Bel­licum slash­es 79% of staffers af­ter ear­ly da­ta quash hope around next-gen CAR-T

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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

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.

Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

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.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Masayoshi Son, SoftBank CEO (glen photo/Shutterstock)

Japan's Soft­Bank plots bil­lions in biotech in­vest­ments in move that could keep the val­u­a­tion flood ris­ing — re­port

The valuation crazy train in biotech continues to roll into the new year with more than a dozen companies taking a chance on Nasdaq and money flowing in from all sides. Now, a Japanese institutional investor is reportedly weighing an entry into the market in a big way — will it keep the bitcoin-esque flood rising?

Already a part-time investor in biotech, SoftBank could drop billions of dollars into the industry as part of helmsman Masayoshi Son’s plan to spend around $80 billion of the firm’s own assets, according to a report from Bloomberg citing people familiar with the plan.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Biden is look­ing be­yond Wood­cock or Sharf­stein for FDA com­mis­sion­er — re­port

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.