Black Di­a­mond rais­es an­oth­er $85M to bring new onco­gene ap­proach in­to clin­ic

Near­ly a year af­ter rais­ing $85 mil­lion from in­vestors, Black Di­a­mond Ther­a­peu­tics has raised an­oth­er $85 mil­lion to help push its al­losteric ther­a­pies in­to the clin­ic in the next few months. The Se­ries C round was led by Box­er Cap­i­tal.

Black Di­a­mond launched last De­cem­ber as the first com­pa­ny to come out of Ver­sant’s Ridge­line dis­cov­ery en­gine in Basel. They had two for­mer de­vel­op­ers of the can­cer drug Tarce­va as co-founders in David Ep­stein and Eliz­a­beth Buck and a rel­a­tive­ly new ap­proach to on­col­o­gy. With­in a month of their full launch, they al­so had $105 mil­lion in back­ing.

Eliz­a­beth Buck

Al­losteric ther­a­pies are es­sen­tial­ly like oth­er onco­ge­net­ic ther­a­pies, such as ki­nase drugs, that in­hib­it a pro­tein fu­el­ing can­cer. But rather than try to in­hib­it the pro­tein straight-on, these ther­a­pies tar­get can­cers that emerge from mu­ta­tions in net­works, or an “en­sem­ble,” of do­mains that af­fect each oth­er from a dis­tance.

For can­cer, that can mean a mu­ta­tion some­where away from the main bind­ing site of, say, the HER2 re­cep­tor can cause changes to the en­tire pro­tein and fu­el tu­mors.

Black Di­a­mond has spent the last year map­ping these al­losteric mu­ta­tions, par­tic­u­lar­ly around the well-known onco­genes EGFR and HER2. They’ve pub­lished pa­pers sug­gest­ing that the in­hibitors for these pro­teins have failed in some pa­tients be­cause the can­cer-caus­ing mu­ta­tion is not at the main bind­ing site, but rather an al­losteric mu­ta­tion else­where.

David Ep­stein

Now they are ready to head in­to the clin­ic. They plan to start a Phase I/II tri­al of their lead drug BDTX-189 in the first half of 2020. They have not said which tar­get it hits, but the pipeline on their web­site lists the HER2 pro­gram as the on­ly one that’s reached the IND stage. The EGFR pro­gram ap­pears not far be­hind, fol­lowed by three more un­named ones.

On top of the Box­er Group, new in­vestors in­clude Welling­ton Man­age­ment Com­pa­ny, BVF Part­ners, Deer­field Man­age­ment, Cas­din Cap­i­tal, and Lo­gos Cap­i­tal. Pre-ex­ist­ing in­vestors who joined the new round in­clude Ver­sant Ven­tures, New En­ter­prise As­so­ci­ates, RA Cap­i­tal Man­age­ment, Nex­tech In­vest, In­vus, Per­cep­tive Ad­vi­sors, City Hill Ven­tures, and Roche Ven­ture Fund.

In ad­di­tion to the fund­ing, Black Di­a­mond al­so an­nounced to­day that CRISPR Ther­a­peu­tics CEO Samarth Kulka­rni is join­ing the board of di­rec­tors.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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