Slammed by more deaths, Seat­tle Ge­net­ics scraps a PhI­II study and pulls back (again) on vadas­tux­imab

Clay Sie­gall

Just three months af­ter the FDA lift­ed a clin­i­cal hold on its late-stage can­cer drug vadas­tux­imab talirine (SGN-CD33A), the biotech abrupt­ly scrapped a Phase III study and halt­ed en­roll­ment across a slate of stud­ies af­ter in­de­pen­dent mon­i­tors tracked a high­er rate of deaths among pa­tients tak­ing its drug.

The deaths in the study — for front­line use against acute myeloid leukemia — in­clud­ed fa­tal in­fec­tions but were ev­i­dent­ly not as­so­ci­at­ed with liv­er tox­i­c­i­ty, which had al­ready killed 4 pa­tients, forc­ing the FDA to hit the brakes on the study in late De­cem­ber, 2016.

The lat­est safe­ty cri­sis will hit Seat­tle Ge­net­ics $SGEN hard. The com­pa­ny had been re­port­ing pos­i­tive da­ta on the drug, its most ad­vanced ex­per­i­men­tal drug in the pipeline, and an­a­lysts were look­ing for new ways for the com­pa­ny to ex­pand be­yond Ad­cetris. Just a few weeks ago Seat­tle Ge­net­ics was al­so forced to throw the tow­el in on a $2 bil­lion deal to col­lab­o­rate with Im­munomedics, fur­ther lim­it­ing its late-stage ef­fort.

The com­pa­ny’s stock dropped 12% on the news, mark­ing the loss of about $1 bil­lion in mar­ket cap.

Da­ta at one point for vadas­tux­imab demon­strat­ed that 15 of 23 (65%) evalu­able pa­tients achieved CR/CRi. At a me­di­an fol­low-up of 7.7 months, me­di­an sur­vival had not yet been reached, and 72 per­cent of pa­tients re­mained alive and on study.

Back in March the biotech re­port­ed that it was get­ting restart­ed on the clin­i­cal work af­ter it came up with “re­vised el­i­gi­bil­i­ty cri­te­ria and stop­ping rules for veno-oc­clu­sive dis­ease.” The FDA agreed to lift the hold on­ly two months af­ter it was dropped on Seat­tle Ge­net­ics. And the agency may face ques­tions about why it was so quick to agree to the green light, giv­en the re­cent deaths.

Seat­tle Ge­net­ics CEO Clay Sie­gall tried to shift the fo­cus to the pos­i­tive. He not­ed:

“We are en­thu­si­as­tic about the many op­por­tu­ni­ties across our broad pipeline, in­clud­ing AD­CETRIS (bren­tux­imab ve­dotin), en­for­tum­ab ve­dotin (ASG-22ME) and SGN-LIV1A. No­tably, we are look­ing for­ward to re­port­ing da­ta from our AD­CETRIS phase 3 ECH­E­LON-1 tri­al in front­line Hodgkin lym­phoma, and we are on track to ad­vance en­for­tum­ab ve­dotin in­to a piv­otal tri­al in metasta­t­ic urothe­lial can­cer in the sec­ond half of 2017 un­der our col­lab­o­ra­tion with Astel­las.”

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.