Ke­to in a pill? Jim Mel­lon de­buts an­ti-ag­ing joint ven­ture with the Buck ded­i­cat­ed to in­duc­ing ke­to­sis

Jim Mel­lon

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Jim Mel­lon’s crew at Ju­ve­nes­cence has found its lat­est ven­ture idea in a pop­u­lar di­et mak­ing its rounds in biotech cir­cles.

Er­ic Verdin

Once again team­ing up with the Buck In­sti­tute for Re­search on Ag­ing, Ju­ve­nes­cence has launched BHB Ther­a­peu­tics to ex­plore pre­ven­ta­tive med­i­cines that have po­ten­tial to pro­tect against age-re­lat­ed dis­ease by in­duc­ing a state of ke­to­sis, where the body burns fat in­stead of carbs, spurring the pro­duc­tion of an­ti-in­flam­ma­to­ry ke­tone bod­ies.

In par­tic­u­lar, the biotech start­up will fo­cus on the ke­tone body be­ta-hy­drox­y­bu­tyrate, or — you guessed it — BHB. Er­ic Verdin, the Buck pres­i­dent and CEO whose re­search in­spired an­oth­er Ju­ve­nes­cence spin­out, has dis­cov­ered that BHB helps the body re­spond to stress.

John New­man

A ke­to­genic di­et — which has been her­ald­ed for its ef­fects in weight loss, hunger sup­pres­sion as well as con­cen­tra­tion — and the con­se­quent longterm ex­po­sure to ke­tone bod­ies can al­so ex­tend healthy lifes­pan in mod­el sys­tems, Verdin and col­lab­o­ra­tor John New­man found.

The duo has gen­er­at­ed “hard sci­en­tif­ic da­ta” in mice that show ke­to­sis can be car­dio-pro­tec­tive, CEO Greg Bai­ley told End­points News. Ob­vi­ous­ly, they have a long way to go.

“The rea­son we think that car­dio-pro­tec­tion may trans­late to hu­mans is be­cause if giv­en sug­ar or ke­tones, many peo­ple’s hearts pre­fer ke­tones, where­as the brain is the op­po­site,” he said. “If giv­en the op­tion be­tween sug­ar or ke­tones, the brain will take sug­ar. Un­for­tu­nate­ly, in­di­vid­u­als when they hit 50 (plus or mi­nus a cou­ple years) they be­come in­sulin re­sis­tant — and then the sug­ar can go se­ri­ous­ly high in a va­ri­ety of or­gans and that leads to a va­ri­ety of dif­fer­ent patholo­gies.”

The com­pa­ny is look­ing to be­gin “ag­gres­sive safe­ty stud­ies” in the near-term, Bai­ley added. Should the com­pounds be found safe, he plans to take al­ter­na­tive routes rather than the con­ven­tion­al reg­u­la­to­ry path­way — which he be­lieves can lead to quick­er hu­man test­ing.

Greg Bai­ley

Just days ago, Ju­ve­nes­cence un­veiled the first $46 mil­lion tranche of a promised $100 mil­lion raise that’s de­signed to bankroll longevi­ty projects with the col­lec­tive goal of ex­tend­ing the hu­man lifes­pan to 150 years. So far, it’s ticked off stem cell tech and or­gan re­gen­er­a­tion among the fields it’s es­tab­lished it­self through joint ven­tures with AI groups — In­sil­i­co and Ne­tra­mark — and con­trol­ling in­ter­ests in AgeX and Ly­Ge­n­e­sis.

The goal, founder and chair­man Mel­lon said back then, is to have 18 projects un­der­way by the end of the year.

Look for two or three of them to be an­nounced over the next few weeks, Bai­ley said, not­ing that there should al­so be three or four let­ters of in­tent go­ing out short­ly.


With ad­di­tion­al re­port­ing by Na­tal­ie Grover.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.