Tem­pest Ther­a­peu­tics jumps on­to Nas­daq in merg­er with strug­gling Mil­len­do Ther­a­peu­tics; Bio­haven hits $100M mile­stone as it gears up for a late-stage study in mi­graine pa­tients

Less than a month af­ter land­ing a Big Phar­ma part­ner on one of its lead on­col­o­gy pro­grams, Tem­pest Ther­a­peu­tics is back­flip­ping on­to Nas­daq through a re­verse merg­er with Mil­len­do Ther­a­peu­tics.

Back in Jan­u­ary, Mil­len­do shut down the sole re­main­ing ear­ly-stage study for its NK3R an­tag­o­nist MLE-301 — just nine months af­ter pulling the plug on a piv­otal study for its lead drug liv­o­le­tide. The biotech planned some deep cuts for the re­main­ing staff, while look­ing for a sale or merg­er.

In sup­port of the merg­er, Tem­pest se­cured com­mit­ments from a slate of in­vestors for a $30 mil­lion PIPE fi­nanc­ing, in­clud­ing Ver­sant Ven­tures, Rock Springs Cap­i­tal, F-Prime Cap­i­tal, Monashee In­vest­ment Man­age­ment, Quan Cap­i­tal, Lyfe Cap­i­tal, Maven In­vest­ment Part­ners US, Lil­ly Asia Ven­tures and Eight Roads Ven­tures, the com­pa­ny said on Mon­day. Over­all, the deal should ex­tend the com­pa­ny’s cash run­way through ear­ly 2023, ac­cord­ing to a state­ment.

Tom Duben­sky

Ear­li­er this month, the com­pa­ny inked a deal with Roche to study its TPST-1120 in com­bi­na­tion with Tecen­triq and Avastin in pre­vi­ous­ly un­treat­ed pa­tients with ad­vanced he­pa­to­cel­lu­lar car­ci­no­ma (HCC). The com­pa­ny al­so has TPST-1495, which is in a Phase Ia/Ib dose and sched­ule op­ti­miza­tion study in pa­tients with ad­vanced sol­id tu­mors, specif­i­cal­ly known prostaglandin-dri­ven tu­mors like col­orec­tal can­cer, lung ade­no­car­ci­no­ma and urothe­lial can­cer.

“The tran­si­tion of Tem­pest to a pub­lic com­pa­ny en­hances our abil­i­ty to fund these po­ten­tial­ly im­por­tant prod­uct can­di­dates, as well as con­sid­er ad­di­tion­al pro­grams with ex­cit­ing new tar­gets,” CEO Tom Duben­sky said in a state­ment.

The merg­er is ex­pect­ed to close in the first half of this year, with Mil­len­do stock­hold­ers ex­pect­ed to own ap­prox­i­mate­ly 18.5% of the com­bined com­pa­ny and pre-merg­er Tem­pest stock­hold­ers to hold 81.5%.

Bio­haven hits $100M mile­stone as it gears up for a late-stage study in mi­graine pa­tients

Bio­haven has of­fi­cial­ly launched a Phase II/III tri­al for its oral mi­graine drug, trig­ger­ing a $100 mil­lion pay­off from Roy­al­ty Phar­ma.

Back in Au­gust, Bio­haven added near­ly $1 bil­lion to its bal­ance sheet through a pair of cre­ative agree­ments with Roy­al­ty Phar­ma and the in­vest­ment firm Sixth Street to bol­ster the com­mer­cial launch of its new mi­graine drug, Nurtec. As part of an agree­ment with Roy­al­ty, Bio­haven was promised up to $250 mil­lion to ad­vance its za­veg­epant in mi­graine and oth­er CGRP-me­di­at­ed dis­eases. Bio­haven had al­ready pock­et­ed $150 mil­lion, and will now re­ceive the last $100 mil­lion as it en­rolls the first pa­tient in the Phase II/III study. In to­tal, Bio­haven is look­ing for 2,900 mi­graine pa­tients to test the ef­fi­ca­cy and safe­ty of 100 mg and 200 mg dos­es of oral za­veg­epant.

“Our suc­cess­ful, mul­ti-year part­ner­ship with Bio­haven to sup­port both the reg­u­la­to­ry ap­proval and com­mer­cial­iza­tion of Nurtec as well as pipeline de­vel­op­ment is an ex­cel­lent ex­am­ple of how Roy­al­ty Phar­ma can be a col­lab­o­ra­tive part­ner to in­no­v­a­tive bio­phar­ma com­pa­nies,” Roy­al­ty CSO and co-head of re­search and in­vest­ments Jim Red­doch said in a state­ment.

An in­tranasal for­mu­la­tion of za­veg­epant, for­mer­ly known as vazegepant, achieved su­pe­ri­or ef­fi­ca­cy to place­bo in a Phase II/III study, the com­pa­ny said.

Sim­cere promis­es near­ly $300M for the rights to a for­mer Genen­tech can­di­date

There’s a new glioblas­toma can­di­date in Greater Chi­na.

Sim­cere Phar­ma­ceu­ti­cal Group is putting down $11 mil­lion up­front and up to $281 in mile­stones for the de­vel­op­ment and com­mer­cial­iza­tion rights to Kazia Ther­a­peu­tics’ pax­al­is­ib — a PI3K in­hibitor li­censed from Genen­tech back in 2016. The can­di­date en­tered a piv­otal study ear­li­er this year, and is in sev­en ad­di­tion­al stud­ies for oth­er brain can­cers.

“The need for new ther­a­pies in brain can­cer is sig­nif­i­cant in Chi­na, and we share Kazia’s com­mit­ment to bring­ing for­ward new treat­ment op­tions for pa­tients,” Sim­cere se­nior VP Ren­hong Tang said in a state­ment.

Pax­al­is­ib is dis­tin­guished by its abil­i­ty to cross the blood-brain bar­ri­er, which pre­vents many drugs from ful­ly af­fect­ing brain tis­sue, the com­pa­ny said.

Sim­cere’s up­front pay­ment in­cludes $7 mil­lion in cash and a $4 mil­lion eq­ui­ty in­vest­ment. In ad­di­tion to the $281 mil­lion in mile­stones for glioblas­toma, Kazia can snag more for oth­er in­di­ca­tions, ac­cord­ing to the deal. And Sim­cere will dole out com­mer­cial roy­al­ties in the “mid-teens.” Sim­cere can de­vel­op and mar­ket the drug in Main­land Chi­na, Hong Kong, Macau, and Tai­wan, while Kazia re­tains the rights every­where else.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.