Yuval Cohen, Corbus CEO (Corbus via YouTube)

An­oth­er Cor­bus pro­gram hits the skids af­ter late-stage flop, plum­met­ing the small biotech's shares

Cor­bus Phar­ma­ceu­ti­cals’ plans to po­si­tion lenaba­sum as a pipeline-in-a-prod­uct aren’t go­ing so well.

Af­ter shelv­ing a pro­gram in scle­ro­der­ma, the Nor­wood, MA-based biotech has re­vealed that its lead can­di­date failed both the pri­ma­ry and sec­ondary end­points in an­oth­er Phase III tri­al.

Lenaba­sum failed to show a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in to­tal im­prove­ment com­pared with place­bo in treat­ing der­mato­myosi­tis, a rare dis­ease that caus­es mus­cle in­flam­ma­tion and skin rash, the com­pa­ny said Thurs­day. The news sent Cor­bus’ $CRBP stock spi­ral­ing around 30% ear­ly Thurs­day morn­ing.

Par­tic­i­pants in the study re­ceived one of two dos­es of lenaba­sum (20 mg or 5 mg) twice a day, or a place­bo, all in ad­di­tion to back­ground treat­ments. At week 28, those in the 20 mg group saw a mean to­tal im­prove­ment score (TIS) of 28.3, ver­sus 26.7 in the place­bo group. How­ev­er, the p-val­ue came in at 0.1965, which is far over the gold­en 0.05 num­ber of­ten used in drug tri­als to mea­sure sta­tis­ti­cal sig­nif­i­cance.

“We are dis­ap­point­ed that the tri­al did not meet the pri­ma­ry end­point of TIS at Week 28,” CMO and head of re­search Bar­bara White said in a state­ment.

Lenaba­sum is a small mol­e­cule that binds to and ac­ti­vates CB2, which is ex­pressed on ac­ti­vat­ed im­mune cells. The Phase III study, dubbed DE­TER­MINE, en­rolled pa­tients with two types of der­mato­myosi­tis: those who have both mus­cle weak­ness and skin in­volve­ment, and those with skin in­volve­ment but no sig­nif­i­cant mus­cle weak­ness.

In an at­tempt to look on the bright side, Cor­bus said high­er TIS scores were seen in par­tic­i­pants who had mus­cle weak­ness and were treat­ed with two 20 mg dos­es com­pared to place­bo, with a nom­i­nal p-val­ue of 0.0302. And pa­tients with skin symp­toms but no mus­cle weak­ness showed greater im­prove­ments on the Cu­ta­neous Der­mato­myosi­tis Ac­tiv­i­ty and Sever­i­ty In­dex (CDASI), which mea­sures in­flam­ma­to­ry skin in­volve­ment, with a nom­i­nal p-val­ue of 0.0166.

How­ev­er, the drug flopped on an­oth­er sec­ondary end­point: ef­fect on lung func­tion. No sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence was seen at week 28 com­pared to the con­trol group, ac­cord­ing to Cor­bus.

CEO Yu­val Co­hen told End­points News that the com­pa­ny will have a dis­cus­sion with reg­u­la­tors, and if the next step is to con­duct an­oth­er study, they’ll dis­cuss which pa­tients and which end­points to fo­cus on.

“While, again, we did not hit on the pri­ma­ry, it’s the sec­ond time that we’re see­ing signs of what we think is clear: clin­i­cal ac­tiv­i­ty,” he said. “What we’re al­so wait­ing for are the bio­mark­er da­ta from skin biop­sies. In our Phase II, the bio­mark­er da­ta was very en­cour­ag­ing.”

Lenaba­sum is the com­pa­ny’s on­ly clin­i­cal can­di­date, ac­cord­ing to their web­site. It has oth­er CB2 ag­o­nists in the works for sol­id tu­mors, as well as CB1 in­verse ag­o­nists for me­tab­o­lism dis­eases and two mon­o­clon­al an­ti­bod­ies for sol­id tu­mors and fi­bro­sis.

Cor­bus spent years build­ing up in­vestors’ hope in lenaba­sum. But back in Sep­tem­ber, the drug failed a Phase III study for a rare au­toim­mune con­di­tion called scle­ro­der­ma. The fol­low­ing month, it an­nounced it would shave its work­force by 54%. The com­pa­ny, which once had hopes for lenaba­sum as a pipeline in a prod­uct, said it would re­fo­cus on pro­grams in der­mato­myosi­tis and sys­temic lu­pus ery­the­mato­sus, and its pre­clin­i­cal can­di­dates.

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.

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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.

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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.

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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.

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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.

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