Curasight Announces Successful Dosing of First Patient in Phase 1 trial with uTREAT® in Brain Cancer

On December 18, 2025 Curasight A/S ("Curasight" or "the Company" – TICKER: CURAS) reported the successful and safe dosing of the first patient in the Phase 1 trial using uTREAT in brain cancer (high grade gliomas). The news marks the initiation of the first clinical trial under the company’s therapeutic platform uTREAT, investigating it as a potential treatment option for glioblastoma.

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The start of the phase 1 study with uTREAT means that Curasight is now in the clinical phase with both parts of its theranostic platform aimed at improving treatment and diagnosis of certain cancers. The company’s diagnostic platform uTRACE is currently in a Phase 2 trial for prostate cancer under the strategic partnership with Curium Inc.

"The dosing of the first patient with uTREAT in this Phase 1 trial marks an important step in the development of the therapeutic arm of our theranostic platform, making Curasight a clinical stage therapeutic company". Said Curasight’s CEO Ulrich Krasilnikoff. "I very much look forward to seeing the data and would like to take this opportunity to thank the patient and doctors involved in this trial in supporting our efforts to develop uTREAT ".

About the Phase 1 trial with uTREAT in brain cancer

The trial aims to investigate Curasight’s uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders.

About the uPAR theranostic platform

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE and uTREAT both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight’s ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers.

About high grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.

(Press release, Curasight, DEC 18, 2025, View Source [SID1234661545])

Orum Therapeutics Secures Approximately US$100 Million to Accelerate Development of Leading Degrader Antibody Conjugate Programs to Treat Serious Diseases

On December 18, 2025 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a public biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported that it secured 145 billion KRW (approximately US$100 million) in convertible referred stock investments. This round is led by returning investor KB Investment and includes other existing investors, IMM Investment, Woori Venture Partners and Stassets Investment. New investors include Weiss Asset Management, a Boston-based global investment firm, and Korea Investment Partners, a major institutional venture investor with a strong track record in biotech investment. Additional new investors in this round are DSC Investment, Company K Partners, AON Investment, and DAYLI Partners.

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"Our mission is to deliver degrader-antibody conjugate therapeutics that apply powerful degrader payloads with antibody-targeted precision to improve the treatment of cancer and other serious diseases," said Sung Joo (SJ) Lee, Ph.D., Founder and CEO of Orum. "This investment supports the next stage of our growth as we prepare to advance our next therapeutic programs towards clinical evaluation, develop additional novel payloads, and continue to build platforms that can generate differentiated drug candidates across oncology and beyond. We appreciate the confidence of both new and existing investors who share our commitment to delivering meaningful innovation for patients."

This investment supports the advancement of ORM-1153 and additional programs in Orum’s pipeline and continued refinement of the Company’s DAC platforms, including development of additional novel payload classes beyond GSPT1. It also supports the expansion of Orum’s scientific and operational infrastructure as the Company advances additional targeted DAC programs based on principles of selectivity, potency, and rational payload design. These efforts are foundational to Orum’s strategy to generate differentiated therapeutic DAC programs for oncology and other serious diseases.

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

(Press release, Orum Therapeutics, DEC 18, 2025, View Source [SID1234661530])

Syneron Bio Closes Nearly $100M in Series A and A+ Rounds

On December 18, 2025 Syneron Bio, an macrocyclic peptide drug discovery company driven by intelligent high-throughput platform, reported it has successfully completed its Series A and A+ financing rounds, raising close to USD 100 million in total. Top-tier investors participated in the round, including AstraZeneca, AZ-CICC Healthcare Investment Fund, Pfizer Biotech Development Investment Fund, GL Ventures, 5Y Capital, Sinovation Capital, Lenovo Capital, Gree Capital and KHK fund.

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Dr. Xiao Zhang, Founder and CEO of Syneron Bio, commented:
"We are honored to receive the recognition and support of leading global pharmaceutical companies and top-tier investment institutions. This financing will significantly strengthen the development of our intelligent high-throughput macrocyclic peptide development platform, Synova, and provide the resources needed to advance multiple pipelines toward clinical stages."

(Press release, Syneron Tech, DEC 18, 2025, View Source [SID1234661546])

The FDA approves PharmaMar’s Investigational NewDrug (IND) application for the combination of PM54with immunotherapy in solid tumors

On December 18, 2025 PharmaMar (MSE:PHM) reported that it has received an investigational new drug (IND) approval from the U.S Food and Drug Administration (FDA), to start a Phase 1/2 multicenter clinical trial for the combination of PM54 with immunotherapy for the treatment of advanced stage solid tumors.

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This refers a Phase 1 study for the evaluation of the safety, followed by a Phase 2 to evaluate the safety and efficacy profile in patients affected by tumors with significant unmet medical needs such as advanced-stage melanoma, endometrial cancer, extrapulmonary neuroendocrine cancer and mesothelioma.

The approval of this IND allows, after the positive evaluation of the dossier with the preclinical data, manufacturing information and the protocol of the proposed clinical trial, the beginning of the activities related to the study in the United States.

PM54 is a novel inhibitor of the oncogenic transcription of the ecteinascidin family, currently being evaluated as a monotherapy in Phase 1/1b studies, in patients with advanced solid tumors to assess safety, tolerability, pharmacokinetics and preliminary antitumor activity.

Preliminary data from ongoing studies, together with evidence from preclinical studies and the mechanism of action, support the advancement of the clinical development plan for PM54 and the initiation of the study in combination with immunotherapy.

(Press release, PharmaMar, DEC 18, 2025, View Source [SID1234661531])

New Publication Shows PROSTOX™ ultra Test Delivers Significant Health System Cost Savings and Quality-of-Life Gains for Prostate Cancer Patients Undergoing Radiation Therapy

On December 18, 2025 MiraDx, a molecular diagnostics company focused on germline genetic testing to personalize cancer treatment, reported a new analysis has been published in the Journal of Health Economics and Outcomes Research demonstrating that the PROSTOX ultra test can deliver substantial long-term economic and quality-of-life benefits for patients and the healthcare system.

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PROSTOX ultra is a clinically validated germline genetic test for men with localized prostate cancer considering stereotactic body radiation therapy (SBRT), a treatment that delivers high doses of radiation over a short time period, with 5-7 treatments. The test identifies patients at higher risk of developing late genitourinary (GU) toxicity—urinary side effects such as urgency, leakage, or discomfort that may occur after treatment. While SBRT is a very effective and convenient treatment for prostate cancer, a subset of patients experience urinary side effects that present months or even years after treatment and can persist throughout the patient’s lifetime. By identifying patients with increased risk of these side effects from SBRT, PROSTOX ultra helps doctors and patients make more informed treatment decisions and consider alternative options when needed.

The study, which modeled clinical pathways incorporating PROSTOX ultra versus treatment guided by the current standard of care for patients receiving treatment for localized prostate cancer, found a significant cost savings of $19,615 per tested patient. Over a lifetime, the benefits grow even larger. The analysis showed that each patient tested with PROSTOX ultra is expected to save the health care system approximately $24,777 over the patient’s lifetime, while also gaining 0.24 additional quality-adjusted life years (QALYs) compared to patients evaluated without genetic risk assessment.

The publication, "Economic Evaluation of a Novel MicroRNA-Based Assay to Determine Risk of Late Genitourinary Radiation Toxicity in Patients With Prostate Cancer," can be viewed in its entirety by visiting the Journal of Health Economics and Outcomes Research website here: View Source

"Physicians in practice using PROSTOX ultra are seeing its benefits in helping their patients avoid late GU toxicity from SBRT. These new results also now show that PROSTOX ultra meaningfully reduces the long-term cost burden on the healthcare system," said Melissa Stoppler, MD, Executive Vice President of Medical Affairs at MiraDx. "This new evidence further validates the value of integrating the test into treatment considerations for localized prostate cancer."

(Press release, MiraDx, DEC 18, 2025, View Source [SID1234661547])