Founders David Epstein and Elizabeth Buck [file photo]

Can­cer-fo­cused Black Di­a­mond vaults on to Nas­daq in $200M+ pub­lic de­but, mark­ing biggest biotech IPO in 2020 so far

Ver­sant-backed Black Di­a­mond Ther­a­peu­tics has set its sights on an up­sized biotech IPO to kick 2020 off.

The first start­up out of Ver­sant’s Ridge­line dis­cov­ery en­gine in Basel is set to make its pub­lic de­but on Thurs­day, rais­ing gross pro­ceeds of $201 mil­lion through the sale of 10.6 mil­lion shares priced at $19 a pop.

That ex­ceeds the ini­tial plan to raise $151 mil­lion by of­fer­ing 8.9 mil­lion shares at a price range of $16 to $18 — a pos­i­tive sign that the IPO win­dow is still wide open for busi­ness, es­pe­cial­ly for can­cer biotechs. On­col­o­gy is lu­cra­tive, with can­cer fast catch­ing up with car­dio­vas­cu­lar dis­ease as the most dead­ly con­di­tion in the de­vel­oped world.

Ahead of the IPO, Black Di­a­mond’s tu­mor-ag­nos­tic ap­proach to fight­ing can­cer spawned more than $200 mil­lion in ven­ture fund­ing. At the end of 2018 the com­pa­ny — found­ed by two sci­en­tists in­volved in the de­vel­op­ment of the can­cer drug Tarce­va, David Ep­stein and Eliz­a­beth Buck — ini­tial­ly raised $20 mil­lion in its Se­ries A. That in­jec­tion was sup­ple­ment­ed by two back-to-back to $85 mil­lion rounds of fi­nanc­ing, led by sev­er­al high pro­file groups in­clud­ing New En­ter­prise As­so­ci­ates, RA Cap­i­tal Man­age­ment and Box­er Group.

While in­hibitors used to sup­press ki­nase do­main mu­ta­tions, or TKIs, are con­sid­ered stan­dard-of-care treat­ment for many types of can­cer, al­losteric mu­ta­tions are still un­chart­ed ter­ri­to­ry. Us­ing their tech plat­form, Black Di­a­mond is look­ing to map al­losteric mu­ta­tions dri­ving can­cer to de­vel­op in­hibitors that are tu­mor ag­nos­tic.

Onco­genes — which have the po­ten­tial to cause the growth of can­cer cells — are ac­ti­vat­ed by ki­nase do­main mu­ta­tions or by al­losteric mu­ta­tions. Al­lostery is a com­mon process by which pro­teins trans­mit the ef­fect of bind­ing at one site to an­oth­er — of­ten dis­tal — func­tion­al site, al­low­ing for reg­u­la­tion of ac­tiv­i­ty.

“World­wide sales of ki­nase in­hibitors, one class of tar­get­ed ther­a­pies, ex­ceed­ed $25 bil­lion in 2018. De­spite the suc­cess of these drugs, a re­cent analy­sis found that on­ly nine per­cent of pa­tients with metasta­t­ic can­cer have tu­mors with ge­net­ic pro­files that could make them el­i­gi­ble for treat­ment with an ap­proved pre­ci­sion on­col­o­gy med­i­cine,” Black Di­a­mond cit­ed in its IPO fil­ing ear­li­er this month,

As in­creas­ing ge­nom­ic pro­fil­ing of can­cer pa­tients iden­ti­fies clus­ters of un­char­ac­ter­ized ge­nom­ic al­ter­ations, the biotech’s tech­nol­o­gy is de­signed to iso­late “drug­gable mu­ta­tion bas­kets” to cre­ate pre­ci­sion med­i­cines that could ben­e­fit a broad­er swathe of pa­tients.

The com­pa­ny’s lead ex­per­i­men­tal ther­a­py, BDTX-189, is en­gi­neered to thwart the func­tion of onco­genic pro­teins that af­fect both EGFR and HER2, and is be­ing groomed for a Phase I/II tri­al set to kick off in the first half of this year. Black Di­a­mond al­so has a pre­clin­i­cal can­di­date — among oth­er undis­closed as­sets brew­ing in its pipeline — de­signed to com­bat glioblas­toma, a par­tic­u­lar­ly ag­gres­sive and dead­ly form of brain can­cer.

Black Di­a­mond will make its de­but on the Nas­daq un­der the sym­bol “$BDTX.”

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

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Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.