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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

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