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.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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