As gener­ic com­pe­ti­tion stut­ter sales of top on­col­o­gy drugs, Roche se­cures speedy re­view for pair of ex­per­i­men­tal can­cer of­fer­ings

As drug de­vel­op­ers seek ways to ex­pand ther­a­peu­tic ap­pli­ca­tions and over­come the hur­dles seen with the first gen­er­a­tion of an­ti­body drug con­ju­gates (AD­Cs), Roche is cap­i­tal­iz­ing on its tro­jan horse ADC — pow­ered by Seat­tle Ge­net­ics’ tech­nol­o­gy — as gener­ics eat in­to the sales of its tri­fec­ta of top can­cer drugs. On Tues­day, the Swiss drug­mak­er said its an­ti-CD79b ADC — po­latuzum­ab ve­dotin — had won the FDA’s pri­or­i­ty re­view for use in pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL), a field that is with­in the clutch of CAR-T ther­a­pies.

The FDA is ex­pect­ed to make its de­ci­sion by Au­gust 19, Roche said on Tues­day.

Po­latuzum­ab ve­dotin is be­ing re­viewed by the reg­u­la­tor when added to ben­damus­tine and Rit­ux­an (BR). The triplet had pre­vi­ous­ly se­cured break­through ther­a­py sta­tus. The pri­or­i­ty re­view was grant­ed on the ba­sis of an 80-pa­tient study in heav­i­ly pre-treat­ed sub­jects that showed the com­bo eclipsed me­di­an over­all sur­vival (an ex­plorato­ry end­point) com­pared to BR alone, help­ing pa­tients live longer by 12.4 months ver­sus 4.7 months. Da­ta al­so showed 40% of peo­ple treat­ed with po­latuzum­ab ve­dotin plus BR achieved a com­plete re­sponse (CR), while on­ly 18% of peo­ple treat­ed with BR alone achieved a CR.

The CD79b pro­tein is ex­pressed in the ma­jor­i­ty of types of B-cell non-Hodgkin lym­phomas, the most com­mon sub­type of NHL. Al­though pa­tients are gen­er­al­ly re­spon­sive to first­line treat­ment, as many as 40% of pa­tients re­lapse, af­ter which op­tions are lim­it­ed and sur­vival is short. Po­latuzum­ab ve­dotin, which is be­ing test­ed for use in sev­er­al types of NHL, binds to CD79b and dec­i­mates B-cells via a tar­get­ed ap­proach: min­i­miz­ing the ef­fects on healthy cells while max­i­miz­ing tu­mour cell death, us­ing ADC tech that is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get.

Sep­a­rate­ly, Roche has al­so won a pri­or­i­ty re­view for en­trec­tinib, a drug for use in neu­rotroph­ic tropomyosin re­cep­tor ki­nase (NTRK) fu­sion-pos­i­tive, lo­cal­ly ad­vanced or metasta­t­ic sol­id tu­mors in pa­tients whose can­cer has pro­gressed de­spite ther­a­py as well as pa­tients with metasta­t­ic ROS-1 pos­i­tive non-small cell lung can­cer (NSCLC).

The FDA is ex­pect­ed to make its de­ci­sion on the drug, which has pre­vi­ous­ly se­cured break­through ther­a­py sta­tus, by Au­gust 18, Roche said.

Roche, which bagged en­trec­tinib late in 2017 with its $1.7 bil­lion Igny­ta buy­out, hopes the drug will fare well ver­sus Bay­er’s Vi­t­rakvi — the first drug ap­proved by the FDA for NTRK fu­sion can­cers and the run­ner up ’tis­sue ag­nos­tic’ can­cer treat­ment that won the US reg­u­la­to­ry nod. With­in NSCLC, en­trec­tinib will be up against Pfiz­er’s Xalko­ri, which is the stan­dard treat­ment in ROS-1 pos­i­tive pa­tients.

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?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

UP­DAT­ED: In­di­v­ior's Shaun Thax­ter heads to prison, join­ing In­sys' John Kapoor among jailed opi­oid ex­ecs

Update: An earlier version of this article misidentified the jailed Insys CEO. Former CEO John Kapoor was sentenced to 5.5 years in prison in January. Endpoints News regrets the error.

The Justice Department’s years-long battle with Indivior has arrived at a rare place: the jailing of a pharmaceutical executive.

A US district court sentenced long-running Indivior CEO Shaun Thaxter to 6 months in federal prison for his role in company efforts to mislead a major healthcare provider about the safety and abusability of their opioid addiction drug Suboxone, which generated billions in revenue over the last decade. Thaxter joins former Insys CEO John Kapoor as one of the only two executives to face prison time for their roles in the opioid epidemic.