Ad­verum is mov­ing for­ward with its eye dis­ease gene ther­a­py that caused headaches in April 2021, but is do­ing so with few­er staff on board.

The biotech is lay­ing off 78 em­ploy­ees, or about 38% of its work­force, in or­der to con­serve cash and keep the lights on in­to 2025, ac­cord­ing to an SEC fil­ing.

Ad­verum CMO Richard Beck­man

The Red­wood City, CA, biotech said Wednes­day it has amend­ed the IND for a Phase II study of its gene ther­a­py in wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD). The tri­al of AD­VM-022 will kick off this quar­ter, CMO Richard Beck­man said in a state­ment.

Ad­verum’s stock $AD­VM rose near­ly 9% af­ter the open­ing bell Thurs­day. The re­struc­tur­ing will elim­i­nate about $15.3 mil­lion an­nu­al­ly in “di­rect la­bor cost,” ac­cord­ing to the biotech’s SEC fil­ing.

Now dubbed ixobero­gene soropar­vovec (Ixo-vec), an ear­li­er tri­al of the gene ther­a­py led to a loss of vi­sion in one pa­tient’s treat­ed eye last year. That pa­tient had di­a­bet­ic mac­u­lar ede­ma and re­ceived a high­er dose of the gene ther­a­py.

The safe­ty is­sues from the high dose end­ed up af­fect­ing five of 12 pa­tients with di­a­bet­ic mac­u­lar ede­ma in that Phase II tri­al, the com­pa­ny said last Ju­ly. It is now mov­ing for­ward with a low­er dose and is on­ly test­ing the gene ther­a­py in pa­tients with wet AMD in the Phase II LU­NA tri­al.

“We de­signed the LU­NA tri­al af­ter a thor­ough re­view of da­ta gen­er­at­ed in all 55 study par­tic­i­pants treat­ed to date with a sin­gle in­jec­tion of AD­VM-022, some of whom have now demon­strat­ed con­tin­u­ous and sta­ble afliber­cept ex­pres­sion for over three years. We have deep­ened our un­der­stand­ing of ade­no-as­so­ci­at­ed virus (AAV) me­di­at­ed oc­u­lar gene ther­a­py, in­clud­ing the in­flam­ma­to­ry re­sponse to AAV, and this is in­form­ing our strat­e­gy to mit­i­gate im­muno­genic­i­ty,” Beck­man, the med­ical chief, said in a state­ment.

CEO Lau­rent Fis­ch­er said the com­pa­ny has worked on its man­u­fac­tur­ing strat­e­gy to have a “scal­able ap­proach de­signed to pro­vide an am­ple sup­ply of Ixo-vec to sup­port our clin­i­cal de­vel­op­ment pro­gram through bi­o­log­ics li­cense ap­pli­ca­tion fil­ing.”

With the lay­offs and re­fined fo­cus on AD­VM-022, Ad­verum has enough cash to fund it­self be­yond one-year topline re­sults from the 72-pa­tient LU­NA tri­al, Fis­ch­er said in a state­ment. The biotech had $271.1 mil­lion in cash as of March 31.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.