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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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