Mer­ck has signed a re­search deal with 4D Phar­ma to use its Mi­croRX plat­form to turn liv­ing bac­te­ria in­to vac­cines.

The col­lab­o­ra­tion comes in the nascent field of “live bio­ther­a­peu­tics” – a term the FDA us­es to de­scribe liv­ing or­gan­isms, gen­er­al­ly bac­te­ria, used as med­i­cine. 4D Phar­ma, a small biotech based in Leeds, UK, builds its LBP by ex­tract­ing bac­te­ria from a healthy donor and putting it in a cap­sule pa­tients swal­low.

The deal al­lows 4D Phar­ma to cause New Jer­sey-based Mer­ck to pur­chase $5 mil­lion of or­di­nary 4D Phar­ma shares dur­ing the first year. There’s an undis­closed cash pay­ment to 4D, along with $347.5 mil­lion in op­tions hing­ing on de­vel­op­ment and reg­u­la­to­ry mile­stones, and roy­al­ties.

But there’s no word yet on what those in­di­ca­tions are. Or what pre­cise­ly these vac­cines are. 

Al­though 4D Phar­ma talks about de­vel­op­ing  “live bio­ther­a­peu­tic vac­cines” with Mer­ck, the FDA’s 2016 guid­ance on LBP clin­i­cal tri­als specif­i­cal­ly de­fines LBPs as some­thing that con­tains liv­ing or­gan­isms, is used to pre­vent or cure hu­man ail­ments, and “is not a vac­cine.”  

It ap­pears, though, that this is a new de­vel­op­ment and not an at­tempt by ei­ther com­pa­ny to re­brand the more es­tab­lished pre­ven­ta­tive LBP tar­gets. To its long list of pipeline tar­gets, the com­pa­ny very re­cent­ly – the Way­back Ma­chine on­ly lets us check as re­cent­ly as Ju­ly 15, when it was not yet there – added “MRx Vac­cines.” It ap­pears with the short­est line, and links to the mes­sage: “We have en­tered a re­search col­lab­o­ra­tion and op­tion agree­ment with MSD, util­is­ing the Mi­croRx plat­form to dis­cov­er and de­vel­op LBPs as nov­el vac­cines.”

LBPs are cur­rent­ly be­ing in­ves­ti­gat­ed as a pre­ven­ta­tive treat­ment for bac­te­r­i­al vagi­nosis, necro­tiz­ing en­te­ro­col­i­tis, and al­ler­gic rhini­tis. 4D is cur­rent­ly in­volved in four clin­i­cal tri­als, study­ing Blau­tix in IBS, MRx0518 in com­bi­na­tion with Mer­ck’s Keytru­da on sol­id tu­mors and MRx0518 in a neoad­ju­vant set­ting for sol­id tu­mors, and MRx-4DP0004 for asth­ma.

Daria Hazu­da, Mer­ck’s VP of in­fec­tious dis­eases and vac­cines dis­cov­ery re­search added, “we hope to gain mean­ing­ful in­sights in­to the role for the host mi­cro­bio­me in mod­u­lat­ing the im­mune re­sponse and ul­ti­mate­ly pro­tec­tion con­ferred by vac­cines.”

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.