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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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