Bris­tol-My­ers, Clo­vis leap in­to PhI­II com­bo stud­ies in a PD-1/PARP play as ri­vals cir­cle

The check­point com­bo deal fren­zy con­tin­ues this morn­ing with a tie-up be­tween Bris­tol-My­ers Squibb and Clo­vis that will mar­ry their PD-1/PARP drugs and leap straight in­to Phase III reg­is­tra­tion stud­ies.

Clo­vis CEO Patrick Ma­haffy

As we learned again at the end of last week, as As­traZeneca buck­led un­der the weight of a failed pri­ma­ry end­point in its in-house com­bi­na­tion study of dur­val­um­ab and treme­li­mum­ab, piv­otal com­bi­na­tion bets loom large these days as key play­ers race to con­quer — or stay ahead of — a mega­mar­ket. This time Clo­vis will look to quick­ly check in­tense ri­val­ry from Tesaro and As­traZeneca in the PARP busi­ness, with Bris­tol-My­ers com­ing along as a part­ner.

Bris­tol-My­ers may have been bad­ly dent­ed by its own re­cent set­backs in im­muno-on­col­o­gy with key fail­ures for Op­di­vo, but it re­mains a dom­i­nant play­er in the field.

Now Bris­tol and Clo­vis will pair their drugs — Op­di­vo and Rubra­ca — in Phase III pro­grams for ad­vanced ovar­i­an can­cer as well as triple-neg­a­tive breast can­cer. A Phase II study will al­so get un­der­way for cas­tra­tion-re­sis­tant prostate can­cer. In the deal, Bris­tol-My­ers will take the lead on the breast and prostate can­cer stud­ies while Clo­vis helms the ovar­i­an can­cer work, where it is mak­ing its first big splash.

Along­side the bad news for dur­val­um­ab/treme­li­mum­ab last week, As­traZeneca al­so un­veiled a deal with Mer­ck that in­cludes an in­de­pen­dent fo­cus for both on Lyn­parza com­bi­na­tions with Keytru­da as well as As­traZeneca’s dur­val­um­ab. Tesaro has its own PD-1 in a reg­is­tra­tion study now, part of a huge sec­ond wave of check­points in the clin­ic as com­pa­nies line up their own pro­grams rather than part­ner with oth­ers.

The news to­day may douse some of the buzz that’s been cir­cu­lat­ing that Cel­gene may look to buy Clo­vis af­ter bag­ging rights to BeiGene’s PD-1 in a rich deal.

“We are very en­thu­si­as­tic about study­ing Rubra­ca and Op­di­vo in com­bi­na­tion, and the po­ten­tial to cre­ate new treat­ment op­tions for pa­tients with mul­ti­ple tu­mor types, as well as for pa­tients be­yond those with BR­CA mu­ta­tions,” said Patrick J. Ma­haffy, the CEO of Clo­vis On­col­o­gy, in a pre­pared state­ment. “This sub­stan­tial clin­i­cal col­lab­o­ra­tion in ovar­i­an, triple-neg­a­tive breast and prostate can­cers rep­re­sents a sig­nif­i­cant ef­fort by Clo­vis and Bris­tol-My­ers Squibb to re­al­ize that po­ten­tial.”

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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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.

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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Covid-19 roundup: BAR­DA qui­et­ly pulls plug on IL-6 drugs; BioN­Tech and Fo­s­un be­gin mR­NA tri­al

IL-6 inhibitors showed some early promise in potentially treating Covid-19 patients, but recent trial flops have dashed hopes. Now it appears BARDA has officially pulled the plug.

The HHS office’s website has quietly updated to reflect that it is “no longer supporting product development” for Covid-19 in both Actemra (tocilizumab) and Kevzara (sarilumab), dealing a blow to the Roche and Regeneron/Sanofi drugs. This all but assures that IL-6 drugs repurposed to treat Covid-19 are essentially dead in the water.

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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.

Kiersten Stead, John Hamer (DCVC Bio)

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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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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