On May 27, 2025 BetaGlue Therapeutics S.p.A. ("BetaGlue"), a clinical-stage oncology company developing an innovative radiotherapy platform for the targeted and personalised treatment of unresectable solid tumours, called YntraDose, reported that an abstract was published by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) entitled: "Preclinical study of safety and efficacy in vivo of a yttrium-90 resin microspheres glue formulation in a large animal model of pancreatic cancer."

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The abstract describes the use of YntraDose to treat orthotopic tumors in an advanced in vivo porcine model called ‘oncopig’. Five animals were treated and followed-up over 30 days, the findings were:

No adverse events were reported throughout the study period;
YntraDose implantation and its associated radiotherapeutic payload were confined to the site of administration as demonstrated by radiological PET/CT assessment; and
At 30days visual necropsy assessment not only revealed evidence of tumor necrosis but also indicated tumor debulking.
Dr Colin Story, CEO, BetaGlue Therapeutics commented: "This study utilised a cutting edge advanced large animal model of pancreatic cancer where procedures were performed by world-renowned Interventional Radiologist and key opinion leader Professor Govindarajan Narayanan. BetaGlue is focused on bringing YntraDose to patients that present with Locally-Advanced Pancreatic Cancer which by definition is inoperable. We are very grateful to our collaborators Prof. Narayanan, Dr Geschwind and Ms Felicia Bealo for their contribution to this work."

Professor Govindarajan Narayanan, Chief of Interventional Oncology for the Miami Cancer Institute and lead author of the abstract commented: "Locally-Advanced Pancreatic Cancer (LAPC) accounts for around 30% of all Pancreatic Cancers worldwide. This study provides preliminary evidence of the utility for YntraDose as a local treatment option for LAPC with the potential to down-stage patients and enabling surgical resection to take place."

(Press release, BetaGlue Therapeutics, MAY 27, 2025, View Source [SID1234661239])

On May 27, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported a debt financing agreement for up to USD 262.5 million from funds managed by Blue Owl Capital, Inc ("Blue Owl"). The capital will be used to prepare for commercial readiness and potential market launch of the company’s lead candidate, n.c.a.177Lu-edotreotide (also known as ITM-11 or177Lu-edotreotide). ITM-11 recently met the primary endpoint in the COMPETEPhase 3 study as a potential treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM plans to submit a New Drug Application (NDA) for this asset to the U.S. FDA in 2025. In addition, the company will continue to accelerate the development of its innovative targeted radiopharmaceutical pipeline and the scale-up of Actinium-225 manufacturing through its joint venture, Actineer. Under the terms of the agreement, ITM will receive USD 140 million upon closing and can exercise additional tranches. Further details of the agreement have not been disclosed.

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"Blue Owl is a highly regarded investor with a deep appreciation for the potential of radiopharmaceuticals, and we see their debt capital for ITM as a validation of our position as a cornerstone of the radiopharmaceutical industry," said Dr. Andrew Cavey, CEO of ITM. "This strategic funding agreement enables us to move rapidly toward the potential U.S. commercialization of ITM-11, subject to FDA approval, and provides flexibility for the development and expansion of our innovative pipeline of targeted radiopharmaceuticals across a broad range of indications."

"With its vertically integrated approach that combines a profitable radioisotope manufacturing business with radiopharmaceutical pipeline development, we believe ITM is uniquely positioned to positively impact the precision oncology sector. We look forward to supporting ITM’s continued growth and mission to bring innovative treatment options to people living with cancer," said Sandip Agarwala, Managing Director and Head of Life Sciences at Blue Owl.

About n.c.a.177Lu-edotreotide (ITM-11)
177Lu-edotreotide is a radiolabeled peptide conjugate that delivers beta radiation specifically to SSTR-positive tumor cells, sparing healthy organs and tissue. The drug candidate, delivered intravenously, is comprised of non-carrier-added Lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. 177Lu-edotreotide was granted orphan drug designation in the E.U. and the U.S., and fast track designation in the U.S. for the treatment of GEP-NETs, based on positive results from a retrospective Phase 2 study with177Lu-edotreotide.

(Press release, ITM Isotopen Technologien Munchen, MAY 27, 2025, View Source [SID1234661160])

On May 27, 2025 TCG Labs Soleil, a venture firm integrating dedicated capital with an in-house biotech R&D hub, and EpimAb Biotherapeutics, Inc. ("EpimAb") reported that Juri Biosciences, Inc. ("Juri"), a portfolio company of TCG Labs Soleil, has entered into a worldwide licensing agreement with EpimAb, a clinical-stage biopharmaceutical company specializing in the discovery and development of multi-specific antibodies for diseases with high unmet need (Press release, EpimAb Biotherapeutics, MAY 27, 2025, View Source [SID1234654051]). The agreement grants Juri exclusive global rights to a development-ready T-cell engager targeting kallikrein-related peptidase 2 (KLK2) and CD3 for the treatment of metastatic prostate cancer.

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Under the terms of the agreement, EpimAb is eligible to receive up to $210 million, including an upfront payment and milestone payments tied to development, regulatory, and commercial events, plus tiered royalties. Further financial details were not disclosed.

Juri is one of several portfolio companies formed by TCG Labs Soleil. Dr. Charles Sawyersi, the inaugural Director of the Human Oncology and Pathogenesis Program at Memorial Sloan Kettering Cancer Center, will serve as a strategic scientific advisor, working closely with the TCG Labs Soleil team to support the program and help guide the advancement of KLK2-directed therapies. A leading expert in metastatic prostate cancer and translational oncology, Dr. Sawyers co-discovered enzalutamide, one of the most widely used therapies for advanced prostate cancer today.

"This agreement with EpimAb is a clear demonstration of our venture-biotech model at work. We’ve acquired an exciting external innovation and are deploying our dedicated capital, scientific leadership and operational infrastructure to move it rapidly into the clinic," said Jin-Long Chen, Ph.D., Managing Partner of TCG Labs and Chief Executive Officer of TCG Labs Soleil. "Prostate cancer remains a leading cause of cancer-related death in men, and KLK2 is a highly prostate-specific antigen with the potential to enable more precise, targeted therapy. We look forward to advancing this program through our portfolio company, Juri Biosciences."

Chengbin Wu, Ph.D., Founder and Chief Executive Officer of EpimAb Biotherapeutics, commented, "We are pleased to have identified a partner for our KLK2 program in Juri Biosciences, backed by the experienced team of TCG Labs Soleil. By partnering in the solid tumor space, EpimAb further validated the broad potential of our TCE platform beyond immunology and hematology."

On May 27, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ; TSX: BCT), a clinical-stage biotechnology company advancing personalized immunotherapies for cancer, reported that Bria-OTS has cleared its safety evaluation in the Phase 1/2 monotherapy study and has now transitioned to dosing patients in combination with a checkpoint inhibitor (CPI) (Press release, BriaCell Therapeutics, MAY 27, 2025, View Source [SID1234653599]). The first patient has been dosed in the checkpoint inhibitor combination cohort of the ongoing Phase 1/2 study of Bria-OTS (NCT06471673) in metastatic breast cancer.

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Bria-OTS, a personalized next-generation version of Bria-IMT—currently in a pivotal Phase 3 trial—is designed to enhance immune responses against tumors. The CPI combination cohort follows the successful completion of a three-patient monotherapy safety run-in. Notably, the first monotherapy patient remains on study with complete resolution of lung metastasis .

"The encouraging responses seen will give us reason to believe that combining Bria-OTS with a checkpoint inhibitor could yield even greater anti-tumor activity," said Neal S. Chawla, MD, Director at the Sarcoma Oncology Center, Santa Monica, Ca., and Principal Investigator for the Bria-OTS study. "This approach may offer a new option for patients who have not responded to existing to antibody-drug-conjugates (ADCs) or checkpoint inhibitors. We are excited to further explore the therapeutic potential of the Bria-OTS platform."

"Initiating the CPI combination cohort marks a significant milestone for BriaCell," added Dr. William V. Williams, BriaCell’s President and CEO. "We believe Bria-OTS has the potential to address major gaps in current cancer care, and this step brings us closer to offering a much-needed personalized immunotherapy for difficult-to-treat cancers."

The ongoing study will assess Bria-OTS in combination with a CPI in up to 12 patients with metastatic breast cancer, with safety and objective response rate (ORR) as primary endpoints. BriaCell also plans to evaluate Bria-OTS+, a further optimized version of the platform, across multiple cancer types including breast and prostate cancers.

On May 27, 2025 Sanofi reported the completion of its acquisition of DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., a private clinical-stage biopharmaceutical company (Press release, Sanofi, MAY 27, 2025, View Source [SID1234653524]). The acquisition bolsters Sanofi’s ambition to become the foremost immunology company and broadens the company’s leading immunology pipeline.

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DR-0201, now named SAR448501, has shown robust B-cell depletion in pre-clinical and early clinical studies. The potential first-in-class targeted bispecific myeloid cell engager targets and engages specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis.

Recent pre-clinical and early clinical study data in autoimmune diseases suggest that deep B- cell depletion has the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.

Sanofi acquired DR-0201 through the acquisition of the Dren Bio affiliate Dren 0201, Inc. for an upfront payment of $600 million and potential future payments totaling $1.3 billion upon achievements of certain development and launch milestones. Dren Bio will continue to operate independently to advance its pipeline of antibody therapeutics that selectively deplete pathogenic cells and other disease-causing agents.