Arthur Kuan, CG Oncology CEO

CG On­col­o­gy spot­lights on­colyt­ic virus com­bo da­ta ahead of full read­out due next year

CG On­col­o­gy has been qui­et­ly chug­ging along — on­ly giv­ing up­dates at se­quen­tial can­cer con­fer­ences ahead of a full read­out on its on­colyt­ic virus can­cer ther­a­py next year.

In its lat­est at SITC, the Irvine, CA-based biotech showed up with longer-term da­ta on its ther­a­py, CG0070, in com­bi­na­tion with Mer­ck’s Keytru­da. While the da­ta are still ear­ly, they sug­gest more dura­bil­i­ty where the biotech had ini­tial­ly turned heads on ef­fi­ca­cy.

The biotech is test­ing its ther­a­py in pa­tients with non-mus­cle in­va­sive blad­der can­cer who did not re­spond to stan­dard BCG ther­a­py. Of 32 pa­tients, 28 had no signs of can­cer at the 3-month fol­low-up. Go­ing out to 6 months, that num­ber changes to 25 of 29. And at one year, the pri­ma­ry end­point of the study, 11 of 15 pa­tients had a com­plete re­sponse to treat­ment — good for a 73% re­sponse rate.

Roger Li

That adds two non-re­spon­ders to the com­bo ther­a­py since CG’s last up­date at AS­CO in June, but of the pa­tients who had a com­plete re­sponse at three months, while some have had dis­ease re­cur­rence, none have seen their dis­ease progress, lead in­ves­ti­ga­tor Roger Li told End­points News. He al­so not­ed that of the two pa­tients with two years’ fol­low-up at his site, Mof­fitt Can­cer Cen­ter, both still have com­plete re­spons­es.

CG On­col­o­gy CEO Arthur Kuan not­ed that while the da­ta are still ear­ly, they seem promis­ing thus far, and the biotech is plan­ning ad­di­tion­al tri­als for the on­colyt­ic virus treat­ment. The cur­rent tri­al is ful­ly en­rolled, and Kuan said that the biotech plans to read out the full da­ta on the com­bo ther­a­py at a ma­jor can­cer con­fer­ence some­time next year. The biotech is al­so test­ing the treat­ment as a monother­a­py in a Phase III tri­al, but re­sults are still a bit away, as the study won’t have topline da­ta un­til 2024, ac­cord­ing to clin­i­cal­tri­als.gov.

Li said that one of the non-re­spon­ders had a case of un­di­ag­nosed lym­phoma at the time of en­roll­ment, of which they don’t know the im­pact on the pa­tient’s re­sponse to treat­ment.

In terms of safe­ty, the most com­mon ad­verse re­ac­tions were blad­der-re­lat­ed, such as fre­quent uri­na­tion, Li said. There was one case of grade three im­mune-me­di­at­ed he­pati­tis and three cas­es of hy­per­thy­roidism, which Li not­ed are in line with the side ef­fects of Keytru­da. “We don’t think that adding on CG0070 re­al­ly adds too much to the sys­temic tox­i­c­i­ty pro­file,” he said of the safe­ty of the treat­ment over­all.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

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