GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, new­ly brand­ed and soon-to-be de­merged, shared in­ter­im re­sults from its Phase II tri­al on its chron­ic he­pati­tis B treat­ment, one that it says has the “po­ten­tial to lead to a func­tion­al cure.”

At a pre­sen­ta­tion at the EASL In­ter­na­tion­al Liv­er Con­gress, GSK shared that in around 450 pa­tients who re­ceived its hep B drug bepirovirsen for 24 weeks, just un­der 30% had he­pati­tis B sur­face anti­gen and vi­ral DNA lev­els that were too low to de­tect.

No­tably, pa­tients who were tak­ing nu­cle­o­side analogs (the cur­rent stan­dard of care treat­ment) along­side bepirovirsen and those who were not had sim­i­lar out­comes.

Chris Cor­si­co

To put that in­to per­spec­tive, pa­tients with chron­ic he­pati­tis B of­ten have to take nu­cle­o­side analogs, which sup­press he­pati­tis B virus (HBV) ex­pres­sion, through­out their life­time. Alone, nu­cle­o­side analogs have a func­tion­al cure rate that hov­ers around 1-5%, and in com­bi­na­tion with in­ter­fer­on treat­ment, that num­ber jumps a lit­tle high­er.

To be con­sid­ered a func­tion­al cure, the virus has to be sti­fled enough that the im­mune sys­tem can con­trol it on its own, GSK’s head of de­vel­op­ment Chris Cor­si­co told End­points News.

“If we were able … to — us­ing monother­a­py for 24 weeks and then stop­ping ther­a­py — get any­thing close to the in­ter­fer­on plus nu­cle­o­side/nu­cleotide stan­dard of care, that would be ab­solute­ly a phe­nom­e­nal re­sult,” Cor­si­co said.

The big ques­tion now is dura­bil­i­ty. And with­out that da­ta in hand yet, Cor­si­co said he can’t call GSK’s treat­ment a func­tion­al cure, though he said their cur­rent num­bers were ex­cit­ing for “the long-term prospects.”

How­ev­er, Cor­si­co al­so said he “rec­og­nized [there is] a large group of pa­tients who need fur­ther ther­a­py.” On that end, GSK is ex­plor­ing tri­als to put bepirovirsen in com­bi­na­tion with an in­ter­fer­on treat­ment as well as with its he­pati­tis B im­munother­a­py, ac­cord­ing to a press re­lease.

Cor­si­co not­ed that more in­sight on who the treat­ment was and wasn’t work­ing for would be com­ing lat­er. “One of the pur­pos­es of this study was to col­lect a whole bunch of bio­mark­ers to see if we could then start us­ing that da­ta to help us pre­dict who was re­spond­ing and who was not re­spond­ing,” he said, adding that GSK wouldn’t have that da­ta un­til the end of the tri­al.

Around 1% of pa­tients had treat­ment-re­lat­ed se­ri­ous ad­verse events, and Cor­si­co not­ed that a few of those cas­es were re­lat­ed to the in­jec­tion site.

GSK li­censed bepirovirsen from Io­n­is in 2019. The drug is a sin­gle strand of syn­thet­ic nu­cleotides that com­ple­ment HBV RNA and re­cruit liv­er en­zymes to de­stroy it.

Else­where in the he­pati­tis B space, the FDA slapped a clin­i­cal hold on An­tios’ Phase II tri­al in May, lead­ing to part­ner As­sem­bly Bio­sciences ditch­ing the duo’s he­pati­tis B col­lab­o­ra­tion.

GSK’s fi­nal study re­sults, which in­clude two oth­er treat­ment arms with dif­fer­ent dosage sched­ules, will be pre­sent­ed to­wards the end of the year, Cor­si­co said.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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