Gilead and No­vo Nordisk ex­pand NASH deal with new study; Pfiz­er out-li­cens­es AD­Cs to a biotech start­up

Pfiz­er has out-li­censed a pair of an­ti­body-drug con­ju­gates to Cam­bridge, MA-based Pyx­is On­col­o­gy.

Pyx­is is hand­ing over an un­spec­i­fied up­front pay­ment, mile­stones and a chunk of eq­ui­ty to Pfiz­er, and al­so gains rights to Pfiz­er’s ADC plat­form, “in­clud­ing var­i­ous pay­load class­es, link­er tech­nol­o­gy and site-spe­cif­ic con­ju­ga­tion tech­niques for the fu­ture de­vel­op­ment of ad­di­tion­al AD­Cs.”

Ronald Herb­st, the CSO at Long­wood-fund­ed Pyx­is, said:

The ear­ly gen­er­a­tions of AD­Cs demon­strat­ed sig­nif­i­cant po­ten­cy, but con­sid­er­able room re­mains for in­no­va­tion to gen­er­ate high­ly ef­fec­tive AD­Cs with an im­proved safe­ty pro­file. PYX-201 and PYX-203 rep­re­sent the next gen­er­a­tion of AD­Cs that use in­no­v­a­tive con­ju­ga­tion tech­nolo­gies.

John Car­roll

Gilead, No­vo take NASH com­bo part­ner­ship in­to PhI­Ib

Gilead and No­vo Nordisk are ex­pand­ing a col­lab­o­ra­tion in a field that’s had quite the rough and tum­ble scene late­ly.

The duo is en­gag­ing in fur­ther work in their clin­i­cal NASH deal, launch­ing a new Phase IIb study to eval­u­ate No­vo’s block­buster semaglu­tide and two ex­per­i­men­tal Gilead can­di­dates in the in­di­ca­tion. The tri­al will look at semaglu­tide alone and in com­bi­na­tion with the FXR ag­o­nist cilofex­or and the ACC in­hibitor fir­so­co­stat as part of the four-arm study.

Gilead and No­vo plan to en­roll about 440 pa­tients across all four arms, look­ing at the im­pact on liv­er fi­bro­sis im­prove­ment and NASH res­o­lu­tion. The tri­al will be dou­ble-blind­ed and place­bo-con­trolled.

Re­searchers will look to build off a Phase IIa tri­al, which showed semaglu­tide alone and in com­bi­na­tion with cilofex­or and/or fir­so­co­stat was well tol­er­at­ed in 108 peo­ple over 24 weeks. Ad­di­tion­al­ly, post-hoc analy­ses of ex­plorato­ry ef­fi­ca­cy end­points showed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in he­pat­ic steato­sis and liv­er in­jury in the com­bo arm when com­pared to semaglu­tide alone.

Semaglu­tide has been ap­proved by the FDA to treat type 2 di­a­betes, but not in NASH. Nei­ther cilofex­or nor fir­so­co­stat have been ap­proved for any in­di­ca­tion. — Max Gel­man

Mer­ck ex­tends long-run­ning can­cer da­ta col­lab­o­ra­tion with M2GEN

Mer­ck has struck a deal with Tam­pa-based M2GEN which gives the phar­ma gi­ant ac­cess to its anony­mous da­ta bank gleaned from can­cer pa­tients at 18 par­tic­i­pat­ing can­cer clin­ics. Pa­tients agree to do­nate their clin­i­cal and mol­e­c­u­lar da­ta to M2GEN, which then leas­es it out to drug de­vel­op­ers.

This new 5-year deal builds on a col­lab­o­ra­tion that dates back to 2006 and gave Mer­ck some in­sights as it de­vel­oped Keytru­da. And re­searchers ex­pect they can con­tin­ue to use it for the next round of can­cer drugs in the clin­ic. — John Car­roll

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.