Au­to­lus claims a CAR-T win at EHA; Ima­go touts two PhII tri­al wins for rare dis­ease drug

Pre­sen­ta­tions at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion be­gan Fri­day, with Au­to­lus Ther­a­peu­tics re­veal­ing da­ta they say con­tin­ue to show the ben­e­fit of their CAR-T pro­gram.

The Au­to­lus pro­gram, known as 0be-cel, achieved a 100% com­plete re­mis­sion rate in a co­hort of in­do­lent B Cell Non-Hodgkin lym­phoma pa­tients, with all nine treat­ed pa­tients hit­ting the mark as of the May 17 cut­off. An­oth­er three pa­tients are still await­ing treat­ment, while a fourth en­rolled in­di­vid­ual died due to a Covid-19 in­fec­tion.

At a me­di­an fol­low-up of six months and rang­ing from four to 8.1 months, eight of nine pa­tients were dis­ease free at their last fol­low-up. One in­di­vid­ual re­lapsed at month 6 but was res­cued with ra­dio­ther­a­py. The Covid-19 pa­tient had achieved com­plete re­mis­sion, Au­to­lus says, at 5.6 months.

Ad­di­tion­al­ly, in an­oth­er co­hort for acute lym­phoblas­tic leukemia, 17 of 20 pa­tients saw MRD-neg­a­tive com­plete re­mis­sion af­ter one month. Fri­day’s news comes af­ter Au­to­lus chopped 20% of its staff in Jan­u­ary and set out to find a new part­ner for its CAR-T pro­gram. — Max Gel­man

Ima­go an­nounces re­sults from 2 PHII tri­als for bomedem­stat

Two Phase II stud­ies of bomedem­stat in pa­tients re­ceived pos­i­tive re­sults, Ima­go Bio­Sciences an­nounced Fri­day.

In a study in pa­tients with es­sen­tial throm­bo­cythemia, a rare dis­or­der in which the body pro­duces too many platelets, the da­ta showed that 83% of the 12 pa­tients dosed for more than six weeks showed a sig­nif­i­cant re­duc­tion of platelet counts. The drop hap­pened while pa­tients main­tained sta­ble he­mo­glo­bin lev­els, the com­pa­ny said.

Mean­while, the da­ta from a study in pa­tients with ad­vanced myelofi­bro­sis — a type of bone can­cer that dis­rupts the body’s nor­mal pro­duc­tion of blood cells — 94% of pa­tients showed a re­duc­tion of 50% or more in symp­toms. In 34 pa­tients eval­u­at­ed for mu­tant al­lele fre­quen­cies, the num­ber de­creased in 44% of pa­tients and re­mained the same in 47%, with no new mu­ta­tions in the 660 days that fol­lowed.

In the press re­lease, Ima­go CMO Wan-Jen Hong said:

These up­dat­ed clin­i­cal re­sults re­veal that bomedem­stat con­tin­ues to of­fer dis­tinct clin­i­cal ben­e­fits for pa­tients with ad­vanced MF, show­ing over­all im­prove­ment in to­tal symp­tom scores, spleen vol­umes and ane­mia. The study is now ful­ly en­rolled, so we look for­ward to shar­ing our cu­mu­la­tive da­ta as we con­tin­ue to ad­vance this in­ves­ti­ga­tion­al pro­gram for pa­tients who have few ther­a­peu­tic al­ter­na­tives.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

Con­sor­tium of 5 drug reg­u­la­tors plot path to in­crease har­mo­niza­tion through 2024

A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.

While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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