Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Da­ta re­veal that dif­fer­ent racial and eth­nic groups — by na­ture and/or nur­ture — can re­spond dif­fer­ent­ly in terms of phar­ma­co­ki­net­ics, ef­fi­ca­cy, or safe­ty to ther­a­peu­tics, but this dis­par­i­ty is not nec­es­sar­i­ly ac­count­ed for in clin­i­cal tri­als. A fresh analy­sis of the last decade of US can­cer drug ap­provals sug­gests the trend con­tin­ues, ce­ment­ing pre­vi­ous re­search that sug­gests on­col­o­gy tri­als are woe­ful­ly un­der-rep­re­sen­ta­tive of the racial make­up of the re­al world.

The study, pub­lished in the jour­nal JA­MA On­col­o­gy, eval­u­at­ed 230 tri­als to see whether spon­sors re­port­ed the racial com­po­si­tion of the pa­tients en­rolled in their stud­ies, and how mi­nori­ties were rep­re­sent­ed (ver­sus their ac­tu­al pop­u­la­tion preva­lence) in clin­i­cal tri­als that led to can­cer drug ap­provals from 2008 to 2018.

Re­searchers from the Uni­ver­si­ty of British Co­lum­bia, the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter, the Fred Hutchin­son Can­cer Cen­ter in Seat­tle and Bay­lor Uni­ver­si­ty found that 145 (63%) dis­closed at least one race — but a mea­ger 18 (7.8%) doc­u­ment­ed the four ma­jor races: White, Asian, Black and His­pan­ic.

Com­pared to the ac­tu­al make­up of US can­cer pa­tients — Blacks (22% of ex­pect­ed) and His­pan­ics (44% of ex­pect­ed) were un­der­rep­re­sent­ed com­pared with Whites (98% of ex­pect­ed) and Asians (438% of ex­pect­ed), the analy­sis found.

This pat­tern is con­sis­tent — even though the NIH re­quires that mi­nor­i­ty pop­u­la­tions be ap­pro­pri­ate­ly rep­re­sent­ed in clin­i­cal re­search. Cor­po­ra­tions, which car­ry the li­on’s share of drugs across the fin­ish line, are on­ly rec­om­mend­ed to shore up rep­re­sen­ta­tion by the FDA.

A study ex­plor­ing the rea­sons be­hind chron­ic un­der­rep­re­sen­ta­tion of mi­nori­ties in on­col­o­gy tri­als, pub­lished in 2016, cit­ed a sys­tem­at­ic re­view of late-stage can­cer tri­als from 1990 to 2000 and 2001 to 2010 showed that eth­nic mi­nori­ties, par­tic­u­lar­ly African-Amer­i­cans, were not ad­e­quate­ly rep­re­sent­ed.

In stud­ies con­duct­ed be­tween 2001 and 2010 that re­port­ed race/eth­nic­i­ty, re­view­ers found that 82.9% of par­tic­i­pants were White, 6.2% were African Amer­i­can, 3.3% were Asian, 2.2% were His­pan­ic, and 0.1% were Na­tive Amer­i­can. In tri­als con­duct­ed be­tween 1990 and 2000, 89% of par­tic­i­pants were White, 10.5% were African Amer­i­can, 0.4% were His­pan­ic, and 0.04% were Asian. Even though the pro­por­tion of White par­tic­i­pants de­creased across the two pe­ri­ods, Whites con­tin­ued to com­prise a large ma­jor­i­ty of par­tic­i­pants, and the pro­por­tion of African Amer­i­can par­tic­i­pants de­creased be­tween the pe­ri­ods 1990 to 2000 and 2001 to 2010, the re­searchers ex­trap­o­lat­ed. Low mi­nor­i­ty rep­re­sen­ta­tion re­sults from “pre­ventable and in­ter­linked poli­cies, prac­tices, and bar­ri­ers at the sys­tem, in­di­vid­ual, and in­ter­per­son­al lev­els,” they con­clud­ed.

The pat­tern of dis­pro­por­tion­ate en­roll­ment in tri­als test­ing treat­ments for can­cer — a dis­ease which there are pro­nounced racial and eth­nic dis­par­i­ties in in­ci­dence and mor­tal­i­ty — is es­pe­cial­ly con­cern­ing giv­en the new wave of check­point in­hibitors.

In a sep­a­rate study pub­lished this May, re­searchers found that Black pa­tients con­sti­tut­ed less than 4% of pa­tients re­cruit­ed across mul­ti­ple tri­als that sup­port­ed the ap­proval of im­mune check­point in­hibitors for lung can­cer. The dis­crep­an­cy was echoed in tri­als con­duct­ed in re­nal cell car­ci­no­ma and oth­er tu­mor types.

“The in­ad­e­quate rep­re­sen­ta­tion of mi­nor­i­ty pa­tients on im­munother­a­py clin­i­cal tri­als could per­pet­u­ate out­come dis­par­i­ty be­cause the unique bi­ol­o­gy of the host and the tu­mors from this sub­pop­u­la­tion is not ac­count­ed for as new treat­ment al­go­rithms to guide op­ti­mal use of im­munother­a­py are de­vel­oped for use in the re­al world,” the re­searchers sug­gest­ed.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.