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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

NIH re­jects an­oth­er at­tempt to 'march-in' on prostate can­cer drug over ex­ces­sive price

The National Institutes of Health (NIH) has declined to use so-called “march-in” rights to lower the price of Astellas’ prostate cancer drug Xtandi even as the federal government helped to pay for its development.

NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News, the institutes’ analyses found Xtandi “to be widely available to the public” and “given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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Someit Sidhu, JATT Acquisition CEO

Af­ter rais­ing $140M, SPAC will take biotech pub­lic with a frac­tion of planned funds

A SPAC closed its merger with its private biotech partner Tuesday morning, sending the company to Nasdaq with extra cash in its coffers. But the transaction was completed with less than half the money than was originally expected.

JATT Acquisition, a blank check company that went public in June 2021, and Zura Bio announced the completion of their merger Tuesday morning, giving Zura $65 million to use for R&D purposes and “potential future acquisitions.” But the final amount is a far cry from the nearly $140 million JATT had in its trust account two years ago — another sign of the turbulent market for equities and new offerings.

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