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

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”