The first biotech IPO of the new decade has land­ed — and of course it's an­oth­er can­cer drug de­vel­op­er

The first biotech IPO of 2020 is here, and it’s for a com­pa­ny found­ed by two mar­quee names in on­col­o­gy.

Cam­bridge-based Black Di­a­mond Ther­a­peu­tics filed on Fri­day for an IPO worth up to $100 mil­lion, be­com­ing the first biotech of the decade to an­nounce their in­ten­tion to go pub­lic. They’ll use their pro­ceeds to bring their new onco­gene ap­proach in­to the clin­ic.

The fact that an on­col­o­gy biotech will be the first IPO of the new decade should come as lit­tle sur­prise. The cal­en­dar may have changed but the ba­sic in­cen­tives that have dri­ven record in­vest­ment in­to and rev­enue from can­cer drugs haven’t. Last year’s first IPO — Po­sei­da Ther­a­peu­tics — was al­so a can­cer-fo­cused biotech.

The first com­pa­ny launched out of Ver­sant’s Basel-based dis­cov­ery en­gine in De­cem­ber 2018, Black Di­a­mond lever­aged a high-pro­file C-suite and emerg­ing sci­ence to rapid­ly rake in cash: Near­ly $200 mil­lion with­in a year of their emer­gence from stealth mode, in­clud­ing an $85 mil­lion Se­ries C last month.

David Ep­stein

The biotech is run by David Ep­stein and Eliz­a­beth Buck, two for­mer de­vel­op­ers of the can­cer drug Tarce­va. The tech is a form of tar­get­ed on­col­o­gy called al­losteric ther­a­pies. These ther­a­pies are sim­i­lar to oth­er onco­genic drugs, such as ki­nase in­hibitors, that in­hib­it the main bind­ing site of a pro­tein fu­el­ing can­cer. It just does so by in­hibit­ing a dif­fer­ent part of the pro­tein that may have mu­tat­ed.

Black Di­a­mond has spent over a year map­ping these mu­ta­tions, be­fore rais­ing the Se­ries C on the promise of push­ing their BDTX-189 drug for HER2 and EGFR mu­ta­tions in­to a Phase I/II tri­al.

They promise to use the bulk of their IPO pro­ceeds for the same goal, with some of the rest go­ing to a pre­clin­i­cal glioblas­toma pro­gram.

Eliz­a­beth Buck

I-Mab Bio­phar­ma

The same day as Black Di­a­mond’s fil­ing, Shang­hai-based on­col­o­gy start­up I-Mab Bio­phar­ma up­dat­ed their fil­ing with de­tailed in­for­ma­tion. They’re ex­pect­ed to be the year’s first biotech to price, on Jan­u­ary 16.

I-Mab’s an­nounce­ment came in Oc­to­ber, but the new fil­ing of­fers more de­tail in­to a com­pa­ny that hopes to be­come the first Chi­nese biotech to list on the Nas­daq ex­change since Zai Lab de­buted in 2017.

They ex­pect to price be­tween $13 and $14 per share and raise $87 mil­lion. They will use the pro­ceeds large­ly to fund a long list of clin­i­cal tri­als, while slot­ting sig­nif­i­cant por­tions for build­ing their own man­u­fac­tur­ing fa­cil­i­ty in Chi­na and re­search fa­cil­i­ties in the US.

The teem­ing num­ber of as­sets has to do with I-Mab’s un­usu­al but thus-far suc­cess­ful mod­el. The com­pa­ny has spread wide­ly, li­cens­ing a long list of as­sets from more es­tab­lished biotechs. They con­duct proof-of-con­cept tri­als in the US, and then use the da­ta for tri­als in Chi­na. Once the drug is clin­i­cal­ly val­i­dat­ed in the US, I-Mab re­tains Chi­nese rights for fur­ther de­vel­op­ment and glob­al out-li­cens­ing.

Most of these as­sets are in on­col­o­gy — in­clud­ing lead mul­ti­ple myelo­ma as­set TJ202 — al­though TJ101 is a long-act­ing hor­mone for pe­di­atric growth de­fi­cien­cy and TJ301 is an IL-6 for au­toim­mune dis­or­ders.

It’s a mod­el that’s al­ready gained over $400 mil­lion in pri­vate fund­ing. Their Nas­daq bid re­flects the grow­ing im­por­tance of Chi­na, not on­ly as a bur­geon­ing mar­ket for es­tab­lished phar­ma com­pa­nies but as a grow­ing hub for drug de­vel­op­ment.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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