Im­muno­core's bis­pe­cif­ic lands speedy re­view with FDA, EMA; Low-pro­file gene ther­a­py play­er grabs $30M

UK TCR-fo­cused biotech Im­muno­core an­nounced that it scored a pri­or­i­ty re­view with the FDA for lead drug tebenta­fusp.

The bis­pe­cif­ic al­ready boasts a break­through ther­a­py des­ig­na­tion thanks to pos­i­tive Phase III da­ta. The pri­or­i­ty re­view shaves four months off the reg­u­lar 10-month process, lead­ing to an ex­pect­ed PDU­FA date of Feb. 23.

Across the At­lantic, the EMA agreed to ac­cel­er­ate its as­sess­ment of Im­muno­core’s mar­ket­ing au­tho­riza­tion ap­pli­ca­tion, which it has al­ready ac­cept­ed. That ac­cel­er­at­ed time­line re­duces the as­sess­ment process from up to 210 days to 150 days, ex­clud­ing clock stops.

Bahi­ja Jal­lal, CEO of Im­muno­core, said in a re­lease: “There is an ur­gent need for an ap­proved treat­ment for metasta­t­ic uveal melanoma, an ag­gres­sive form of can­cer for which there are very lim­it­ed treat­ment op­tions.” — Paul Schloess­er

Xalud Ther­a­peu­tics nabs $30M to push non-vi­ral gene ther­a­py in in­flam­ma­tion

Xalud Ther­a­peu­tics an­nounced that it fin­ished a round of Se­ries C fi­nanc­ing with $30 mil­lion raised. Ac­cord­ing to CEO Diem Nguyen, “We are well po­si­tioned to con­tin­ue ad­vanc­ing XT-150, our lead ther­a­peu­tic can­di­date, through clin­i­cal de­vel­op­ment and fur­ther ex­pand our plat­form.”

Nguyen, who took on the role of CEO in Jan­u­ary, has led a com­pa­ny that has op­er­at­ed un­der a very low pro­file. Very lit­tle in­for­ma­tion about the com­pa­ny be­fore Nguyen took the helm is pub­licly avail­able.

The NYC-based biotech has spent a sig­nif­i­cant amount of its re­sources on XT-150, a lo­cal­ly in­jectable, non-vi­ral gene ther­a­py that tar­gets chron­ic in­flam­ma­tion. That ther­a­py is cur­rent­ly in a Phase IIb tri­al for os­teoarthri­tis of the knee and a Phase I/IIa clin­i­cal study for pe­riph­er­al neu­ro­path­ic pain. — Paul Schloess­er

FDA ex­pands la­bel for J&J’s Xarel­to 

J&J sub­sidiary Janssen Phar­ma­ceu­ti­cals has the FDA’s bless­ing for an ex­pand­ed pe­riph­er­al artery dis­ease (PAD) in­di­ca­tion for Xarel­to plus as­pirin to in­clude pa­tients who have re­ceived re­cent low­er-ex­trem­i­ty revas­cu­lar­iza­tion (LER) due to symp­to­matic PAD. FDA’s ap­proval is based on da­ta from a Phase III study known as VOY­AGER PAD.

That study showed that when Xarel­to and as­pirin are com­bined, pa­tients with symp­to­matic PAD and LER had a 15% de­creased risk in ma­jor ad­verse limb and car­dio­vas­cu­lar events.

With this ap­proval, Xarel­to, a blood thin­ner, brings its num­ber of in­di­ca­tions to nine.

“We’re thrilled to bring Xarel­to to even more pa­tients with PAD who have been liv­ing for two decades with­out any new in­no­va­tion in the an­tithrom­bot­ic space,” said James List, glob­al ther­a­peu­tic area head, car­dio­vas­cu­lar and me­tab­o­lism of Janssen R&D. — Paul Schloess­er

Lux Cap­i­tal leads $50M in­fu­sion in­to rare dis­ease re­search plat­form

All­Stripes has some new mon­ey to play around with.

The San Fran­cis­co-based com­pa­ny an­nounced a new $50 mil­lion Se­ries B round Tues­day morn­ing, led by Lux Cap­i­tal. All­Stripes said the cash will sup­port launch­ing 100 new rare dis­ease re­search pro­grams while ex­pand­ing its glob­al op­er­a­tional foot­print.

“Be­gin­ning re­search on a rare con­di­tion can feel like be­ing dropped in­to a new world with­out a map and we are on a mis­sion to change that with da­ta,” CEO Nan­cy Yu said in a state­ment. “This in­vest­ment will al­low us to bet­ter sup­port the rare dis­ease com­mu­ni­ty, where each per­son’s ex­pe­ri­ence is es­sen­tial to un­der­stand­ing dis­ease pro­gres­sion.”

In ad­di­tion to the re­search ex­pan­sion, All­Stripes al­so plans to build out its tech­nol­o­gy and da­ta au­toma­tion to im­prove re­search in­sights, which will fur­ther de­vel­op its plat­form ca­pa­bil­i­ties. That will help the biotech con­tin­ue to in­vest in grow­ing the com­pa­ny’s team to sup­port cre­at­ing the play­book for rare dis­ease re­search, the biotech said.

All­Stripes is a pub­lic ben­e­fit cor­po­ra­tion that ad­vo­cates for more re­al-world ev­i­dence while treat­ments are be­ing de­vel­oped. It aims to build tools that make re­search more in­clu­sive for the glob­al rare dis­ease com­mu­ni­ty. Cur­rent­ly, the com­pa­ny is part­nered with 30 pa­tient ad­vo­ca­cy groups. — Max Gel­man

Catch­ing up with gi­ants, Chi­na’s Rei­s­tone touts PhII alope­cia area­ta for JAK1 in­hibitor

A Shang­hai biotech is join­ing Eli Lil­ly, Pfiz­er and Con­cert Phar­ma and oth­ers in the rush to bring JAK in­hibitors in­to alope­cia area­ta.

In a Phase II study, Rei­s­tone Bio­phar­ma re­ports, its oral JAK1 block­er SHR0302 met the pri­ma­ry end­point of spurring sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly rel­e­vant per­cent­age change of SALT score — a mea­sure of hair loss — ver­sus place­bo.

Re­cruit­ed across Aus­tralia, Chi­na and the US, 94 pa­tients en­tered the tri­al with 25% or greater scalp hair loss and were ran­dom­ized to one of four groups: 8mg drug, 4mg, 2 mg or place­bo. The high and mid dos­es met the pri­ma­ry end­point as well as the sec­ondary end­point of ab­solute change in SALT score at week 24.

Rei­s­tone first li­censed SHR0302 from Jiang­su Hen­grui.

CEO Min Ir­win calls the re­sults “en­cour­ag­ing” and says Phase III plan­ning is un­der­way.

Clear­ly cog­nizant of the safe­ty con­cerns that have plagued the class, the biotech high­light­ed that “safe­ty of SHR0302 was con­sis­tent with es­tab­lished pro­files from pre­vi­ous stud­ies of oth­er JAK class of med­ica­tion and was well tol­er­at­ed with no ma­jor ad­verse car­dio­vas­cu­lar events (MACE), deaths, or ve­nous throm­boem­bol­ic events (VTEs) re­port­ed from the study.”

But it’s far from the on­ly one mak­ing those claims, as a slate of play­ers clam­or for a stake in this au­toim­mune dis­ease. Lil­ly, in par­tic­u­lar, is lin­ing up its NDA any day now fol­low­ing a break­through ther­a­py des­ig­na­tion. — Am­ber Tong

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.