NUCLIDIUM Presents Positive Phase I/II Results for First Copper-based PET Diagnostic in Neuroendocrine Tumors at EANM Congress 2025

On October 8, 2025 NUCLIDIUM AG a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, reported positive clinical data from the ongoing Phase I/II trial (NCT06455358) evaluating its novel copper-radiolabeled PET tracer, 61Cu-TraceNetTM ([61Cu]Cu-NODAGA-LM3) in patients with SSTR-positive gastroenteropancreatic and bronchopulmonary neuroendocrine tumors (GEP & BP-NETS) (Press release, NUCLIDIUM, OCT 8, 2025, https://nuclidium.com/nuclidium-presents-positive-phase-1-2-results-for-first-copper-based-pet-diagostic-in-neuroendocrine-tumors-at-eanm-congress-2025/ [SID1234656513]). Principal investigator Dr. Guillaume Nicolas, Deputy Head of Nuclear Medicine at the Department of Theragnostics at University Hospital Basel, Switzerland, presented the results in an oral session during the European Association of Nuclear Medicine (EANM) Congress in Barcelona, Spain.

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The first-in-human, open-label, randomized, reader-blinded, Phase I/II study compared the safety, biodistribution, tumor uptake, and image quality of NUCLIDIUM’s copper-61-radiolabeled somatostatin receptor subtype 2 (SSTR2) antagonist, 61Cu-TraceNetTM with the standard of care gallium-68-labelled SSTR2 agonist, [68Ga]Ga-DOTA-TOC. In the first 22 patients with well-differentiated GEP and BP-NETs evaluated at the University Hospital Basel, 61Cu-TraceNET was well tolerated with no clinically significant adverse events reported. 61Cu-TraceNET showed a higher tumor uptake and tumor-to-background ratio and detected additional lesions in the liver and lungs. In a blinded analysis, independent readers rated the 61Cu-TraceNET image quality as superior compared to 68Ga-DOTATOC at both 1- and 3-hour imaging post-injection, supported by its 5.6-hour half-life, which enables broader distribution and delayed imaging. The image quality of 61Cu-TraceNET at 1- and 3-hours post-injection was assessed as equally good.

"Next-generation radiopharmaceuticals have the potential to transform the diagnosis and management of difficult-to-treat cancers. The first-in-human data with NUCLIDIUM’s novel copper-based diagnostic, 61Cu-TraceNETTM, show its excellent tumor specificity, improved image quality, and its ability to detect additional metastases," said Guillaume Nicolas, MD, PhD, Principal Investigator of the trial. "I am also encouraged by the safety, pharmacokinetic data, and the strong potential for 61Cu-TraceNETTM to support clinicians in the diagnosis in a range of SSTR2-positive tumors, including metastatic breast cancer, where better diagnostic approaches are urgently needed to improve treatment strategies."

Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM added "This rapidly generated first clinical data with 61Cu-TraceNETTM validates the potential of our copper-based platform and our ability to radiolabel an SSTR2 antagonist with high yield at room temperature for convenient patient diagnosis. With high specificity, low toxicity, and the potential to detect even the smallest primary and metastatic tumors early, 61Cu-TraceNET is well positioned to become a best-in-class diagnostic. We remain committed to rapidly advancing our copper-based theranostic pipeline to improve outcomes for patients across multiple cancer types with a focus on women’s health."

61Cu-TraceNETTM is the diagnostic component of NUCLIDIUM’s TraceNETTM program, targeting NETs and other SSTR-positive tumors such as metastatic breast cancer. A clinical trial of the corresponding therapeutic, 67Cu-TraceNET, is expected to start enrolling patients in 2026.

Bayer and Kumquat Biosciences initiate Phase I study with KRAS G12D inhibitor in patients with KRAS-mutated tumors

On October 8, 2025 Bayer and Kumquat Biosciences Inc., a clinical-stage biotech company founded by pioneers of targeting the KRAS pathway, reported the initiation of a Phase I clinical trial with KQB548 (BAY 3771249), an investigational inhibitor designed to treat KRAS G12D-mutated tumors, such as pancreatic, colorectal and lung cancer (Press release, Kumquat Biosciences, OCT 8, 2025, View Source [SID1234656511]). The first-in-human, dose-escalation study (NCT07207707) will evaluate the safety and preliminary efficacy of KQB548 (BAY 3771249) as a monotherapy in patients with KRAS G12D mutated tumors. KRAS mutations occur in nearly 25 percent of human cancers, yet the most prevalent and oncogenic KRAS variant (G12D) still lacks effective treatment options.

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"Initiating clinical development of investigational KRAS G12D inhibitor KQB548 (BAY 3771249) marks an important milestone in our commitment to develop new medicines targeting highly relevant signaling pathways that promote tumor growth and survival," said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. "Targeting KRAS has been considered quite challenging. We aim to deliver treatment options for patients with cancers driven by the KRAS G12D mutation. Through continued research innovation we can unlock the potential of precision oncology and improve the lives of people living with cancer."

KRAS G12D mutations are found most frequently in approximately 37 percent of pancreatic ductal adenocarcinoma (PDAC), 13 percent of colorectal cancer and 4 percent of non-small cell lung cancers. These mutations are often recognized as important targets for cancer treatment, and their detection paves the way for the creation of tailored therapies.

Despite recent scientific advancements, there are currently no effective treatments available that provide durable therapeutic benefits for most patients with KRAS-G12D-mutated cancers. Introducing the KRAS G12D inhibitor into clinical trials aims to address the long-standing unmet need.

"We are excited to initiate the clinical trial of our KRAS G12D inhibitor KQB548, which holds the prospect of transforming the KRAS G12D treatments for the deadly malignancies such as pancreatic, lung and colorectal cancers," said Dr. Nicolas Acquavella, Senior Vice President of Clinical Development and Corporate Alliance Management of Kumquat. "The speedy enrollment highlights our team’s execution capabilities and Kumquat’s long-standing commitment to delivering potentially life-changing medicines to cancer patients."

About KRAS G12D inhibitor (KQB548 – BAY 3771249)
KQB548 (BAY 3771249) is an investigational KRAS G12D inhibitor being developed to treat KRAS-mutated tumors, such as pancreatic, colorectal and lung cancer. KQB548 (BAY 3771249) is the lead program from the Bayer and Kumquat global exclusive license and collaboration in precision oncology. Kumquat received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) for its KRAS G12D inhibitor in July 2025.

Karyopharm Announces Strategic Financing Transactions to Support Growth; Extends Cash Runway Into Second Quarter of 2026, Beyond Expected Top-Line Readout of Phase 3 SENTRY Trial in Myelofibrosis

On October 8, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that it has entered into comprehensive financing and capital structure transactions expected to provide the Company with $100 million of financial flexibility and additional capital, extending the Company’s cash runway into the second quarter of 2026 based on the Company’s current operating plans (Press release, Karyopharm, OCT 8, 2025, View Source,-Beyond-Expected-Top-Line-Readout-of-Phase-3-SENTRY-Trial-in-Myelofibrosis [SID1234656510]).

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"Following the recent completion of enrollment of our Phase 3 SENTRY trial in myelofibrosis, we are excited to announce this strategic financing which is expected to provide us with the resources needed to deliver top-line data from this pivotal trial," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "I would like to thank our lenders, noteholders and equity investors for their ongoing support to strengthen our balance sheet, equitize near-term debt maturities and support our potentially transformational Phase 3 myelofibrosis program. We believe that selinexor plus ruxolitinib has the potential to be the first combination therapy approved for the treatment of myelofibrosis. By combining selinexor with the current standard of care, we have the potential to redefine the way people living with myelofibrosis are treated."

Each of the financing and capital structure transactions is expected to close on or around October 10, 2025 (Closing Date), subject to the satisfaction of customary closing conditions. The Company’s existing senior lenders have agreed to multi-faceted financing transactions with the following key components:

$67.5 million in financial flexibility and new capital consisting of $27.5 million in new term loan borrowings and new convertible notes, $25 million of near-term deferrals of interest and royalty payments, and a $15 million temporary reduction in the Company’s minimum liquidity covenant. In addition, holders of the Company’s convertible notes due 2029 have agreed to exchange $15 million of their notes for newly issued shares of common stock or pre-funded warrants in lieu thereof.
Holders of approximately $24.25 million aggregate principal amount of the Company’s senior unsecured convertible notes due October 15, 2025 have agreed to exchange their notes and accrued interest due thereon at a discount to par value for newly issued shares of common stock, or pre-funded warrants in lieu thereof, plus warrants to purchase shares of common stock.
In addition, the Company has entered into a securities purchase agreement for a private placement in which the Company agreed to sell 1,487,917 shares of common stock and accompanying warrants to purchase 1,317,771 shares of common stock with an exercise price of $6.64 per share. The warrants issued in the private placement will be exercisable on or before the 30th day following the public announcement of top-line results from the Company’s XPORT-EC-042 trial in endometrial cancer, which is anticipated in mid-2026. The private placement is expected to result in gross proceeds of approximately $8.75 million before deducting any offering expenses.

The Company intends to use the proceeds of the financing transactions to pay transaction expenses and for general corporate purposes, including to support the Company’s ongoing and planned clinical trial activities.

At closing of the financing transactions, the Company will issue an aggregate of 7,223,982 newly issued shares of common stock, newly issued pre-funded warrants to purchase an aggregate of 2,913,136 shares of common stock, and newly issued warrants to purchase an aggregate of 5,918,358 shares of common stock with an exercise price of $6.64 per share, a 15% premium to the Nasdaq minimum price. In addition, the Company will reduce the exercise price of outstanding warrants to purchase 3,068,417 shares from $16.50 per share to $6.64 per share. The financing transactions are intended to comply with Nasdaq rules, including being priced at the "minimum price" (as defined in the Nasdaq rules). Following consummation of the transactions, the Company expects to have an aggregate of 15,926,939 shares of common stock outstanding (assuming no exercise of any pre-funded warrants or warrants or conversions of any outstanding convertible notes).

Additional details on the financing transactions will be available in a Form 8-K that the Company will file with the United States Securities and Exchange Commission.

Preliminary Third Quarter 2025 Financial Results

Based on preliminary financial information, the Company expects total revenue, which includes license and royalty revenue from partners, to be in the range of $42 to $44 million and U.S. XPOVIO net product revenue to be approximately $32 million for the three months ended September 30, 2025.

Prior to the receipt of approximately $36 million of gross proceeds from the financing transactions, the Company expects to report that it had cash, cash equivalents, restricted cash and investments as of September 30, 2025 of approximately $46 million.

The financial information presented in this press release reflects the Company’s estimates with respect to total revenue, U.S. XPOVIO net product revenue and its cash balance and is based on currently available information, which is preliminary. The Company’s final results may vary from these preliminary estimates as a result of the completion of customary quarterly review procedures, including those conducted by the Company’s external auditors.

Endometrial Cancer Program

Enrollment continues in the Phase 3 XPORT-EC-042 (NCT05611931) trial evaluating selinexor as a maintenance-only therapy following systemic therapy versus placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer. The Company continues to expect to report top-line data from this event-driven trial in mid-2026.

Ongoing Efforts to Further Enhance Liquidity and Maximize Value

The Company expects to continue exploring potential financing and strategic alternatives to enhance liquidity and maximize value with the assistance of its advisors, including its financial advisor Centerview Partners LLC.

Centerview Partners LLC and J. Wood Capital Advisors LLC acted as financial advisors to Karyopharm and Sidley Austin LLP acted as legal counsel to Karyopharm in connection with these transactions.

The offer and sale of the shares of common stock, pre-funded warrants, warrants, the New 2028 Notes, the New 2029 Notes or any other securities (including the shares of common stock issuable upon conversion of the New 2028 Notes, the New 2029 Notes and the shares of common stock issuable upon exercise of the warrants and pre-funded warrants issued in the financing transactions) are not being registered under the Securities Act, or any state securities laws. The shares of common stock, pre-funded warrants, warrants, the New 2028 Notes, the New 2029 Notes or any other securities (including the shares of common stock issuable upon conversion of the New 2028 Notes, the New 2029 Notes and the shares of common stock issuable upon exercise of the warrants and pre-funded warrants issued in the financing transactions) may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy shares of common stock, pre-funded warrants, warrants, the New 2028 Notes, the New 2029 Notes or any other securities, nor shall there be any offer, solicitation or sale of shares of common stock, pre-funded warrants, warrants, the New 2028 Notes, the New 2029 Notes or any other securities (including the shares of common stock issuable upon conversion of the New 2028 Notes, the New 2029 Notes and the shares of common stock issuable upon exercise of the warrants and pre-funded warrants issued in the financing transactions) in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About the Phase 3 SENTRY Trial

SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 109/L. Patients are randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline.

About Myelofibrosis

Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union1. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib. Patients treated with the most commonly prescribed JAK inhibitor often require blood transfusions, and more than 30% will discontinue treatment due to anemia.2 Anemia and transfusion dependence are strongly correlated with poor prognosis and shortened survival.3

1. Clarivate/DRG (2023)
2.. Palandri, F., Palumbo, G.A., Elli, E.M. et al. Ruxolitinib discontinuation syndrome: incidence, risk factors, and management in 251 patients with myelofibrosis. Blood Cancer J. 11, 4 (2021).
3. Pardanani, A., & Tefferi, A. (2011). Prognostic relevance of anemia and transfusion dependency in myelodysplastic syndromes and primary myelofibrosis. Haematologica, 96(1), 8–10.

About the Phase 3 XPORT-EC-042 Trial

EC-042 (XPORT-EC-042; NCT05611931) is a global, Phase 3, randomized, double-blind clinical trial evaluating selinexor as a maintenance therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer. The EC-042 trial is expected to enroll approximately 276 patients who will be randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The trial includes two patient populations, for which, the primary endpoint of progression free survival will be tested sequentially and the key secondary endpoint of overall survival will be evaluated: 1) a modified intent to treat population (mITT) that will include patients with either, a) TP53 wild-type tumors with proficient mismatch repair status (pMMR); or, b) TP53 wild-type tumors with deficient mismatch repair status (dMMR), who are medically ineligible to receive checkpoint inhibitors; and, 2) the trial’s original intent to treat (ITT) population, which will include all patients enrolled in the trial whose tumors are TP53 wild-type, regardless of MMR status. The mITT population is expected to include approximately 220 patients. In connection with the EC-042 trial, Karyopharm entered into a global collaboration with Foundation Medicine, Inc. to develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test to identify and enroll patients whose tumors are TP53 wild-type.

GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies

On October 8, 2025 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE natural killer (NK) cell engager platform, reported that enrollment in the dose escalation cohorts of the Phase 1 trial, evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies, is well on track (Press release, GT Biopharma, OCT 8, 2025, View Source [SID1234656509]).

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Enrollment in Cohorts 1 and 2 were successfully completed; both patients in Cohort 3 have now initiated treatment with no evidence of dose-limiting toxicities or safety concerns to date. The level of immune activation observed from multiple biomarkers in the first patient of Cohort 3 is consistent with the evidence of heightened immune activity in the first four patients from Cohorts 1 and 2. Assuming Cohort 3 is completed with no new safety findings, the trial will continue to dose-escalate into the higher ranges of GTB-3650 anticipated to be necessary to translate heightened immune activation into clinically meaningful evidence of therapeutic activity. Initiation of dosing in Cohort 4 is planned by year-end 2025 and additional data updates are anticipated in Q1 2026.

The Phase 1 protocol allows evaluation of GTB-3650 in up to approximately 14 patients (two patients in each of seven cohorts), with doses ranging from 1.25ug/kg/day in Cohort 1 to 100ug/kg/day in Cohort 7. GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off (defining a treatment cycle), for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. More details can be found on clinicaltrials.gov with the identifier: NCT06594445.

EORTC shines a light on advancements in radioligand therapy

On October 8, 2025 EORTC reported it is at the forefront of advancing cancer research, and one of the key areas of focus is Radioligand Therapy (RLT) (Press release, EORTC, OCT 8, 2025, View Source [SID1234656508]). On the occasion of the upcoming European Association of Nuclear Medicine (EANM) Congress (4-8 October 2025, Barcelona, Spain), where EORTC co-hosted a symposium, we are excited to highlight the significant strides being made by EORTC in this innovative field.

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EANM-EORTC collaboration
The EANM and EORTC collaborate to advance cancer care by integrating nuclear medicine into clinical research. They leverage their combined expertise to design and run large, multidisciplinary clinical trials, especially in areas like radioligand therapy. This partnership is essential for establishing the robust clinical evidence needed to develop new standards of care and improve patient outcomes across Europe.

To further this partnership, EORTC & EANM co-hosted a symposium at the EANM Congress on Monday 6 October entitled "Oncology & Theranostics Committee / EORTC – Oncological Response Criteria for PET: beyond RECIST, EORTC & PERCIST".

Check the programme here.

EORTC’s Radioligand Task Force: driving clinical innovation
A cornerstone of EORTC’s commitment to RLT, this dedicated Task Force, chaired by Matthias Preusser & Christophe Deroose, was established to address the critical need for robust clinical evidence in this rapidly evolving field.

LINK TO VIDEO: View Source

Its primary mission is to design and implement meaningful clinical trials using radioligands as theranostics-based approach, ensuring the generation of high-quality data to advance patient care. The Task Force also plays a crucial role in promoting standardisation and quality assurance within RLT research.

Learn more about the Task Force

Trials in the spotlight
LUMEN-1 trial: improving patient outcomes recurrent meningioma
The RLT Task Force plays a crucial role in designing and implementing studies that aim to improve patient outcomes. A prime example of this dedication is the EORTC-2334-BTG LUMEN-1 clinical trial. This pivotal trial will evaluate the effectiveness of a new treatment strategy for meningioma called [177Lu]Lu-DOTATATE in patients with recurrent meningioma.

This treatment has shown promising results in smaller studies and is now being tested in a larger, randomised phase II trial involving 136 patients across 35 sites in 10 European countries.

You can also learn more by checking the publication of the protocol of LUMEN-1 in the Journal of Nuclear Medicine by Nathalie Albert et al.: View Source

The study is supported by Advanced Accelerator Applications (a Novartis company).

RENALUT: expanding the therapeutic landscape of renal cancer
Emmanuel Seront, study coordinator, introduces the Renalut study: View Source

The EORTC-2361-GUCG RENALUT is a phase II, single-arm, multicentre trial led by EORTC. The objective of the trial is to evaluate the efficacy of [177Lu]Lu-PSMA-617 in second/third line metastatic clear cell renal cell carcinoma (ccRCC). The utilisation of [177Lu]Lu-PSMA-617, which targets PSMA (prostate-specific membrane antigen), has demonstrated both efficacy and safety in the treatment of metastatic prostate cancer. Although PSMA has been observed to be present on prostate tumour cells, the term is considered inappropriate due to its concomitant expression in neo vasculature and in other organs. Hypervascularization represents a significant consequence of the mutation of the Von Hippel-Lindau (VHL) gene, which is prevalent in cases of clear cell renal cell carcinoma (ccRCC). PSMA targeted imaging has been reported to demonstrate a high degree of accuracy in the evaluation of metastatic ccRCC, thus indicating its potential as a target for radioligand therapy.

The current standard of care involves the combination of a vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) and an immune checkpoint inhibitor (ICI). After progression on these regimens, the standard approach is sequential VEGFR-TKI therapy. Nevertheless, the efficacy is modest.

This innovative study introduces a novel therapeutic approach for aggressive disease, leveraging promising outcomes observed in prostate cancer and the known PSMA overexpression in ccRCC. RENALUT aims to expand the therapeutic landscape and provide new hope for patients with limited treatment options.

The study is supported by Advanced Accelerator Applications (a Novartis company).

PEACE III: unlocking the potential of therapeutic radionuclides
The EORTC-1333-GUCG PEACE III phase III trial, which presented its late-breaking results at ESMO (Free ESMO Whitepaper) 2024 (European Society for Medical Oncology) on 14 September 2024 during a presidential symposium, is a landmark study demonstrating a significant improvement in patient outcomes for metastatic castration-resistant prostate cancer (mCRPC) patients with bone metastases.

The trial successfully showed that adding six cycles of the alpha-emitting radionuclide radium-223 (223RaCl2) to enzalutamide, an AR pathway inhibitor, increased median progression-free survival from 16 to 19 months, with an interim analysis also suggesting an overall survival advantage.

This groundbreaking study perfectly symbolises our work in nuclear medicine — specifically, using a targeted therapeutic radiopharmaceutical to provide effective, manageable, combination treatment—to meaningfully prolong life and establish a new standard of care in advanced cancer treatment.

The trial was a collaboration between EORTC, CTI CUOG, LACOG, and GETUG/UNICANCER, and also shows the importance of partnerships in clinical trials.

This trial is supported by an investigator driven clinical trial agreement from Bayer HealthCare Pharmaceuticals Inc. and Astellas Pharma Europe.

EORTC’s broader commitment to Radioligand Therapy: a multidisciplinary approach
To conclude, EORTC’s work in radioligand therapy is highly representative of EORTC’s overarching multi-tumour approach to cancer research, leveraging the organisation’s unique multidisciplinary infrastructure. Its work is intrinsically linked to and supported by various EORTC Disease-Oriented Groups (e.g., Brain Tumour Group, Genito-Urinary Cancers Group) and transversal platforms, like the EORTC Imaging Group. This collaborative model ensures that the expertise in imaging and nuclear medicine is central to designing and executing studies across diverse cancer types.