G1 touts PhII can­cer da­ta, but shares tank on place­bo re­sults; Mer­ck bags an­oth­er ap­proved in­di­ca­tion for Keytru­da

→ G1 Ther­a­peu­tics $GTHX tried their lev­el best to tout the re­sults of their Phase II study of tri­laci­clib in com­bi­na­tion with topote­can for small cell lung can­cer, demon­strat­ing myelo­p­reser­va­tion ben­e­fits. In­vestors, though, couldn’t get past the fact that the ORR rate was high­er in the place­bo group com­pared to their drug. The stock tanked, drop­ping by more than 30% on Thurs­day morn­ing.

→ Pfiz­er and their part­ners at Astel­las say that a Phase III study of Xtan­di plus an­dro­gen de­pri­va­tion ther­a­py — ADT — in hor­mone-sen­si­tive prostate can­cer met the pri­ma­ry end­point in ra­di­ograph­ic progress-free sur­vival when com­pared to ADT alone. “While XTAN­DI is cur­rent­ly ap­proved for both metasta­t­ic and non-metasta­t­ic CR­PC, there still re­mains a need for more treat­ment op­tions for men with metasta­t­ic hor­mone-sen­si­tive prostate can­cer,” said Mace Rothen­berg, who heads up Pfiz­er’s on­col­o­gy R&D group. “With these top-line re­sults, we be­lieve XTAN­DI has the po­ten­tial to help men whose dis­ease has pro­gressed out­side the prostate gland, but still re­sponds to treat­ment to low­er testos­terone.”

— Mer­ck’s $MRK im­munother­a­py ex­tra­or­di­naire Keytru­da won its umpteeth ap­proval on Thurs­day, this time for pa­tients with re­cur­rent lo­cal­ly ad­vanced or metasta­t­ic Merkel cell car­ci­no­ma (MCC) un­der the ac­cel­er­at­ed ap­proval path­way.

— Al­cy­one Life­sciences, which has a drug de­liv­ery plat­form, has tied up with Roche’s $RHB­BY neu­rol­o­gy group so the Swiss drug­mak­er can em­ploy the pri­vate­ly-held com­pa­ny’s in­trathe­cal de­liv­ery plat­form in de­vel­op­ing its CNS drugs.

 

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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FDA ac­cepts pri­or­i­ty re­view of CSL-uniQure he­mo­phil­ia B gene ther­a­py; Fo­s­un Phar­ma nets an­oth­er deal

The first potential gene therapy for hemophilia B has gotten one step closer to reaching patients as the FDA has accepted CSL Behring’s BLA for its uniQure-partnered one-time treatment. The therapy, dubbed etranacogene dezaparvovec, was accepted under “accelerated assessment” by the European Medicines Agency in March.

A priority review will be conducted for the gene therapy intended for patients with the hereditary bleeding disorder, CSL said Tuesday morning. The Pennsylvania biotech did not indicate the regulator’s decision date, but a priority review generally means the treatment’s fate will be handed down within six months rather than 10.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.