Phil L’Huillier, CatalYm CEO

Ger­man biotech CatalYm rais­es $50M to flip weight loss tar­get for can­cer

GDF15 might sound fa­mil­iar. It’s a pro­tein that Am­gen, Mer­ck and Eli Lil­ly built analogs for in at­tempts to make new weight loss drugs. But those drugs large­ly failed — and Am­gen, the last stand­ing of the three — qui­et­ly pulled the plug on its GDF15 pro­gram in Jan­u­ary.

But GDF15 is not dead. The sci­ence be­hind the weight loss drugs goes back to the ob­ser­va­tion that some can­cer pa­tients have high lev­els of GDF15 and lose a lot of weight, so can­cer re­searchers have been mak­ing an­ti­bod­ies that in­hib­it the pro­tein in­stead of mim­ic­k­ing it.

Ger­man biotech CatalYm, named for “Cat­alyz­ing an­ti­bod­ies,” is run­ning a mid-stage pro­gram for a GDF15 an­ti­body, vi­sugromab, in sol­id tu­mors. It’s now raised €50 mil­lion (rough­ly $49 mil­lion USD) in a Se­ries C to “be more ag­gres­sive with the Phase II,” CEO Phil L’Huil­li­er told End­points News.

An­dreas Wall­nöfer

New in­vestors Bran­don Cap­i­tal and Jeito Cap­i­tal are lead­ing the round, fol­lowed by ex­ist­ing in­vestors For­bion, No­var­tis’ ven­ture arm, Vesal­ius Bio­cap­i­tal III, Bay­ern Kap­i­tal, Bio­Gen­er­a­tion Ven­tures and Co­par­i­on. In ad­di­tion, Bran­don’s Jonathan To­bin and Jeito’s An­dreas Wall­nöfer are join­ing CatalYm’s board. Ac­cord­ing to Wall­nöfer, CatalYm marks Jeito’s first in­vest­ment in Ger­many.

At ES­MO ear­li­er this year, CatalYm read out the full da­ta from an 18-per­son Phase I study on vi­sugromab in com­bi­na­tion with Op­di­vo in pa­tients who were heav­i­ly pre­treat­ed and pro­gressed on pre­vi­ous PD-1 ther­a­py — pa­tients who’ve ex­haust­ed all their op­tions. In that study, three pa­tients had a par­tial re­sponse, one of whom had a durable re­sponse for over a year. Three ad­di­tion­al pa­tients al­so had sta­ble dis­ease on the treat­ment, and one of those pa­tients saw their can­cer stop pro­gress­ing on treat­ment for over a year as well.

Wall­nöfer high­light­ed the po­ten­tial for vi­sugromab as a com­bi­na­tion ther­a­py for sol­id tu­mor pa­tients, not­ing that the drug had a durable ef­fect as the last line of treat­ment on top of its “be­nign” safe­ty pro­file — no dose-lim­it­ing tox­i­c­i­ties or grade 4 or 5 ad­verse events were ob­served in the Phase I study.

In March, CatalYm be­gan a Phase II study on vi­sugromab. Tak­ing the two high­er dos­es from the first study (10 and 20 mg/kg), the new pro­gram plans to en­roll around 160 pa­tients. It’s al­so ex­pand­ed to the US — a de­ci­sion that came af­ter the Phase I read­out, L’Huil­li­er said, not­ing that CatalYm met a clin­i­cian at MD An­der­son who showed in­ter­est in open­ing a study site for vi­sugromab.

That Phase II study and an­oth­er bio­mark­er study are slat­ed for ini­tial read­outs in the first half of next year, L’Huil­li­er said.

The Se­ries C comes at a time when the pub­lic mar­ket is ice cold. “In terms of the fi­nanc­ing, it start­ed out fair­ly chal­leng­ing be­cause of the glob­al sit­u­a­tion and the IPO win­dow be­ing closed,” L’Huil­li­er said. “That in­flu­enced the way we looked at fi­nanc­ing. We said, ‘Let’s stay and do an­oth­er pri­vate round rather than a crossover or an IPO round.’” In No­vem­ber, just one biotech, Acrivon Ther­a­peu­tics, made the pri­vate-to-pub­lic jump, while oth­ers pulled away from plans.

Pfiz­er al­so has a GDF15-tar­get­ed an­ti­body for can­cer, known as pon­segromab, for which it re­cent­ly start­ed a Phase II tri­al. But Pfiz­er’s drug is for a dif­fer­ent pur­pose — stem­ming weight and mus­cle loss in can­cer pa­tients.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Ali Madani, Profluent founder and CEO

Proflu­ent de­buts to de­sign pro­teins with ma­chine learn­ing in bid to move past 'AI sprin­kled on top'

While OpenAI’s Microsoft-allied ChatGPT takes the world by storm, a fledgling startup in Berkeley, CA is debuting to take a similar language-learning model approach, but with the goal of designing new proteins.

Profluent, founded by a former Salesforce AI research leader, has secured $9 million to kick-start its work, with proceeds going toward building out an integrated wet lab and recruiting machine learning scientists and biologists. Insight Partners led the seed round. The investor base also includes Air Street Capital, AIX Ventures and Phoenix Venture Partners.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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