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

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.