Ver­sant-backed Tem­pest grabs a $70M round with plans to dri­ve a slate of I/O drugs in­to the clin­ic

The boom­ing can­cer drug R&D field can count one more play­er with some big dreams to pur­sue in im­muno-on­col­o­gy.

San Fran­cis­co-based Tem­pest Ther­a­peu­tics is mak­ing its de­but to­day af­ter land­ing a $70 mil­lion B round, fu­el­ing the work of the start­up team as­sem­bled at Ver­sant Ven­tures — which pro­vid­ed a pre­clin­i­cal pipeline that fea­tures some new con­tenders in some fast-grow­ing nich­es.

At the front of the queue is TPST‐8844, an IDO in­hibitor which will look to make a rep for it­self as In­cyte and Bris­tol-My­ers Squibb push more ad­vanced pro­grams. Then there’s TPST-1120, a PPARα block­er de­signed to in­flame the tu­mor mi­croen­vi­ron­ment and ac­ti­vates im­por­tant tu­mor‐killing im­mune cells. And they are al­so en­gaged on E‐prostanoid (EP) re­cep­tor an­tag­o­nists, look­ing to in­ter­rupt the im­muno‐sup­pres­sive ef­fects of prostaglandin.

Pep­pi Pr­a­sit

By last count at the Can­cer Re­search In­sti­tute, there were 18 IDO in­hibitors in the clin­ic. To­day’s an­nounce­ment brings the tal­ly to at least 19. But the folks be­hind Tem­pest be­lieve that Pep­pi Pr­a­sit’s dis­cov­ery group at Ver­sant’s In­cep­tion Sci­ences has as­sem­bled a first-class on­col­o­gy pipeline that can still make a splash in crowd­ed fields.

“To be com­pet­i­tive here you had to be a lot bet­ter, it had to be a su­pe­ri­or mol­e­cule,” says Brad Bol­zon, the man­ag­ing di­rec­tor at Ver­sant. “We wouldn’t have brought for­ward a pro­gram un­less it could re­al­ly com­pete.”

As for the IDO drug, he says: “We feel pret­ty con­fi­dent that this is go­ing to be a game-chang­ing as­set.”

Tom Duben­sky

Tem­pest turned to Tom Duben­sky — up un­til last Au­gust the chief sci­en­tif­ic of­fi­cer at Aduro Biotech— to take the wheel. Duben­sky tells me he’s known the Ver­sant team for years, oc­ca­sion­al­ly help­ing out ad­vis­ing on deals. And he sounds primed and ready to roll as the new CEO.

“I would have been a fool not to jump at the chance,” Duben­sky tells me. The field may be crowd­ed, he says, but the right IDO pro­gram can at­tract plen­ty of pos­i­tive at­ten­tion.

“For those com­pa­nies with­out an IDO,” he says, “there will be a re­al land rush to­ward IDO in­hibitors.”

Duben­sky al­so counts him­self as a big fan of Pr­a­sit’s work at In­cep­tion. “It’s a col­lec­tion of med­i­c­i­nal chemists,” he says, “and they know how to de­vel­op small mol­e­cules.”

The syn­di­cate Ver­sant Ven­tures as­sem­bled in­cludes some big play­ers out of Asia, an in­creas­ing­ly com­mon fea­ture in US rounds — par­tic­u­lar­ly in San Fran­cis­co. The round in­volved F‐Prime Cap­i­tal and Quan Cap­i­tal, with ad­di­tion­al funds com­ing from Lil­ly Asia Ven­tures, Fore­site Cap­i­tal and Eight Roads Ven­tures.

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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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.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.

Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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