Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of ra­dio­phar­ma­ceu­ti­cals has been heat­ing up over the last few years, and Thurs­day saw an­oth­er com­pa­ny fo­cused on the field pull in a new nine-fig­ure raise.

Ger­many’s ITM, or Iso­topen Tech­nolo­gien München, scored a $109 mil­lion round of loan fi­nanc­ing to push for­ward its pre­ci­sion on­col­o­gy pipeline and fund late-stage de­vel­op­ment for its lead pro­gram. As part of the agree­ment, the loan will con­vert to shares in the event of fu­ture fi­nan­cial or cor­po­rate trans­ac­tions, ITM said.

Be­hind ra­dio­phar­ma is a con­cept sim­i­lar to that of an­ti­body-drug con­ju­gates. Rather than a drug pay­load be­ing de­liv­ered to a spe­cif­ic tar­get, it’s a ra­dioac­tive mol­e­cule or iso­tope that’s trans­port­ed to where it needs to go. And it’s usu­al­ly not an an­ti­body per­form­ing the de­liv­ery, but pep­tides or oth­er types of mol­e­cules.

In ITM’s case, they have de­vel­oped their own ther­a­peu­tic ra­dioiso­tope called Lutetium-177, CEO Stef­fen Schus­ter told End­points News, which emits a low amount of ra­dioac­tive en­er­gy. Their lead pro­gram com­bines this mol­e­cule with an edotreotide com­po­nent, which tar­gets re­cep­tors in neu­roen­docrine cells that have gone awry as a re­sult of the can­cer.

Where­as AD­Cs have to be in­ter­nal­ized, the ra­dio­phar­ma­ceu­ti­cals on­ly need to bind to the tu­mor sur­faces, Schus­ter said. ITM’s can­di­dates func­tion as what he calls a high­ly-pre­cise “cage,” trap­ping the ra­dionu­clide with­in the tar­get­ing mol­e­cule that can then bind to the tu­mor sur­face. The can­di­date — whose full name is N.c.a. 177Lu-Edotreotide — is cur­rent­ly in a Phase III tri­al for gas­troen­teropan­cre­at­ic neu­roen­docrine tu­mors.

Schus­ter is keep­ing his cards close to the vest re­gard­ing da­ta read­outs, but not­ed that they’re “pret­ty far” in the 300-per­son study.

Sig­nif­i­cant in­ter­est from in­vestors and Big Phar­ma com­pa­nies have heat­ed up the space re­cent­ly, most no­tably from a hand­ful of ac­qui­si­tions by No­var­tis. There was the Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions buy­out from France back in 2017, giv­ing the phar­ma gi­ant its ra­dio­phar­ma plat­form and Luthera for $3.9 bil­lion.

Then came the En­do­cyte ac­qui­si­tion in 2018, where the for­mer­ly small biotech turned a $12 mil­lion li­cens­ing agree­ment in­to a deal with No­var­tis. The drug in­volved there was Lu-PS­MA-617, a ra­dioiso­tope tar­get­ing prostate-spe­cif­ic mem­brane anti­gen, or PS­MA, com­mon­ly found in metasta­t­ic prostate can­cer. No­var­tis shelled out $2.1 bil­lion to get its hand on that drug af­ter En­do­cyte hus­tled it in­to Phase III.

“We see oth­er com­pa­nies in the same space as part­ners and less as com­peti­tors,” Schus­ter told End­points. “One thing we have in com­mon with them is more — ‘fight’ is the wrong word — but we want to demon­strate that our ther­a­pies are bet­ter than some of the chemos which are re­al­ly bad for the pa­tients.”

More re­cent­ly, the biotechs Rayze­Bio and Ak­tis se­cured hefty rais­es from promi­nent in­vestors, sig­nal­ing a fur­ther ap­petite for the po­ten­tial be­hind these ther­a­pies. Rayze­Bio has tal­lied $150 mil­lion over two fund­ing rounds, in­clud­ing from an Oc­to­ber launch, while Ak­tis se­cured $72 mil­lion from a syn­di­cate led by MPM Cap­i­tal.

Oth­er play­ers like Fu­sion Phar­ma­ceu­ti­cals and Clo­vis are al­so an­gling for mar­ket en­try, with the for­mer so­lid­i­fy­ing an IPO last June for $212.5 mil­lion.

Where ITM hopes to dif­fer­en­ti­ate it­self is through its man­u­fac­tur­ing ca­pa­bil­i­ties. ITM had been con­vinced of the ef­fec­tive­ness of these drugs since its found­ing in 2004, Schus­ter said, but there sim­ply hadn’t been enough sup­ply of ra­dionu­clides. By mak­ing their own drugs, and al­so sell­ing the nec­es­sary com­po­nents to oth­er phar­ma com­pa­nies, ITM is shoot­ing to be a leader in the field on two fronts.

“The Lutetium-177, from our stand­point, is go­ing to be the work­horse for ra­dio­phar­ma­ceu­ti­cals for the next 10 years,” Schus­ter said. “We were the ones who start­ed from 2004 on mak­ing this avail­able on scale in big quan­ti­ties to every­body. Not just us, but we sup­ply who was in­ter­est­ed, so we have been in­stru­men­tal over the last [sev­er­al] years to cre­ate this in­dus­try be­cause of the sup­ply of ra­dionu­clides.”

ITM’s Thurs­day raise was led by Pet­ri­chor Health­care Cap­i­tal Man­age­ment. Fur­ther terms of the deal be­yond de­tails of the con­vert­ible loans were not dis­closed.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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 still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.