Vi­gene Bio­sciences goes big on Mary­land vi­ral vec­tor ex­pan­sion as it rides high on Al­tim­mune vac­cine deal

Boost­ed by a gang­busters year for Rockville-based Emer­gent BioSo­lu­tions and its vi­ral vec­tors for Covid-19 vac­cines, the state of Mary­land has con­tin­ued to ce­ment its place as a hotbed for next-gen man­u­fac­tur­ing. Now, a small­er play­er is look­ing to build out its own small foothold in the state.

Vi­gene Bio­sciences, al­so based in Rockville, has snagged a pub­lic-pri­vate part­ner­ship with the state of Mary­land and its home base of Mont­gomery Coun­ty to add 52,000 feet of man­u­fac­tur­ing space at its head­quar­ters site.

The state’s com­merce de­part­ment ap­proved a $1.225 mil­lion loan to Vi­gene that’s con­tin­gent on “job cre­ation and cap­i­tal in­vest­ment,” ac­cord­ing to a re­lease. Vi­gene es­ti­mates the ad­di­tion will bring on 245 new jobs by the end of 2025 in ad­di­tion to keep­ing the com­pa­ny’s cur­rent staff of 125 em­ploy­ees.

Al­so, Mary­land state ap­proved a $100,000 train­ing grant pro­gram for the com­pa­ny, while Mont­gomery Coun­ty ap­proved a $125,000 grant al­so con­tin­gent on job cre­ation and cap­i­tal in­vest­ment.

The new space will help sup­port the com­pa­ny’s 4,000 clients, Vi­gene said, in­clud­ing Gaithers­burg, Mary­land-based Al­tim­mune and its sin­gle-dose in­tranasal Covid-19 vac­cine.

The agree­ment with Al­tim­mune came in Ju­ly, and de­tails were rel­a­tive­ly scarce. Al­tim­mune said at the time it hoped to pro­duce at least 100 mil­lion dos­es of its vac­cine in 2021 and was con­sult­ing with oth­er man­u­fac­tur­ers in ad­di­tion to Vi­gene.

Found­ed in 2012, Vi­gene fo­cus­es not on­ly on gene ther­a­py, but ways to make it af­ford­able, specif­i­cal­ly for those with can­cer and a se­ries of ge­net­ic dis­or­ders. Its most no­table progress of late in that ef­fort came in Feb­ru­ary 2020, when it was grant­ed a patent for new tech­nol­o­gy called “helper vec­tors”.

Those vec­tors, the com­pa­ny said at the time, can in­crease the pro­duc­tion of re­com­bi­nant­ly-mod­i­fied ade­no-as­so­ci­at­ed virus­es which in turn makes their out­put cheap­er since the yield is three-to-five-times high­er.

As for Emer­gent BioSo­lu­tions, they inked an ini­tial $628 mil­lion deal in June with the Trump ad­min­is­tra­tion’s Op­er­a­tion Warp Speed to pro­duce Covid-19 vac­cines for John­son & John­son, No­vavax and Vaxart, and has con­tin­ued to ex­pand its im­pact in fight­ing the res­pi­ra­to­ry virus.

The com­pa­ny now has over half a dozen CD­MO con­tracts for vac­cines and an­ti­body hope­fuls, which now most no­tably fo­cus on the J&J and As­traZeneca vac­cines, plus a late-stage Hu­mani­gen an­ti­body ther­a­peu­tic.

Zairen Sun, Vi­gene CEO

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Avid Bioser­vices, with re­cent IPO and Covid-19 part­ner­ship in hand, launch­es 2nd phase of fa­cil­i­ty ex­pan­sion

California’s Avid Bioservices now has two simultaneous expansion projects underway as the CDMO’s projections for customer demand sparked the launch this week of the second phase of building out its Myford facility.

Avid expects construction on the second phase, which will be known as its Myford South facility to take 18 to 24 months to complete at a cost of roughly $45 million to $55 million, it said in a press release.

Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden wants a re­view of the API sup­ply chain. Will that par­lay in­to an ef­fort to 'on­shore' drug man­u­fac­tur­ing?

When former President Donald J. Trump was voted out of office Nov. 2, his gung-ho effort to “onshore” drug manufacturing was left mostly up in the air. Joe Biden has been mostly mum on whether he would continue that effort, but a new executive order could provide a clue — at least in a few months.

In an order signed Wednesday, Biden demanded a 100-day governmental review of key supply chains, including for active pharmaceutical ingredients (API) used in American drugs.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Dutch biotech In­travacc seeks to bol­ster Nether­lands vac­cine man­u­fac­tur­ing abil­i­ties with new plants

The pandemic has given a huge edge to any country that can produce vaccine in its borders. Now one vaccine biotech is looking to make sure their country has that edge for any future pandemic.

Arguing Covid-19 exposed the Netherlands’ “vulnerability,” Dutch vaccines company Intravacc recently announced that its new “modern pilot production plant” will soon be functional and that it’s spearheading a conglomerate designing a multipurpose vaccine production plant.