So­sei and Ver­i­ly part­ner on GPCRs; Ob­sE­va touts PhI­II da­ta in en­dometrio­sis pain

So­sei Hep­tares is team­ing up with a big-name part­ner: Al­pha­bet’s Ver­i­ly.

No fi­nan­cials were dis­closed, but the pair will aim to use Ver­i­ly’s im­mune pro­fil­ing and So­sei Hep­tares’ GPCR drug de­sign ca­pa­bil­i­ties to de­vel­op a va­ri­ety of new ther­a­peu­tics. The col­lab­o­ra­tion will fo­cus on GPCR drugs in the im­munol­o­gy, gas­troen­terol­o­gy and im­muno-on­col­o­gy spaces, as well as oth­er dis­or­ders with im­muno­pro­tec­tive or im­munopath­o­gen­ic mech­a­nisms, the com­pa­nies said.

“Im­munol­o­gy is a key area of fo­cus for So­sei Hep­tares and this new col­lab­o­ra­tion brings to­geth­er two world-class tech­nolo­gies and teams with the skills and ex­per­tise to de­fine key GPCRs as tar­gets for the dis­cov­ery of new med­i­cines that could have sig­nif­i­cant im­pact on pa­tients with im­mune-based dis­eases world­wide,” So­sei VP for drug dis­cov­ery Matt Barnes said in a state­ment. — Max Gel­man

Ob­sE­va un­veils new PhI­II da­ta for en­dometrio­sis pain 

Just a month af­ter women’s health biotech Ob­sE­va brought on a new CFO, the com­pa­ny has some Phase III tri­al da­ta for pain as­so­ci­at­ed with en­dometrio­sis.

The tri­al was for lin­zagolix, an oral GnRH an­tag­o­nist can­di­date for women with mod­er­ate-to-se­vere en­dometrio­sis-as­so­ci­at­ed pain, al­so known as EAP. Two dos­es — 200 mg once-dai­ly with add-back ther­a­py (ABT) and 75 mg dai­ly with­out back ther­a­py — were test­ed.

The 200 mg dose, ac­cord­ing to Ob­sE­va, met the study’s co-pri­ma­ry ef­fi­ca­cy ob­jec­tives: re­duc­ing dys­men­or­rhea (DYS) and non-men­stru­al pelvic pain (NMPP) at 3 months. At 6 months of treat­ment at 200 mg, there were list­ed im­prove­ments in five sec­ondary end­points: dys­men­or­rhea, non-men­stru­al pelvic pain, dyschezia, over­all pelvic pain, and abil­i­ty to do dai­ly ac­tiv­i­ties.

The 75 mg dose did show a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion ver­sus place­bo in DYS at 3 months. Al­though it showed im­prove­ment in NMPP at 3 months, it did not reach sta­tis­ti­cal sig­nif­i­cance ver­sus place­bo.

Ob­sE­va CMO Eliz­a­beth Gar­ner praised the re­sults, say­ing in a state­ment that the biotech plans to com­plete its Phase III pro­gram for EAP, and said that it would ex­plore a non-ABT op­tion for that in­di­ca­tion. — Paul Schloess­er

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.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Yingli Phar­ma brings small mol­e­cule re­search to the US in new pact with MD An­der­son; UCB's pso­ri­at­ic arthri­tis drug shows pos­i­tive PhI­II re­sults

Shanghai biotech Yingli Pharma wants to bring its small molecule drug research global — and a new pact with MD Anderson will help it get there.

Yingli and MD Anderson have inked a 5-year collaboration deal that will put its cancer candidates — some of which have already generated data in China — into trials in the US. The lead program is linperlisib, a PI3Kδ inhibitor that’s in a Phase III trial in follicular lymphoma, according to Yingli’s website. In the US, MD Anderson will work with Yingli to put the candidate in a Phase II trial for peripheral T cell lymphoma (PTCL), an uncommon and aggressive type of non-Hodgkin’s lymphoma.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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