Stéphane Bancel, Moderna CEO (JPM20/Jeff Rumans)

With mR­NA proof of con­cept on dis­play in Covid-19, Mod­er­na plots HIV vac­cine moon­shot as part of pipeline ex­pan­sion

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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

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.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

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.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; Flood, dead­ly fire threat­en As­traZeneca vac­cine plants

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.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

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.