No­var­tis dives even deep­er in­to ra­di­oli­gands, notch­ing li­cens­ing deal with iTher­a­nos­tics for mul­ti­ple com­pounds

No­var­tis cap­tured at­ten­tion last week for its Phase III prostate can­cer win with a ra­di­oli­gand ther­a­py it picked up for $2 bil­lion back in 2018. Now, No­var­tis is dou­bling down on the field.

No­var­tis will ac­quire de­vel­op­ment and com­mer­cial rights to two iTher­a­nos­tics ra­di­oli­gand ther­a­pies tar­get­ing fi­brob­last ac­ti­va­tion pro­teins on the sur­face of tu­mor cells, the Swiss drug­mak­er said Tues­day. The deal cov­ers can­di­dates FAPI-46 and FAPI-74.

In tar­get­ed ra­di­oli­gand ther­a­py, a ra­dioac­tive iso­tope rides a tar­get­ed lig­and to the tu­mor site and kills it, po­ten­tial­ly of­fer­ing a new path to can­cer care. No­var­tis’ 177Lu-PS­MA-617 re­cent­ly hit both co-pri­ma­ry end­points on over­all sur­vival and ra­di­ograph­ic pro­gres­sion-free sur­vival for prostate can­cer pa­tients in that Phase III tri­al, which will like­ly set up a FDA fil­ing in the near fu­ture and could set the stage for an­nu­al sales at around $1.3 bil­lion.

This time around, No­var­tis’ in-li­censed com­pounds will chase fi­brob­last pro­teins, a sur­face pro­tein that is of­ten found in large quan­ti­ties on cer­tain can­cers. The pro­teins are key for cell growth, and a high amount of fi­brob­last in can­cer cells is of­ten tied to a worse prog­no­sis for care.

By dou­bling down on ra­di­oli­gands — and the broad­er field of ra­dio­phar­ma­ceu­ti­cals in gen­er­al — No­var­tis is squar­ing up with a slate of biotechs al­so look­ing to cap­i­tal­ize in the space.

Su­sanne Schaf­fert

In No­vem­ber, start­up Rayze­Bio re­leased a breed of phar­ma­ceu­ti­cals that use pep­tide binders and Ac­tini­um-225 to tar­get can­cer cells. In 2020, the founders of Ak­tis On­col­o­gy joined the ra­dio­phar­ma­ceu­ti­cals space, win­ning No­var­tis back­ing in the process.

In mid-March, biotech in­vestor Pe­ter Kolchin­sky raised $300 mil­lion for Point Bio­phar­ma’s ra­dio­phar­ma­ceu­ti­cals play.

“We be­lieve work­ing across mul­ti­ple ap­proach­es is the key to reimag­in­ing can­cer care,” No­var­tis pres­i­dent Su­sanne Schaf­fert said in a state­ment. “FAP is an ex­cit­ing tar­get and these agents are a great fit with our ra­di­oli­gand ther­a­py pipeline, which we are ac­tive­ly in­ves­ti­gat­ing across mul­ti­ple tu­mor types. We be­lieve this tech­nol­o­gy has the po­ten­tial to trans­form many pa­tients’ lives.”

No­var­tis has been a ma­jor play­er in the space for the past sev­er­al years, as the com­pa­ny rolled the dice on ra­dio­phar­ma­ceu­ti­cals in 2018, ac­quir­ing rights to FF-10158 from Fu­ji­film Toya­ma Chem­i­cal af­ter it picked up En­do­cyte in a $2.1 bil­lion deal, and added it to the Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions group that it ac­quired in 2017 for $3.9 bil­lion.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

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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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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