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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Getty Images

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Paul Biondi (File photo)

Bris­tol-My­er­s' strat­e­gy, BD chief Paul Bion­di ex­it­ed the com­pa­ny — just ahead of the $74B Cel­gene deal close

Paul Biondi, who orchestrated billions of dollars in deals for Bristol-Myers Squibb over the 5 years he’s run their business development team, has exited the company. Biondi left last month, according to a company spokesperson, in pursuit of another — unspecified — external opportunity.

After 17 years with Bristol-Myers Squibb, Paul Biondi, Head of Strategy and Business Development, decided to leave the company to pursue an external opportunity. The company wishes him well in his new endeavors. Bristol-Myers Squibb  is actively searching for Paul’s successor, and will make an announcement, as appropriate.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Arie Belldegrun at UKBIO 2019. Shai Dolev for Endpoints News

Kite Phar­ma's ex-CEO con­tra­dicts founder as CAR-T patent tri­al heats up, with con­flict­ing val­u­a­tions

Two days after Kite Pharma founder Arie Belldegrun told a federal courtroom that a meeting he had with a Memorial Sloan Kettering executive wasn’t about licensing their immunotherapy patent, Kite’s ex-CEO Aya Jakobovits said it was.

The admission came Tuesday during cross-examination in a patent infringement case that features two of the biggest cancer biotechs and some of the most well-known names in American medicine.

Jakobovits initially said she was not in attendance, didn’t know it was going to happen and didn’t know what took place, according to Law360. But then the plaintiff’s lawyer handed her a document – whose contents were not publicly revealed – and asked again if she learned after-the-fact that the meeting involved a potential patent license.

“Yes,” Jakobovits eventually said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.