Neon Ther­a­peu­tics bags a $70M round for ear­ly-stage neoanti­gen re­search

Hugh O’Dowd

Neoanti­gens emerged as one of the hot new trends in biotech R&D a lit­tle more than a year ago. Af­ter a slate of can­cer vac­cines had strug­gled and failed in the clin­ic, the idea that you could fash­ion a vac­cine di­rect­ly tar­get­ing an in­di­vid­ual pa­tient’s tu­mors be­came fash­ion­able in cer­tain seg­ments of the ven­ture com­mu­ni­ty. And a group of in­vestors has joined hands to fund the next stage of clin­i­cal de­vel­op­ment at Neon Ther­a­peu­tics with a hefty $70 mil­lion B round.

The Cam­bridge, MA-based Neon was launched by Third Rock back in late 2015. And it’s al­ready in a Phase Ib study with its lead pro­gram NEO-PV-01. That study launched in No­vem­ber, look­ing to re­cruit 90 pa­tients in 3 co­horts cov­er­ing melanoma, blad­der can­cer and non-small cell lung can­cer. Pa­tients are get­ting a cus­tom-built vac­cine along with Op­di­vo, one of the top check­point in­hibitors.

“This is first be­spoke (made to suit) vac­cine,” says CEO Hugh O’Dowd, a No­var­tis vet who made the jump to biotech. “When I was look­ing at a va­ri­ety of op­por­tu­ni­ties ear­li­er, I frankly looked down on the vac­cine op­por­tu­ni­ties of the past.” Tu­mor-as­so­ci­at­ed anti­gens were the fo­cus, but it took tu­mor spe­cif­ic anti­gens, these neoanti­gens, to get his at­ten­tion.

“I don’t think any­one could spell neoanti­gens 5 years ago,” he adds. “And we’re learn­ing every day. One of the most re­cent pa­tients with non-small cell lung can­cer, had 2,400 unique mu­ta­tions in their tu­mor. If you take a num­ber of lung can­cer pa­tients, there’s no sim­i­lar­i­ty in mu­ta­tions from pa­tient to pa­tient. We call them non-small cell lung can­cer, but mu­ta­tions are dri­ving their dis­ease.”

And you’re go­ing to need a be­spoke, per­son­al­ized, on time can­cer vac­cine to stop it. That means work­ing on a pro­duc­tion and de­liv­ery mod­el that can tai­lor each pa­tient’s vac­cine in a time­ly and ef­fi­cient man­ner.

Says O’Dowd: “We are think­ing cost of goods and one that is scal­able for a mod­el that can work around the world.”

Neon is al­so build­ing out its pipeline. Build­ing on a foun­da­tion of re­search from the Broad In­sti­tute and Dana-Far­ber Can­cer In­sti­tute, the biotech is work­ing on NEO-PTC-01, a pre­clin­i­cal per­son­al­ized adop­tive T cell pro­gram, as well as a “Shared Neoanti­gen Pro­gram.”

The first round of da­ta from their work should be avail­able lat­er in the year.

Neon is ob­vi­ous­ly not alone. UK in­vestors launched Achilles Ther­a­peu­tics last fall, a year af­ter Grit­stone land­ed $102 mil­lion for its work. Mod­er­na and Mer­ck — keen­ly fo­cused on ex­pand­ing its Keytru­da fran­chise — are part­nered on a per­son­al­ized can­cer vac­cine. Sean Park­er’s new in­sti­tute has been cre­at­ing a neoanti­gen col­lab­o­ra­tive. And biotech bil­lion­aire Patrick Soon-Sh­iong has shown in­ter­est as well.

Part­ner Fund Man­age­ment stepped in to lead the lat­est round. They were joined by Third Rock Ven­tures and Ac­cess In­dus­tries, with ad­di­tion­al new in­vestors that in­clud­ed Fi­deli­ty Man­age­ment & Re­search Com­pa­ny, Welling­ton Man­age­ment Com­pa­ny, In­bio Ven­tures and Nex­tech In­vest.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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FDA ap­provals roundup: Zo­genix's Fin­tepla, Ul­tragenyx's Do­jolvi, and Genen­tech's Ph­es­go

A weekly update on new drug approvals and indications from the FDA:

New approvals

Fintepla gets the go-ahead for Dravet syndrome

Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.

The approval was based on findings from two clinical studies in 202 participants aged between 2 and 18 years, in which the change from baseline in frequency of convulsive seizures was measured. In both studies, children who received Fintepla had significantly greater reductions in the frequency of convulsive seizures, compared with those receiving placebo. The reductions were seen within 3-4 weeks of therapy initiation and remained generally consistent during the treatment periods of 14-15 weeks.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Josh Cohen, Justin Klee

Armed with pos­i­tive ALS da­ta, Amy­lyx scores $30M in fresh fund­ing to com­plete Alzheimer's PhII

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from Termeer’s widow, Belinda, and other unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.