed South Ko­re­an biotech LegoChem Bio­sciences for a five-tar­get ADC deal. The duo did not dis­close the up­front pay­ment, but said the deal could be good for $1.25 bil­lion in to­tal.

Last year, Czech-based So­tio Biotech al­so paid $29.5 mil­lion up­front for a deal with LegoChem. That deal sim­i­lar­ly was for five tar­gets and worth a po­ten­tial $1 bil­lion.

— Lei Lei Wu 

Pep­tides get the spot­light in new Mer­ck deal

Mer­ck is tap­ping a part­ner to ex­plore pep­tide-drug con­ju­gates, or PD­Cs.

Japan’s Pep­tiDream is tasked with iden­ti­fy­ing pep­tide can­di­dates for use in PD­Cs in a new pact worth as much as $2.1 bil­lion, in­clud­ing an un­spec­i­fied up­front pay­ment, plus mile­stones. Mer­ck will get ex­clu­sive rights to con­ju­gate those pep­tides to cy­to­tox­ic pay­loads — bring­ing the pay­loads to spe­cif­ic cells — and take charge of all de­vel­op­ment.

Mer­ck and Pep­tiDream have been col­lab­o­rat­ing on pep­tide dis­cov­ery since 2015.

Pep­tiDream it­self lists a dozen of PD­Cs in its own pipeline for both di­ag­nos­tic and ther­a­peu­tic pur­pos­es, in­clud­ing a PD-L1 di­ag­nos­tic PDC part­nered with Bris­tol My­ers Squibb and oth­er undis­closed pro­grams with No­var­tis and Rayze­Bio.

— Am­ber Tong

In­ter­cept re­sub­mits NASH drug to FDA

In­ter­cept Phar­ma­ceu­ti­cals is mov­ing an­oth­er hope­ful step for­ward with obeti­cholic acid as a treat­ment for non­al­co­holic steato­hep­ati­tis (NASH), a pro­gres­sive liv­er dis­ease.

The biotech an­nounced just be­fore Christ­mas that it had re­sub­mit­ted a new drug ap­pli­ca­tion to the FDA for obeti­cholic acid fol­low­ing two pos­i­tive analy­ses of its Phase III RE­GEN­ER­ATE study. Liv­er scar­ring, stiff­ness and blood lev­els of liv­er en­zymes all showed im­prove­ments in pa­tients that took the drug.

If the agency gives the thumbs-up, it would be the first time that obeti­cholic acid has been ap­proved for the treat­ment of NASH “by any reg­u­la­to­ry au­thor­i­ty in any ge­og­ra­phy,” ac­cord­ing to In­ter­cept. Obeti­cholic acid is al­ready ap­proved for pri­ma­ry bil­iary cholan­gi­tis as Ocali­va.

The PDU­FA tar­get re­view time by the FDA is ex­pect­ed to be six months, the com­pa­ny said.

The FDA re­ject­ed the drug in 2020 for liv­er scar­ring due to NASH af­ter dis­ap­point­ing Phase III tri­als.

— Kather­ine Lewin

Zinc, sil­ver nanocrys­tal drug fails Covid study

Clene Nanomed­i­cine, which joined a long list of biotechs in test­ing com­pounds for Covid-19, has run in­to the same dis­ap­point­ing re­sult as many oth­ers.

Its drug flunked a Phase II study in­volv­ing non-hos­pi­tal­ized but symp­to­matic Covid-19 pa­tients, the Salt Lake City-based biotech re­port­ed. The tri­al showed that the drug didn’t help pa­tients’ symp­toms re­solve more quick­ly than a place­bo.

Rob Ether­ing­ton

In the tri­al, which was con­duct­ed in Brazil, 288 pa­tients re­ceived ei­ther a low dose of Clene’s zinc and sil­ver nanocrys­tal sus­pen­sion, dubbed CNM-ZnAg, a high dose, or a place­bo on top of stan­dard sup­port­ive care for up to 21 days. They were then tracked through 28 days.

“No clin­i­cal ben­e­fit was ob­served ver­sus place­bo,” the com­pa­ny said.

“At this time, we will cease fur­ther de­vel­op­ment for COVID,” CEO Rob Ether­ing­ton said in a state­ment.

Clene will fo­cus on its lead as­set, a gold nanocrys­tal-based drug, as a treat­ment for mul­ti­ple scle­ro­sis. The drug failed an ALS tri­al last year.

— Am­ber Tong

Brii drops one HIV can­di­date while FDA lifts hold on an­oth­er

A year ago, in the wake of a safe­ty scare around Mer­ck’s HIV drug is­la­travir, the FDA placed a clin­i­cal hold on a pro­drug of is­la­travir be­ing de­vel­oped by Brii Bio.

Brii Bio now says the agency has lift­ed the hold, clear­ing the way for a planned Phase I study that will test a low­er once-week­ly oral dose of BRII-732.

The biotech, which has pres­ence in both Durham, NC and Bei­jing, Chi­na, said it’s al­so ex­plor­ing part­ner­ship op­por­tu­ni­ties to con­tin­ue de­vel­op­ing the com­pound as a long-act­ing op­tion for HIV pa­tients.

Da­ta from the healthy vol­un­teers who were dosed be­fore the study halt­ed sug­gest­ed an ac­cept­able safe­ty and tol­er­a­bil­i­ty pro­file, as well as promis­ing phar­ma­co­ki­net­ics, Brii added.

On the oth­er hand, the same can’t be said about an­oth­er HIV can­di­date, BRII-778. Brii said it is shut­ter­ing that pro­gram based on phar­ma­co­ki­net­ic da­ta from a com­plet­ed Phase I study.

— Am­ber Tong

Min­er­va ‘dis­ap­point­ed’ in FDA’s re­fusal-to-file let­ter for schiz­o­phre­nia symp­toms treat­ment

The FDA told Min­er­va Neu­ro­sciences that its Oc­to­ber re­fusal-to-file let­ter isn’t go­ing away af­ter a meet­ing in No­vem­ber.

Re­my Luthringer

Min­er­va CEO Re­my Luthringer said in a state­ment that he’s “dis­ap­point­ed” in the FDA’s spurn­ing of rolu­peri­done even af­ter the Nov. 30 meet­ing to hash out the agency’s long­stand­ing con­cerns.

Rolu­peri­done is an ex­per­i­men­tal treat­ment for the symp­toms of schiz­o­phre­nia, such as the in­abil­i­ty to com­plete tasks or feel plea­sure, changes in sleep and a loss of in­ter­est and mo­ti­va­tion in life.

Luthringer con­firmed that the FDA “will not file our NDA for rolu­peri­done for the treat­ment of neg­a­tive symp­toms of schiz­o­phre­nia.”

The FDA has had con­cerns about the drug since 2020, but Min­er­va pushed ahead any­way. The FDA is­sued the let­ter on­ly eight weeks af­ter the com­pa­ny’s ap­proval ap­pli­ca­tion in Au­gust 2022.

— Kather­ine Lewin

French Biotech gets a €40M cred­it to fund R&D

An­dré Chouli­ka

France-based cell and gene ther­a­py biotech Cel­lec­tis has en­tered a €40 mil­lion ($42.7 mil­lion) cred­it fa­cil­i­ty agree­ment with the Eu­ro­pean In­vest­ment Bank. Cel­lec­tis will use the funds to fur­ther de­vel­op its pipeline of CAR-T cell can­di­dates.

The cash will be di­vid­ed in­to three tranch­es. Cel­lec­tis will re­ceive €20 mil­lion in the first tranche, €15 mil­lion in the sec­ond and €5 mil­lion in the third. The re­lease of the funds will al­so be sub­ject to cer­tain con­di­tions, which were not de­tailed.

The fi­nanc­ing “is min­i­mal­ly di­lu­tive for our share­hold­ers, is ex­cel­lent news for Cel­lec­tis and a recog­ni­tion of the work ac­com­plished by our teams,” Cel­lec­tis CEO An­dré Chouli­ka said in a state­ment.

-Tyler Patchen

No­var­tis to pay $245M to put an end to an­titrust lit­i­ga­tion — re­port

No­var­tis will pay $245 mil­lion to bring an end to an an­titrust case.

Ac­cord­ing to a re­port from Reuters, the pay­ment will end ac­cu­sa­tions that No­var­tis tried to de­lay the launch of gener­ic forms of its hy­per­ten­sion drug Ex­forge in the US. Reuters said the lit­i­ga­tion came from a 2011 li­cens­ing agree­ment be­tween No­var­tis and Par Phar­ma­ceu­ti­cals. Both No­var­tis and Par were ac­cused of en­ter­ing in­to an il­le­gal agree­ment to de­lay the launch of less ex­pen­sive and gener­ic forms of Ex­forge.

Reuters stat­ed that the plain­tiffs had ac­cused Par of agree­ing not to launch the gener­ic for two years af­ter one of No­var­tis’ patents had ex­pired, with the Swiss phar­ma al­leg­ing to have al­so agreed to not com­pete with Par by launch­ing its own Ex­forge gener­ic dur­ing the 180-day “ex­clu­siv­i­ty pe­ri­od” af­ter Par en­tered the mar­ket.

The case saw groups such as CVS, Kroger, Wal­greens and Rite Aid in the list of plain­tiffs when lit­i­ga­tion kicked off in 2018.

–Tyler Patchen

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.