No­var­tis nabs pri­or­i­ty re­view for a block­buster-to-be aimed at NSCLC niche — de­light­ing In­cyte ex­ecs

In­cyte fi­nal­ly has some good news to share about one drug it’s dis­cov­ered that’s not Jakafi — al­beit one that doesn’t be­long to it any­more.

FDA reg­u­la­tors have ac­cept­ed cap­ma­tinib, an or­phan and “break­through” MET in­hibitor, for pri­or­i­ty re­view. The hon­or tech­ni­cal­ly goes to No­var­tis, which li­censed world­wide de­vel­op­ment and com­mer­cial­iza­tion rights to the drug back in 2009.

But that didn’t stop In­cyte from brag­ging about it in a re­lease, re­mind­ing in­vestors that if every­thing goes well, it’s el­i­gi­ble for $500 mil­lion-plus in mile­stones as well as roy­al­ties up to 14% of glob­al sales.

Shav­ing four months off the re­view time­line — as­sum­ing there aren’t hic­cups — helps en­sure that No­var­tis can score an ap­proval with­in this year. The phar­ma gi­ant had des­ig­nat­ed cap­ma­tinib (for­mer­ly INC280) as one of four ma­jor launch­es of 2020, pre­dict­ing a block­buster fu­ture for a drug ini­tial­ly aimed at a sub­type of non-small cell lung can­cer.

NSCLC pa­tients who har­bor a MET ex­on-14 skip­ping mu­ta­tion cur­rent­ly have no ap­proved tar­get­ed ther­a­py. A No­var­tis-spon­sored Phase II tri­al showed that cap­ma­tinib in­duced an over­all re­sponse rate of 67.9% among treat­ment-naïve pa­tients (du­ra­tion of re­sponse 11.14 months) and 40.6% among pre­vi­ous­ly treat­ed ones (DOR 9.72 months).

Those 97 pa­tients had EGFR wild­type, ALK-neg­a­tive tu­mors, and took 400 mg cap­ma­tinib tablets twice a day.

“ME­Tex14 mu­ta­tions oc­cur in 3-4% of new­ly di­ag­nosed ad­vanced NSCLC cas­es and is a rec­og­nized onco­genic dri­ver,” No­var­tis not­ed in a state­ment.

Mer­ck KGaA and Pfiz­er al­so an­gling for this un­tapped niche; both have been grant­ed break­through ther­a­py des­ig­na­tions, though theirs on­ly cov­er sec­ond-line ther­a­py fol­low­ing plat­inum-based chemo. While tepo­tinib from the Ger­man drug­mak­er was en­gi­neered as a se­lec­tive MET in­hibitor, the drug Pfiz­er has put for­ward is Xalko­ri, orig­i­nal­ly tar­get­ed at ALK and ROS1 mu­ta­tions.

Mean­while, in Chi­na, Chi-Med is al­so test­ing As­traZeneca’s MET in­hibitor, savoli­tinib, in a Phase II reg­is­tra­tional tri­al among pa­tients who have pro­gressed fol­low­ing pri­or sys­temic ther­a­py or are un­able to re­ceive chemo.

A com­pan­ion di­ag­nos­tic will like­ly be key to the adop­tion of any of these treat­ments. No­var­tis has teamed up with Foun­da­tion Med­i­cine — now a Roche sub­sidiary — to in­clude tu­mor tis­sue and liq­uid biop­sy di­ag­nos­tics on its flag­ship prod­ucts.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

Four months after J&J’s infused drug Rybrevant scored the industry’s first win in a rare type of non-small cell lung cancer (NSCLC), Takeda is following up with an oral option for the small but desperate patient population.

The FDA granted an accelerated approval to Takeda’s oral TKI inhibitor Exkivity (mobocertinib) in metastatic NSCLC patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, the company announced on Wednesday.

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Multiple antibiotic resistant Pseudomonas aeruginosa bacterium

A new way to in­fil­trate (and de­stroy) some of the dead­liest drug-re­sis­tant bugs

About four years ago, Ruben Tommasi, the gregarious scientific chief of antibiotics startup Entasis, walked into a meeting with his top chemist and top biologist to chew over another batch of unchanging results.

“It felt like we were running the same experiment over and over,” Tommasi told Endpoints News. “We had all sort of come to that point in time where we felt like we were banging our heads against the wall.”

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