Brig­gs Mor­ri­son’s lit­tle biotech Syn­dax con­cedes 2 key tri­al set­backs for its lead drug, as shares shriv­el some more

It takes a lit­tle pa­tience, but if you bore through some com­ments about how en­thu­si­as­tic Syn­dax $SNDX CEO Brig­gs Mor­ri­son is about their on­go­ing piv­otal tri­al in breast can­cer with their lead drug, you’ll find that the ther­a­py just failed a cou­ple of key com­bi­na­tion stud­ies with two ap­proved PD-L1s.

Brig­gs Mor­ri­son

Mor­ri­son — who had a se­nior R&D post at As­traZeneca be­fore mak­ing the leap to biotech — notes that the 2 Phase Ib/II stud­ies com­bined enti­no­s­tat with Roche’s Tecen­triq and Pfiz­er/Mer­ck KGaA’s Baven­cio for triple neg­a­tive breast can­cer and ovar­i­an can­cer. But it failed to ex­tend pro­gres­sion-free sur­vival sig­nif­i­cant­ly.

As a re­sult, the Waltham, MA-based biotech is de­fer­ring the PD-1 pro­gram for enti­no­s­tat, which in­cludes a study in non-small cell lung can­cer. In­stead, the biotech is cir­cling the wag­ons around enti­no­s­tat “in HR+ breast can­cer and SNDX-5613, a Menin in­hibitor be­ing de­vel­oped for ge­net­i­cal­ly-de­fined pop­u­la­tion(s) of acute leukemias.”

Mor­ri­son, who’s kept a low pro­file since leav­ing As­traZeneca, prefers to fo­cus on the pos­i­tive. In a pre­pared state­ment, he not­ed:

We re­main high­ly en­cour­aged by the po­ten­tial for a pos­i­tive over­all sur­vival read­out in E2112, our Phase III reg­is­tra­tion tri­al of enti­no­s­tat plus ex­emes­tane in HR+, HER2- breast can­cer, and ex­pect the next in­ter­im analy­sis in the sec­ond quar­ter. As a re­minder, any pos­i­tive over­all sur­vival re­sult would al­low us to file for full reg­u­la­to­ry ap­proval in an in­di­ca­tion for which ex­ist­ing ther­a­pies have failed to show a sur­vival ben­e­fit. In ad­di­tion, we con­tin­ue to ex­pect to file an IND in the sec­ond quar­ter for our tar­get­ed ther­a­py, SNDX-5613, an in­hibitor of the Menin-MLL in­ter­ac­tion.

A fail­ure would prob­a­bly cap­size the com­pa­ny at this point.

The small-cap biotech has a lit­tle more than $80 mil­lion in re­serves, which ac­counts for close to half of its mar­ket cap of $155 mil­lion. Its stock is trad­ing at less than half of where it peaked in the spring of 2018, and slid 12% in af­ter-mar­ket trad­ing.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Roger Perlmutter, Merck R&D chief (YouTube)

Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

Once a gem, now just a rock, Take­da punts PhI­II IBD drug as ri­vals mus­cle ahead

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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