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: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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