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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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