With Al­im­ta patent cliff loom­ing, Lil­ly plots stronger foothold in front­line NSCLC with Cyra­mza

With Lil­ly’s foothold in the non-small cell lung can­cer (NSCLC) field weak­en­ing as its Al­im­ta fran­chise march­es to­ward a patent cliff, an­oth­er can­cer treat­ment man­u­fac­tured by the drug­mak­er could be used as a front­line treat­ment in the lu­cra­tive mar­ket. On Tues­day, the In­di­anapo­lis com­pa­ny said its drug, Cyra­mza, in com­bi­na­tion with Roche’s Tarce­va, helped stem the spread and growth of can­cer as an ini­tial treat­ment in cer­tain pa­tients with metasta­t­ic NSCLC in a piv­otal study.

Cyra­mza is al­ready ap­proved for use in com­bi­na­tion with the chemother­a­py drug do­c­etax­el in metasta­t­ic NSCLC pa­tients whose can­cer had pro­gressed on or af­ter pri­or plat­inum-based chemother­a­py. This Phase III 449-pa­tient tri­al, called RE­LAY, test­ed the Cyra­mza+Tarce­va com­bo in pre­vi­ous­ly un­treat­ed pa­tients with EGFR-pos­i­tive mu­ta­tions.

De­tailed re­sults will be pro­vid­ed at a fu­ture med­ical meet­ing, Lil­ly said, adding that it was prepar­ing for glob­al reg­u­la­to­ry mar­ket­ing sub­mis­sions in mid-2019.

About 228,150 of new cas­es of lung can­cer are ex­pect­ed in the Unit­ed States this year, the Amer­i­can Can­cer So­ci­ety es­ti­mates. It is a dead­ly dis­ease — and most pa­tients un­der­go sev­er­al ther­a­peu­tic reg­i­mens to ex­tend their sur­vival. Ty­ro­sine ki­nase in­hibitors (TKIs) are the cur­rent stan­dard treat­ment op­tion for EGFR-mu­tat­ed NSCLC, and Tarce­va is con­sid­ered stan­dard-of-care for this type of lung can­cer, Lil­ly said.

Mau­ra Dick­ler

“De­spite re­cent treat­ment ad­vances in metasta­t­ic EGFR-mu­tat­ed non-small cell lung can­cer, prog­no­sis re­mains poor and there is an on­go­ing need for ad­di­tion­al first-line treat­ment op­tions to help pa­tients with this dead­ly dis­ease,” said Mau­ra Dick­ler, vice pres­i­dent of late phase de­vel­op­ment, Lil­ly On­col­o­gy.

Cyra­mza, which is al­so ap­proved for sec­ond-line gas­tric and col­orec­tal can­cer, gen­er­at­ed about $822 mil­lion last year and is cur­rent­ly un­der re­view as a sec­ond-line treat­ment for pa­tients with he­pa­to­cel­lu­lar car­ci­no­ma.

In Jan­u­ary, Lil­ly $LLY agreed to pay $8 bil­lion for Loxo On­col­o­gy $LOXO, which man­aged to get a drug — a site-ag­nos­tic can­cer treat­ment — ap­proved in a rel­a­tive­ly quick 5 years. But the main at­trac­tion for Lil­ly is Loxo’s ex­per­i­men­tal LOXO-292, which has sig­nif­i­cant com­mer­cial po­ten­tial in pa­tients with NSCLC. Up­on the an­nounce­ment, Stifel an­a­lysts sug­gest­ed the trans­ac­tion was strate­gic con­sid­er­ing Al­im­ta has lost patent pro­tec­tion in parts of Eu­rope and is thought to soon be los­ing US ex­clu­siv­i­ty: “(A)pprox­i­mate­ly 55-60% of the end-mar­ket for LOXO-292 – the val­u­a­tion cen­ter­piece of this trans­ac­tion per LLY – is rep­re­sent­ed by RET-fu­sion NSCLC and thus rep­re­sents a read­i­ly-ac­ces­si­ble op­por­tu­ni­ty re­quir­ing min­i­mal in­fra­struc­ture build-out.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.