Can a Nek­tar ri­val make it on Nas­daq with a $100M IPO? Syn­thorx is giv­ing it a shot

Af­ter all the hub­bub around Nek­tar’s sec­ond-gen take on a pe­gy­lat­ed IL-2, is Nas­daq ready for a ri­val that be­lieves it can do the whole field one bet­ter?

Syn­thorx, a pre­clin­i­cal biotech with pri­mate da­ta that was set up by Aval­on, has filed for a $100 mil­lion IPO — hop­ing to catch a wave of ex­cite­ment that has pro­pelled scores of S-1s this year for ear­ly-stage com­pa­nies.

Like Nek­tar, Syn­thorx start­ed out with the knowl­edge that Pro­leukin nev­er lived up to its in­cred­i­ble ini­tial promise in can­cer, large­ly be­cause of a bad tox pro­file high­light­ed by vas­cu­lar leak syn­drome. And the lit­tle biotech has been work­ing on its own al­ter­na­tive un­der the guid­ance of CEO Lau­ra Shawver, an ex­pe­ri­enced biotech vet.

Here’s the rel­e­vant sec­tion from the S-1 filed with the SEC:

Us­ing our Ex­pand­ed Ge­net­ic Al­pha­bet plat­form tech­nol­o­gy, we site-specif­i­cal­ly pe­gy­lat­ed IL-2 to in­vent THOR-707 for im­muno-on­col­o­gy, or IO. We have de­signed THOR-707 to kill tu­mor cells by in­creas­ing CD8+ T and NK cells with­out caus­ing VLS (vas­cu­lar leak syn­drome) that has been ob­served with aldesleukin. In our non-hu­man pri­mate…pre­clin­i­cal stud­ies THOR-707 at dos­es ten times high­er than the dos­es ob­served to max­i­mal­ly ex­pand CD8+ T cells in NHP did not re­sult in signs of VLS, as mea­sured by in­creas­es in eosinophil count and lung and liv­er weight. Pub­lished pre­clin­i­cal lit­er­a­ture shows that com­bin­ing IL-2 treat­ment with PD-1 in­hibitors could have syn­er­gis­tic ef­fects in en­hanc­ing CD8+ T cell re­spons­es. As a re­sult, we be­lieve that THOR-707 in com­bi­na­tion with im­mune check­point in­hibitors may have greater an­ti-tu­mor ef­fects than PD-1 in­hibitors alone with­out the VLS ob­served with aldesleukin.

There’s al­so an­oth­er IL-2 pro­gram that works in re­verse, pro­mot­ing reg­u­la­to­ry T cells that sup­press the im­mune sys­tem to the ad­van­tage of pa­tients suf­fer­ing from au­toim­mune dis­ease.

Nek­tar’s NK­TR-214 is spot­light­ed as the biggest ri­val in the clin­ic. But the S-1 al­so cites Roche’s RO6874281, which spurred 3 ob­jec­tive re­spons­es in an ear­ly study. That drug, they say, is sim­i­lar to their own. And there is al­so Alk­er­mes’ ALKS-4230, “where a por­tion of the al­pha re­cep­tor is at­tached to IL-2, which dis­ables al­pha bind­ing. In a Phase I study of ad­vanced sol­id tu­mors, no re­spons­es were ob­served in 24 pa­tients.”

Jay Lichter’s Aval­on still con­trols the largest batch of stock, with 32%, with Pe­ter Kolchin­sky at RA Cap­i­tal in for 28.2% and Or­biMed hold­ing 21.5%. Those are the big 3. Shawver her­self has a slight 1% of the eq­ui­ty. Tighe Rear­don, the CFO at Aval­on, has 6.5% of the shares.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

In­tel­lia and Iver­ic sell stocks to raise mon­ey, each net­ting $300M

Wednesday afternoon, Gene editing company Intellia and eye disease company Iveric Bio announced that they had each raised $300 million by selling off some of their stocks. The two biotechs are the latest to raise money via public stock offerings, an increasingly popular tactic used by public companies as the industry falls back from its pandemic boom.

Intellia’s raise comes a few weeks after it posted an update on its hereditary angioedema program that uses CRISPR/Cas9 to directly edit the gene that makes the protein responsible for the attacks that occur with the disease. In that interim cut, Intellia showed that patients dosed with its one-time therapy became attack free (at least thus far) after an observation period of 16 weeks, with the longest patient remaining attack free for 10 months.

Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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