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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Frank Zhang (AP Images)

Plot thick­ens around Leg­end Biotech, Gen­Script with founder Frank Zhang's ar­rest

Two months after Legend Biotech made the startling disclosure that founder and then-CEO Frank Zhang was placed under “residential surveillance,” its parent company revealed that he’s been formally arrested.

Zhang — who, since founding GenScript 18 years ago, has taken the CRO public and groomed Legend Biotech in-house until the J&J-partnered CAR-T player was mature enough for its own Nasdaq listing — is severing his final ties with both. He is resigning as board chair/non-executive director of GenScript and director of Legend.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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