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.

Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

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Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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President Trump (left) and NIAID chief Anthony Fauci in the White House press room, April 22, 2020 (Michael Reynolds/Sipa via AP Images)

White House tries to dis­cred­it An­tho­ny Fau­ci — could he be on his way out?

For two months in late winter and early spring, Anthony Fauci and President Trump stood in uneasy co-existence at White House briefings — an unlikely truce between an infectious disease official who had helped combat AIDS and Ebola and a president who repeatedly denied the danger of a virus that would go on to kill 100,000 Americans, repeatedly rejected masks and certain social distancing efforts, and promoted a drug with little scientific basis.

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FDA re­jects Ver­ri­ca’s skin warts pitch, a month af­ter flag­ging ap­pli­ca­tion ‘de­fi­cien­cies’

Two years ago, Verrica Pharma landed a $75 million IPO on the promise they could develop the first ever-FDA approved drug for molluscum contagiosum, an infection that causes warts. Now that won’t happen, at least not this summer.

The FDA today rejected Verrica’s application to have their lead topical drug VP-102 approved for molluscum contagiosum. The news likely came as little surprise to Verrica or its investors; the biotech disclosed in late June that the FDA sent a letter saying “deficiencies” in their application precluded a discussion around labeling or post-marketing commitments.

Andrew Allen, Gritstone Oncology CEO

A neoanti­gen pi­o­neer says its tech is work­ing great. So what wrecked the share price?

Gritstone Oncology was one of the original neoantigen upstarts, raising cash and planning to disrupt the immuno-oncology field with a bold new approach to fighting cancer with a new brand of vaccines.

On Monday, the crew in charge ran out a full display of what they’ve been seeing in a Phase I study. And everything seems to be working perfectly with one big exception: It didn’t significantly shrink tumors, let alone eradicate them.

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Janet Woodcock, CDER chief (AP Images)

More Warp Speed con­tracts com­ing, vac­cine pro­duc­tion to be­gin in 4-6 weeks — of­fi­cials

Operation Warp Speed has already handed out 4 of what they once said would be 3-5 major contracts to develop Covid-19 vaccines, but administration officials indicated Monday that more would be on their way.

“The slate is not closed,”  a senior HHS official said on a call with reporters. “We’ve invested in four … but the slate is not closed.”

At the same time, the official indicated that Warp Speed would continue to focus on three technologies: mRNA, viral vectors and protein subunits. That leaves the door open for a wide range of platforms, notably including both of Merck’s vaccine candidates — one of which has already received BARDA funding — and one of Sanofi’s candidates. It appears to preclude, though, the potential for Inovio and Vaxart, among certain other small developers that have hyped their ties to the Trump administration, to be included.

Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

Covid-19 roundup: Af­ter re­ports of de­lays, gov­ern­ment dis­putes, Mod­er­na sets PhI­II launch; Clin­i­cal tri­als have re­turned — for now

After reported disputes between company officials and government scientists delayed a much-anticipated Phase III trial, Moderna has set a start date for the 30,000-person study that will determine whether its vaccine can actually protect people from developing Covid-19.

The study will start on July 27th, according to clinicaltrials.gov, in line with Moderna’s promise of a July launch but a bit more than 2 weeks after the July 10 date Reuters reported the trial was originally supposed to start. Conducted in collaboration with the NIH and BARDA, the trial will inoculate volunteers with placebo or mRNA-1273 at 87 sites across the country.

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Steve Arkinstall, Revitope CEO

Mass­a­chu­setts biotech Re­vi­tope scores first col­lab­o­ra­tion thanks to dual-en­gag­ing T cell plat­form

Revitope Oncology began 2020 hopeful that its cancer immunology platform would be finally ready to flourish. On Monday night, that platform nabbed the biotech its first collaboration.

The Massachusetts-based company has agreed to a licensing agreement with Shanghai-based Junshi Biosciences in which Revitope can receive up to $160 million in development and commercial milestones, plus royalties. In addition, Junshi will make a direct equity investment of $10 million, equal to 9.99% of Revitope shares, as the two companies work to develop a dual-antigen targeting cancer therapies.