News brief­ing: Mer­ck preps FDA pitch af­ter adding more da­ta on V114; Bris­tol My­ers, Ex­elix­is get quick re­view for can­cer com­bo

Mer­ck has new da­ta out from two Phase III tri­als on its pneu­mo­coc­cal con­ju­gate vac­cine can­di­date cov­er­ing 15 dif­fer­ent serotypes.

The pro­gram, dubbed V114, was test­ed in the first study in healthy adults aged 50 or old­er, with pa­tients re­ceiv­ing ei­ther the ex­per­i­men­tal vac­cine or the ap­proved Pre­vnar 13, fol­lowed by Mer­ck’s Pneu­movax 23 vac­cine one year lat­er. Af­ter that pe­ri­od, im­mune re­spons­es were com­pa­ra­ble in both vac­ci­na­tion groups for the 15 serotypes in V114.

In the sec­ond tri­al, which stud­ied the V114 vac­cine in adults be­tween 18 and 49 years old with un­der­ly­ing med­ical con­di­tions as­so­ci­at­ed with high­er risks of pneu­mo­coc­cal dis­ease, Mer­ck’s can­di­date saw com­pa­ra­ble im­mune re­spons­es to Pre­vnar 13 in the 13 over­lap­ping serotypes. V114 al­so showed high­er im­mune re­spons­es in the two serotypes not in­clud­ed in the Pre­vnar vac­cine — 22F and 33F — 30 days af­ter vac­ci­na­tion.

Those two ad­di­tion­al serotypes are among the most com­mon caus­es of in­va­sive pneu­mo­coc­cal dis­ease in adults old­er than 65 out of more than 90 to­tal serotypes. Mer­ck said its plans to file with the FDA for ap­proval be­fore the end of the year re­mains on track. — Max Gel­man

Armed with stel­lar PhI­II, Bris­tol My­ers, Ex­elix­is are flagged in­to the FDA’s fast lane

The FDA is of­fer­ing swift ac­tion on the ap­pli­ca­tion to com­bine Op­di­vo and Cabome­tyx for ad­vanced re­nal cell car­ci­no­ma. The part­ners picked up a pri­or­i­ty re­view for their pitch, with a PDU­FA date of Feb. 20.

Giv­en their track records, though, reg­u­la­tors may not re­quire all that time to make a de­ci­sion.

The de­vel­op­ers sub­mit­ted da­ta from the Phase 3 Check­Mate -9ER tri­al to back their ap­pli­ca­tion. The col­lab­o­ra­tors pulled the cur­tain back on some stel­lar da­ta for their com­bi­na­tion of Op­di­vo (the PD-1) and Cabome­tyx (the TKI) at ES­MO, mark­ing a sig­nif­i­cant ad­vance for the block­buster Bris­tol My­ers fran­chise while of­fer­ing a big leg up for the team at Ex­elix­is. — John Car­roll

Re­verse merg­er adds ra­di­a­tion de­fense to im­munomod­u­la­tion play­er’s menu

Im­munomod­u­la­tion-fo­cused biotech Cy­to­com is merg­ing with Cleve­land Bi­o­Labs to grab a spot on Nas­daq — and ex­pand its al­ready-broad port­fo­lio even fur­ther.

While the new com­pa­ny will be named Cy­to­com, Cleve­land Bi­o­Labs’ lead can­di­date, en­tolimod, will re­main in the pipeline for fur­ther de­vel­op­ment in can­cer and ra­di­a­tion de­fense. Mean­while, Cy­to­com will con­tin­ue to de­vel­op its four late-stage pro­grams for Crohn’s dis­ease, fi­bromyal­gia, mul­ti­ple scle­ro­sis and pan­cre­at­ic can­cer.

Michael Han­d­ley

That makes Cy­to­com, which was found­ed on a plat­form dubbed Ad­vanced Im­munomod­u­lat­ing Mul­ti-re­cep­tor Sys­tem, of­fi­cial­ly a play­er in acute ra­di­a­tion in­jury, on­col­o­gy, in­fec­tious dis­ease, in­flam­ma­tion and au­toim­mune-me­di­at­ed con­di­tions.

“We plan to uti­lize the com­bined plat­form to fur­ther dri­ve val­ue with ad­di­tion­al clin­i­cal and com­mer­cial prod­ucts and con­tin­ue to seek strate­gic part­ner­ships and ac­qui­si­tions,” CEO Michael Han­d­ley said in a state­ment.

Just a few months ago he en­gi­neered an all-stock deal to buy out a sub­sidiary of the con­tract re­search or­ga­ni­za­tion ImQuest, bag­ging new tools for in­ter­nal drug dis­cov­ery and de­vel­op­ment. — Am­ber Tong

Sci­ence 37 and Sig­nant part­ner on vir­tu­al clin­i­cal tri­als 

Sci­ence 37 and Sig­nant Health are team­ing up to pave the way for vir­tu­al cen­tral ner­vous sys­tem-fo­cused clin­i­cal tri­als.

David Co­man

The part­ner­ship will com­bine Sci­ence 37’s tech­nol­o­gy and net­work of pa­tients, telemed­i­cine staff, cen­tral raters and mo­bile nurs­es with Sig­nant’s elec­tron­ic clin­i­cal out­comes as­sess­ment soft­ware and ran­dom­ized and tri­al sup­ply man­age­ment (RTSM) tech­nol­o­gy. As a re­sult, pa­tients will have more op­tions for par­tic­i­pat­ing in clin­i­cal tri­als, in­clud­ing vir­tu­al and hy­brid mod­els.

The goal, ac­cord­ing to Sci­ence 37 CEO David Co­man, is to “bring clin­i­cal tri­als to pa­tients.”

“Out of ne­ces­si­ty, our in­dus­try has ac­cel­er­at­ed the path­way to dig­i­tal­ly en­abled clin­i­cal tri­als,” Sig­nant CEO Roger Smith said in a state­ment. “That’s why we are proud to part­ner with Sci­ence 37 and help all clin­i­cal tri­al stake­hold­ers con­tin­ue the progress we have col­lec­tive­ly made in clin­i­cal tri­al con­duct.” — Nicole De­Feud­is 

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.