No­var­tis takes the long view on CAR-T, grab­bing li­cens­es on new tech for next-gen ther­a­pies

Af­ter lin­ing up their ap­pli­ca­tion for a pi­o­neer­ing CAR-T ther­a­py, No­var­tis’ $NVS cell ther­a­py group is demon­strat­ing some longterm in­ter­est in the field, bag­ging li­cens­ing deals on new tech to help de­liv­er their ther­a­py as well as fo­cus on next-gen off-the-shelf cell ther­a­pies that are form­ing in a sec­ond wave of ex­per­i­men­tal pro­grams.

Ear­ly this morn­ing the Bel­gian biotech Celyad $CYAD an­nounced that No­var­tis had gained non-ex­clu­sive rights to IP it has on al­lo­gene­ic CAR-Ts, off-the-shelf cell ther­a­pies for can­cer that many be­lieve could even­tu­al­ly prove su­pe­ri­or to the au­tol­o­gous pro­grams now lin­ing up for an ap­proval from Kite and No­var­tis. The lead au­tol­o­gous drugs ex­tract T cells from pa­tients and then en­gi­neer them in­to ther­a­pies tar­get­ing can­cer cells. Al­lo­gene­ic CAR-Ts will use gener­ic T cells, but have to be able to avoid be­ing re­ject­ed by the host — a ma­jor chal­lenge.

Cam­bridge, MA-based blue­bird $BLUE then fol­lowed up with its news of a non-ex­clu­sive li­cense with No­var­tis cov­er­ing “cer­tain blue­bird patent rights re­lat­ed to lentivi­ral vec­tor tech­nol­o­gy” for CAR-Ts.

In blue­bird’s case, none of the fi­nan­cial terms were dis­closed, while Celyad says it can earn up to $96 mil­lion from their pact.

These are some of the first new moves by the phar­ma gi­ant to demon­strate that it has a keen in­ter­est in stay­ing in the lead with Kite as CAR-Ts jump past the first ap­provals and then shoot for new and bet­ter drugs. Last sum­mer No­var­tis stunned the bio­phar­ma world with its abrupt and un­ex­pect­ed de­ci­sion to shut­ter its stand-alone gene and cell ther­a­py unit, which had been her­ald­ed as a key fea­ture in its dri­ve to de­vel­op im­por­tant new ther­a­pies.

An­a­lysts are wait­ing on No­var­tis to re­veal da­ta from its JULI­ET study on CTL019 lat­er this sum­mer, which will be viewed in di­rect com­par­i­son with Kite’s ri­val drug.

Right on the heels of its No­var­tis deal, blue­bird fol­lowed up not­ing a new pact with Glax­o­SmithK­line $GSK cov­er­ing its de­liv­ery tech for the phar­ma gi­ant’s gene ther­a­py work on Wis­cott-Aldrich syn­drome and metachro­mat­ic leukody­s­tro­phy, two rare ge­net­ic dis­eases.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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