Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face-off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the rel­a­tive short his­to­ry of in­flam­ma­some re­search, Adam Keeney sees two time points mark­ing ma­jor break­throughs: the ear­ly 2000s, when the role of in­flam­ma­somes as a ma­jor in­nate im­mu­ni­ty node was elu­ci­dat­ed; and 2015, when sci­en­tists ob­served that an old Pfiz­er com­pound they thought were block­ing IL-1 ac­tu­al­ly tar­get­ed NL­RP3. Keeney’s biotech, NodThera, was found­ed the year af­ter along­side sev­er­al oth­ers to cre­ate its own su­pe­ri­or small mol­e­cule drugs.

“It was a rel­a­tive­ly good NL­RP3 in­hibitor, just not a good drug in terms of PK and PD — it need­ed to be giv­en 3, 4 times a day at very high dos­es — but it is a good tool com­pound,” the CEO told End­points News.

Hav­ing made some break­throughs on the chem­istry side on the back of $40 mil­lion in Se­ries A cash, NodThera is now ready to har­vest Phase I da­ta on its lead com­pound, push a sec­ond one to­ward the clin­ic, and eval­u­ate sev­er­al more, all based on the same start­ing point.

Nan­na Lüneborg

No­vo Ven­tures is lead­ing the $55 mil­lion fund­ing, with both new in­vestors (Cowen Health­care In­vest­ments and Sanofi Ven­tures) and old sup­port­ers (5AM Ven­tures, F-Prime Cap­i­tal, Sofinno­va Part­ners and found­ing in­vestor Ep­i­darex Cap­i­tal) chim­ing in.

If noth­ing else, NodThera is “cer­tain­ly equal” to elite peers like IFM, In­fla­zome, Roche’s Je­cure and Olatec, said No­vo Ven­tures part­ner Nan­na Lüneborg. But giv­en the broad ap­pli­ca­tion of this mech­a­nism of ac­tion in in­flam­ma­to­ry con­di­tions, the top team — with Keeney lead­ing a grow­ing clin­i­cal group in Boston, CSO Alan Watt man­ning the head­quar­ters in Cam­bridge, UK and a lab in Seat­tle, WA — is per­haps a more im­por­tant part of the bet.

While No­vo had known NodThera since its found­ing and con­sid­ered NL­RP3 a wor­thy tar­get, the firm wait­ed un­til the C-suite was in place and the pipeline was more ma­ture.

“It’s not just about the mol­e­cules here, it’s very much about find­ing a clever clin­i­cal de­vel­op­ment path as well,” she said.

With quite a so­phis­ti­cat­ed un­der­stand­ing of how the tar­get in­ter­acts chem­i­cal­ly, Keeney said, NodThera al­so boasts of a plat­form that al­lows its sci­en­tists to de­sign drugs with new prop­er­ties to cater to dif­fer­ent dis­eases. The sec­ond can­di­date, for ex­am­ple, makes for a good neu­ro drug be­cause of its abil­i­ty to pen­e­trate the blood-brain bar­ri­er.

The com­ing months, though, will be ded­i­cat­ed to fin­ish­ing the healthy vol­un­teer study of NT-0167, the lead drug, through clin­i­cal proof of con­cept.

“It’s a very rich, bio­mark­er-dri­ven Phase I pro­gram that I think will build con­fi­dence in the mol­e­cule (and) that will have dose se­lec­tion da­ta avail­able for it to launch in­to a com­pre­hen­sive clin­i­cal pro­gram,” he said.

The re­sult­ing da­ta could po­si­tion NodThera for a pub­lic of­fer­ing, per­haps to be pre­ced­ed by a crossover round — hope­ful­ly one where due dili­gence and oth­er dis­cus­sions aren’t done in a pan­dem­ic-strick­en, locked-down world.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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