J&J re­ports sec­ond HIV vac­cine reg­i­men fail­ure in 18 months

Af­ter more than four decades, there is still no ap­proved HIV vac­cine. And an­oth­er so-called mo­sa­ic reg­i­men has end­ed in dis­ap­point­ment.

John­son & John­son’s Janssen unit said Wednes­day that an in­de­pen­dent da­ta and safe­ty mon­i­tor­ing team found the Big Phar­ma’s reg­i­men to be in­ef­fec­tive at pre­vent­ing HIV in­fec­tion com­pared to place­bo. The drug de­vel­op­er re­port­ed no safe­ty is­sues.

With that, J&J end­ed the Phase III Mo­saico study, which en­rolled 3,900 cis­gen­der men and trans­gen­der in­di­vid­u­als in Ar­genti­na, Brazil, Italy, Mex­i­co, Pe­ru, Poland, Puer­to Ri­co, Spain and the US. Peo­ple in the tri­al who con­tract­ed the virus were giv­en “prompt HIV treat­ment and care,” the com­pa­ny said.

Pen­ny Heaton

“We are dis­ap­point­ed with this out­come and stand in sol­i­dar­i­ty with the peo­ple and com­mu­ni­ties vul­ner­a­ble to and af­fect­ed by HIV,” Janssen’s vac­cines R&D leader, Pen­ny Heaton, said in a state­ment. “Though there have been sig­nif­i­cant ad­vances in pre­ven­tion since the be­gin­ning of the glob­al epi­dem­ic, 1.5 mil­lion peo­ple ac­quired HIV in 2021 alone, un­der­scor­ing the high un­met need for new op­tions and why we have long worked to tack­le this glob­al health chal­lenge.”

Re­searchers gave par­tic­i­pants a tetrava­lent vac­cine known as Ad26.Mos4.HIV, us­ing a com­mon-cold virus, via an in­tra­mus­cu­lar in­jec­tion on days 1, 3, 6 and 12, and a bi­va­lent vac­cine, which in­cludes Ad­ju­vant­ed Clade C gp140 and Mo­sa­ic gp140, at months six and 12, ac­cord­ing to a clin­i­cal­tri­als.gov study en­try.

Janssen, oth­er bio­phar­mas and re­searchers have for decades tried to cre­ate an ef­fec­tive vac­cine for HIV, but none have made it across the reg­u­la­to­ry fin­ish line. Mul­ti­ple treat­ment op­tions have been avail­able for decades, as have pre­ven­ta­tive mea­sures known as PrEP, but on­ly a few vac­cine at­tempts have come close to suc­cess.

As part of the study, clin­ic staffers asked com­mu­ni­ty mem­bers if they were in­ter­est­ed in PrEP. If they didn’t choose PrEP, they were con­sid­ered for the tri­al, ac­cord­ing to study co­or­di­na­tor the HIV Vac­cine Tri­als Net­work, at Fred Hutch.

“We on­ly en­rolled par­tic­i­pants not on PrEP af­ter they had been giv­en an au­then­tic choice to go on PrEP, with bar­ri­ers re­moved to ac­cess­ing these drugs,” said study co-chair Su­san Buch­binder, a Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co clin­i­cal pro­fes­sor, in a state­ment. “One thing we’ve clear­ly learned from study par­tic­i­pants is that peo­ple want a choice, and that a vac­cine will be an im­por­tant op­tion for those who don’t want PrEP.”

A dif­fer­ent vac­cine reg­i­men from Janssen failed the Phase II Im­boko­do study last year. That can­di­date used the same tech be­hind the phar­ma gi­ant’s Covid-19 shot, which is large­ly on its way out from the US mar­ket.

At the time of the Im­boko­do tri­al stop­page, the da­ta and safe­ty mon­i­tor­ing board rec­om­mend­ed Mo­saico con­tin­ue be­cause it was test­ing a slight­ly dif­fer­ent reg­i­men and was be­ing in­ves­ti­gat­ed in a dif­fer­ent pa­tient pop­u­la­tion.

In ear­ly 2020, a reg­i­men from Sanofi and GSK al­so missed the bar in a Phase IIb/III tri­al that en­rolled 5,407 peo­ple in South Africa.

While the late-stage pipeline has now dwin­dled, oth­er groups are in ear­li­er phas­es of test­ing new vac­cines, in­clud­ing Mod­er­na, Vir Biotech­nol­o­gy, the Na­tion­al In­sti­tutes of Health and Gilead-al­lied Aelix Ther­a­peu­tics.

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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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.

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.

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.

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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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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