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.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.