More than two years in­to the Covid-19 pan­dem­ic, we’re not done see­ing its dis­rup­tion of biotech.

That’s ac­cord­ing to Cal­adrius ex­ecs, who cit­ed the pan­dem­ic as one rea­son for sus­pend­ing its Phase IIb tri­al of a cell ther­a­py as a treat­ment for coro­nary mi­crovas­cu­lar dys­func­tion (CMD). The com­pa­ny plans to go ahead on an in­ter­im analy­sis be­fore de­cid­ing what to do with the pro­gram, which was built on a li­cens­ing deal with Shire in 2018.

In ret­ro­spect, the writ­ing may have been on the wall last month when Cal­adrius an­nounced its merg­er with Cend Ther­a­peu­tics, a lit­tle-known biotech fo­cused on sol­id tu­mors. Cal­adrius had plans to re­name it­self in­to Lisa­ta and make Cend’s can­cer work the “em­pha­sis” of its R&D group mov­ing for­ward.

Over its 16-year his­to­ry — it was found­ed as NeoStem and al­ready re­brand­ed once, in 2015 — Cal­adrius has tried and failed to bring for­ward cell ther­a­pies for a num­ber of dis­eases, and its shares have been lan­guish­ing in pen­ny stock ter­ri­to­ry.

Xow­na, the drug be­ing test­ed in its halt­ed tri­al, com­pris­es an in­fu­sion of au­tol­o­gous CD34+ cells.

Cal­adrius had pre­vi­ous­ly com­plet­ed a Phase IIa open-la­bel, proof-of-con­cept study in CMD. The Phase IIb FREE­DOM study was meant to con­firm those re­sults in a con­trolled tri­al — as well as bet­ter gauge how big the treat­ment ef­fect might be, as mea­sured by clin­i­cal end­points the FDA would like­ly be look­ing for in a lat­er piv­otal tri­al.

But while the study kicked off as planned in Oc­to­ber 2020 and treat­ed the first pa­tient the next Jan­u­ary, Cal­adrius ran in­to se­ri­ous trou­ble en­rolling pa­tients. On top of the im­pact of Covid-19, the biotech said sup­ply chain is­sues made it tough to get the catheters need­ed for both the di­ag­no­sis and ad­min­is­tra­tion of Xow­na, as the man­u­fac­tur­er stopped mak­ing the equip­ment orig­i­nal­ly spec­i­fied in the tri­al to qual­i­fy pa­tients for the study while a com­mon­ly used con­trast agent was al­so in short­age.

Thrown off the orig­i­nal sched­ule, the com­pa­ny said the re­vised time­line is sim­ply “not vi­able for fi­nan­cial and com­mer­cial rea­sons and an al­ter­na­tive de­vel­op­ment plan must be con­sid­ered.”

De­spite the mul­ti­ple pro­to­col amend­ments to ad­dress these ob­sta­cles, along with an in­creased num­ber of sites in the study, the FREE­DOM tri­al has on­ly en­rolled ap­prox­i­mate­ly one third of the tar­get­ed 105 pa­tients, and at this rate, more than four years would like­ly be re­quired to reach the pri­ma­ry end­point fol­low-up at 6 months post-treat­ment for all sub­jects.

CEO David Maz­zo added that paus­ing en­roll­ment now and tak­ing a look at the in­ter­im re­sults is in the “best in­ter­est” of the com­pa­ny.

Re­sults of the in­ter­im analy­sis are ex­pect­ed in Au­gust.

Ed­i­tor’s note: This sto­ry has been up­dat­ed to clar­i­fy the ori­gin of the Xow­na pro­gram in CMD. While Cal­adrius li­censed a no-op­tion re­frac­to­ry dis­abling angi­na pro­gram from Shire, it for­mu­lat­ed and owns the IP for CMD.

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.