Dou­bling down on the Keytru­da fran­chise, Mer­ck pays $300M and promis­es $5B-plus to part­ner with Ei­sai on its bud­ding can­cer star

Im­pressed by the po­ten­tial of a com­bo fea­tur­ing Keytru­da with Ei­sai’s star can­cer drug Lenvi­ma (lenva­tinib me­sy­late), Mer­ck $MRK has stepped up with $300 mil­lion in cash and a com­mit­ment of more than $5 bil­lion in mile­stones to kick off a full slate of tri­als for the duo.

Roger Perl­mut­ter, Mer­ck

An oral TKI al­ready ap­proved for thy­roid can­cer and in com­bi­na­tion with everolimus for kid­ney can­cer, Ei­sai not­ed a lit­tle more than a month ago that their drug scored well in a Phase III study for first-line liv­er can­cer. And Mer­ck sees a big fu­ture for this drug tied to Keytru­da, which is now in­volved in more than 700 clin­i­cal tri­als.

In this pact, Ei­sai and Mer­ck will de­vel­op Lenvi­ma as a monother­a­py and in com­bi­na­tion with the check­point, with the two shar­ing de­vel­op­ment costs. Ei­sai will book glob­al sales while the two com­pa­nies share rev­enue. And they’ll work to­geth­er now on a pipeline of their own tar­get­ing en­dome­tri­al can­cer, non-small cell lung can­cer, he­pa­to­cel­lu­lar car­ci­no­ma, head and neck can­cer, blad­der can­cer and melanoma, as well as a bas­ket tri­al tar­get­ing mul­ti­ple can­cer types.

This deal fol­lows Mer­ck CEO Ken Fra­zier’s vow to fol­low up on his $8.5 bil­lion part­ner­ship with As­traZeneca on Lyn­parza with more such rev­enue-gen­er­at­ing pacts.

In a break­down of the mon­ey at stake, Mer­ck will be on the hook for $650 mil­lion for op­tions through 2020 and will pro­vide $450 mil­lion to re­im­burse Ei­sai on its share of the re­search costs. There’s an­oth­er $385 mil­lion on the ta­ble in de­vel­op­ment mile­stones and close to $4 bil­lion for sales goals.

What got them here?

In the RCC co­hort of Study 111/KEYNOTE-146, re­searchers tracked an ORR af­ter 24 weeks of treat­ment of 63%, with tu­mor re­gres­sion ob­served in 93% (28/30) of RCC pa­tients since the ini­ti­a­tion of treat­ment.

From their state­ment:

The re­sults of the in­ter­im analy­sis (n=23) of the en­dome­tri­al can­cer co­hort in Study 111/KEYNOTE-146 as of De­cem­ber 1, 2016, in­di­cat­ed ORR Week 24 of 52.2 per­cent (95% CI, 30.6-73.2) based on in­de­pen­dent ra­di­o­log­ic re­view and 47.8 per­cent (95% CI, 26.8-69.4) based on in­ves­ti­ga­tor re­view. Ad­di­tion­al­ly, tu­mor re­gres­sion was ob­served re­gard­less of the state of mi­crosatel­lite in­sta­bil­i­ty (MSI). An­ti-PD-1 an­ti­bod­ies are gen­er­al­ly less ef­fec­tive in pa­tients with low fre­quen­cy of MSI, which is a bio­mark­er for the in­abil­i­ty to re­pair er­rors in the base se­quence of DNA, or who are MSI neg­a­tive.

“To­geth­er with Ei­sai, we aim to max­i­mize the val­ue of Lenvi­ma for its cur­rent in­di­ca­tions while joint­ly pur­su­ing ad­di­tion­al ap­provals in com­bi­na­tion with Keytru­da across a wide range of can­cers,” said Mer­ck R&D chief Roger Perl­mut­ter. “There is strong sci­en­tif­ic ev­i­dence sup­port­ing syn­er­gis­tic ef­fects of Keytru­da when used in com­bi­na­tion with Lenvi­ma, and the com­pa­nies have al­ready re­ceived Break­through Ther­a­py Des­ig­na­tion from the U.S. FDA for the Keytru­da/Lenvi­ma com­bi­na­tion in re­nal cell car­ci­no­ma. Through this col­lab­o­ra­tion, we will both broad­en our on­col­o­gy port­fo­lio and have the op­por­tu­ni­ty to help even more can­cer pa­tients around the world.”

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.

Deep tech, round 2: DCVC Bio bags $350M fund to chase the tip of the life sci­ence spear

It took one trip from San Francisco to Vancouver for Kiersten Stead and her DCVC Bio crew to feel confident about throwing their weight — and cash — behind AbCellera.

CEO Carl Hansen’s academic background and the potential of the platform, which combined machine vision and robotics with microfluidics, were promising. But the site visit sealed the Series A deal, where DCVC was the lead and only investor.

Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

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