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.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantiating reforms to the advisory committee process at the agency.

Short on examples, Cavazzoni said at a BIO event aired on Monday that some recent adcomms show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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Terns Phar­ma­ceu­ti­cals touts safe­ty da­ta from an ex-Eli Lil­ly can­di­date in the hunt for NASH treat­ment

While many others have tried — and failed — to get a NASH candidate across the finish line, Terns Pharmaceuticals thinks its FXR agonist will eventually earn its wings without the safety issues that have slowed others down. Now, a mid-stage safety readout could help add some validity to those hopes.

No patients in the Phase IIa LIFT study discontinued TERN-101 due to side effects, CMO Erin Quirk said during a call with investors on Monday morning. That includes pruritus, an uncomfortable itching sensation that frequently leads patients to drop out of other FXR agonist studies.

Paul Burton, incoming Moderna CMO (J&J/file photo)

Look­ing be­yond the pan­dem­ic, Mod­er­na ap­points J&J vet­er­an Paul Bur­ton as new CMO

Moderna is turning to one of its Covid-19 vaccine competitors to fill its open CMO slot, but this time, it’s not the vaccine experience they’re after.

Paul Burton, who’s spent 16 years at J&J, most recently as chief global medical affairs officer of Janssen, will take over as Moderna CMO on July 6.

With an eye toward a future beyond the pandemic, the mRNA biotech went with Burton, who earned his MD and PhD degrees in London, as he offers experience on a range of therapeutic areas, as well as work as a cardiothoracic surgeon and leading tech projects with Apple.

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