Mod­er­na’s march from ear­ly her­ald of mR­NA to sav­ior in the fight against Covid-19 has been a sight to be­hold as bet­ter-fund­ed com­peti­tors in the race for a vac­cine have fall­en by the way­side. Now, with its proof of con­cept val­i­dat­ed, Mod­er­na is adding to its ag­gres­sive R&D plan and look­ing to break ground along the way.

With an FDA emer­gency use au­tho­riza­tion for its mR­NA-based Covid-19 vac­cine show­ing promise for its once-un­like­ly mech­a­nism of ac­tion, Mod­er­na is ex­pand­ing its ever-grow­ing pipeline, which now in­cludes two long-shot tries at HIV, the com­pa­ny said Mon­day.

Mod­er­na will try its mR­NA sci­ence in two vac­cines tar­get­ing HIV, both of which are ex­pect­ed to en­ter Phase I tri­al in 2021, the Boston area biotech said. In ad­di­tion, Mod­er­na will ad­vance three new vac­cines against the flu, with tri­als al­so ex­pect­ed this year, and in Ni­pah virus, which can cause se­vere res­pi­ra­to­ry and neu­ro­log­ic com­pli­ca­tions and has no treat­ment oth­er than in­ten­sive sup­port­ive care, Mod­er­na said.

In all, Mod­er­na’s pipeline now in­cludes 24 sep­a­rate vac­cines across five ther­a­peu­tic ar­eas, the com­pa­ny said, and 13 of those prospects are in some phase of clin­i­cal de­vel­op­ment.

“Even as we have shown that our mR­NA-based vac­cine can pre­vent COVID-19, this has en­cour­aged us to pur­sue more-am­bi­tious de­vel­op­ment pro­grams with­in our pro­phy­lac­tic vac­cines modal­i­ty,” CEO Stéphane Ban­cel said in a re­lease.

A col­lab­o­ra­tion with the In­ter­na­tion­al AIDS Vac­cine Ini­tia­tive and the Bill and Melin­da Gates Foun­da­tion, mR­NA-1644 will aim to use a “nov­el ap­proach” to elic­it HIV neu­tral­iz­ing an­ti­bod­ies, Mod­er­na said, with a Phase I study aim­ing to iden­ti­fy and use mul­ti­ple anti­gens for germline tar­get­ing and im­muno-fo­cus­ing. The sec­ond vac­cine hope­ful, mR­NA-1574, a col­lab­o­ra­tion with the NIH, will use a sim­i­lar ap­proach with mul­ti­ple na­tive-like trimer­ic anti­gens.

If the pro­gram even­tu­al­ly turns out a win­ner, it would be the first vac­cine ap­proved for HIV, which af­fects around 38 mil­lion pa­tients world­wide.

Once con­sid­ered a biotech with as­pi­ra­tions slight­ly out of whack with re­al­i­ty, Mod­er­na has gone on to prove the haters wrong with a De­cem­ber EUA for its Covid-19 vac­cine, join­ing just Pfiz­er and BioN­Tech as one of two shots ap­proved for the nov­el coro­n­avirus on the US mar­ket. With most of the ground­work for that mech­a­nism of ac­tion now laid at the FDA’s feet, Mod­er­na’s ex­pan­sive pipeline now looks primed to keep adding mar­ket­ed prod­ucts in the com­ing years.

That pipeline in­cludes both pro­phy­lac­tic vac­cines tar­get­ing cy­tomegalovirus and Ep­stein-Barr, res­pi­ra­to­ry dis­eases and pub­lic health ini­tia­tives like Zi­ka and in­fluen­za, and “ex­plorato­ry” us­es in can­cer and re­gen­er­a­tive ther­a­peu­tics like VEGF-A.

Mod­er­na’s R&D growth has been com­ple­ment­ed by a boom in the com­pa­ny’s work­force, it said in a re­lease. Mod­er­na sits at rough­ly 1,300 em­ploy­ees — a big jump from the 820 work­ers on staff at the end of 2019.

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Seven years after the FDA first approved Esbriet, the blockbuster Roche IPF drug is getting an expedited review for a second indication.

On Thursday, the agency gave Esbriet priority review for unclassified interstitial lung diseases, or forms of pulmonary inflammation and scarring that don’t fit easily into the over 200 known types of ILD. The move comes 10 months after Esbriet received breakthrough designation and sets Roche up for a decision by May.

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.