James Cullem, Allarity interim CEO

Af­ter FDA re­quests a new tri­al, Al­lar­i­ty drops a can­cer drug from so­lo de­vel­op­ment

The US-Dan­ish biotech Al­lar­i­ty Ther­a­peu­tics is hav­ing to piv­ot its pipeline strat­e­gy af­ter the FDA forced them to go back to the draw­ing board for an on­col­o­gy ther­a­py.

Al­lar­i­ty an­nounced on Tues­day that the board has man­dat­ed the biotech to re­fo­cus its on­col­o­gy strat­e­gy away from the de­vel­op­ment of monother­a­pies and to­ward the de­vel­op­ment of “more promis­ing and clin­i­cal­ly rel­e­vant com­bi­na­tion ther­a­pies.”

The move al­so comes af­ter the FDA had an ad­vi­so­ry meet­ing over the Phase III de­vel­op­ment for dovi­tinib — a for­mer No­var­tis can­di­date, as a ther­a­py for metasta­t­ic re­nal cell car­ci­no­ma (mR­CC). The FDA in­di­cat­ed the com­pa­ny would need to con­duct a new dos­ing study be­fore any Phase III can move for­ward. How­ev­er, con­duct­ing a new dos­ing study would cause fur­ther de­lays and dri­ve up the cost and time of pro­duc­tion so the com­pa­ny has cho­sen to drop it in­stead.

While Al­lar­i­ty de­ter­mined that ad­vanc­ing dovi­tinib is no longer com­mer­cial­ly vi­able, the drug will con­tin­ue to be ex­ter­nal­ly de­vel­oped as a po­ten­tial monother­a­py for pe­di­atric can­cers.

With its switch to com­bi­na­tions, the board said this can po­ten­tial­ly in­crease the com­pa­ny’s abil­i­ty to at­tract ad­di­tion­al fund­ing from life sci­ence in­vestors, as well as broad­en the po­ten­tial for fu­ture part­ner­ships with larg­er phar­ma­ceu­ti­cal com­pa­nies.

But Al­lar­i­ty will al­so be fac­ing stiff com­pe­ti­tion in the com­bi­na­tion ther­a­pies field. Sev­er­al ma­jor phar­mas have been rac­ing to get com­bi­na­tion ther­a­pies out to the pub­lic.

For Al­lar­i­ty’s new pipeline, it will start en­roll­ment for Phase Ib/II of a PARP in­hibitor with dovi­tinib, for the treat­ment of metasta­t­ic ovar­i­an can­cer by the end of the year. It is not shy­ing away from the mR­CC space, as the biotech is al­so eval­u­at­ing oth­er po­ten­tial stud­ies for ei­ther stenoparib or dovi­tinib com­bined with an­oth­er on­col­o­gy ther­a­peu­tic for its treat­ment. Al­lar­i­ty’s on­go­ing Phase II stud­ies of stenoparib, for ovar­i­an can­cer on its own, and Ix­em­pra for metasta­t­ic breast can­cer, will con­tin­ue through their da­ta read­outs.

“I am con­fi­dent that our strate­gic shift of fo­cus and re­sources is the cor­rect path for­ward for Al­lar­i­ty giv­en the cur­rent reg­u­la­to­ry and mar­ket re­al­i­ties and will best lever­age our DRP com­pan­ion di­ag­nos­tics to match the right pa­tients to can­cer ther­a­peu­tic from which they will most like­ly ben­e­fit,” said Al­lar­i­ty’s in­ter­im CEO James Cullem.

The move needs to have a pos­i­tive ef­fect on in­vestors as the com­pa­ny is sit­ting just above pen­ny stock sta­tus and its stock price $ALLR has fall­en 89% since De­cem­ber 2021.

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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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.

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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.

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.

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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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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