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

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Jeff Albers, Blueprint Medicines CEO

Look­ing past Big Phar­ma ri­vals, Blue­print buys a pre­clin­i­cal biotech for $250M+

J&J’s Rybrevant scored the first approval back in May for a small group of lung cancer patients with a rare EGFR mutation. Despite a swarm of other biopharma companies angling for a piece of that market, Blueprint Medicines is betting nearly $500 million on a candidate it thinks will stand out.

Blueprint is putting down $250 million in cash and another $215 million in biobucks for Lengo Therapeutics and its preclinical non-small cell lung cancer program LNG-451. Though it hasn’t been tested in humans, Blueprint says the candidate was “highly brain-penetrant” in preclinical trials, and has the potential to inhibit all common EGFR exon 20 insertion variants — which are found in just 2% to 3% of NSCLC patients.

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Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

Dutch VC Forbion is hopping on the ever-lengthening SPAC train.

To be led by Jasper Bos, who joined Forbion Growth as a general partner back in May just after the fund closed at $428 million, Forbion European Acquisition will target late-stage opportunities in the life sciences industry in Europe to merge with and bring onto Nasdaq.

Cyril Lesser, senior controller at Forbion, will be the CFO while Bos serves as CEO.