In­cyte's good week con­tin­ues with an en­cour­ag­ing up­date on IDO1 star epaca­do­stat

In­cyte’s com­plete re­sponse rate for a mid-stage com­bo of its IDO1 drug epaca­do­stat with check­point leg­end Keytru­da took a hit in the lat­est da­ta up­date, but the grow­ing biotech came away with a thumbs-up from an­a­lysts who have been track­ing this tri­al care­ful­ly.

Hervé Hop­penot, In­cyte

In­cyte $IN­CY is steadi­ly beef­ing up the num­bers on their big drug. Go­ing in­to ES­MO next week — where they will add a few more re­sults — re­searchers re­port­ed on 54 pa­tients evalu­able for ef­fi­ca­cy.

Leerink’s Michael Schmidt took a close look, and was com­fort­ed over­all to see some con­sis­ten­cy and con­tin­ued promise. His bot­tom line:

Ef­fi­ca­cy and safe­ty da­ta high­light­ed in the ab­stract in this larg­er (n=54) melanoma co­hort look very con­sis­tent rel­a­tive to ear­li­er dose-es­ca­la­tion re­sults pre­sent­ed pre­vi­ous­ly in n=19 pa­tients. Im­por­tant­ly, da­ta con­tin­ue to com­pare fa­vor­ably not on­ly to his­toric Keytru­da or Op­di­vo monother­a­py re­sults, but al­so com­pared to the com­bi­na­tion of Op­di­vo with Yer­voy in treat­ment-naïve metasta­t­ic melanoma pa­tients, which we think bodes well for the prob­a­bil­i­ty-of­suc­cess of the on­go­ing ECHO-301 Phase III tri­al, which is ex­pect­ed to read out in ear­ly 1H18.

That’s based on these re­sults, which in­clud­ed a drop in com­plete re­spons­es from 26% to 13%:

1. In all 54 ef­fi­ca­cy evalu­able pa­tients, re­ports Leerink, an ORR of 56% was achieved (8 com­plete re­spons­es [CRs] and 22 par­tial re­spons­es [PRs], n=54 pa­tients). In treat­ment-naïve pa­tients, an ORR of 56% was achieved (6 CRs and 19 PRs, n=45 pa­tients). In treat­ment-naïve pa­tients re­ceiv­ing the Phase III epaca­do­stat dose (100mg BID) an ORR of 60% was achieved (2 CRs and 16 PRs, n=30 pa­tients). This com­pares to the ORR of 58% in n=19 treat­ment-naïve pa­tients pre­sent­ed pre­vi­ous­ly at ES­MO 2016.

2. In all 54 evalu­able pa­tients, a me­di­an pro­gres­sion-free sur­vival [PFS] of 12.4 months was achieved with PFS rates at 6, 12, and 18 months of 70%, 54%, and 50%, re­spec­tive­ly. In treat­ment naïve pa­tients, me­di­an PFS had not been reached with PFS rates at 6, 12, and 18 months of 68%, 52%, and 52%, re­spec­tive­ly.

So far, so good. We’ll keep up­dat­ing these small num­bers from ECHO-202 while the piv­otal tri­al pro­gress­es to a near-term read­out.

It’s been a good week for In­cyte, which an­nounced with Eli Lil­ly yes­ter­day that the FDA is let­ting the part­ners re­sub­mit their rheuma­toid arthri­tis drug baric­i­tinib with­out the new late-stage tri­al that was in­sist­ed on ear­li­er this year. If in fact the FDA changed its mind, af­ter the ar­rival of Scott Got­tlieb as com­mis­sion­er, then the agency has shift­ed course on safe­ty. That’s a big deal for every­one.

In the mean­time, In­cyte is al­so pur­su­ing its own PD-1 pro­gram with a part­ner, look­ing to line up an in-house com­bo that could even­tu­al­ly sup­plant ag­nos­tic col­lab­o­ra­tions with Mer­ck and Bris­tol-My­ers Squibb.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Credit: Shutterstock

New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.

Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,800+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.