Black Di­a­mond turns down an open stretch of R&D high­way, head­ed to a show­down with onco­genes

As one of the lead sci­en­tists in­volved in the de­vel­op­ment of Tarce­va, David Ep­stein had plen­ty of op­por­tu­ni­ty to con­sid­er the many ways in which can­cer can evade a drug and kill pa­tients.

David Ep­stein

For the last 4 years, Ep­stein has been qui­et­ly work­ing away at the prob­lem, and he’s tak­en a turn down a stretch of R&D high­way which he be­lieves can lead to a full pipeline of new can­cer drugs that can broach that is­sue for par­tic­u­lar sub­sets of pa­tients. 

Ep­stein and co-founder Eliz­a­beth Buck have been build­ing a com­pa­ny — called Black Di­a­mond — based in New York but work­ing with Ver­sant’s Ridge­line dis­cov­ery en­gine in Basel. And from to­day, they’re plan­ning to start mak­ing some noise about the work they are do­ing.

Ver­sant hand­ed over a $20 mil­lion A round to fire up the work last year, giv­ing Ep­stein a chance to grow the crew to 15 or so. And they’re work­ing on a sec­ond round now that is de­signed to get them down the road to the clin­ic, with plans to build the team to the 40-50 range.

Jump­ing past the ki­nase do­main in­hibitors — TKIs —that have been used to counter the work of can­cer-dri­ving onco­genes, Black Di­a­mond has its eye pri­mar­i­ly on al­losteric mu­ta­tions. 

Find the right al­losteric onco­genes dri­ving can­cer, they say, and you can de­vel­op in­hibitors for them that work across tu­mor types.

“We have two pro­grams,” says Ep­stein, “al­losteric HER2 and EGFR dri­ver mu­ta­tions that oc­cur across a range of tis­sue type tu­mors, so we can be tis­sue ag­nos­tic.”

The big idea at Black Di­a­mond is that there are “whole sets of onco­genic le­sions out­side the ATP bind­ing site that are ac­ti­vat­ed by com­mon mech­a­nisms and are in­hib­it­ed by a sin­gle class of our drugs,” says the CEO. “Our plat­form gen­er­ates sin­gle mol­e­cules able to treat en­tire bas­kets of mu­ta­tions that oth­er­wise would have been deemed un­ac­tion­able.”

Alex May­weg

“This was a phe­nom­e­nal idea of pre­ci­sion med­i­cine,” says Ver­sant part­ner Alex May­weg, who’s hap­py to play a big role in as­sist­ing the cre­ation of Black Di­a­mond.

By this time next year, Ep­stein plans to have the B round in the bank and the first of their pro­grams in the clin­ic, with the sec­ond to fol­low in 2020.

A lot of their work re­lies on the spread­ing use of se­quenc­ing to al­low for per­son­al­ized ther­a­py. 

“This will take the un­ac­tion­able and make it ac­tion­able,” says Ep­stein. “We think this is a po­ten­tial huge ap­pli­ca­tion.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

A T-cell play­er with back­ing from Roche takes next big step for BiTE drugs with 'on-of­f' switch to avoid tox­i­c­i­ty

The bispecific T cell engager field is absolutely packed with big-name players who have crowded in despite some high-profile failures in the class. Now, a Bay Area biotech thinks it may have the key to tackling BiTE toxicity, using an old “on-off switch” idea to give doctors more control of the drugs’ effect on patients.

San Francisco-based Soteria Biotherapeutics uncloaked Monday with a $42 million Series A co-led by Roche Venture Fund and 5AM Ventures with participation from the Novartis Venture Fund to advance its bispecific T cell engagers with an “on-off” switch the founders think can avoid some of the dire safety flags endemic to the class.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.