Amid Covid-19 hunt, Pfiz­er adds Ly­me dis­ease vac­cine in $308M deal with Val­ne­va

In the midst of their $500 mil­lion pro­gram to build a Covid-19 vac­cine with BioN­Tech, Pfiz­er has an­nounced a siz­able deal to com­mer­cial­ize a vac­cine for a far dif­fer­ent dis­ease.

Pfiz­er and Val­ne­va have agreed to an up-to $308 mil­lion deal on the French biotech’s Ly­me dis­ease vac­cine. The deal in­cludes a $130 mil­lion up­front pay­ment for Val­ne­va, whose can­di­date is now in Phase II. On top of that, there are mile­stones and ul­ti­mate­ly a 19% roy­al­ty on sales. Val­ne­va will still be in charge of 30% of the com­mer­cial­iza­tion costs.

Al­though the vac­cine mar­ket has been ail­ing for years, Pfiz­er has a block­buster in their pneu­mo­coc­cal vac­cine, Pre­vnar 13, and are in late stages on a suc­ces­sor vac­cine. The deal comes at a time of re­newed in­ter­est in the field, a phe­nom­e­non the Covid-19 pan­dem­ic and the drug hunt around it have on­ly ac­cel­er­at­ed. Ear­li­er this month, Affini­vax raised $120 mil­lion in a Se­ries C, and in March, SutroVax raised $110 mil­lion for their at­tempt to ri­val Pfiz­er’s Pre­vnar 13 — both stan­dard sums these days for on­col­o­gy but large in the con­text of in­fec­tious dis­ease re­search.

The hunt for a Ly­me dis­ease vac­cine is decades old, dat­ing to not long af­ter the dis­cov­ery of the tick-born ill­ness and the bac­te­ria that caused it in the 1970s and 80s. In 1998, SmithK­line Beecham beat out Pas­teur Mérieux Con­naught (the Sanofi Pas­teur pre­de­ces­sor) and got LY­MEr­ix, a re­com­bi­nant DNA vac­cine that re­quired 3 shots and was about 80% ef­fec­tive, ap­proved by the FDA.

The ap­proval, though, dove­tailed with the be­gin­nings of the mod­ern an­ti-vac­ci­na­tion move­ment in the Unit­ed States. Grow­ing re­ports of joint pain and oth­er safe­ty com­plaints with the vac­cine led to a class ac­tion law­suit against SmithK­line. Al­though the suit was set­tled with­out com­pen­sa­tion and an FDA re­view found no ev­i­dence for arthri­tis or oth­er un­ex­pect­ed ad­verse ef­fects, sales dropped pre­cip­i­tous­ly. SmithK­line pulled the drug off the mar­ket in 2002, cit­ing poor com­mer­cial per­for­mance.

The con­tro­ver­sy set back the field con­sid­er­ably. Pas­teur Mérieux Con­naught nev­er ap­plied for their vac­cine. To­day, al­though you can in­oc­u­late your dog against Ly­me dis­ease, you can­not in­oc­u­late your­self or your kid.

Thomas Lin­gel­bach

Val­ne­va, cre­at­ed af­ter the failed Aus­tri­an vac­cine com­pa­ny In­ter­cell merged with the French biotech Vi­valis in 2012, be­gan work­ing on a Ly­me dis­ease vac­cine short­ly af­ter its birth. They claim to have the on­ly Ly­me dis­ease vac­cine in de­vel­op­ment.

The vac­cine, VLA15, tar­gets the six most com­mon types of Bor­re­lia bac­te­ria that cause Ly­me dis­ease, mak­ing it a po­ten­tial can­di­date for use across Eu­rope and North Amer­i­ca. It is a pro­tein sub­unit vac­cine, mean­ing it con­tains on­ly the anti­gens from the bac­te­ria that the body will make an­ti­bod­ies against. They have fast-track des­ig­na­tion and are ex­pect­ing re­sults from their Phase II by mid-2020. CEO Thomas Lin­gel­bach has said he ex­pects to bring the prod­uct to mar­ket in 4-5 years.

The num­ber of peo­ple di­ag­nosed with Ly­me dis­ease has ex­pand­ed con­sid­er­ably in Amer­i­ca and Eu­rope in the two decades since LY­MEx­is’s ap­proval, po­ten­tial­ly set­ting up a large mar­ket if the vac­cine is ap­proved.

So­cial: Thomas Lin­gel­bach, Val­ne­va CEO via YouTube

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Paul Wotton, Obsidian CEO

Ver­tex adds a new gene edit­ing part­ner, pay­ing Ob­sid­i­an $75M for con­trol­lable CRISPR sys­tem

When Paul Wotton became CEO of Obsidian Therapeutics two years ago, he asked his team to explore where they could apply the company’s technology beyond cancer.

Launched by Michael Gilman in 2017, the GV-backed company had been working on a way of controlling cell therapies after they’re administered to a patient, allowing doctors to modulate the potency of CAR-T and other drugs as you might volume on a television set. Wotton wanted to them look beyond cancer, into areas such as gene editing.