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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.