Neoanti­gen pi­o­neer Neon Ther­a­peu­tics casts off in search of $115M IPO to fu­el the race to a per­son­al­ized can­cer treat­ment

Can a be­spoke can­cer vac­cine ac­tu­al­ly suc­ceed in treat­ing in­di­vid­ual on­col­o­gy cas­es? 

Er­ic Lan­der

Neon Ther­a­peu­tics launched three years ago, set­ting out on a mis­sion to prove that it could, and it now has enough ex­am­ples of a se­lect hand­ful of in­di­vid­ual re­spons­es to their neoanti­gen plat­form to gam­ble that in­vestors will come in to back a $115 mil­lion IPO as they look to tran­si­tion from their first ex­plorato­ry hu­man stud­ies in­to ad­vanced de­vel­op­ment work.

Over the start­up pe­ri­od, Neon has been de­vel­op­ing its first pep­tide-based in­di­vid­u­al­ized can­cer vac­cines, work­ing with the mu­ta­tions present in each case. Their work has steered them to­ward a set of can­cers like non-small cell lung can­cer, which have a high mu­ta­tion bur­den and a rich set of in­di­vid­ual anti­gen tar­gets to se­lect from.

By ze­ro­ing in on these neoanti­gens, they say, they can make the first gen­er­a­tion of check­point in­hibitors — de­signed to un­leash a swarm of T cells on can­cer cells — far more ef­fec­tive. But ground­break­ing new tech­nolo­gies like these al­so re­quire their own man­u­fac­tur­ing base, and they won’t come cheap.

Cather­ine Wu, Neon Ther­a­peu­tics

Third Rock launched Neon Ther­a­peu­tics with a high coun­cil of promi­nent sci­en­tists from Dana-Far­ber, MIT and else­where. The ad­vi­so­ry group in­clud­ed Er­ic Lan­der from the Broad In­sti­tute of MIT and Har­vard, MD An­der­son’s Jim Al­li­son and Cather­ine Wu with Dana-Far­ber. In true Third Rock style they re­cruit­ed No­var­tis vet Hugh O’Dowd to come in and take the helm, and the VC group still owns 44.4% of the eq­ui­ty.

Ac­cess In­dus­tries weighs in at 12% with Fi­deli­ty at 7.5% and Part­ner Fund Man­age­ment at 7%. O’Dowd has a 2.6% slice.

Neon has burned through $111 mil­lion to get to this stage, and the team has $62 mil­lion in re­serve. A suc­cess here would ex­tend their run­way con­sid­er­ably, if they can get enough sup­port for what re­mains a high-risk ef­fort to break se­ri­ous new ground in on­col­o­gy.

Not at all un­sur­pris­ing­ly in an era of ram­pant I/O en­thu­si­asm, Neon is al­so busy in a field crowd­ed with would-be pi­o­neers. The most promi­nent group in­cludes Aduro Biotech, Ad­vax­is, Agenus, BioN­Tech AG, Grit­stone On­col­o­gy, Mod­er­na Ther­a­peu­tics, PACT Phar­ma, and Zio­pharm.

Neon plans to trade as $NT­GN.

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

As it works to pad the case for expanding its Ayvakit and Gavreto labels, Blueprint Medicines has lined up $1.25 billion in funding, with some of that money seemingly earmarked for acquisitions or pipeline expansion projects.

Following the likes of BioCryst, Cytokinetics and MorphoSys, Blueprint is aiming to monetize the royalties of its RET+ non-small cell lung cancer and thyroid cancer drug Gavreto with Royalty Pharma. The investment group will dole out $175 million upfront and might tack on another $165 million in biobucks as part of Blueprint’s royalties receivable from net sales of the drug by Roche outside the US, sans China.

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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.

The investment will enhance Fujifilm Diosynth Biotechnologies’ sites in Hillerød, Denmark, and College Station, TX. The investment is expected to create approximately 450 jobs across both facilities.

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.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

Man­u­fac­tur­ing Roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA opens plant for HPA­PI pro­duc­tion

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.

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

The rise of pharma environmental, social and governance (ESG) efforts in the past two years has been meteoric as investors turn their attention to sustainable funding. However, investors aren’t the only ones watching. Patients are beginning to tune into pharmas’ ESG promises too.

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.

Eric Shaff, Seres CEO

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.

Bo Cumbo, AavantiBio CEO

Scoop: A small gene ther­a­py biotech, flush with ex-Sarep­ta and blue­bird lead­ers, guts CMC

En route to entering the clinic with its first AAV-based gene therapy for a rare neuromuscular disease, AavantiBio has let go of 30 employees, Endpoints News has learned.

The move comes after a year stacking its executive bench with ex-Sarepta and bluebird bio leaders and inking multiple partnerships with the likes of Aldevron, Catalent and Resilience. The biotech also formed a scientific advisory board in February.

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