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.”

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.