Brian Wong. RAPT

RAPT signs on with strug­gling Han­mi for Asian en­trance of can­cer ther­a­py aimed at 'charged tu­mors'

In the ear­ly 60s, two British vi­rol­o­gists an­a­lyz­ing tu­mor cells from Ugan­da made a land­mark sci­en­tif­ic dis­cov­ery that would lead to a land­mark sci­en­tif­ic er­ror.

They dis­cov­ered the first can­cer-caus­ing virus, lat­er epony­mous­ly named Ep­stein-Barr, and Amer­i­ca — fresh off the po­lio vac­cine’s un­prece­dent­ed suc­cess — was ready to be­lieve that most can­cers were caused by virus­es and thus could be cured by vac­cines. The prob­lem was sim­ple: Most can­cers weren’t, and the ones caused by Ep­stein-Barr most­ly af­flict­ed peo­ple oceans away from Wash­ing­ton DC, where the Na­tion­al Can­cer In­sti­tute be­gan spend­ing mil­lions on the sub­field.

So as RAPT Ther­a­peu­tics watched the ear­ly Phase I re­sults roll in last year on a treat­ment aimed large­ly at virus-fu­eled tu­mors, they be­gan plan­ning to cross the Pa­cif­ic. To­day they an­nounced a col­lab­o­ra­tion with South Ko­rea’s Han­mi Phar­ma­ceu­ti­cals worth $10 mil­lion up­front and up to $108 mil­lion in po­ten­tial de­vel­op­ment and sales mile­stones.

“It pro­vides ad­di­tion­al shots on goal and more proof-of-con­cept da­ta,” RAPT CEO Bri­an Wong told End­points News. “The sec­ond thing it does is pro­vide a piv­ot to Asia.”

The deal came af­ter sev­er­al months of ne­go­ti­a­tions with a va­ri­ety of Asian play­ers in mul­ti­ple coun­tries, Wong said. It will give Han­mi an ex­clu­sive li­cense to de­vel­op and com­mer­cial­ize RAPT’s lead prod­uct, FLX475, for can­cer in South Ko­rea, Chi­na, Hong Kong and Tai­wan. Han­mi will aug­ment an ex­ist­ing Phase I/II and be­gin their own Phase II in par­al­lel with a forth­com­ing US Phase II.

Formed from spare parts left­over af­ter Bris­tol-My­ers Squibb bought Flexus in 2015, RAPT – known as FLX Bio un­til this past May – tar­gets what they call “charged tu­mors.” These are tu­mors that have all the com­po­nents to be hit by the body’s im­mune re­sponse but sur­vive by har­ness­ing reg­u­la­to­ry T cells.

These T cells are meant to sup­press the im­mune sys­tem and stop the body from at­tack­ing healthy cells, but a tu­mor can al­so some­times use them to sur­vive. FLX475 blocks a path­way on those cells called CCR4, and RAPT thinks that will pre­vent them from en­ter­ing the tu­mor and turn­ing down the im­mune re­sponse.

And these charged tu­mors hap­pen to in­clude many virus-as­so­ci­at­ed can­cers and oth­ers, such as gas­tric can­cer, that are more preva­lent in Asia.

“We are run­ning our own glob­al tri­als but we re­al­ly we couldn’t ac­cess all of the charged tu­mors,” Wong said. “This is what the col­lab­o­ra­tion al­lows us to do.”

For RAPT, the part­ner­ship comes af­ter its hopes of a $70-mil­lion-plus IPO got cold-shoul­dered by an oth­er­wise pop­ping sum­mer biotech mar­ket. Ul­ti­mate­ly, they set­tled for rais­ing $36 mil­lion on 3 mil­lion shares.

For Han­mi, the small biotech deal comes af­ter it’s been spurned by its old deep-pock­et­ed part­ners. J&J and Eli Lil­ly dumped two deals with the com­pa­ny this year worth a com­bined $1.5 bil­lion, and of course, in 2016 Boehringer In­gel­heim abrupt­ly walked out of a $730 mil­lion part­ner­ship af­ter Han­mi failed to re­port pa­tient deaths in a tri­al.

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

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Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

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FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

Bio­phar­ma has aban­doned an­tibi­ot­ic de­vel­op­ment. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

PhII fail­ure in rare neu­rode­gen­er­a­tive dis­ease? No mat­ter, Bio­gen will mo­tor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.