Gain­ing steam in PD-1/L1 race, Roche re­ports pos­i­tive PhI­II OS da­ta on Tecen­triq com­bo in NSCLC

Roche trot­ted out some ear­ly OS da­ta Mon­day morn­ing from its com­bo study of Tecen­triq in lung can­cer, re­port­ing that the com­bo met its co-pri­ma­ry end­point and helped pa­tients live longer.

The da­ta will back up the com­pa­ny’s up­com­ing bid for ap­proval of the drug com­bo as a front-line ther­a­py, mak­ing Roche a stronger con­tender among ri­vals Bris­tol-My­ers Squibb and Mer­ck as the PD-1/L1 mar­ket leader war wages on.

San­dra Horn­ing

Roche’s close­ly watched Phase III IM­pow­er150 study of a triple com­bo of Tecen­triq, Avastin and chemo showed a sur­vival ben­e­fit “across key sub­groups,” in­clud­ing those with vary­ing lev­els of PD-L1 ex­pres­sion. Genen­tech, a mem­ber of the Roche group, said its com­bo helped pa­tients live “sig­nif­i­cant­ly longer” than those tak­ing Avastin plus car­bo­platin and pa­cli­tax­el.

“We are pleased that the IM­pow­er150 study demon­strat­ed a clin­i­cal­ly mean­ing­ful sur­vival ben­e­fit for peo­ple re­ceiv­ing their ini­tial treat­ment for this type of ad­vanced lung can­cer,” said San­dra Horn­ing, Genen­tech’s CMO and head of glob­al prod­uct de­vel­op­ment, in a state­ment. “These re­sults add to the grow­ing body of ev­i­dence sup­port­ing the role of com­bin­ing Tecen­triq with Avastin. We will sub­mit these ad­di­tion­al da­ta to glob­al health au­thor­i­ties and hope to bring this po­ten­tial treat­ment op­tion to pa­tients as soon as pos­si­ble.”

While the com­bo with Tecen­triq, Avastin, and chemo met its OS co-pri­ma­ry end­point, the com­pa­ny not­ed that leav­ing out Avastin didn’t per­form so well.

At this in­ter­im analy­sis, the study found that sub­sti­tut­ing Avastin with Tecen­triq in the com­bi­na­tion with car­bo­platin and pa­cli­tax­el did not show a sta­tis­ti­cal­ly sig­nif­i­cant OS ben­e­fit in peo­ple with ad­vanced NSCLC com­pared to a com­bi­na­tion of Avastin plus car­bo­platin and pa­cli­tax­el. The study will con­tin­ue as planned to the fi­nal analy­sis.

The new OS da­ta comes af­ter Roche re­port­ed out sol­id PFS da­ta in De­cem­ber. The com­bo demon­strat­ed a dou­bling in 12-month pro­gres­sion-free sur­vival rates among a broad group of front­line lung can­cer pa­tients, set­ting the stage for a quick reg­u­la­to­ry OK on both sides of the At­lantic. Com­par­ing the triple against Avastin and chemo alone, re­searchers tracked a 38% re­duc­tion in the risk of dis­ease pro­gres­sion, with the pro­gres­sion-free sur­vival rate hit­ting 8.3 months for the triple against 6.8 months for the dou­ble. The haz­ard ra­tio (HR) was 0.62. In a sub­group of peo­ple de­fined by a bio­mark­er (T-ef­fec­tor “Teff” gene sig­na­ture ex­pres­sion Teff WT), the PFS hit an im­pres­sive 11.3 months for the triple.

Roche al­so re­port­ed out good news just days ago from the same com­bo in squa­mous NSCLC. At an in­ter­im point, that tri­al, called IM­pow­er131, showed the com­bo beat out chemo on PFS with a sta­tis­ti­cal­ly sig­nif­i­cant out­come but had yet to show an over­all sur­vival ben­e­fit.

IM­pow­er150 is one of eight Phase III lung can­cer stud­ies un­der­way at Genen­tech, eval­u­at­ing Tecen­triq alone or in com­bi­na­tion with oth­er med­i­cines. Three more Phase III lung can­cer stud­ies are ex­pect­ed to re­port this year.

 

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.