José Baselga (Getty Images)

UP­DAT­ED: José Basel­ga, ac­claimed drug hunter, physi­cian and As­traZeneca's pi­o­neer­ing can­cer R&D chief, has died

José Basel­ga, the bril­liant on­col­o­gy R&D chief at As­traZeneca and a tow­er­ing fig­ure in can­cer drug de­vel­op­ment who had ear­li­er been chief med­ical of­fi­cer at Memo­r­i­al Sloan Ket­ter­ing, has died at the age of 61.

Basel­ga suc­cumbed to Creutzfeldt-Jakob dis­ease, a rapid­ly pro­gres­sive and lethal neu­rode­gen­er­a­tive dis­ease close­ly as­so­ci­at­ed with mad cow dis­ease that is trig­gered in about 1 in every mil­lion peo­ple.

Pas­cal So­ri­ot moved swift­ly to re­or­ga­nize As­traZeneca’s R&D op­er­a­tions around Basel­ga af­ter he joined from Memo­r­i­al Sloan Ket­ter­ing, where he had gar­nered ac­co­lades for his work in can­cer R&D.

News of his sud­den and shock­ing death spread swift­ly on Twit­ter, as col­leagues and friends weighed in with their farewells.

The Barcelona na­tive had an in­stant im­pact on the pipeline at As­traZeneca, di­rect­ing the phar­ma gi­ant to a late-stage al­liance on En­her­tu, which was quick­ly re­ward­ed with an ap­proval and a shot at a rapid­ly ex­pand­ing fran­chise. So­ri­ot hailed him at the time he joined the com­pa­ny as an “out­stand­ing sci­en­tif­ic leader” whose work at MSK had led to a va­ri­ety of sig­nif­i­cant new can­cer drugs. He had worked as an ad­vis­er with some of the biggest play­ers in on­col­o­gy, though his fail­ure to con­sis­tent­ly cite those re­la­tion­ships in the lit­er­a­ture would lead to a dust-up that led to his ex­it from MSK.

Basel­ga apol­o­gized di­rect­ly for that, and quite a num­ber of peo­ple in in­dus­try had felt that the con­tro­ver­sy was overblown at the time.

A not­ed breast can­cer spe­cial­ist, Basel­ga has been cit­ed for his ef­forts around PI3K re­search, which has more re­cent­ly in­spired fur­ther in­ves­ti­ga­tion around mTOR and AKT in­hi­bi­tion.

So­ri­ot of­fered a heart­felt trib­ute to­day:

José cham­pi­oned our trans­for­ma­tive col­lab­o­ra­tions with Dai­ichi-Sankyo in re­la­tion to the clin­i­cal de­vel­op­ment of En­her­tu (trastuzum­ab derux­te­can) and datopotam­ab derux­te­can, two med­i­cines which have demon­strat­ed great po­ten­tial to ben­e­fit can­cer pa­tients. He led a team to ac­cel­er­ate oth­er ex­cit­ing new sci­ence in an­ti­body-drug con­ju­gates, cell ther­a­py, epi­ge­net­ics, as well as new can­cer treat­ments. He al­so cham­pi­oned the use of re­al-world ev­i­dence and dig­i­tal tools to trans­form the way we de­sign and im­ple­ment clin­i­cal tri­als.

José built a world-class On­col­o­gy R&D team who will miss him dear­ly, just as all his col­leagues will through­out our en­tire Com­pa­ny.

José was more than a col­league to me. He was a friend, and some­one I im­mense­ly re­spect­ed and cher­ished. I will enor­mous­ly miss hav­ing him along­side me, and I will con­tin­ue to be in­spired by his work and vi­sion.

I had a chance to talk to Basel­ga about his work at As­traZeneca re­cent­ly, which you can see here.

Basel­ga’s daugh­ter — Clara Basel­ga-Gar­ri­ga — launched a fundrais­er Sun­day to sup­port re­search in­to Creutzfeldt-Jakob dis­ease (CJD). You can check it out here.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Back-to-back piv­otal fail­ures force Ther­a­vance to lay off 270 staffers, prune R&D fo­cus

If it all went well, Q3 was supposed to be harvest time for Theravance.

Both of its lead drugs — the pan-JAK inhibitor izencitinib and blood pressure drug ampreloxetine — were slated for crucial readouts. The biotech was, as SVB Leerink analyst Geoffrey Porges put it, “entering the most important period of validation events in its history.”

Instead, izencitinib flopped a key Phase IIb trial in ulcerative colitis, putting the J&J partnership around it in jeopardy. A month later, Theravance is reporting that the Phase III trial testing ampreloxetine in symptomatic neurogenic orthostatic hypotension is also a failure, imploding the company’s entire pipeline and forcing a rethink on R&D strategy.

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Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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