Fabian Gerlinghaus (Cellares)

A cou­ple months af­ter land­ing $100 mil­lion in fund­ing, Cel­lares grabs part­ner for its Cell Shut­tle

The team at Cel­lares hopes that its Cell Shut­tle is the fu­ture of end-to-end cell ther­a­py man­u­fac­tur­ing. On Wednes­day, the com­pa­ny an­nounced that one more com­pa­ny has signed up to work along­side it.

Po­sei­da has signed on to pro­vide ther­a­pies for the Cell Shut­tle, a portable fac­to­ry Cel­lares hopes will dis­rupt the ex­pen­sive and lo­gis­ti­cal­ly com­pli­cat­ed cell ther­a­py man­u­fac­tur­ing process. The com­pa­ny is the third to ink a deal with Cel­lares, which is based out of South San Fran­cis­co, CA. Cel­lares has al­ready has been col­lab­o­rat­ing with PACT Phar­ma and the Fred Hutchin­son Can­cer Re­search Cen­ter.

“We were very sys­tem­at­ic about how we se­lect po­ten­tial part­ners, and re­al­ly, amongst oth­er things what we were look­ing for were phar­ma com­pa­nies that have a very deep pipeline, so not a one-trick pony but ide­al­ly many dif­fer­ent as­sets, al­ready clin­i­cal stage, dif­fer­ent cell ther­a­py modal­i­ties,” CEO Fabi­an Ger­ling­haus said in an in­ter­view with End­points News. “In Po­sei­da’s case, they meet all of those cri­te­ria.”

The Cell Shut­tle is an end-to-end plant in a box de­signed to cre­ate an au­to­mat­ed cell ther­a­py plat­form that takes in a pa­tient’s cells at the start and turns out a fin­ished cell ther­a­py prod­uct ready to be in­ject­ed back in­to a pa­tient at the end. The in­no­va­tion could be an an­swer to the pro­duc­tion bot­tle­neck that has im­pact­ed the world of cell ther­a­py.

The shut­tle would al­low phar­ma­ceu­ti­cal com­pa­nies to ef­fec­tive­ly scale and de­ploy the tech wher­ev­er it works best, be it a hos­pi­tal or a clean room in a man­u­fac­tur­ing fa­cil­i­ty. Cel­lares land­ed a Se­ries B round of fundrais­ing in May, bring­ing its to­tal fund­ing to $100 mil­lion so far.

Po­sei­da has two pa­tient-de­rived CAR-T prod­uct can­di­dates in the clin­ic right now, in­clud­ing P-BC­MA-101 for pa­tients with re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma and P-PS­MA-101 for metasta­t­ic cas­trate-re­sis­tant prostate can­cer. Po­sei­da will eval­u­ate the shut­tle pro­to­types, and give back da­ta and feed­back to im­prove per­for­mance and help get the tech ready for the mar­ket.

The com­pa­ny has off-the-shelf ver­sions of both P-BC­MA-101 and P-PS­MA-101, and is ex­plor­ing TCR-T, an an­ti-c-kit CAR-T, nat­ur­al killer cells and ge­net­i­cal­ly mod­i­fied hematopoi­et­ic stem cells. The con­nec­tion came through Carl June, an on­col­o­gist and pro­fes­sor at the Uni­ver­si­ty of Penn­syl­va­nia who is an ad­vi­sor to Cel­lares and a mem­ber of the Po­sei­da ad­vi­so­ry board.

“We’re al­so look­ing for part­ners that re­al­ly get it and are ex­cit­ed to be work­ing with us and are the first adopters and cham­pi­ons,” Ger­ling­haus said. “(Part­ners) who say ‘look, we have some imag­i­na­tion, we see this as the fu­ture of cell ther­a­py man­u­fac­tur­ing and we want to be a part of that, we’re in.’ We found that in Po­sei­da, and they’ve been very proac­tive.”

Cel­lares is in the process of or­ga­niz­ing user stud­ies right now, and gath­er­ing in­for­ma­tion about how the Cell Shut­tle in­ter­acts with a com­pa­ny’s can­di­dates helps Cel­lares inch clos­er to the end goal. So far, Ger­ling­haus says that the com­pa­ny has made two small tweaks and one “not-so small” change to the shut­tle as a re­sult of its work with ex­ist­ing part­ners.

“Hap­py to re­port that the ear­ly part­ner­ship pro­gram is work­ing as de­signed, it’s ac­tu­al­ly de­liv­er­ing on its pur­pose, and you can quote me on that,” he said Mon­day.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Pascal Soriot, AstraZeneca CEO (via Getty images)

As­traZeneca's MCL-1 can­cer drug put on hold af­ter flag­ging a safe­ty is­sue — 2 years af­ter Am­gen axed ri­val drug

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca is now flagging safety issues for a rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.” There was no further explanation and a spokesperson for AstraZeneca hadn’t followed up with us ahead of our publishing deadline.

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FDA shoots down a biotech’s last-stand pa­tient pitch af­ter fault­ing da­ta

Stealth BioTherapeutics appeared unsure its pitch for an ultra-rare disease would be accepted when submitting an NDA in August, and on Wednesday its fears came to pass.

The FDA issued Stealth a refusal to file letter for a candidate looking to treat Barth syndrome, the biotech announced Wednesday morning. It’s a move not entirely unexpected, given Stealth’s own admission earlier this year that the agency didn’t find existing data to support NDA review.

Kelly Martin, Radius Health CEO

Ra­dius rock­ets high­er as Kel­ly Mar­tin boasts of a big PhI­II suc­cess — but the spoils be­long to Menar­i­ni

Radius Health stuck with some fuzzy top-line Phase III results for its oral SERD therapy elacestrant, but investors saw enough to push a rally that sparked a big surge in its share price.

According to researchers, the drug hit both primary endpoints among ER+/HER2- breast cancer patients: beating standard of care on progression-free survival in the overall population and PFS with tumors harboring estrogen receptor 1 mutations — a key factor in developing resistance. And while some analysts were left wondering about specific data, most of the crowd seemed happy to hear that the drug is now being steered to the FDA.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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