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 his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Chi­nese in­vestors wa­ger $105M on an IPO-bound biotech look­ing to push RNAi as main­stream can­cer ther­a­py

Shortly after Sirnaomics brought in a $47 million Series C for its small interfering RNA pipeline last year, Patrick Lu — the founder, president and CEO — was asked to outline the scientific advances that will be necessary to make better drugs out of RNA tech.

“The next step in the evolution of RNAi as a leading therapeutic will be the ability to safely target organs outside the liver such as lung, brain, etc,” he had offered. “This will revolutionize disease treatments if the industry can demonstrate similar data sets for non-liver targets as we have seen in liver-based diseases.”

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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