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.

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

Gilead is still some days away from turning the card on its first round of data on remdesivir’s ability to fight severe cases of Covid-19, but the big biotech is ramping up an emergency supply of a million courses of therapy as it starts free distribution of the drug to tens of thousands of patients under their compassionate use and expanded access program as well as clinical trials.

In his latest open letter posted over the weekend, Gilead CEO Dan O’Day outlined how the company has been successful in cutting production time on remdesivir while repurposing some of their own facilities and turning to contract manufacturers to build a near-term supply of 1.5 million doses. They are still working on efficacy and dosing, but that supply could cover 140,000 courses of treatment. That supply, he added, would be more widely available following a potential approval.

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.

John Maraganore and Douglas Fambrough used to be at each other’s throats as Alnylam pursued claims that its RNAi rivals at Dicerna had improperly purloined the IP it had picked up from Merck in a bargain basement fire sale.

But that was all settled up close to 2 years ago with a settlement from Dicerna’s Fambrough. And now the two are moving ahead in a close R&D partnership that makes them collaborators on a couple of key disease targets.