All in on IL-11, Fra­zier un­veils lat­est start­up with dual fo­cus on fi­bro­sis and can­cer

In late 2017, a team of Sin­ga­pore­an sci­en­tists pub­lished a Na­ture pa­per high­light­ing what they call a “ground­break­ing” and “out­stand­ing” new tar­get for fi­bro­sis. In­ter­leukin-11, a cy­tokine down­stream of the well-known TGFβ1 path­way, had been over­looked but ac­tu­al­ly plays an even more cen­tral role in the fi­brot­ic process, they wrote.

“The dis­cov­ery that IL11 is a crit­i­cal fi­brot­ic fac­tor is the type of break­through that the sci­en­tists and phar­ma­ceu­ti­cal com­pa­nies have been search­ing for,” Stu­art Cook, a se­nior au­thor and the di­rec­tor of the Na­tion­al Heart Re­search In­sti­tute Sin­ga­pore, said then.

Cook and Se­bas­t­ian Schäfer, a co-au­thor, had found­ed a biotech named En­le­ofen that would go on to score a ma­jor al­liance with Boehringer In­gel­heim. Now, Fra­zier Health­care is de­but­ing its own ef­fort to drug the tar­get — aim­ing not just at var­i­ous types of fi­bro­sis but al­so can­cer.

Mark Bar­rett

With Mark Bar­rett, Sanofi Gen­zyme vet and now Fra­zier en­tre­pre­neur-in-res­i­dence, at the helm, Lassen Ther­a­peu­tics has $31 mil­lion to find out which in­di­ca­tions they’d like to start with and reach IND next year.

The Na­ture pa­per had piqued their in­ter­est in IL-11, Bar­rett told End­points News, just as he and co-founder David King were search­ing for a new con­cept that would play to King’s ex­per­tise in an­ti­body dis­cov­ery and de­vel­op­ment.

“We be­lieved that there’s such a great pro­lif­er­a­tion of re­al­ly high-qual­i­ty and high-ca­pa­bil­i­ty an­ti­body gen­er­a­tion tech­nolo­gies avail­able that a biotech com­pa­ny to­day can be high­ly suc­cess­ful lever­ag­ing those tech­nolo­gies for the right ap­pli­ca­tions,” he said.

King, who had had a com­pa­ny cre­ation ex­er­cise with Fra­zier at Anap­tys­Bio, brought over a few sci­en­tists to the found­ing team and built it out to a group of 10 based out of San Diego. Bar­rett re­mains in Boston, where he’s been based for the past decade — not that it had made a dif­fer­ence for the last few months as his West Coast col­leagues found them­selves chat­ting with him and one an­oth­er over video calls amid a statewide shut­down.

David King

They be­gan by scour­ing the patent lit­er­a­ture on IL-11 block­ade and dis­cov­ered an IP es­tate that CSL had cre­at­ed around a suite of an­ti­bod­ies hit­ting the IL-11 re­cep­tor. The Aus­tralian phar­ma gi­ant had done some work with them in COPD and asth­ma but it was, af­ter all, not a great fit for their core plas­ma and vac­cines busi­ness.

“They had worked on the pro­gram but had kind of parked it at the stage where it need­ed more fo­cus and in­vest­ment,” Bar­rett said. “We hap­pened to come in at just the right mo­ment” last year to li­cense it all.

Through the deal CSL be­came an eq­ui­ty hold­er in Lassen along­side Fra­zier (with its lat­est, $617 mil­lion fund), Al­ta Part­ners and Long­wood Fund. An­drew Nash, the SVP of re­search at CSL, is al­so join­ing the biotech’s sci­en­tif­ic ad­vi­so­ry board.

Bar­rett has been around long enough to re­mem­ber that IL-11 does have a past in on­col­o­gy. Cam­bridge, MA-based Ge­net­ics In­sti­tute had ush­ered a re­com­bi­nant IL-11 to the mar­ket as a sup­port ther­a­peu­tic to chemother­a­py be­fore get­ting ac­quired by Wyeth, which in time rolled up in­to Pfiz­er.

“But the fur­ther bi­ol­o­gy in terms of its role in fi­bro­sis or can­cer just wasn’t well enough un­der­stood, I guess, for peo­ple to be suc­cess­ful to de­vel­op block­ing ther­a­peu­tics like IL-6, al­though IL-11 and IL-6 are in the same fam­i­ly of cy­tokines,” he said. “It’s just one of those things; bi­ol­o­gy is hard. Fig­ur­ing out the right ap­pli­ca­tion takes time — decades, some­times.”

Lassen now has its foot on the gas ped­al, look­ing to ac­cel­er­ate the R&D work by part­ner­ing with both aca­d­e­m­ic in­ves­ti­ga­tors and Fu­ji­film Diosynth, which will man­u­fac­ture clin­i­cal-grade ma­te­r­i­al for them once they de­cide on the fi­brot­ic con­text and or­gan sys­tem to tar­get first.

There’s plen­ty of room for both Boehringer and Lassen to bring forth new treat­ments in the broad space, Bar­rett added, es­pe­cial­ly as “we may di­verge in the way we fo­cus.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

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