Jonathan Montagu, HotSpot Therapeutics CEO

Ab­b­Vie puts up $40M to li­cense a treat­ment from HotSpot Ther­a­peu­tics

HotSpot Ther­a­peu­tics has man­aged to gain some steam fi­nan­cial­ly in the past few years, as the com­pa­ny wran­gled sev­er­al mul­ti-mil­lion dol­lar rais­es. But its lat­est deal not on­ly puts more cash in­to its pock­ets, it al­so con­nects with a ma­jor name in phar­ma.

On Tues­day, Ab­b­Vie and HotSpot an­nounced they have en­tered an “ex­clu­sive” glob­al col­lab­o­ra­tion, with the op­tion to li­cense HotSpot’s IRF5 pro­gram, which is de­signed to treat au­toim­mune dis­eases. The deal will see Ab­b­Vie hand HotSpot $40 mil­lion up­front, with the biotech el­i­gi­ble to re­ceive $295 mil­lion in “op­tion fees” and R&D mile­stones.

The deal al­so has the po­ten­tial for fur­ther com­mer­cial mile­stones and oth­er roy­al­ties on glob­al net sales. If Ab­b­Vie does ex­er­cise the op­tion, the phar­ma will con­duct all fu­ture clin­i­cal de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion for the pro­gram. HotSpot would have a one-time op­tion to share in the R&D costs in ex­change for a boost to the roy­al­ty pay­ments.

The IRF5 pro­tein it­self acts as a reg­u­la­tor of cer­tain types of im­mune re­spons­es, and its dys­reg­u­la­tion is a fac­tor in sev­er­al au­toim­mune dis­or­ders. Ef­forts to mod­u­late IRF5 us­ing the stan­dard small mol­e­cule ap­proach­es have not been very suc­cess­ful due to the mol­e­cule lack­ing a “tra­di­tion­al ac­tive site,” the biotech says. HotSpot, us­ing its plat­form, is de­sign­ing a small mol­e­cule IRF5 in­hibitor that tar­gets an un­known pock­et on the pro­tein that is crit­i­cal for reg­u­la­tion.

It’s not clear what stage of test­ing this pro­gram has reached, or if it’s been stud­ied in hu­mans yet. In an email to End­points News HotSpot COO Eva Jack said that it has not pro­vid­ed any guid­ance for the time­line to the clin­ic at this point as the IRF5 pro­gram is cur­rent­ly in the dis­cov­ery stage.

Jonathon Sedg­wick

“This col­lab­o­ra­tion with HotSpot has the po­ten­tial to de­liv­er an en­tire­ly new tar­get class of mod­u­la­tors to pa­tients with se­ri­ous au­toim­mune dis­eases, such as sys­temic lu­pus ery­the­mato­sus, and will help to fur­ther strength­en our ro­bust im­munol­o­gy pipeline,” Jonathon Sedg­wick, VP and glob­al head of dis­cov­ery re­search at Ab­b­Vie, said in a state­ment.

Sedg­wick al­so added in his state­ment that the drug dis­cov­ery plat­form has been able to find mol­e­cules that can bind to the IRF5 pro­tein that can ef­fec­tive­ly drug “what has been con­sid­ered an un­drug­gable tar­get.”

Ab­b­Vie has been shelling out mil­lions for deals with biotechs in 2022. In May, the Chica­go-based phar­ma start­ed col­lab­o­rat­ing with the pri­vate biotech Cu­gene to ad­vance a sin­gle Treg pro­gram tar­get­ing IL-2, spend­ing $48.5 mil­lion in up­front costs and an undis­closed sum of mile­stones and roy­al­ties to go along with it.

On the West Coast, the San Diego-based biotech Plex­i­um inked a deal with Ab­b­Vie as the phar­ma hoped to use Plex­i­um’s “ag­nos­tic” tar­get­ed pro­tein degra­da­tion (TPD) plat­form to screen for new ther­a­pies for neu­ro­log­i­cal dis­eases, Plex­i­um an­nounced in April. That deal in­clud­ed a $35 mil­lion up­front and $530 mil­lion in down­stream mile­stones, along with fu­ture roy­al­ties.

For HotSpot, the last cou­ple of years have been marked by steady fi­nanc­ing rounds, as the com­pa­ny put to­geth­er a $65 mil­lion Se­ries B in 2020 and a $100 mil­lion Se­ries C last year.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.