New in­vestors pool $120M to bankroll Al­lo­gene's off-the-shelf CAR-T pipeline in dri­ve to stay in the lead

It was clear from Al­lo­gene Ther­a­peu­tics’ day 1 that Arie Bellde­grun and David Chang were in no short­age of in­vestors ea­ger to back their al­lo­gene­ic CAR-T ther­a­pies: They gath­ered $300 mil­lion in short or­der from a syn­di­cate that fea­tures Pfiz­er, TPG and Vi­da Ven­tures.

The pair of Kite vets have dri­ven the point home again with a $120 mil­lion pri­vate fi­nanc­ing an­nounced Thurs­day morn­ing as they worked to fill out the full team of ex­ecs who will run the show.

David Chang

A con­sid­er­able num­ber of first-time in­vestors jumped on board: Per­cep­tive Ad­vi­sors (which led the fi­nanc­ing), Deer­field Man­age­ment, Fi­deli­ty Man­age­ment, Franklin Tem­ple­ton In­vest­ments, Jen­ni­son As­so­ci­ates, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), and “ad­di­tion­al large mu­tu­al funds.”

“We are very pleased to sig­nif­i­cant­ly ex­pand our in­vestor base with sup­port from a dis­tin­guished syn­di­cate who un­der­stand the cell ther­a­py land­scape,” said Chang, co-founder and CEO, in a state­ment. “Our goal is to main­tain our lead­er­ship in al­lo­gene­ic CAR T ther­a­py and be the first com­pa­ny to de­vel­op and com­mer­cial­ize an al­lo­gene­ic CAR T prod­uct. This fi­nanc­ing will help us ac­cel­er­ate the de­vel­op­ment of our broad port­fo­lio and in­vest in world class tech­ni­cal op­er­a­tions to make po­ten­tial­ly life­sav­ing cell ther­a­pies more read­i­ly ac­ces­si­ble to pa­tients.”

It’s a big goal that won’t come cheap. And Al­lo­gene is in for the long haul.

“While we are in a very strong fi­nan­cial po­si­tion fol­low­ing our $300 mil­lion fi­nanc­ing in April, we re­ceived much in­ter­est in Al­lo­gene from new in­vestors,” chief com­mu­ni­ca­tions of­fi­cer Chris­tine Cas­siano elab­o­rat­ed in an email. “As we look ahead, it was im­por­tant to not on­ly strength­en our cash po­si­tion, but to build re­la­tion­ships with some very high cal­iber in­vest­ment firms.”

Arie Bellde­grun

Al­lo­gene emerged overnight as a top can­di­date to com­mer­cial­ize the first off-the-shelf CAR-T ther­a­pies by grab­bing Pfiz­er’s port­fo­lio of 16 pre­clin­i­cal tar­gets as well as a part­ner­ship on UCART19, a Phase I as­set co-de­vel­oped by Cel­lec­tis. It’s cur­rent­ly based out of Pfiz­er’s old digs at South San Fran­cis­co,

In­stead of a lengthy and ex­pen­sive per­son­al­ized au­tol­o­gous ap­proach that re­quires the ex­trac­tion and reengi­neer­ing of pa­tient cells in­to a po­tent ther­a­py that has proved par­tic­u­lar­ly ef­fec­tive in blood can­cers, Al­lo­gene is look­ing to per­fect a gene edit­ing process that can de­vel­op 50 to 100 ther­a­peu­tic batch­es from a sin­gle donor. If it works, it will be cheap­er and faster than the first CAR-Ts, Yescar­ta and Kym­ri­ah.

Bellde­grun and Chang — who rose to star sta­tus af­ter run­ning and even­tu­al­ly sell­ing Kite to Gilead for $12 bil­lion — have been re­cruit­ing es­teemed ex­ecs to help car­ry out that vi­sion.

Al­i­son Moore joined as chief tech­ni­cal of­fi­cer in June fol­low­ing a ca­reer at Am­gen and Genen­tech; two months lat­er Susie Jun, for­mer­ly of Am­gen and Gilead, jumped from Ab­b­Vie-Stem­cen­trx to be­come the chief de­vel­op­ment of­fi­cer; then there’s David Tillet, SVP of qual­i­ty, who came on board days ago af­ter con­sult­ing with the biotech for some time.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

Seven years after founding Roivant Sciences as an upstart contender in the world of biotech creation, Vivek Ramaswamy and his recently anointed CEO Matt Gline are gliding into Nasdaq on the gilded wings of a cash-heavy SPAC.

In a carefully crafted SPAC pact aimed at wedding new investors at Montes Archimedes Acquisition Corp. with a syndicate of investors coming back to re-up for the next round of company building, they’ve assembled a fresh $611 million in financing for Roivant — $411 million held in trust from the investors in MAAC with a fresh $200 million from the syndicate.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.