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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

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.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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