The field of off-the-shelf cell ther­a­peu­tics is grow­ing, with the promise of quick­er, cheap­er, and eas­i­er to man­u­fac­ture ther­a­pies than the first gen­er­a­tion of au­tol­o­gous CAR-Ts that im­pressed with their po­ten­cy but fell short on adop­tion due to man­u­fac­tur­ing wob­bles. And Pre­ci­sion Bio­Sciences — which is us­ing its gene edit­ing tech­nol­o­gy to de­vel­op cell based im­munother­a­pies de­rived from healthy donors in­stead of the pa­tient — is plan­ning ahead. On Thurs­day, the com­pa­ny un­veiled a new Durham, NC fa­cil­i­ty ded­i­cat­ed to mak­ing its off-the-shelf CAR-T prod­ucts.

No­var­tis’ pi­o­neer­ing CAR-T drug — Kym­ri­ah — was ap­proved by the FDA amidst great fan­fare in 2017, but adop­tion was ham­pered by man­u­fac­tur­ing woes. No­var­tis lat­er added ca­pac­i­ty, hav­ing bought cell and gene ther­a­py man­u­fac­tur­er Cell­for­Cure. These prod­ucts re­quire enor­mous man­u­fac­tur­ing heft — mak­ers first iso­late cells from the pa­tient, ma­nip­u­late them in the lab by adding chimeric anti­gen re­cep­tors to di­rect T cells to snuff out can­cer cells and then re-in­fuse them back in­to the pa­tient.

Durham, North Car­oli­na-based Pre­ci­sion is hard­ly the first drug de­vel­op­er that has tak­en note of these chal­lenges. Take­da, for in­stance, which plans to take its off-the-shelf CAR-Ts in­to the clin­ic in 2021, is in the fi­nal stages of com­plet­ing its in-house man­u­fac­tur­ing fa­cil­i­ty in the Boston area, which is armed with the ca­pac­i­ty to sup­ply a range of clin­i­cal tri­als.

For Pre­ci­sion $DTIL, this new plant is part of a larg­er in­vest­ment in its can­cer im­munother­a­py plat­form and fa­cil­i­ties ex­pan­sions in North Car­oli­na this year.

“(W)e’ve known from the be­gin­ning that it was crit­i­cal for us to ad­dress the need for scal­able man­u­fac­tur­ing of cell-ther­a­py prod­ucts…” not­ed co-founder and chief Matt Kane in a state­ment.

“[The plant] al­so has the po­ten­tial to be a com­mer­cial launch fa­cil­i­ty with the ca­pac­i­ty to gen­er­ate up to 10,000 dos­es of CAR T cell ther­a­pies and 4,000 dos­es of gene ther­a­pies per year,” he added.

The drug de­vel­op­er is aim­ing to have its cer­ti­fi­ca­tions in place to be­gin man­u­fac­tur­ing in the fourth quar­ter — and plans to use the fa­cil­i­ty to cre­ate drug in­gre­di­ents for Phase I/II clin­i­cal tri­als sched­uled to be­gin next year.

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.