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. 

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.