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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.