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. 

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.