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

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.

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.

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.

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.

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.

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.