In­cyte pulls away 'dam­aged good­s' baric­i­tinib to fo­cus on in­ter­nal pipeline

Jakafi-mak­er In­cyte has ef­fec­tive­ly made Olu­mi­ant (baric­i­tinib) — the tar­nished JAK in­hibitor dogged by safe­ty con­cerns that bare­ly crossed the FDA fin­ish line with a small­er dose — Eli Lil­ly’s prob­lem.

Last June, the FDA ap­proved on­ly the small 2 mg dose of the drug — which In­cyte part­nered with Lil­ly on — with a black box warn­ing high­light­ing the ther­a­py’s side ef­fects, in­clud­ing a star­tling throm­boem­bolism sig­nal, quash­ing Lil­ly’s block­buster dreams. The agency had ini­tial­ly re­ject­ed the drug, de­mand­ing a new study, but un­der the lead­er­ship of now for­mer FDA com­mis­sion­er Scott Got­tlieb, the FDA had an un­ex­plained change of heart, and al­lowed the mar­ket­ing ap­pli­ca­tion to pro­ceed.

In the first quar­ter of 2019, In­cyte $IN­CY earned baric­i­tinib roy­al­ty pay­ments of rough­ly $16 mil­lion. The com­pa­ny, as part of its quar­ter­ly re­sults on Tues­day, said it had elect­ed to no longer co-fund the de­vel­op­ment of baric­i­tinib, but will con­tin­ue to re­ceive roy­al­ties on glob­al net sales of the drug, in ac­cor­dance with its deal with Lil­ly $LLY.

Da­ta from two late-stage stud­ies eval­u­at­ing baric­i­tinib in pa­tients with mod­er­ate-to-se­vere atopic der­mati­tis is ex­pect­ed to be pre­sent­ed by Lil­ly lat­er this year, in ad­di­tion to re­sults from oth­er on­go­ing Phase III tri­als in the same in­di­ca­tion. Lil­ly, which is com­bat­ing its own pipeline is­sues, has shelved plans to test the treat­ment for pso­ri­at­ic arthri­tis

The de­ci­sion to pull out of baric­i­tinib is not based on the drug’s fu­ture, but rather on the cu­mu­la­tive in­vest­ment In­cyte has made so far, In­cyte chief Hervé Hop­penot told an­a­lysts in a post-earn­ings con­fer­ence call. “There is a point we reached where we be­lieve we have a bet­ter re­turn-on-in­vest­ment…by re­al­lo­cat­ing our re­sources to oth­er pro­grams.”

Hervé Hop­penot

The move is set to save In­cyte be­tween $40 mil­lion and $60 mil­lion this year, which it can pour in­to oth­er pro­grams such as its ex­per­i­men­tal rux­oli­tinib cream, which is be­ing eval­u­at­ed for use in atopic der­mati­tis and vi­tili­go, com­pa­ny ex­ec­u­tives un­der­scored.

On Tues­day, In­cyte al­so is­sued a spate of pipeline up­dates, in­clud­ing that rux­oli­tinib cream had cleared a mid-stage vi­tili­go study, for which de­tailed da­ta will be dis­closed in the sec­ond quar­ter. Mean­while, an FDA de­ci­sion to ex­pand the use of Jakafi for treat­ment of steroid-re­frac­to­ry acute GvHD is ex­pect­ed by May 24. Sales of its flag­ship drug, Jakafi, con­tin­ue to grow steadi­ly.

Marc Frahm

“In­cyte post­ed a rea­son­able quar­ter…We are en­cour­aged that In­cyte has de­cid­ed to dis­con­tin­ue co-fund­ing of baric­i­tinib as we viewed that prod­uct as “dam­aged goods” based up­on its DVT/TE risk. We think in 2019 in­vestors will seek con­fi­dence that In­cyte’s broad on­col­o­gy and in­flam­ma­tion pipeline con­tains growth as­set(s). With mul­ti­ple pipeline op­por­tu­ni­ties (itac­i­tinib, pemi­ga­tinib, top­i­cal rux­oli­tinib, etc.) be­gin­ning to emerge we re­main at Out­per­form,” Cowen’s Marc Frahm wrote in a note.

Shares of the Wilm­ing­ton, Delaware-based drug­mak­er were up near­ly 5% at $78.01 in ear­ly Tues­day trad­ing.

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.

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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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

EQRx chairman Alexis Borisy and CEO Melanie Nallichieri

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

As a self-stylized drug pricing disruptor, EQRx has high hopes for its lead PD-(L)1 to offer proof of concept for the entire business model. After touting a win back in May, the biotech is back with full data in lung cancer that could back up an approval.

Patients dosed with EQRx and CStone Pharmaceuticals’ sugemalimab posted median progression-free survival of 9 months compared with 5.8 months for patients given placebo (p=0.0026), according to full data from the Phase III GEMSTONE-301 study in Stage III non-small cell lung cancer set to be presented at this weekend’s #ESMO21.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.