News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

Ab­b­Vie and Roche’s Ven­clex­ta has got­ten a new FDA thumbs up.

The pair an­nounced Mon­day that reg­u­la­tors have ap­proved the drug in com­bi­na­tion with azac­i­ti­dine or low-dose cy­tara­bine for new­ly-di­ag­nosed acute myeloid leukemia in adults who are 75 or old­er or those who can’t un­der­go in­ten­sive chemother­a­py. This fol­lows the drug’s ac­cel­er­at­ed ap­proval in 2018 and pos­i­tive da­ta from two Phase III con­fir­ma­to­ry tri­als.

In the first Phase III, en­rolling 431 pa­tients, re­searchers found that Ven­clex­ta with azac­i­ti­dine showed a 34% re­duc­tion in mor­tal­i­ty com­pared to azac­i­ti­dine alone, with over­all sur­vival reach­ing an av­er­age 14.7 months against 9.6 months. Those in the tri­al arm al­so saw a com­plete re­mis­sion rate of 37% com­pared to just 18% for pa­tients on azac­i­ti­dine with place­bo.

The sec­ond Phase III com­bined Ven­clex­ta with low-dose cy­tara­bine and ex­am­ined 211 pa­tients. Ven­clex­ta’s com­bo did not sig­nif­i­cant­ly im­prove over­all sur­vival, but showed a com­plete re­mis­sion rate of 27% where­as the low-dose cy­tara­bine arm saw on­ly a 7.4% rate.

Ven­clex­ta had pre­vi­ous­ly been ap­proved to treat adults with chron­ic lym­pho­cyt­ic leukemia or small lym­pho­cyt­ic lym­phoma back in 2018. That ap­proval is for sec­ond-line treat­ment and com­bines Ven­clex­ta with Rit­ux­an. — Max Gel­man

Im­muno­Gen adds $40M, a Chi­na deal to its come­back sto­ry

Im­muno­Gen’s once-re­ject­ed an­ti­body-con­ju­gate is get­ting star treat­ment in Chi­na, pick­ing up $40 mil­lion in cash from its new part­ner, Huadong Med­i­cine.

The deal comes a year and a half af­ter Im­munomedics smashed records with a Chi­na deal for its own once-re­ject­ed ADC, which lat­er scored an FDA OK and paved the way for a $21 bil­lion buy­out by Gilead.

With Im­muno­Gen’s col­lab­o­ra­tion, Huadong gets the rights to de­vel­op and com­mer­cial­ize mirve­tux­imab so­rav­tan­sine in main­land Chi­na, Hong Kong, Macau and Tai­wan while the US de­vel­op­er is free to mar­ket it in the rest of the world.

Al­though the drug failed an ini­tial Phase III in ovar­i­an can­cer, Im­muno­Gen is bet­ting on its po­ten­tial for a key pop­u­la­tion of plat­inum-re­sis­tant pa­tients.

Huadong is on the hook for an ad­di­tion­al $265 mil­lion in mile­stones in ad­di­tion to roy­al­ties. — Am­ber Tong

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.

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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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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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.

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.

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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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.