Gale­na im­plodes as tri­al mon­i­tors call a halt to a failed PhI­II can­cer study

Shares of Gale­na ($GALE) were evis­cer­at­ed this morn­ing, drop­ping 78% af­ter the biotech an­nounced that it had stopped a Phase III study of its lead can­cer vac­cine Neu­Vax af­ter the mon­i­tor­ing com­mit­tee flagged it for fail­ing to help breast can­cer vic­tims.

Prov­ing yet again that an en­tire wave of can­cer vac­cines has been a dis­ap­point­ing flop, the San Ra­mon, CA-based biotech says it will now as­sess the pro­gram — but it doesn’t look good.

Gale­na CEO Mark W. Schwartz

“To date, the tri­al has not been un-blind­ed oth­er than by the IDMC, and we need to eval­u­ate the da­ta,” says CEO Mark W. Schwartz in a state­ment. “We ex­pect to host a con­fer­ence call next week to pro­vide a pre­lim­i­nary re­view of the PRE­SENT tri­al and an up­date on all of our im­munother­a­py and hema­tol­ogy clin­i­cal de­vel­op­ment pro­grams.”

Neu­Vax, or nelipepimut-S, is de­signed to whip up a T cell re­sponse tar­get­ing HER2 pos­i­tive can­cer cells. Gale­na be­lieved that it had the right de­sign to hunt down and de­stroy mi­grat­ing cells that could trig­ger a re­cur­rence of can­cer. But like sev­er­al pre­de­ces­sors, that proved not to be the case.

Gale­na spelled out the dis­as­ter in a fil­ing with the SEC:

“On 24 June 2016, the as­sem­bled In­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee met to re­view the ef­fi­ca­cy and safe­ty da­ta avail­able for the afore­men­tioned pro­to­col. At this time the DMC rec­om­mends that the study be stopped for fu­til­i­ty un­less it is de­ter­mined that there has been a sys­tem­at­ic re­ver­sal in the study drug treat­ments in the two arms, in which case the IDMC should reeval­u­ate the clin­i­cal ev­i­dence. The IDMC rec­om­mends that this be in­ves­ti­gat­ed as quick­ly as pos­si­ble and, in the mean­time, that this in­for­ma­tion be dis­closed on­ly to any in­di­vid­ual(s) with a need to know about the pro­ce­dures used to clar­i­fy the cur­rent sit­u­a­tion. Fi­nal­ly, the DMC re­quests that Gale­na Bio­phar­ma in­form the IDMC mem­bers of the out­come of this in­ves­ti­ga­tion and any de­ci­sion with re­spect to dis­con­tin­u­a­tion of the clin­i­cal tri­al as soon as pos­si­ble.”

As­traZeneca trum­pets the good 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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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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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Iron­wood kicks de­layed-re­lease Linzess for­mu­la­tion to the curb af­ter tri­al fail­ure

The delayed-release formulation of Ironwood and Allergan’s bowel drug Linzess will not see the light of day.

The experimental drug, MD-7246, failed to help patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) in a mid-stage study, prompting the partners to abandon the therapy.

First approved in 2012, Linzess (known chemically as linaclotide) enhances the activity of the intestinal enzyme guanylate cyclase-C to increase the secretion of intestinal fluid and then transit through the intestinal tract, as well as reduce visceral pain, to relieve pain and constipation associated with IBS.

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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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.

Loew’s departure comes amid a slow-moving shakeup to the French pharma giant’s executive team. The company also announced today that Alan Main, the head of their consumer healthcare unit, is out, and they named four executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma. Thomas Triomphe will be the one promotion from inside the company, as he moves to take Loew’s position at the helm of Sanofi Pasteur, one of the world’s largest vaccine divisions.

Look­ing to move past an R&D fi­as­co, Ipsen poach­es their new CEO from Sanofi

Ipsen has turned to another Paris-based biopharma company for its next CEO.

Sanofi Pasteur chief David Loew — who’s been leading one of the most advanced efforts to develop vaccines for Covid-19 — is making the journey to Ipsen, 5 months after David Meek jumped ship to run a startup in late-stage development.

Loew arrives as Ipsen works to get back on track with their rare bone disease drug palovarotene, picked up in the $1.3 billion Clementia buyout, which was slammed with a partial hold after researchers observed cases of “early growth plate closure” in patients under the age of 14. But they are pushing ahead with the over-14 crowd after writing down slightly more than half of its initial development.

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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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: 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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