On November 17, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ITM-94 ([68Ga]Ga-DPI-4452) as a diagnostic agent for the detection of clear cell renal cell carcinoma (ccRCC). The Fast Track designation was granted based on the potential of ITM-94 as a more effective, non-invasive diagnostic agent designed to improve outcomes for people living with ccRCC, a condition with high unmet medical need1.

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"The FDA’s Fast Track designation is a validation of ITM-94’s potential to aid in the non-invasive diagnosis of renal cell carcinoma," said Dr. Celine Wilke, chief medical officer of ITM. "We have seen promising data in our ongoing clinical trial that suggest ITM-94 could change how clinicians diagnose and stage patients across the broader ccRCC disease landscape, with potential utility in supporting clinical decision-making for indeterminate renal masses as well. This news highlights the innovation within our pipeline and the important role an effective diagnostic can play in cancer treatment."

ITM-94 is a gallium-68-radiolabeled PET imaging agent and, together with radiotherapeutic compound ITM-91 ([177Lu]Lu-DPI-4452), comprise a first-in-class, peptide-based theranostic pair. The theranostic pair targets carbonic anhydrase IX (CAIX), a cell surface protein that plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. ITM-94 is currently being evaluated in Part D of the ongoing Phase 1/2 clinical trial for its effectiveness to accurately detect ccRCC in patients with indeterminate renal masses (IDRM) when compared to CT/MRI imaging, with histopathological confirmation of diagnosis. Secondary endpoints include assessments of the imaging agent’s sensitivity, specificity and Positive Predictive Value (PPV) and Negative Predictive Value (NPV) compared to histology.

FDA Fast Track designation is designed to facilitate the development and expedite the review of new diagnostics and therapies that are intended to treat serious or life-threatening conditions and have the potential to address an unmet medical need. Programs granted this designation are eligible for more frequent communications with the FDA during clinical development and for accelerated approval and/or priority review over standard reviews if relevant criteria are met.

About the Phase 1/2 ITM-91/ITM-94 Trial
The multi-part clinical trial (NCT05706129) is designed to assess the safety and tolerability, imaging characteristics, and efficacy of the theranostic pair ITM-91/ITM-94 in patients with unresectable, locally advanced or metastatic solid tumors. In the first-in-human part of the trial (Part A), ITM-94 has demonstrated exceptional tumor imaging characteristics, with a high tumor-to-background ratio and a favorable tolerability profile in patients with confirmed ccRCC1. Part B is currently assessing increasing doses of the therapeutic agent, ITM-91, in ccRCC patients whose tumors show CAIX expression as evidenced by uptake of the imaging tracer, ITM-94. Based on the recommended dose and treatment schedule obtained from Part B, expansion Part C of the trial will evaluate the safety and preliminary efficacy of ITM-91 in patients with ccRCC, and potentially other CAIX-expressing tumor types. Part D is evaluating the effectiveness of ITM-94 in classifying indeterminate renal masses, such as ccRCC.

(Press release, ITM Isotopen Technologien Munchen, NOV 17, 2025, View Source [SID1234661165])

On November 17, 2025 One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering a novel cancer therapy, reported that the first subject has been successfully dosed in its ODIN Phase 1/2 clinical trial (NCT07151040) evaluating TH9619, a first-in-class MTHFD1/2 inhibitor.

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This milestone was achieved at START Madrid/Fundación Jiménez Díaz University Hospital, under the supervision of Dr. Victor Moreno, Director of Clinical Research and Principal Investigator. Dr. Moreno commented: "I am pleased that our subjects now have access to next-generation investigational therapies such as TH9619. This study opens new possibilities for cancer treatments where options remain limited, and we look forward to continuing collaborating with One-carbon Therapeutics."

"Dosing the first subject in our ODIN study represents a significant step in turning our cutting-edge science into first-in-class therapies," said Ana Slipicevic, Chief Executive Officer of One-carbon Therapeutics. "TH9619 embodies our unique strategy of targeting one-carbon metabolism proteins, by killing cancer cells while sparing normal cells and bringing new hope to subjects with high unmet medical need. We are deeply grateful to the investigators, clinical teams, our collaborators, and most importantly, the subjects who make this progress possible."

About TH9619

TH9619 is a first-in-class, potent, small-molecule, and a dual inhibitor of MTHFD1/2, highly overexpressed and cancer-specific enzymes within the one-carbon metabolic pathway – TH9619 kills cancer cells via a dual mechanism of action (1) inhibition of MTHFD1 traps folate leading to thymidine depletion (2) inhibition of nuclear MTHFD2 disrupts DNA damage response and repair pathways. With its unique characteristics, TH9619 kills tumor cells, while sparing healthy tissue.

About ODIN Phase 1/2 Clinical Study

This is a first in human, multicenter, open label, dose escalation and expansion study, aiming at evaluating safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of TH9619 as monotherapy in subjects with advanced refractory solid tumors, including colorectal cancer, non-small cell lung cancer, head & neck squamous cell carcinoma, gastric cancer or gastroesophageal junction cancer. The trial is currently being conducted across leading academic and clinical research centers in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.

Clinicaltrials.gov NCT07151040; EudraCT No. 2024-519639-40-00

(Press release, One-carbon Therapeutics, NOV 17, 2025, View Source [SID1234661124])

On November 17, 2025 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, reported that the first patient has been dosed in its ANK-101-004 clinical trial (NCT07027514). This study will evaluate the combination of Ankyra’s tolododekin alfa (ANK-101), an anchored IL-12 drug conjugate with the anti-PD1 agent, cetrelimab, in patients who have progressed after initial treatment of metastatic, non-mutated non-small cell lung cancer (NSCLC). In addition, the study will evaluate tolododekin alfa in combination with standard of care immune checkpoint blockade in first-line treatment of patients with metastatic, non-mutated NSCLC and a tumor proportion score (TPS) of ≥ 50%.

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"While there has been considerable progress in the treatment of lung cancer many patients do not respond to current approaches", said Thomas Marron, MD, PhD, Director of the Early Phase Trials Unit at the Tisch Cancer Institute at Mount Sinai and Chief Medical Officer of OCCAM Immune and the principal investigator of the study. "The potential use of anchored IL-12 to drive better responses without adding appreciable toxicity could be an important advance for patients."

"Tolododekin alfa has already demonstrated objective responses as a single agent in patients with anti-PD-1-refractory cancers in phase 1 trials", stated Howard L. Kaufman, MD. CEO at Ankyra Therapeutics, "and now we have an opportunity to test tolododekin in patients with advanced lung cancer." Ankyra is working with OCCAM Immune at Mount Sinai in support of Ankyra the LANTERN clinical trial, which is evaluating ANK-101 in combination with PD-1 blockade in patients with first- and second-line NSCLC. Through state-of-the-art immune profiling, OCCAM Immune aims to generate a comprehensive immune atlas to correlate immune modulation with therapeutic efficacy and disease progression, advance biomarker discovery and deepen mechanistic insights into Ankyra’s novel therapeutic approach.

The ANK-101-004 (LANTERN) trial will be conducted at several institutions, including, Icahn School of Medicine at Mount Sinai, Roswell Park Cancer Institute, Mayo Clinic, Moffitt Cancer Center, The University of Chicago, Community Health Network, The University of Miami Sylvester Comprehensive Cancer Center, Karmanos Cancer Institute, FirstHealth of the Carolinas, and OSF Saint Francis Medical Center with additional sites expected as well.

About Tolododekin alfa (ANK-101)

Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer.

(Press release, Ankyra Therapeutics, NOV 17, 2025, View Source [SID1234660046])

On November 17, 2025 Incyte (Nasdaq:INCY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.

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"If approved, Minjuvi in combination with rituximab and lenalidomide will represent the first CD19- and CD20-dual-targeted immunotherapy for patients in Europe living with relapsed or refractory FL," said Lee Heeson, Executive Vice President and Head of Incyte International. "Based on the inMIND clinical trial results, Minjuvi has demonstrated its ability to offer patients improved progression free survival. The positive CHMP opinion is an encouraging step in our ongoing efforts to advance treatments that address critical gaps for patients."

The positive CHMP opinion is based on data from the Phase 3 inMIND trial evaluating the efficacy and safety of Minjuvi in combination with rituximab and lenalidomide in 548 adult patients with relapsed or refractory FL. Results from the trial, featured at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress and 2025 International Conference on Malignant Lymphoma (ICML), showed that Minjuvi combined with rituximab and lenalidomide met its primary endpoint. The data demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab. Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56]).

Minjuvi was well tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of tafasitamab to lenalidomide in combination with rituximab. The most common adverse reactions (≥ 20%) in recipients of Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough.2

FL is the most common slow-growing form of B-cell non-Hodgkin lymphoma (NHL), representing about 30% of NHL cases globally. It is considered incurable, with patients frequently relapsing after initial therapy and experiencing a progressively worsening prognosis with each recurrence. Despite advances in treatment, there remains a significant unmet need for additional options for relapsed or refractory FL, with 2-4 out of every 100,000 people affected In Western countries.1

"In Europe, patients with relapsed or refractory FL after one prior treatment line currently receive a limited set of treatment options in the second-line setting," said Stefano Luminari, M.D., Professor of Oncology, University of Modena and Reggio Emilia, Italy and inMIND study investigator. "The approval of Minjuvi would introduce an important second-line chemotherapy-free alternative which has demonstrated a significant reduction in the risk of disease progression across a wide patient demographic."

The CHMP opinion is now being reviewed by the European Commission, which has the authority to grant approval for all centrally authorized products in the EU. If approved, this would mark the second indication for Minjuvi, which was previously approved by the European Commission in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

About inMIND

A global, double-blind, randomized, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years).

The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.

For more information about the study, please visit View Source

About Minjuvi (tafasitamab)

Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received accelerated approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, Minjuvi received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

Safety Information from the EU Summary of Product Characteristics (SmPC)

Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.

Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded.

The most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%).

Minjuvi may cause serious adverse reactions. The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).

Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.

For more information, see the Minjuvi SmPC.

(Press release, Incyte, NOV 17, 2025, View Source [SID1234660045])

On November 17, 2025 Mosaic Therapeutics, Ltd, (‘Mosaic’, or ‘the Company’) an oncology therapeutics company building the category leader in Synergistic Precision Oncology, reported the appointment of Dr Stephen Shuttleworth as Chief Scientific Officer (CSO).

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Stephen has over 30 years’ experience as a pharmaceutical scientist, senior executive, entrepreneur and investor. He has been a Venture Partner at Samsara BioCapital, Palo Alto, US since 2019, where his responsibilities include R&D due diligence, new company creation and C-suite level company leadership. He also previously served as CSO, COO and Executive Director for over 10 years at Karus Therapeutics, where he was the founding scientist and R&D director of the company’s two small molecule oncology programmes, and raised blue-chip VC investment. Prior to Karus, Stephen held scientific leadership positions in the UK, US and Canadian biotech industries, notably at Piramed Pharma, Tularik, BioChem Pharma and CRUK. He began his industrial career in Cambridge, UK, at Chiroscience.

Stephen brings to Mosaic significant scientific expertise in small molecule cancer therapeutics R&D and medicinal chemistry. He has directed multiple small molecule therapeutics research programmes, primarily in cancer, and also in immunology and inflammation, metabolic disorders and infectious diseases. Of note, he led the design, research and preclinical development of three small molecule cancer therapeutics, all completing phase I clinical studies: Pictilisib (pan-class I PI3K), KA2237/CVL-237 (selective PI3K-b/d), and KA2507 (HDAC6). Stephen holds a PhD in Chemistry from the University of Liverpool, and is a Fellow of the Royal Society of Chemistry.

Stephen succeeds Dr Barry Davies, who is retiring as CSO at the end of November.

Stephen Shuttleworth, CSO, Mosaic Therapeutics, commented: "I am delighted to be joining Mosaic, and for the opportunity to work with this world-class team in its pursuit of cutting-edge, precision combination therapies for the treatment of patients with cancer. Mosaic’s Synergistic Precision approach to the discovery of biomarker-defined, targeted therapies is truly innovative and I look forward to working alongside the team to realise the full potential of the Company’s discovery platform and capabilities."

"We are excited to welcome Stephen to the Mosaic leadership team," said Thomas Fuchs, CEO, Mosaic Therapeutics. "He is a seasoned scientific leader and biotech investor, and I look forward to working with him as we bring our lead products into the clinic and work to build out our pipeline of precision oncology programmes. We also thank Barry for his leadership and significant contributions to the Mosaic team, in particular guiding our platform and pipeline development, and wish him all the best in his well-deserved retirement."

Mosaic is applying its advanced experimental and computational platform to identify oncology combinations that have synergistic activity in biomarker-defined patient populations. The Company’s pipeline of combination programmes is anchored by ASTX029, an ERK1/2 inhibitor, and ASTX295, an MDM2 antagonist, both in-licensed from Astex Pharmaceuticals in April 20251. Mosaic’s first clinical combination study is expected to commence in 2026.

Learn more about Mosaic’s molecularly-guided approach to oncology medicine: View Source

(Press release, Mosaic Therapeutics, NOV 17, 2025, View Source [SID1234660044])