De­sert­ed by Take­da, Mer­sana aban­dons lead drug

Mer­sana Ther­a­peu­tics’ rocky road in de­vel­op­ing its lead drug has cul­mi­nat­ed in the aban­don­ment of the ex­per­i­men­tal can­cer treat­ment, days af­ter its high-pro­file part­ner Take­da de­cid­ed to walk away from their deal.

Back in 2016, Take­da and its unit Mil­len­ni­um ex­pand­ed a pri­or part­ner­ship with Mer­sana by se­cur­ing the the ex-US com­mer­cial rights to the Cam­bridge, Mass­a­chu­setts-based com­pa­ny’s then-lead pre­clin­i­cal an­ti­body drug con­ju­gate — XMT-1522 — for $60 mil­lion up­front and a host of oth­er mile­stone pay­ments, which in tan­dem with their ex­ist­ing agree­ment added up to a $1 bil­lion-plus deal.

Take­da backed Mer­sana $MRSN on the promise of its next-gen an­ti­body-drug con­ju­gates (AD­Cs), or armed an­ti­bod­ies.

This po­tent class of drugs brings to­geth­er two in­gre­di­ents by chem­i­cal­ly link­ing an­ti­bod­ies to a bi­o­log­i­cal­ly ac­tive drug or cy­to­tox­ic com­pound. This com­bines the tar­get­ing ca­pa­bil­i­ties of an­ti­bod­ies — al­low­ing sen­si­tive dis­crim­i­na­tion be­tween healthy and can­cer tis­sues — with the cell-killing abil­i­ty of chemother­a­pies. While ex­ist­ing AD­Cs can be lim­it­ed to just a few ther­a­pies, Mer­sana’s tech plat­form is de­signed to pro­duce drugs that can link up with 12 to 15, in the­o­ry vast­ly en­hanc­ing the ther­a­peu­tic po­ten­tial of their crop of AD­Cs for dis­eases pre­vi­ous­ly out of reach.

An­na Pro­topa­pas

It was this ad­di­tion­al fire­pow­er that at­tract­ed Take­da to Mer­sana, which is run by for­mer Mil­len­ni­um chief An­na Pro­topa­pas. Mer­sana went pub­lic in 2017, but a year lat­er trou­ble was afoot. Last Ju­ly, Mer­sana re­port­ed a pa­tient death in a Phase I tri­al test­ing XMT-1522 in pa­tients with breast, gas­tric, and non-small cell lung can­cers whose tu­mors ex­press HER2. The com­pa­ny ac­knowl­edged the death could be re­lat­ed to the ex­per­i­men­tal drug, and the FDA slapped a par­tial clin­i­cal hold on the tri­al. Mer­sana’s oth­er can­cer drug-in-de­vel­op­ment, XMT-1536, was un­af­fect­ed.

By Sep­tem­ber, the com­pa­ny and the FDA agreed to a re­vamped de­vel­op­ment pro­gram for XMT-1522, and the agency lift­ed its hold. How­ev­er, it looks like Take­da man­age­ment de­cid­ed that the pro­gram, and in­deed Mer­sana’s tech, was too risky to con­tin­ue their col­lab­o­ra­tion. In an SEC fil­ing, Mer­sana said that the Japan­ese drug­mak­er’s Mil­len­ni­um unit had elect­ed to ter­mi­nate the part­ner­ship on Jan­u­ary 2.

In its press re­lease on Fri­day, Mer­sana said it had aban­doned the de­vel­op­ment of XMT-1522 al­to­geth­er to fo­cus on its oth­er ex­per­i­men­tal drug, XMT-1536. The com­pa­ny’s shares were down about 15% in ear­ly trad­ing.

“We have made the dif­fi­cult de­ci­sion to ter­mi­nate the fur­ther de­vel­op­ment of XMT-1522 de­spite a fa­vor­able emerg­ing pro­file of ef­fi­ca­cy and tol­er­a­bil­i­ty due to the com­pet­i­tive en­vi­ron­ment for HER2-tar­get­ed ther­a­pies,” Mer­sana chief Pro­topa­pas said in a state­ment.

Leerink and Cowen an­a­lysts sug­gest­ed Mer­sana’s de­ci­sion was per­ti­nent, con­sid­er­ing the com­pet­i­tive land­scape for HER2-tar­get­ing ther­a­pies. Sev­er­al such ther­a­pies have al­ready been sanc­tioned ap­proval, and oth­ers are in de­vel­op­ment, in­clud­ing Dai­ichi Sankyo’s DS-8201 that car­ries 7-8 pay­loads, not­ed Cowen’s Boris Peak­er.

“Many in­vestors al­ready had very low ex­pec­ta­tions for XMT-1522…es­pe­cial­ly fol­low­ing the brief par­tial clin­i­cal hold placed on XMT-1522 that has con­tributed to the stock trad­ing near his­toric lows. The de­ci­sion to fo­cus re­sources on ad­vanc­ing XMT-1536 could al­so have a pos­i­tive im­pact on the com­pa­ny’s cash run­way,” Leerink an­a­lysts wrote in a note.

The com­pa­ny al­so pro­vid­ed en­cour­ag­ing ini­tial da­ta on XMT-1536 — a NaPi2b- tar­get­ing ADC — from an on­go­ing dose es­ca­la­tion study.

“Ul­ti­mate­ly…it will be im­por­tant for XMT-1536 to demon­strate dura­bil­i­ty of re­spons­es achieved giv­en Roche’s past NaPi2b dis­ap­point­ments,” they added.

Mer­sana con­tact­ed End­points News to as­sert that the Take­da part­ner­ship was ter­mi­nat­ed by mu­tu­al con­sent, echo­ing its press re­lease post­ed on Fri­day. 

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

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.

James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

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.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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