Stem cell ther­a­pies for space mis­sions? Pluris­tem joins forces with NASA to com­bat space-re­lat­ed ail­ments

When in space, your in­ner ma­chin­ery can go awry — ask as­tro­naut Scott Kel­ly. The as­sault of pro­tract­ed ra­di­a­tion and mi­cro­grav­i­ty can cul­mi­nate in pro­gres­sive bone and mus­cle loss and vex the im­mune sys­tem. Pla­cen­ta-based stem cells may be the an­swer to lim­it­ing that dam­age, and Is­rael’s Pluris­tem is work­ing with NASA to de­vel­op such an an­ti­dote.

The com­pa­ny, which is al­so work­ing with the NIH and the US De­part­ment of De­fense, last year se­cured the FDA’s emer­gency use au­tho­riza­tion for its stem cell prod­uct for ra­di­a­tion poi­son­ing. It al­so has two late-stage pro­grams test­ing the po­ten­tial of its ex­per­i­men­tal stem cell ther­a­pies for use in crit­i­cal limb is­chemia and mus­cle in­jury fol­low­ing sur­gi­cal re­pair. The com­pa­ny’s off-the-shelf prod­uct is de­rived from pla­cen­ta fol­low­ing full term de­liv­ery, and the cells can be ad­min­is­tered to pa­tients with­out the need for tis­sue match­ing.

“Once the cells are in­ject­ed, they se­crete a va­ri­ety of pro­teins and cy­tokines that help the body re­gen­er­ate, em­pow­er­ing the body’s heal­ing abil­i­ty,” Pluris­tem’s co-chief Yaky Yanay told End­points News.

The NASA tie-up came about af­ter Ruth Globus, of NASA’s Ames Re­search Cen­ter in Sil­i­con Val­ley, was giv­en the 2019 NASA Ames Re­search In­no­va­tion Award on the ba­sis of her pro­posed col­lab­o­ra­tion with Pluris­tem.

“Un­less as­tro­nauts al­lo­cate about two hours of time for dai­ly ex­er­cise ses­sions…As­tro­nauts can ex­pe­ri­ence up to 20% mus­cle loss in mus­cle mass on space flights last­ing just five to eleven days and in longer mis­sions, they al­so lose bone den­si­ty at a rate of 1-2% per month which can lead to more frag­ile bones,” Globus said in a state­ment on Wednes­day.

Last week, it was re­port­ed that near­ly a year in space put as­tro­naut Scott Kel­ly’s im­mune sys­tem in hy­per­drive. Typ­i­cal­ly as­tro­nauts are in space about six months at a time, but Kel­ly set a US record af­ter spend­ing 340 days in the skies.

Through Pluris­tem’s work with the NIH and DoD, the com­pa­ny was in­tro­duced to NASA and showed the space agency its da­ta from its mus­cle re­gen­er­a­tion stud­ies. Now with the NASA part­ner­ship in place, the drug de­vel­op­er is gear­ing up for pre­clin­i­cal and in vit­ro stud­ies to test the po­ten­tial of its pla­cen­tal stem cells in pre­vent­ing and treat­ing med­ical con­di­tions caused dur­ing space mis­sions, in­clud­ing in­di­ca­tions re­lat­ing to blood, bone, mus­cle, brain and heart.

Da­ta are ex­pect­ed lat­er this year, and if pos­i­tive, Pluris­tem will work with the FDA to de­ter­mine how to con­duct in-hu­man stud­ies.

“If we are able to demon­strate it in space, which is an ac­cel­er­a­tor (of ag­ing), its some­thing we can use in earth as well, to sup­port well be­ing, ag­ing and qual­i­ty of life,” Yanay said. “Cell ther­a­py on one hand, and space mis­sion on the oth­er end — on­ly good things can come from that!”


Yaky Yanay. PLURIS­TEM via TWIT­TER

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: Chi­na's BeiGene scores first-ever FDA ap­proval — but can they carve up J&J's block­buster fran­chise?

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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Carson Block. Muddy Waters via YouTube

Shorts ga­lore: Mud­dy Wa­ters sees slide for Pep­tiDream, tweets con­cerns about Fi­bro­Gen's new da­ta

The short seller Muddy Waters is taking aim at Japan’s most profitable biotech, projecting a slide for a company that has skyrocketed over the last four years. Meanwhile, the firm tweeted out an analysis accusing FibroGen of manipulating data to obscure safety concerns in their latest reveal, although some investors seem satisfied by the biotech’s explanation.

Muddy Waters shorted PeptiDream, a Japanese biotech-for-hire that leveraged its peptide library into partnerships with some of the world’s largest pharmaceutical companies, a 50% profit margin and $6 billion valuation. The firm noted that despite its esteem, PeptiDream has failed to bring a drug to market 13 years after its 2006 launch (although this is not especially rare for biotech).

Pin­cer move­ment: Cal­i­for­nia biotech gets $35M to suf­fo­cate can­cer in co­or­di­nat­ed at­tack

Having served in Afghanistan, the navy veteran leading California-based EpicentRx wants to leave no patient behind with his arsenal of anti-cancer drugs. On Thursday, the company was given a $35 million boost to further its mission.

The injection of funds will be used to shepherd its late-stage CD47 drug, RRx-001, to the FDA for marketing, and its oncolytic virus program into the clinic.

RRx-001, engineered as an agent that makes tumor cells more sensitive to therapy, is in a Phase III trial in combination with chemotherapy for use in third-line and beyond small cell lung cancer (SCLC). The drug has been granted orphan drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma.