Takeda CEO Christophe Weber (Getty Images)

Take­da an­nounces pos­i­tive new ALK+ lung can­cer da­ta as list of crizo­tinib suc­ces­sors widens

Take­da un­veiled new Phase III front­line da­ta for their ALK in­hibitor at Eu­ro­pean So­ci­ety for Med­ical On­col­o­gy Asia Con­gress, show­ing it could de­ter the spread of lung can­cer for two years or more. But the tri­al com­pared the drug, Alun­brig (briga­tinib), against an ear­ly in­hibitor that is no longer best-in-class and the Japan­ese phar­ma will like­ly face sig­nif­i­cant com­pe­ti­tion if reg­u­la­tors grant an ex­pand­ed la­bel. 

“It’s part of the next gen­er­a­tion of ALK in­hibitors,” San­jay Popat, a tho­racic on­col­o­gist at Roy­al Mars­den Hos­pi­tal and an in­ves­ti­ga­tor on the tri­al, Al­ta-1L, told End­points News. “The up­dat­ed da­ta re­al­ly con­firms that briga­tinib is way su­pe­ri­or to crizo­tinib.”

San­jay Popat

The tri­al com­pared briga­tinib against crizo­tinib in 275 ad­vanced non-small-cell-lung-can­cer pa­tients who test­ed pos­i­tive for the ALK gene, and it pro­duced re­sults that don’t take a bio­sta­tis­ti­cian to un­der­stand.

The re­view com­mit­tee found pa­tients on briga­tinib went a me­di­an 24 months with­out the can­cer spread­ing, hit­ting the pri­ma­ry end­point. For crizo­tinib pa­tients? 11 months. (Take­da in­ves­ti­ga­tors found a slight­ly high­er PFS for briga­tinib and a slight­ly low­er PFS for crizo­tinib). 

In pa­tients whose can­cer had spread to the brain — a no­to­ri­ous­ly-dif­fi­cult place to de­liv­er com­pounds, in­clud­ing crizo­tinib — be­fore the start of the tri­al, the drug im­proved pro­gres­sion-free sur­vival by 76% against the con­trol arm, as as­sessed by in­ves­ti­ga­tors. 

“It’s de­signed to cross the blood-brain bar­ri­er,” Popat said of the drug. Pa­tients with brain metas­tases rep­re­sent­ed about 30% of each arm.

The prob­lem for Take­da is that the ALK-land­scape has changed con­sid­er­ably since the Phase III tri­al be­gan and since they ac­quired the com­pound in the $5.2 bil­lion Ari­ad deal. Even since the FDA grant­ed ac­cel­er­at­ed ap­proval for the drug as a sec­ond-line treat­ment in 2017.

Crizo­tinib, the con­trol in the tri­al, was the first ALK in­hibitor ap­proved and came with much ac­claim. While the drug was in Phase I in the late 2000s, the sto­ries of once-ter­mi­nal pa­tients watch­ing their tu­mors shrink made for TV news fod­der. But Pfiz­er, No­var­tis and Roche have all since un­veiled new in­hibitors that can be more ef­fec­tive than the first drug.

Re­searchers cau­tion against com­par­ing clin­i­cal tri­als too di­rect­ly, but Roche’s Ale­cen­sa al­so showed dra­mat­i­cal­ly im­proved pro­gres­sion free-sur­vival against crizo­tinib in sim­i­lar pa­tient pop­u­la­tions, bol­stered by im­proved re­sults in the cen­tral ner­vous sys­tem metas­tases.

Still, the drugs are not iden­ti­cal and, as with many can­cer drugs, re­sis­tance has be­come a prob­lem, with pa­tients rid­ing one in­hibitor while it works and then go­ing to the next. That makes each new in­hibitor a po­ten­tial life­line.

“The one thing that’s clear is that each of the next-gen in­hibitors have demon­strat­ed true su­pe­ri­or­i­ty,” Popat said. “So choos­ing which one is a de­ci­sion be­tween pa­tients and their on­col­o­gists.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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