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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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John Quisel, Disc Medicine CEO

Disc Med­i­cine goes pub­lic in re­verse merg­er with strug­gling Gem­i­ni Ther­a­peu­tics

After licensing a failed Roche schizophrenia drug last year, Disc Medicine is going public via a reverse merger with Gemini Therapeutics.

The combined company, while still named Disc Medicine, will trade under the stock symbol $IRON, in reference to Disc’s lineup of therapies for blood iron disorders. Alongside the merger, Disc has secured $53.5 million in another financing round, building on the $90 million Series B it raised in September.

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Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The company calls it “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” the Boston Globe reported, quoting a spokesperson.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.