J&J adds yet an­oth­er mul­ti­ple myelo­ma reg­i­men to the Darza­lex la­bel as Sanofi ri­val jumps in

J&J’s third-line mul­ti­ple myelo­ma block­buster Darza­lex got the FDA green light for a new reg­i­men to take an­oth­er swing at the blood can­cer — this time, in a cock­tail with carfil­zomib and dex­am­etha­sone.

The com­bi­na­tion ther­a­py was ap­proved to treat re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma pa­tients who have al­ready re­ceived one to three lines of treat­ment.

Darza­lex, a CD38-di­rect­ed an­ti­body, led the mar­ket for years af­ter its ap­proval in 2015 for third-line mul­ti­ple myelo­ma pa­tients. But this year, it faces com­pe­ti­tion from Sanofi’s Sar­clisa, an­oth­er CD38-tar­get­ing drug ap­proved in April as a third-line treat­ment for mul­ti­ple myelo­ma pa­tients, in com­bi­na­tion with po­ma­lido­mide and dex­am­etha­sone.

In a Phase III study — dubbed CAN­DOR — the Darza­lex cock­tail (DKd) met its pri­ma­ry end­point in pro­gres­sion-free sur­vival. The com­bi­na­tion re­duced pa­tients’ risk of dis­ease pro­gres­sion or death by 37%, com­pared to those on­ly treat­ed with carfil­zomib and dex­am­etha­sone (Kd), ac­cord­ing to J&J. The FDA al­so based its ap­proval on re­sults from EQU­ULEUS, a Phase Ib study that ex­am­ined safe­ty, tol­er­a­bil­i­ty and a dos­ing reg­i­men.

Those who took the Sar­clisa cock­tail in a Phase III study had a me­di­an PFS of 11.5 months, com­pared with 6.5 months for those who took po­ma­lido­mide and dex­am­etha­sone alone.

“The sig­nif­i­cant in­crease in pro­gres­sion-free sur­vival (PFS) seen among pa­tients re­ceiv­ing the DKd reg­i­men sup­ports the use of this new com­bi­na­tion for pa­tients with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma. We con­tin­ue to ad­vance ef­fec­tive reg­i­mens for the most crit­i­cal pa­tients who have al­ready re­lapsed,” Saad Us­mani, Atri­um Health’s Levine Can­cer In­sti­tute di­vi­sion chief and prin­ci­pal CAN­DOR in­ves­ti­ga­tor, said in a state­ment.

“The DKd reg­i­men fills an im­por­tant gap in the treat­ment land­scape, as many pa­tients may re­lapse fol­low­ing an im­munomod­u­la­to­ry drug-based ther­a­py, such as lenalido­mide-con­tain­ing reg­i­mens, and there­fore new ther­a­peu­tic op­tions are need­ed,” Us­mani con­tin­ued.

Craig Tendler

J&J inked a $1.1 bil­lion agree­ment with Gen­mab to de­vel­op, man­u­fac­ture and com­mer­cial­ize dara­tu­mum­ab (Darza­lex) in 2012. It shelled out $55 mil­lion up­front, with tiered “dou­ble dig­it” roy­al­ties. In 2019, Darza­lex raked in near­ly $3 bil­lion in sales.

“With this most re­cent ap­proval of the DKd reg­i­men, pa­tients with mul­ti­ple myelo­ma now have the op­tion to re­ceive treat­ment with DARZA­LEX and carfil­zomib as ear­ly as their first re­lapse, which is a crit­i­cal time in their treat­ment jour­ney,” said Craig Tendler, Janssen’s VP of late de­vel­op­ment and glob­al med­ical af­fairs, in a state­ment.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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