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.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Kate Haviland, Blueprint Medicines CEO

What bear mar­ket? Blue­print lines up $1.25B to ex­pand la­bels, maybe tack on more drugs

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Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fujifilm’s spending spree into its CDMO arm is not slowing down.

The multinational announced on Wednesday that it will invest $1.6 billion to enhance and expand the cell culture manufacturing services of the CDMO arm of the Japanese conglomerate Fujifilm Diosynth.

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Famed oncologist Sid Mukherjee and repeat biotech co-founder Lew Cantley have teamed up to form Faeth Therapeutics, a startup aiming to treat cancer the way other conditions are addressed: pairing nutrition with therapeutics.

The goal is to transform cancer treatment with nutrition and make it the fourth “pillar” in the oncology regimen, which to date has centered on radiotherapy, surgery and drugs, Faeth CEO Anand Parikh told Endpoints News. Other conditions have already been addressed with a side of nutrients or diet, he said, pointing to diabetes, irritable bowel syndrome and other diseases.

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Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

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As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

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Patient advocacy groups familiar with ESG regard it as an important issue and want to be included in helping pharma companies set ESG policies and targets, according to a new report from PatientView. That’s quite different from what the investment community wants across a variety of Gartner’s defined financial, competitive, strategic and perception goals.

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Plot­ting a come­back af­ter 2016 flop, Seres to raise $100M to prep C. dif­fi­cile pro­gram for launch

Microbiome pioneer Seres Therapeutics faced numerous setbacks throughout the years in numerous fields, most prominently for its lead program in C. difficile infections. But the biotech has plotted a comeback after a major flop six years ago, and is confident enough to start seeking cash ahead of a possible market launch.

Seres on Thursday said it plans to raise $100 million by offering stock purchases to new and existing investors, giving the company some money to prepare for commercial activity and additional manufacturing capabilities. The biotech offered the shares $MCRB at $3.15 apiece, equal to Wednesday’s closing price.