One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year af­ter Alex­ion part­ed with $25 mil­lion up­front to se­cure ac­cess to a sec­ond an­ti-FcRn as­set, it is aban­don­ing the ex­per­i­men­tal drug. The dis­con­tin­u­a­tion, dis­closed at the SVB Leerink Glob­al Health­care Con­fer­ence in New York dur­ing a fire­side chat, bodes well for ri­val Im­muno­vant.

The drug (ABY-039), part­nered for de­vel­op­ment with Swe­den’s Af­fi­body, was for­sak­en on the ba­sis of ear­ly-stage da­ta that was not viewed fa­vor­ably, Baird and SVB Leerink an­a­lysts not­ed.

“We be­lieve that this find­ing could have been due to a neg­a­tive safe­ty sig­nal, as Alex­ion al­so ac­knowl­edged that they knew the pro­gram was high-risk, due to the fact that pri­or bac­te­r­i­al se­quences had sug­gest­ed an in­creased like­li­hood of im­muno­genic­i­ty,” Baird’s Bri­an Sko­r­ney said.

“Giv­en this con­text, we do not be­lieve this dis­con­tin­u­a­tion should raise ques­tions re­gard­ing the po­ten­tial ben­e­fits and mech­a­nis­tic prop­er­ties in­volved with FcRn in­hi­bi­tion since Alex­ion di­a­logue may in­fer the de­ci­sion was safe­ty-based.”

Im­muno­vant’s ri­val drug, IMVT-1401, is in mul­ti­ple on­go­ing Phase II tri­als. SVB Leerink’s Thomas Smith has mod­eled peak sales of ~$2.7 bil­lion for the com­pa­ny’s three iden­ti­fied lead in­di­ca­tions: myas­the­nia gravis, thy­roid eye dis­ease and warm au­toim­mune he­molyt­ic ane­mia.

“(T)he dis­con­tin­u­a­tion of ABY-039 reads through as an in­cre­men­tal pos­i­tive for Im­muno­vant. Mov­ing for­ward, we con­tin­ue to be­lieve that IMVT-1401 pos­sess­es best-in-class po­ten­tial as a rapid­ly ad­min­is­tered and high­ly ef­fi­ca­cious FcRn in­hibitor,” Sko­r­ney said.

With the dis­con­tin­u­a­tion of ABY-039, there is one less FcRn an­ti­body in clin­i­cal de­vel­op­ment. How­ev­er, Alex­ion has an­oth­er an­ti-FcRn as­set it will hold on to — ALXN1830 — which it scored in a 2018 buy­out deal of Syn­tim­mune ($400 mil­lion up­front, with a po­ten­tial $800 mil­lion in mile­stones). There are al­so oth­er com­pa­nies in the space, in­clud­ing ar­genx, Har­bour Bio­Med and Mo­men­ta.

The neona­tal Fc re­cep­tor (FcRn) is an im­munoglob­u­lin G (IgG) and al­bu­min bind­ing pro­tein ex­pressed on the cell sur­face of most hematopoi­et­ic, en­dothe­lial, and ep­ithe­lial cells.

FcRn re­cy­cles IgG an­ti­bod­ies by shut­tling them away from lyso­so­mal degra­da­tion, there­by pre­serv­ing path­o­gen­ic an­ti­body lev­els in IgG-me­di­at­ed dis­eases such as myas­the­nia gravis (a long-term neu­ro­mus­cu­lar con­di­tion). Drugs de­signed to in­hib­it FcRn, there­fore, are de­signed to de­crease to­tal IgG — cru­cial­ly path­o­gen­ic IgG — to treat pa­tients.

So­cial im­age: Alex­ion

FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

CymaBay flash­es pos­i­tive re­sults from the tri­al they have to re­launch

Two weeks after the FDA lifted its clinical hold on their lead drug, CymaBay said it showed positive results in an aborted Phase III trial.

The drug, a small molecule known as seladelpar, had been in development for three different liver conditions before an independent review of a NASH study last year showed that it might actually be damaging patient’s liver cells. The FDA slapped a clinical hold across all three trials, only lifting it last month when an FDA review determined that the drug hadn’t caused liver damage.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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Im­mu­nic's lead MS drug hits pri­ma­ry and key sec­ondary end­points in PhII, but ques­tions re­main

Just a week after its lead program began enrolling patients in a study to treat Covid-19, Immunic Therapeutics is making more waves.

This time, the biotech is providing a glimpse at topline data from a Phase II trial studying the efficacy of vidofludimus calcium, or IMU-838, in relapsing-remitting multiple sclerosis patients. Taken orally, the candidate met its primary endpoint in reducing the cumulative number of combined unique active MRI lesions after 24 weeks for a 45 mg dose compared to a placebo, as well as a key secondary endpoint in such reductions for the 30 mg dose.

Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

Frank Zhang (AP Images)

CAR-T fil­ing in sight, Frank Zhang grabs full con­trol of J&J-part­nered Leg­end Biotech, steps down from Gen­Script

Two months after Yuan Xu steered Legend Biotech to a $424 million public debut on the Nasdaq, founder and chairman Frank Zhang is grabbing the reins as CEO.

In conjunction with the move, Zhang is also stepping down from the helm of GenScript — a position he’s held for 18 years. GenScript, a Hong Kong-listed CRO, hatched Legend as a subsidiary in 2015 before spinning it out, and remains a majority shareholder.

Roche de­clares a PhI­II fail­ure for Covid-19 as the IL-6 re­pur­pos­ing the­o­ry bites the dust

Another big IL-6 drug has failed to move the needle for Covid-19 patients, leaving that particular field of repurposed drug R&D on the ropes for the pandemic.

This morning it was Roche’s turn to outline a Phase III failure for Actemra, adding compelling data that have now all but extinguished the theory that an IL-6 drug could significantly help the most severely afflicted patients. That comes just weeks after Regeneron and Sanofi hit the red light on their trial for Kevzara after getting back-to-back readouts that made Roche’s trial a long shot at best.

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Tony Coles, Cerevel Therapeutics CEO

Adding $445M, Tony Coles and his big Pfiz­er neu­ro spin­out hitch a ride to Wall Street on Per­cep­tive’s SPAC

Two years ago, after Pfizer abruptly shut down its entire neuroscience division, Bain Capital bet $350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapeutics. A year later, they got seasoned executive Tony Coles, who had recently jumped back into the C-suite of another neuroscience startup, to run the company.

Now Coles is steering Cerevel public, in what he says is the largest ever transaction of its kind. Cerevel has agreed to merge with Perceptive Advisors’ specialty acquisition company ARYA II. Between the roughly $125 million Perceptive raised through ARYA and an additional investment of $320 million Bain Capital, Perceptive and — yes, really — Pfizer, among others, Cerevel will now move forward with an added $445 million in its coffers.

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