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.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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‘There was a grow­ing weari­ness’: As­pen Neu­ro­sciences se­cures $70M Se­ries A to ease in­vestors' con­cerns

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

A single news report on the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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Covid 19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $175 million financing – $25 million of the first B round is considered part of the second – illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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Flex­ion se­cures Chi­na deal for os­teo­poro­sis drug; Strug­gling to find a buy­er, Ako­rn throws in the tow­el

→ Flexion may be hitting the brakes on clinical trials, including one for its osteoporosis Zilretta, but that’s not stopping the biotech from plotting regulatory action in China. Hong Kong Tainuo has committed $10 million upfront to seize the development and commercialization rights to Zilretta, with plans to apply for a clinical trial in China by the end of the year. Flexion, which said it has 10 months of finished goods in the US and 12 months of active pharmaceutical ingredient available, will supply all products to the Chinese partner.