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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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