Bel­licum Phar­ma­ceu­ti­cals tried to make it work.

Rick Fair

Over the past months the Hous­ton-based CAR-T play­er sold its man­u­fac­tur­ing fa­cil­i­ty to MD An­der­son — trans­fer­ring 35 em­ploy­ees in the process — in fa­vor of an out­sourced arrange­ment and com­plet­ed a re­verse stock split, while drib­bling out new da­ta and get­ting an IND cleared.

But new in­ter­im da­ta from a Phase I/II tri­al pro­vid­ed the last straw. Bel­licum dis­closed late Thurs­day that it will be lay­ing off 79% of its staff, shav­ing the work­force from 68 to just 14 by the end of 2020.

Shares $BLCM of Bel­licum, which has been bat­tling a down­ward trend for years, are down 31.86% pre-mar­ket to $4.02.

With the BC­MA Go­CAR-NK pro­gram on pause and dis­cov­ery re­search chopped along­side new prod­uct de­vel­op­ment, the re­main­ing team will stay laser-fo­cused on the three pro­grams al­ready in the clin­ic: BPX-501, or ri­vo-cel, the lead pro­gram; BPX-601, its first prod­uct gen­er­at­ed from the Go­CAR-T plat­form tar­get­ing PC­SA; and BPX-603, which is tar­get­ing HER2+ sol­id tu­mors.

Then there’s the $35 mil­lion debt plus fees and in­ter­est that it’s still pay­ing down Ox­ford Fi­nance — $27.4 mil­lion of which is due Fri­day.

The re­sults that Bel­licum just re­port­ed came from four pa­tients with re­lapsed/re­frac­to­ry metasta­t­ic pan­cre­at­ic can­cer who re­ceived BPX-601 fol­lowed by re­peat dos­ing of rim­iducid, which are de­signed to ac­ti­vate CAR-T cells.

“Clin­i­cal­ly mean­ing­ful ef­fi­ca­cy as mea­sured by RE­CIST cri­te­ria was not ob­served,” the com­pa­ny stat­ed plain­ly. In­ves­ti­ga­tors doc­u­ment­ed the over­all re­sponse as three sta­ble dis­eases and one pro­gres­sive dis­ease.

CEO Rick Fair, though, re­mains en­cour­aged by what they saw on the safe­ty front as well as Go­CAR-T cell ac­ti­va­tion, pro­lif­er­a­tion and per­sis­tence.

He will wait for the com­ple­tion of the cur­rent safe­ty co­hort to re­view the plans in pan­cre­at­ic can­cer, while Bel­licum goes ahead and en­rolls a new metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer group in­to the tri­al.

Safe­ty, as long­time ob­servers of Bel­licum would re­call, was a key con­cern with BPX-501. Brain dam­age linked to the cell ther­a­py forced the FDA to slam a hold on the clin­i­cal tri­al back in 2018. And al­though the com­pa­ny man­aged to get the hold lift­ed af­ter pro­to­col ad­just­ment, it is now seek­ing a part­ner to help push the pro­gram through the last stage of de­vel­op­ment in blood can­cer and in­her­it­ed blood dis­or­ders.

For BPX-603, a dual-switch Go­CAR-T can­di­date, the plan is to start the first hu­man study by the end of the year.

“We have con­clud­ed that Bel­licum must re­duce spend­ing on pre­clin­i­cal pro­grams and shift its re­sources to en­able achieve­ment of mean­ing­ful mile­stones in the clin­ic,” Fair added.

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Neither Janet Woodcock nor Joshua Sharfstein is likely to be nominated as the permanent FDA commissioner, Steve Usdin at BioCentury reports.

The White House is looking for alternatives to Woodcock, the acting chief and longtime CDER director, after opposition from several Democratic senators who are calling on others to block her nomination if her name is put forth, according to Usdin. Sharfstein, the former principal deputy FDA commissioner and current Johns Hopkins professor, is out of the running altogether.