Bob Ingram (HBM Healthcare Investments)

Black Di­a­mond brings in ex-GSK CEO Bob In­gram to chart new path in pre­ci­sion on­col­o­gy

Black Di­a­mond Ther­a­peu­tics start­ed the year with a more than $200 mil­lion vault on­to Nas­daq and a clin­ic-bound al­losteric ther­a­py — and now, the young biotech has Glax­o­SmithK­line vet Bob In­gram to help pave its way.

In­gram is set to take the reins from Black Di­a­mond’s found­ing chair­man Brad Bol­zon, the com­pa­ny an­nounced on Tues­day. The Mass­a­chu­setts-based biotech was the first to launch out of Ver­sant’s Ridge­line dis­cov­ery en­gine in 2018, co-found­ed by David Ep­stein and Eliz­a­beth Buck, for­mer de­vel­op­ers of the can­cer drug Tarce­va. Bol­zon will re­main on the board.

“Black Di­a­mond pos­sess­es an in­no­v­a­tive and pro­pri­etarpy MAP plat­form, com­pelling clin­i­cal and ear­ly stage as­sets, and dy­nam­ic lead­er­ship team, and has the po­ten­tial to trans­form the on­col­o­gy ther­aeu­tic land­scape,” In­gram said.

The award-win­ning, Porsche-lov­ing, for­mer CEO helmed Glaxo Well­come be­fore co-lead­ing the merg­er that formed GSK in 2000. Af­ter ag­ing out of his po­si­tion at 60, In­gram stuck around at GSK as vice chair­man of phar­ma­ceu­ti­cals and strate­gic ad­vi­sor to the CEO. In 2006, Pres­i­dent George W. Bush ap­point­ed him to the NIH’s Na­tion­al Can­cer Ad­vi­so­ry Board. And last year, he was tapped by Pres­i­dent Don­ald Trump to serve on the Pres­i­den­tial Can­cer Pan­el.

In ad­di­tion to Black Di­a­mond, In­gram chairs BioCryst Phar­ma­ceu­ti­cals, and is on the board at No­van. He’s al­so gen­er­al part­ner at North Car­oli­na-based Hat­teras Ven­ture Part­ners.

“Bob is a world-class leader in the phar­ma­ceu­ti­cal in­dus­try hav­ing guid­ed and shaped nu­mer­ous com­pa­nies in­clud­ing serv­ing as CEO and chair­man of Glaxo Well­come and his role in the merg­er that formed Glax­o­SmithK­line. His lead­er­ship and ex­per­tise will be crit­i­cal as we con­tin­ue to ex­e­cute on our strat­e­gy to be­come a lead­ing pre­ci­sion on­col­o­gy com­pa­ny,” Ep­stein said in a state­ment.

Bol­zon said In­gram is “fit for the com­pa­ny’s next stage of growth,” giv­en his wealth of ex­pe­ri­ence.

Black Di­a­mond set out two years ago to map al­losteric mu­ta­tions, par­tic­u­lar­ly around the onco­genes EGFR and HER2. Its lead can­di­date, BDTX-189, is cur­rent­ly in a Phase I/II tri­al in pa­tients with sol­id tu­mors that have HER2 mu­ta­tion and EGFR mu­ta­tions.

A pre­vi­ous ver­sion of this ar­ti­cle in­cor­rect­ly stat­ed that David Ep­stein pre­vi­ous­ly worked at No­var­tis.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

Endpoints Premium

Premium subscription required

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