Seat­tle Ge­net­ic­s' Astel­las-part­nered ADC nails con­fir­ma­to­ry PhI­II in urothe­lial can­cer

Nine months af­ter Seat­tle Ge­net­ics nabbed an ac­cel­er­at­ed ap­proval for its Astel­las-part­nered an­ti­body-drug con­ju­gate Pad­cev, the part­ners said the ther­a­py has nailed a con­fir­ma­to­ry Phase III, prov­ing its worth in lo­cal­ly ad­vanced or metasta­t­ic urothe­lial can­cer.

Roger Dansey

Pad­cev, which has wide­ly been tapped as a po­ten­tial block­buster, scored im­prove­ments in both over­all sur­vival and pro­gres­sion-free sur­vival com­pared to chemother­a­py, caus­ing a 30% re­duc­tion in risk of death (p = 0.001) and 39% re­duc­tion in risk of dis­ease pro­gres­sion or death (p<0.00001).

The re­sults, which came at an in­ter­im analy­sis, were pos­i­tive enough for the in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee to rec­om­mend stop­ping the study ear­ly. Pa­tients in the chemother­a­py arm of the tri­al will be of­fered the op­por­tu­ni­ty to re­ceive PAD­CEV.

EV-301 builds on EV-201, a sin­gle-arm tri­al in­volv­ing 125 pa­tients that saw an ob­jec­tive re­sponse rate of 44% and a me­di­an du­ra­tion of re­sponse for 7.6 months. Tar­get­ing the third-line set­ting or be­yond, in­ves­ti­ga­tors ad­min­is­tered ei­ther Pad­cev or place­bo to pa­tients who have pro­gressed af­ter both plat­inum-based chemother­a­py and PD-(L)1 in­hibitors.

It’s a tough in­di­ca­tion where check­point in­hibitors like Keytru­da and Imfinzi have failed to in­duce sur­vival ben­e­fits, SVB Leerink an­a­lyst An­drew Berens not­ed.

“We al­so be­lieve Pad­cev’s over­all sur­vival ben­e­fit will raise the bar for its com­peti­tor Trodelvy, which will present fi­nal TRO­PHY-U-01 re­sults in 3L blad­der can­cer pa­tients, seek­ing a po­ten­tial ac­cel­er­at­ed ap­proval in 1H21,” he wrote.

Trodelvy, the crown jew­el ADC in Gilead’s $21 bil­lion buy­out of Im­munomedics, has an ac­cel­er­at­ed ap­proval for metasta­t­ic triple-neg­a­tive breast can­cer.

While Trodelvy tar­gets the TROP2 pro­tein, Pad­cev’s an­ti­body di­rects the pay­load to cells with Nectin-4 on their sur­face. Seat­tle Ge­net­ics will sub­mit its EV-301 da­ta to the FDA in search of a full OK as well as to an up­com­ing sci­en­tif­ic con­fer­ence.

“We con­tin­ue to ex­plore Pad­cev’s ac­tiv­i­ty across the spec­trum of urothe­lial can­cer in­clud­ing its po­ten­tial for use in ear­li­er lines of ther­a­py,” CMO Roger Dansey said in a state­ment.

Berens es­ti­mates $7.8 bil­lion in peak rev­enue for metasta­t­ic blad­der can­cer when count­ing front­line as well as re­frac­to­ry or re­lapsed set­tings, plus an­oth­er $1.8 bil­lion in mus­cle-in­va­sive blad­der can­cer.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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