A Bloomberg-backed can­cer drug sum­mit aims to thaw US-Chi­na re­la­tions

Next week, a new coali­tion will be launched in Sin­ga­pore in an ef­fort to speed can­cer drug de­vel­op­ment and en­hance re­search co­op­er­a­tion be­tween the US and Chi­na, de­spite ris­ing ten­sions.

Launched by bil­lion­aire Michael Bloomberg’s eco­nom­ic fo­rum, dubbed the Bloomberg In­ter­na­tion­al Can­cer Coali­tion, the sum­mit will bring drug ex­ecs to­geth­er from the coun­tries with the two largest can­cer pop­u­la­tions in the world. The coali­tion will aim to cre­ate new can­cer drug stan­dards and cool tem­per­a­tures that have risen dur­ing the Covid-19 pan­dem­ic.

Rep­re­sen­ta­tives from sev­er­al high-pro­file drug­mak­ers will be in at­ten­dance, in­clud­ing J&J, Bay­er, Roche, No­var­tis, BeiGene, Zai Lab and aca­d­e­m­ic in­sti­tu­tions from Chi­na, the US and Eu­rope.

Some cur­rent and for­mer diplo­mats will al­so be in at­ten­dance, but rep­re­sen­ta­tives from Chi­na and its health reg­u­la­tor have not yet said whether they’ll be in Sin­ga­pore, the Fi­nan­cial Times re­port­ed Sun­day.

One diplo­mat, for­mer Aus­tralian Prime Min­is­ter and Asia So­ci­ety chief Kevin Rudd, told FT the ef­fort to lessen the pan­dem­ic-in­duced saber-rat­tling is akin to the 1970s dé­tente be­tween the US and Chi­na, which saw the coun­tries use ta­ble ten­nis as a way to thaw Cold War an­i­mosi­ties.

“The US-Chi­na re­la­tion­ship has got so bad that we at the Asia So­ci­ety have formed a view that can­cer treat­ment tri­als may well be­come the next it­er­a­tion of ping-pong diplo­ma­cy, to get this re­la­tion­ship back on the rails,” he told FT.

Rudd added that dis­agree­ments over in­tel­lec­tu­al prop­er­ty will like­ly be dis­cussed at the sum­mit.

The re­port al­so not­ed the group will at­tempt to use the FDA’s Pro­ject Or­bis as a mod­el to stream­line new drug sub­mis­sions out­side the US. Am­gen’s can­cer drug Lumakras won ap­proval in sev­er­al coun­tries in May un­der the project, and reg­u­la­tors from the US, Aus­tralia, Brazil, Cana­da and the UK re­viewed Am­gen’s sub­mis­sion si­mul­ta­ne­ous­ly.

Sev­er­al is­sues have emerged as flash points dur­ing the pan­dem­ic, caus­ing the re­la­tion­ship be­tween the US and Chi­na to head south. Chief among US con­cerns has been Chi­na’s re­luc­tance to al­low a full in­ves­ti­ga­tion in­to the ori­gins of the nov­el coro­n­avirus, with Chi­nese au­thor­i­ties block­ing WHO re­searchers ear­li­er this year from ac­cess­ing cer­tain da­ta.

Af­ter that group made its re­port in Feb­ru­ary, the WHO an­nounced a sec­ond at­tempt to look in­to the pan­dem­ic’s ori­gins in Ju­ly. But Chi­na said it couldn’t ac­cept the new terms be­cause it in­clud­ed a new pro­vi­sion to in­ves­ti­gate whether the coro­n­avirus might have leaked from a Chi­nese lab­o­ra­to­ry, NPR re­port­ed at the time.

A sci­en­tif­ic con­sen­sus emerged ear­ly in the pan­dem­ic that the SARS-CoV-2 virus jumped from an­i­mals to hu­mans, but one US in­tel­li­gence agency has not ruled out the “lab leak the­o­ry,” ac­cord­ing to a re­port. Four oth­er agen­cies dis­agreed while an­oth­er three couldn’t say for cer­tain one way or an­oth­er.

The WHO es­tab­lished a new sci­en­tif­ic ad­vi­so­ry group to look in­to Covid-19 ori­gins last month.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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UP­DAT­ED: CMS to re­strict cov­er­age of Bio­gen's con­tro­ver­sial Alzheimer's drug to on­ly clin­i­cal tri­als

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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