RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small can­cer and in­flam­ma­tion biotech with back­ing from GV, changed its name to RAPT Ther­a­peu­tics and filed con­fi­den­tial­ly for an IPO. On Ju­ly 5th, they filed to raise up to $86 mil­lion. On Ju­ly 22, they an­nounced the IPO with a $75 mil­lion goal.  And on Au­gust 1, they abrupt­ly and with­out ex­pla­na­tion called it all off.

Now, with­out ex­pla­na­tion, they’re re­viv­ing the bid, fil­ing again for a $75 mil­lion IPO, this time with a new bookrun­ner and a new drug can­di­date in the clin­ic. The terms will be the same: 5 mil­lion shares at $14-$16 per share. It would give them a di­lut­ed mar­ket val­ue of $351 mil­lion.

RAPT CEO Bri­an Wong

The IPO ap­pears to be the com­pa­ny’s first ma­jor fund­ing stream since a $60 mil­lion Se­ries C in 2017 and will sup­ply rev­enue to pro­pel their top can­cer and in­flam­ma­tion drugs, re­spec­tive­ly, fur­ther in­to the clin­ic.

RAPT was formed af­ter Bris­tol-My­ers ac­quired the im­muno-on­col­o­gy biotech Flexus in a 2015 deal worth up to $1.25 bil­lion in 2015.  Flexus then as­signed some of its un­ac­quired as­sets to a new com­pa­ny, FLX Bio, most no­tably FLX925, a CDK4/6 and FLT3 in­hibitor then en­ter­ing Phase 1.

But it wasn’t long be­fore the founders — Ter­ry Rosen and Juan Jaen — left and FLX925 hit a wall. The new own­ers, though, were able to con­vince GV and oth­er funds to put $60 mil­lion be­hind a piv­ot to CCR4 in­hibitors. This was in De­cem­ber 2017, short­ly af­ter Ky­owa Hakko un­veiled pos­i­tive Phase III da­ta for the an­ti-CCR4 ther­a­py moga­mulizum­ab.

RAPT has since fo­cused on two such in­hibitors: FLX475, which they hope will be a monother­a­py for mul­ti­ple can­cers, and RPT193, an an­ti-in­flam­ma­to­ry. This morn­ing, the biotech an­nounced they had be­gun a Phase I tri­al on RPT193 atopic der­mati­tis, al­though like oth­er com­pa­nies they hope to use the skin dis­ease as a launch­ing pad to broad­er an­ti-in­flam­ma­to­ry ap­pli­ca­tions.

The new S-1 ap­pears to be large­ly the same, with up­dat­ed lan­guage to re­flect the ex­pect­ed progress the com­pa­ny has made in the three months since their last fil­ing. (The amend­ment no longer says, for in­stance, that they plan on be­gin­ning a Phase I tri­al on RPT193 in Au­gust 2019.).

RAPT lacks clin­i­cal da­ta be­yond some pos­i­tive Phase I tol­er­a­bil­i­ty find­ings on FLX475. It will use the pro­ceeds to push RPT193 through its Phase I tri­al and FLX475 through a proof-of-con­cept Phase I/II tri­al on what they call “charged” tu­mors — those with high lev­els of CCR4 lig­ands, Treg and CD8+ef­fec­tor cells, in­clud­ing non-small cell lung can­cer, triple-neg­a­tive breast can­cer, and gas­tric can­cer. The tri­al will ex­am­ine the drug as a monother­a­py and in com­bi­na­tion with Keytru­da.

Their pitch to in­vestors when they piv­ot­ed to CCR4 – and which they re­it­er­at­ed in their S-1 — was that by us­ing small mol­e­cules and not an­ti­bod­ies (like moga­mulizum­ab), they could be more se­lec­tive and min­i­mize the im­pact on T-cells through­out the body.

RAPT is al­so de­vel­op­ing an in­hibitor for GCN2i, a path­way they say is gen­er­al­ly not ac­tive in healthy tis­sue and thus a good can­di­date for a tar­get­ed ther­a­py. They aim to file an IND in 2020.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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CEO Marco Taglietti (Scynexis)

'N­ev­er been more ur­gent:' Scynex­is looks to tack­le su­per­bug cri­sis with late-stage read­out for an­ti­fun­gal hope­ful

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

A spot­light schiz­o­phre­nia drug in Neu­ro­crine's $2B Take­da deal flunks its first ma­jor test. But it's not giv­ing up yet

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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