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.
“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.
SAN FRANCISCO — If the annual JP Morgan conference is speed dating for biopharma deals, fewer eligible singles appeared to have shown up for 2023.
While attendees continued to pack the rooms for presentations, panels, networking events and happy hours, multiple people told Endpoints News that the confab felt quieter than past years.
“It’s less busy,” said Vor CEO Robert Ang. “I’d say it’s like 70%. But I think everyone’s really glad to come back.”
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Sun Pharma has enlisted the help of “Dr. Pimple Popper” dermatologist Sandra Lee to teach patients about the hormones behind their acne.
The “AH-ha! It’s Acne Hormones” campaign debuted on Wednesday, more than a year after the launch of Sun’s acne drug Winlevi. Unlike antibiotic acne treatments, Winlevi is an androgen receptor inhibitor, targeting the same hormone that can also cause hair loss.
There’s a foot race developing for the lead of a multibillion-dollar vaccine market. And once again, Moderna $MRNA promises to be right in the thick of things as some of the biggest blockbuster players in biopharma hustle toward the finish line.
After the market closed on Tuesday, the big biotech, which has been in the vanguard of the mRNA revolution on Covid vaccines, put out word that it had aced its pivotal trial for a new RSV vaccine dubbed mRNA-1345 among older people above the age of 60. Moderna CEO Stéphane Bancel headlined the news with a clearly statistically significant effect offering 83.7% efficacy in preventing lower respiratory tract disease among people with two or more symptoms of disease.
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The FDA and the CDC are investigating a “preliminary signal” of whether there might be an increased risk of stroke for people who got Pfizer and BioNTech’s updated Covid-19 vaccine booster.
In a statement posted on the CDC’s website, the agency said its monitoring system for vaccine side effects had been triggered to look for a potential issue with the shots in people ages 65 and older.
Bristol Myers Squibb’s first campaign for Opdualag marks a second stake in the ground for the biopharma. The new work is its second immuno-oncology combo drug, direct-to-consumer (DTC) ad campaign, with both efforts now running on TV, social and digital media.
Opdualag, approved in March 2022, is a combination of Bristol Myers’ blockbuster PD-L1 Opdivo (nivolumab) and relatlimab, approved to treat advanced melanoma cancer. The second campaign is an ongoing effort for Opdivo plus Yervoy, with new creative added in December.
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Bristol Myers Squibb, Novartis, AstraZeneca and industry group BIO are all seeking alterations to the FDA’s recent draft guidance to help sponsors measure the growth and evaluate the pubertal development in pediatric clinical trials.
The 10-page draft guidance, released last October, explains how if a drug could have an impact on the growth or pubertal development of participants in a trial, such trials should include accurate, serial measurements and recordings of growth parameters. The FDA calls on and explains how sponsors should look into participants’ changes in age, length/height, weight, head circumference in some circumstances, and more.
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SAN FRANCISCO — Just a few years since the first gene therapies became available, there has been a shift among small biotechs and large pharma companies about how to best deliver the edited genes, in particular regarding the viruses and other vectors that insert gene therapy payloads into cells.
The goal of these new delivery techniques is a more precise mechanism less likely to produce harmful side effects, and the shift is likely to ripple through the sector.
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Merck has identified what caused levels of the nitrosamine NTTP to appear in batches of its blockbuster diabetes drugs, the company confirmed on Wednesday.
An unnamed source told Bloomberg, which first reported the news, that NTTP contamination in certain batches of its sitagliptin diabetes products Januvia and Janumet occurred during storage and manufacturing processes.
The FDA said last August that it became aware of a nitrosamine impurity in certain samples of Merck’s type 2 diabetes drug Januvia. In order to avoid a shortage of the blockbuster drug, the agency temporarily allowed higher impurity levels than the acceptable intake limit.
With 2023 poised to be a big year for biosimilars, Amgen is marketing to doctors to help them understand the biologic drugs — and get ready for patient questions.
Why will people be asking more about biosimilars this year? The main reason is AbbVie’s megablockbuster Humira will get its first biosimilar competition in the US at the end of January, followed by a raft of other Humira biosimilars launching throughout the year. While that first Humira competitor is Amgen’s own Amjevita, its biosimilar social media campaign is educational only and does not include any mention of its own products.
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