Alain Baron (L), Escient CEO and Marcus Boehm, Escient CSO

Thanks to a $77.5M Se­ries B, Escient moves in­to the clin­ic with the first of its sen­so­ry re­cep­tor can­di­dates

A lit­tle over two years af­ter emerg­ing from stealth, Escient Phar­ma­ceu­ti­cals is back Mon­day with a new fundrais­ing round and their first clin­i­cal tri­al.

The San Diego-based biotech an­nounced a $77.5 mil­lion Se­ries B and a Phase I/Ib study for their EP547 pro­gram, which is aim­ing to treat the neu­ro­log­i­cal “itch” that can man­i­fest when bile and waste prod­ucts are backed up in the liv­er and kid­neys, re­spec­tive­ly. This would be the first in what CEO Alain Baron hopes is a long line of Mas-re­lat­ed G pro­tein-cou­pled re­cep­tor can­di­dates.

“We should have an IND on av­er­age once every year and a half or so,” Baron said. “So it al­lows us to de­vel­op the val­ue of some of these ear­ly tar­gets and cre­ate op­tion­al­i­ty for us to move the com­pa­ny for­ward in a num­ber of ways, and of course we’ll be da­ta-dri­ven.”

Sanofi’s VC arm and Cowen Health­care In­vest­ments led the round and were joined by new in­vestors Red­mile and Per­cep­tive. All pre­vi­ous in­vestors, in­clud­ing The Col­umn Group, 5AM Ven­tures and Os­age Uni­ver­si­ty Part­ners, pitched in again.

MRG­PRs, a fam­i­ly of GPCRs, have been the fo­cus of Escient since its found­ing, stem­ming from re­search by Johns Hop­kins neu­rol­o­gist and Escient sci­en­tif­ic founder Xinzhong Dong. With­in the MRG­PR um­brel­la are eight sen­so­ry re­cep­tor tar­gets, four of which have been de-or­phaned in the last six years, Baron said, while the re­main­ing four are still be­ing de­cod­ed. Escient ex­pects the tar­gets to serve a wide range of ther­a­peu­tic us­es and has spent the last two years try­ing to un­der­stand every­thing about this fam­i­ly while prep­ping their clin­i­cal pro­grams.

“Each re­cep­tor can be uti­lized with an an­tag­o­nist to treat more than one dis­or­der, so if you think about that, it’s pret­ty daunt­ing if we were to dis­cov­er util­i­ties for all eight,” Baron said. “We could have eight times two, eight times three in­di­ca­tions. We’re go­ing to be very dis­ci­plined in how we do this.”

Escient CSO Mar­cus Boehm, pre­vi­ous­ly the co-founder of the biotech Re­cep­tos that sold to Cel­gene for $7.2 bil­lion in 2015, added that MRG­PRs “each rec­og­nize a unique ag­o­nist, so they clear­ly have a func­tion where they rec­og­nize some­thing in the en­vi­ron­ment, or en­doge­nous­ly, that is unique from one an­oth­er.”

EP547 cen­ters around MRG­PRX4, an itch re­cep­tor trig­gered in cholesta­sis and ure­mia. Though the con­di­tions don’t cause an itch in the typ­i­cal sense, pa­tients’ brains per­ceive the sen­sa­tion of bile leak­age as an itch — caus­ing de­bil­i­tat­ing and even “em­bar­rass­ing” dis­com­fort in some cas­es, Baron said.

From the pa­tient’s per­spec­tive, an even­tu­al ther­a­py would like­ly be a once-a-day pill to an­tag­o­nize the re­cep­tors. Should the drug prove ef­fec­tive, Baron an­tic­i­pates the treat­ment to func­tion sim­i­lar­ly to an an­ti­his­t­a­mine, dra­mat­i­cal­ly re­duc­ing the itch sen­sa­tion on the first ad­min­is­tra­tion.

“It im­proves the qual­i­ty of life for these pa­tients that have re­al­ly un­bear­able itch,” Baron said. “Think about be­ing stung by 100 mos­qui­toes every day and you get a sense of the dis­tur­bance in your life that you would ex­pe­ri­ence.”

The Phase I/Ib tri­al has al­ready be­gun en­rolling, and topline da­ta are ex­pect­ed some­time in the first half of next year. Escient plans to ex­am­ine mul­ti­ple dos­es of the can­di­date in a group of about 100 in­di­vid­u­als di­vid­ed in­to sev­er­al co­horts in a ran­dom­ized, dou­ble-blind, place­bo-con­trolled set­ting.

While that work goes on, the biotech has a sec­ond pro­gram in the works tar­get­ing MRG­PRX2, a mast-cell based re­cep­tor, which could prove as a workaround in dis­eases that are not re­spon­sive to con­ven­tion­al mast-cell sta­bi­liz­ing drugs. And with enough run­way to take them past the lead pro­gram’s Phase II and the lat­ter’s Phase Ib, Baron is ex­cit­ed for what’s to come in this fam­i­ly of tar­gets.

“MRP­GRs are very in­ter­est­ing in that each is amenable to prob­a­bly more than one in­di­ca­tion,” Baron said. “So what we’re try­ing to do is pros­e­cute these re­cep­tors, and ba­si­cal­ly we do so ag­nos­tic to the ther­a­peu­tic area…whether it’s asth­ma, whether it’s der­ma­tol­ogy, whether it’s CNS, whether it’s GI, we’ll pur­sue it.”

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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From left: Rajul Jain, Stefan Vitorovic, Arjun Goyal, Arie Belldegrun, Jean-Philippe (JP) Kouakou-Zebouah, Helen Kim

Arie Bellde­grun's Vi­da Ven­tures goes back to the well with $825M mega­fund and its eyes set on more in­no­v­a­tive meds

Among the list of bright names in biopharma, few shine brighter than Kite founder and serial entrepreneur Arie Belldegrun, who has rattled off a remarkable run of success in recent years. Now, a Belldegrun investment team is locking up a massive third fund to keep chasing the cutting edge in therapeutics.

Vida Ventures closed its third investment fund at a whopping $825 million — its largest yet — as the ever-expanding VC firm hits 30 companies in its portfolio developing new routes to hard-to-treat diseases, the company said Thursday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Yuval Cohen, Corbus CEO (Corbus via YouTube)

An­oth­er Cor­bus pro­gram hits the skids af­ter late-stage flop, plum­met­ing the small biotech's shares

Corbus Pharmaceuticals’ plans to position lenabasum as a pipeline-in-a-product aren’t going so well.

After shelving a program in scleroderma, the Norwood, MA-based biotech has revealed that its lead candidate failed both the primary and secondary endpoints in another Phase III trial.

Lenabasum failed to show a statistically significant difference in total improvement compared with placebo in treating dermatomyositis, a rare disease that causes muscle inflammation and skin rash, the company said Thursday. The news sent Corbus’ $CRBP stock spiraling around 30% early Thursday morning.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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