Francis Collins via Getty Images

NIH cor­rals bio­phar­ma com­pa­nies, reg­u­la­tors and tri­al net­works to co­or­di­nate Covid-19 R&D

Fran­cis Collins’ grand plan to bring or­der to the chaot­ic rush for Covid-19 vac­cines and treat­ments is here.

The pub­lic-pri­vate part­ner­ship that the NIH di­rec­tor teased a few days ago will be known as AC­TIV or Ac­cel­er­at­ing COVID-19 Ther­a­peu­tic In­ter­ven­tions and Vac­cines. By com­pil­ing re­sources, lever­ag­ing ex­ist­ing net­works, lob­by­ing reg­u­la­tors and set­ting up a steer­ing com­mit­tee to pri­or­i­tize promis­ing can­di­dates, the goal is to gen­er­ate more com­pre­hen­sive da­ta quick­er.

“We want to do this in the most com­pelling sci­en­tif­ic way,” Collins said in a tele­brief­ing, where he echoed ear­li­er com­ments that he hopes to find 3 to 4 treat­ments that show ben­e­fit around June or Ju­ly.

Aside from gov­ern­ment agen­cies — the FDA and its Eu­ro­pean coun­ter­part, the HHS and the CDC — 16 bio­phar­ma com­pa­nies were al­so named to the group: Ab­b­Vie, Am­gen, As­traZeneca, Bris­tol My­ers Squibb, Evotec, Glax­o­SmithK­line, J&J, KSQ Ther­a­peu­tics, Eli Lil­ly, Mer­ck, No­var­tis, Pfiz­er, Roche, Sanofi, Take­da and Vir.

There are cur­rent­ly more than 400 clin­i­cal tri­als eval­u­at­ing po­ten­tial Covid-19 drugs and vac­cines, ac­cord­ing to clin­i­cal­tri­als.gov — a num­ber that grows by the day. A work­ing group with­in AC­TIV will take all the data­bas­es cur­rent­ly out there, from Bio­Cen­tu­ry’s re­source cen­ter to the Milken Track­er and merge them to get a good idea of every­thing that’s out there, Collins said.

Then they will be­gin rank­ing all the can­di­dates and, when nec­es­sary, re­jig cur­rent arrange­ments:

A num­ber of tri­als, as you know, are un­der­way with hy­drox­y­chloro­quine and chloro­quine. One of the things that the group is try­ing to do is to get an in­ven­to­ry of ex­act­ly how many tri­als of what size and what sever­i­ty of pa­tients are there, be­cause it may well be that we al­ready have enough to in­for­ma­tion to be able to as­sess whether there’s ben­e­fit or not, in which case those tri­als might bet­ter be adapt­ed to some oth­er can­di­date ther­a­peu­tics. The remde­sivir tri­al which NIH is run­ning has al­ready en­rolled 800 par­tic­i­pants when it on­ly need­ed 500 to be pow­ered. One of the ques­tions is should that par­tic­u­lar tri­al net­work, al­ready ex­ist­ing, now be adapt­ed to try a dif­fer­ent ap­proach, a dif­fer­ent can­di­date ther­a­peu­tic, so that we can learn things as quick­ly as pos­si­ble.

Al­so part of the plan: de­sign­ing, launch­ing and shar­ing mas­ter pro­to­cols that use a sin­gle con­trol arm. It would pre­sum­ably be an ex­pan­sion of ACTT, the adap­tive tri­al that the NI­AID has al­ready launched with Gilead’s remde­sivir and Eli Lil­ly’s Olu­mi­ant. Ex­ist­ing NIH net­works that are pre­vi­ous­ly fo­cused on every­thing from HIV to or­gan trans­plants have al­so pledged to help.

While any com­pa­ny is still free to move on with their own ther­a­peu­tic can­di­dates, there may now be less room for them to do so. Be­tween all the play­ers in­volved in AC­TIV, Collins added, they will like­ly have con­trol of the ma­jor­i­ty of pub­lic and pri­vate clin­i­cal tri­al net­works.

For the 40-plus vac­cine pro­grams, the main fo­cus is on de­vel­op­ing as­says, con­sol­i­dat­ing da­ta on im­muno­log­i­cal re­spons­es and fig­ur­ing out sur­ro­gate end­points.

But it al­so goes be­yond what’s al­ready in the clin­ic, with man­dates to stan­dard­ize pre­clin­i­cal eval­u­a­tion and in­crease ac­cess to val­i­date an­i­mal mod­els, which tripped up re­searchers in the ear­ly days.

Like the FDA’s Coro­n­avirus Treat­ment Ac­cel­er­a­tion Pro­gram, it’s all in­tend­ed to find some­thing, any­thing, that can re­duce the dis­ease’s dev­as­tat­ing toll as the White House in­structs states to con­sid­er lift­ing move­ment re­stric­tions in May. In its days of ex­is­tence, crit­ics have lament­ed that CTAP has not lived up to its promise; it re­mains to be seen whether a “na­tion­al strat­e­gy” can speed things up on the ground.

“There’s a lot of re­sources al­ready de­vot­ed to this,” Collins said, cit­ing con­gres­sion­al fund­ing and the phar­ma part­ners’ com­mit­ments. ‘They need to be di­rect­ed in the best way.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Following the release this week of promising early data for their Covid-19 vaccine candidate, Novavax has announced collaborations to supply it to two countries — Japan and India.

The Maryland-based biotech announced a deal Friday morning with Takeda to develop and manufacture up to 250 million doses per year of its adjuvanted vaccine. And late Thursday afternoon, Novavax entered into an agreement with the Serum Institute of India to provide up to 1 billion doses to India and low- and middle-income countries.

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Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

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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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First, the approval.

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