Founders David Epstein and Elizabeth Buck [file photo]

Can­cer-fo­cused Black Di­a­mond vaults on to Nas­daq in $200M+ pub­lic de­but, mark­ing biggest biotech IPO in 2020 so far

Ver­sant-backed Black Di­a­mond Ther­a­peu­tics has set its sights on an up­sized biotech IPO to kick 2020 off.

The first start­up out of Ver­sant’s Ridge­line dis­cov­ery en­gine in Basel is set to make its pub­lic de­but on Thurs­day, rais­ing gross pro­ceeds of $201 mil­lion through the sale of 10.6 mil­lion shares priced at $19 a pop.

That ex­ceeds the ini­tial plan to raise $151 mil­lion by of­fer­ing 8.9 mil­lion shares at a price range of $16 to $18 — a pos­i­tive sign that the IPO win­dow is still wide open for busi­ness, es­pe­cial­ly for can­cer biotechs. On­col­o­gy is lu­cra­tive, with can­cer fast catch­ing up with car­dio­vas­cu­lar dis­ease as the most dead­ly con­di­tion in the de­vel­oped world.

Ahead of the IPO, Black Di­a­mond’s tu­mor-ag­nos­tic ap­proach to fight­ing can­cer spawned more than $200 mil­lion in ven­ture fund­ing. At the end of 2018 the com­pa­ny — found­ed by two sci­en­tists in­volved in the de­vel­op­ment of the can­cer drug Tarce­va, David Ep­stein and Eliz­a­beth Buck — ini­tial­ly raised $20 mil­lion in its Se­ries A. That in­jec­tion was sup­ple­ment­ed by two back-to-back to $85 mil­lion rounds of fi­nanc­ing, led by sev­er­al high pro­file groups in­clud­ing New En­ter­prise As­so­ci­ates, RA Cap­i­tal Man­age­ment and Box­er Group.

While in­hibitors used to sup­press ki­nase do­main mu­ta­tions, or TKIs, are con­sid­ered stan­dard-of-care treat­ment for many types of can­cer, al­losteric mu­ta­tions are still un­chart­ed ter­ri­to­ry. Us­ing their tech plat­form, Black Di­a­mond is look­ing to map al­losteric mu­ta­tions dri­ving can­cer to de­vel­op in­hibitors that are tu­mor ag­nos­tic.

Onco­genes — which have the po­ten­tial to cause the growth of can­cer cells — are ac­ti­vat­ed by ki­nase do­main mu­ta­tions or by al­losteric mu­ta­tions. Al­lostery is a com­mon process by which pro­teins trans­mit the ef­fect of bind­ing at one site to an­oth­er — of­ten dis­tal — func­tion­al site, al­low­ing for reg­u­la­tion of ac­tiv­i­ty.

“World­wide sales of ki­nase in­hibitors, one class of tar­get­ed ther­a­pies, ex­ceed­ed $25 bil­lion in 2018. De­spite the suc­cess of these drugs, a re­cent analy­sis found that on­ly nine per­cent of pa­tients with metasta­t­ic can­cer have tu­mors with ge­net­ic pro­files that could make them el­i­gi­ble for treat­ment with an ap­proved pre­ci­sion on­col­o­gy med­i­cine,” Black Di­a­mond cit­ed in its IPO fil­ing ear­li­er this month,

As in­creas­ing ge­nom­ic pro­fil­ing of can­cer pa­tients iden­ti­fies clus­ters of un­char­ac­ter­ized ge­nom­ic al­ter­ations, the biotech’s tech­nol­o­gy is de­signed to iso­late “drug­gable mu­ta­tion bas­kets” to cre­ate pre­ci­sion med­i­cines that could ben­e­fit a broad­er swathe of pa­tients.

The com­pa­ny’s lead ex­per­i­men­tal ther­a­py, BDTX-189, is en­gi­neered to thwart the func­tion of onco­genic pro­teins that af­fect both EGFR and HER2, and is be­ing groomed for a Phase I/II tri­al set to kick off in the first half of this year. Black Di­a­mond al­so has a pre­clin­i­cal can­di­date — among oth­er undis­closed as­sets brew­ing in its pipeline — de­signed to com­bat glioblas­toma, a par­tic­u­lar­ly ag­gres­sive and dead­ly form of brain can­cer.

Black Di­a­mond will make its de­but on the Nas­daq un­der the sym­bol “$BDTX.”

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 new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Philipp Spycher

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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