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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Top 15 bio­phar­ma R&D spenders; The re­turn of Big Car­dio; Math­ai Mam­men takes biotech CEO role; Kris­ten Hege’s next trek; 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.

Please join us in welcoming Andrew Dunn, Jaimy Lee and Ryan Cross to the Endpoints team! They are coming on board this month and we can’t wait to start working with them.

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Af­ter Ako­rn's site clo­sures in the US, al­buterol re­mains in short­age

The beginning of March saw manufacturer Akorn Pharmaceuticals file for Chapter 7 bankruptcy protection, which led to the closure of all its US manufacturing plants and hundreds of layoffs. But this also had a cascading effect leading to a shortage of albuterol, specifically the 0.5% version, which is used to treat breathing issues.

The closures came at a time when the drug was already in short supply, with the FDA reporting that another manufacturer, Nephron, was in shortage too. The FDA’s drug shortage site states that the drug is still in shortage with no new supply coming from Akron, and Nephron with drug “on allocation.”

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Phar­ma in­dus­try rep­u­ta­tion scores pos­i­tive bump from in­sulin pric­ing news — Har­ris Poll

Insulin drug prices and out-of-pocket costs have been hot topics — and a drag on pharma industry reputation — for years. But now recent news from a trio of drugmakers pledging to cap extra costs for consumers helped push the entire industry reputation upward, according to The Harris Poll.

In polling meant to gauge the impact of the Silicon Valley Bank crash and crisis, Harris found that the pharma industry was only one of two industries among 10 verticals tracked to record a gain between the time before and after the crash. Positive view of pharma grew 49%, up 4% from the beginning to the end of March, the Harris survey found. Government was the other sector gaining with a 1% increase over the month.

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US Solicitor General Elizabeth Prelogar

US gov­ern­ment to SCO­TUS: Take up the Te­va-GSK 'skin­ny' gener­ic drug la­bel case

The US Solicitor General is calling on the Supreme Court to take up a fiercely debated case that could have a chilling effect on generic drug companies’ willingness to bring their copycats to market under so-called “skinny” labels, meaning the generic can only be approved for some of the reference product’s indications.

The case in question relates to GSK’s win over Teva in a long-running battle over the generic giant’s skinny label for GSK’s beta-blocker Coreg (carvedilol). At the time in 2007, Teva’s generic label first included two of the three Coreg indications, but Teva did not initially win approval for the third indication for congestive heart failure.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Aptinyx eval­u­ates fu­ture of the com­pa­ny fol­low­ing two failed tri­als, 60% lay­offs

This year has been tough for Aptinyx — two failed trials, a 60% cut in its workforce, and now the company has brought on a firm to help evaluate the future of the company.

The press release noted it’s working with the firm Ladenburg Thalmann as its financial advisor to assist in exploring and evaluating “strategic alternatives” — a process that a growing group of struggling biotechs has embarked on, sometimes ending in a merger, asset sale or wind-down.

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