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.

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.