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.”

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

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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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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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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