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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.