Daniel O'Day (AP Images)

Amid remde­sivir craze Gilead finds time for an­oth­er on­col­o­gy pact — loop­ing in all things NK cells

Gilead’s $4.9 bil­lion buy­out of Forty Sev­en, an­nounced in ear­ly March, land­ed in a dif­fer­ent era be­fore the pan­dem­ic con­sumed bio­phar­ma news. But even amid all the buzz around its po­ten­tial Covid-19 treat­ment remde­sivir, CEO Daniel O’Day is still mak­ing clear that on­col­o­gy is where he wants to take the com­pa­ny.

His lat­est deal is a re­search col­lab­o­ra­tion in­volv­ing a low-pro­file play­er head­quar­tered in Mel­bourne — so stealthy that the up­front pay­ment and to­tal val­ue are all still un­der wraps. What Gilead did re­veal, how­ev­er, is an in­ter­est in oNKo-in­nate’s ex­per­tise in nat­ur­al killer cells as a new fron­tier of im­muno-on­col­o­gy.

William Lee

“We have a strate­gic fo­cus of grow­ing both our ex­per­tise and pipeline in im­muno-on­col­o­gy and we be­lieve this ex­cit­ing col­lab­o­ra­tion will sup­port each of these ob­jec­tives as we work to dis­cov­er and de­vel­op nov­el can­cer ther­a­pies for pa­tients,” William Lee, Gilead’s EVP of re­search, said in a state­ment.

While T cell me­di­at­ed an­ti-tu­mor ac­tiv­i­ty cur­rent­ly dom­i­nates can­cer im­munother­a­py — from CAR-T to PD-(L)1 in­hi­bi­tion — NK cells, a fel­low mem­ber of the lym­pho­cyte class, al­so plays a sur­veil­lance and ef­fec­tor role.

Mul­ti­ple ap­proach­es have emerged to kick them in­to ac­tion: Af­fimed and Drag­on­fly promise to ac­ti­vate and en­gage what’s al­ready in the body, while oth­ers like Cy­tovia and a Take­da-backed group at MD An­der­son are in­ter­est­ed in at­tach­ing re­cep­tors to de­vel­op a CAR-NK ther­a­py. Among those go­ing the en­gi­neer­ing route, there are yet dif­fer­ent ways to man­u­fac­ture NK cells. J&J re­cent­ly bet on Fate Ther­a­peu­tics’ iP­SC-based ap­proach; Nkar­ta re­lies on healthy donors; while Celar­i­ty ex­tracts them from pla­cen­tas.

oNKo-in­nate, mean­while, says it is “modal­i­ty ag­nos­tic.”

The com­pa­ny’s co-founders Jai Rautela and Nicholas Hunt­ing­ton set out in 2016 to look for the whole range of ways NK cells are in­volved in in­nate tu­mor recog­ni­tion, how they move and per­sist in the body, and are neg­a­tive­ly reg­u­lat­ed.

Over three years, oNKo-in­nate will de­ploy its genome-wide screen­ing tech­niques and im­mune cell tar­get dis­cov­ery plat­form in ser­vice of Gilead’s I/O pro­gram and sub­sidiary Kite Phar­ma’s cell ther­a­py work. The for­mer will like­ly yield tar­gets for an­ti­bod­ies or fu­sion pro­teins — of which there are sev­er­al in Gilead’s ear­ly-stage pipeline — while the goal of the lat­ter is to cre­ate and eval­u­ate NK con­structs.

Jai Rautela and Nicholas Hunt­ing­ton

Click on the im­age to see the full-sized ver­sion

Gilead’s Kite sub­sidiary is run by Christi Shaw — and de­spite a re­cent le­gal set­back, which leaves it on the hook for over a bil­lion dol­lars in IP dam­ages to Juno, the com­pa­ny is hus­tling a sec­ond CAR-T to­ward the FDA and in­tent on de­liv­er­ing more.

On the I/O side, Forty Sev­en marked Gilead’s largest ac­qui­si­tion since they bought Kite for $11.9 bil­lion in 2017, if you leave out the part­ner­ship ex­pan­sion with Gala­pa­gos worth $5 bil­lion. That deal brought in ma­grolimab, a CD47 an­ti­body that came out of Irv Weiss­man and Ravin­dra Ma­jeti’s long­time work on the “don’t eat me” sig­nal. Be­fore that, back in late 2018, Gilead bet $150 mil­lion in cash on Agenus’ plat­form, so far pro­duc­ing one bis­pe­cif­ic mol­e­cule and an­oth­er block­ing CD137.

More deals might yet be on the ta­ble. The lat­est ru­mor cen­ters around Ar­cus, led by biotech vet Ter­ry Rosen and de­vel­op­ing drugs against TIG­IT, CD73 and A2aR/A2bR.

Bot­tom line, as O’Day put it in his first an­a­lyst call of the year: Gilead aims to in­tro­duce 10 new trans­for­ma­tive ther­a­pies in the next 10 years. Bolt-on deals and part­ner­ships will be the way to go.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

Tak­ing an­oth­er shot at mR­NA glo­ry, Cure­Vac inks on­col­o­gy pact while keep­ing up with Covid work

CureVac may have lost out on the initial mRNA race to bring a Covid-19 vaccine to the market, but it’s still eager to prove that it has what it takes to be a serious player in the field.

As it updates investors on its second-generation vaccine candidates for infectious diseases in Q1 results, the German biotech says it’s beefing up its oncology pipeline.

To that end, it has struck a new collaboration with Belgium’s myNEO, which boasts of a neoantigen discovery and selection platform, to identify new targets for mRNA immunotherapies.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.