On December 2, 2025 CatalYm reported that the first patient has been dosed in the randomized Phase 2b GDFATHER‑NSCLC‑02 (GDF‑15 Antibody‑MediaTed‑Human‑Effector‑T‑Cell Relocation) trial (NCT07246863). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab as a second-line treatment in patients with metastatic non-squamous non-small cell lung cancer (nsq NSCLC) who have progressed following initial systemic treatment including an approved immune checkpoint inhibitor.

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The trial will assess multiple treatment strategies combining visugromab with an anti-PD-1 antibody and the chemotherapy docetaxel, including a chemo-free regimen. Standard-of-care chemotherapy alone will serve as the control arm. The trial consists of a safety run-in followed by a randomized phase evaluating visugromab in the different combination regimen settings.

Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and resistance to anti-PD-(L)1 therapies. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab demonstrated encouraging anti-tumor activity when combined with an anti-PD-1 antibody in advanced-stage, anti-PD-(L)1 relapsed/refractory NSCLC patients, demonstrating deep and durable responses, with a median duration of response of 32.2 months and a favorable safety profile. In addition to its ability to restore immune activation, visugromab also showed potential to alleviate cancer cachexia, a severe condition limiting treatment tolerability and responsible for 20-40% of cancer deaths.1

"The decision to evaluate visugromab in second-line nsq NSCLC, in addition to the first-line setting, was driven by the strength of our Phase 1/2a data in heavily pretreated patients, where we observed deep and durable responses well beyond those typically seen with other therapies in this setting," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "By neutralizing GDF-15, a key driver of immune suppression, visugromab may overcome resistance, restore responsiveness to immunotherapy and extend the benefit of anti-PD-1 agents. Its additional potential to mitigate cancer cachexia and support tolerance to chemotherapies and other anti-cancer regimens offers a distinct advantage in this difficult-to-treat population."

"We are expanding visugromab’s development into key settings where immune resistance severely limits treatment options," said Scott Clarke, Chief Executive Officer at CatalYm. "Second-line nsq NSCLC is a particularly challenging indication with limited benefit from current standard-of-care. This trial builds on the compelling rationale for GDF-15 neutralization and is part of our late-stage development program to deliver visugromab’s potential to patients in urgent need of better solutions."

The randomized, multi-arm Phase 2b GDFATHER-NSCLC-02 trial will enroll approximately 131 patients across multiple sites in the US, EU and Switzerland. Following the safety run-in, patients will be randomized into one of four treatment arms:

Visugromab + anti-PD-1 inhibitor + chemotherapy
Visugromab + anti-PD-1 inhibitor (chemo-free)
Visugromab (at lower dose) + anti-PD-1 inhibitor + chemotherapy
Chemotherapy alone (control)
The primary endpoint of the study is objective response rate (ORR) defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), participant weight course over time and safety-related measures.

About NSCLC

Lung cancers remain the leading cause of cancer-related mortality globally and non-small cell lung cancers (NSCLCs) account for approximately 87% of the 210,000 annual lung cancer diagnoses in the US2. Five-year survival rates in the US for non-squamous NSCLC are low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma3. 70-85% of NSCLC patients either exhibit primary resistance to PD-1 blockade or develop acquired resistance to immunotherapy4, emphasizing the need for innovative approaches to overcome immunotherapy resistance.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, DEC 2, 2025, View Source [SID1234661072])

On December 2, 2025 Archeus Technologies, a company developing multiple differentiated radiopharmaceutical therapies for the treatment of patients with cancer, reported that it has dosed the first patient in its Phase 1 clinical trial of ART-101 in men with metastatic castration-resistant prostate cancer (mCRPC).

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ART-101 is a novel receptor-based targeting small molecule developed for the imaging and treatment of prostate cancer. The therapy was invented and developed by Reinier Hernandez, Ph.D., assistant professor of medical physics at the University of Wisconsin School of Medicine and Public Health and chief technology officer of Archeus Technologies, with substantial development support from the Wisconsin Alumni Research Foundation (WARF). ART-101 targets prostate-specific membrane antigen (PSMA), similar to several FDA-approved imaging and therapeutic agents. In preclinical studies, ART-101 has exhibited higher tumor uptake and retention, as well as lower normal tissue and salivary gland uptake, relative to current FDA-approved PSMA-targeting agents.

Through a collaboration agreement with WARF, the designated patent and licensing organization for the University of Wisconsin–Madison, Archeus is leading a first-in-human imaging study in mCRPC patients who are candidates to receive radioligand therapy with FDA-approved prostate cancer treatment Pluvicto (177Lu-PSMA-617). Participants will receive intravenous ART-101 – radiolabeled with the diagnostic isotope Indium-111 – to evaluate its safety, feasibility, biodistribution and kinetics, and tumor targeting.

"While current radioligand therapies provide a meaningful therapeutic benefit to patients with advanced prostate cancer, there are opportunities to even further enhance a patient’s quality of life and reduce even minimal side effects. This is especially important with upcoming alpha emitter-based therapies, where lower salivary gland uptake may help mitigate xerostomia," said Harshad Kulkarni, M.D., chief medical advisor at BAMF Health and principal investigator of the study. "As a vertically integrated comprehensive Theranostics center, BAMF Health was built to facilitate the next generation of theranostic agents. Our nationwide platform allows us to rapidly initiate and complete novel clinical trials like this, accelerating access to innovative options for patients."

"With significant development support, and promising preclinical data, ART-101 is an innovative therapeutic candidate with the potential to address key limitations of currently available radiopharmaceutical therapies for patients with prostate cancer," said Reinier Hernandez, Ph.D. "This clinical trial reflects Archeus’ foundational belief that precision imaging and dosimetry are essential to realizing the full potential of radiopharmaceutical therapy, as well as our commitment to advancing the broader portfolio and platform we are building."

(Press release, Archeus Technologies, DEC 2, 2025, View Source [SID1234661071])

On December 2, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported the initiation of the TheraPb Phase 2 expansion trial (NCT05720130) evaluating its lead investigational candidate, ADVC001, in metastatic prostate cancer. The news follows the encouraging Phase 1b dose escalation results presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 congress that showed a favorable safety profile and compelling anti-tumor activity for ADVC001 in patients with mCRPC (see press release).

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ADVC001 is a first-in-class 212Pb-PSMA RLT in clinical development, with early data indicating a differentiated and competitive profile both within and beyond its class. Development is advancing rapidly; the Phase 1b therapeutic cohorts were enrolled within ten months, and the commencement of Phase 2 expansion sustains this strong program momentum.

The TheraPb Phase 2 expansion will evaluate ADVC001 at two therapeutic dose levels – 160 MBq and 200 MBq – using a randomized, multi-dose-response design aligned with the US Food and Drug Administration (FDA) guidance on dose optimization for oncology therapeutic radiopharmaceuticals1. The study will incorporate novel dosing strategies and the option for treatment with more than six cycles, supported by the favorable dosimetry and pharmacokinetics data from Phase 1b, to optimize clinical outcomes across three key prostate cancer indications:

mHSPC: patients with metastatic hormone-sensitive prostate cancer
mCRPC, pre-chemotherapy: patients with mCRPC who have not received prior chemotherapy for mCRPC
mCRPC, post-177Lu-PSMA RLT: patients with mCRPC who have been previously treated with 177Lu-PSMA
Enrollment for the TheraPb Phase 2 expansion is expected to commence initially at clinical sites in Australia, with planned expansion to sites in the United States in 2026.

"We are excited to initiate the Phase 2 expansion, marking an important milestone in advancing our novel alpha therapy for prostate cancer," said Anna Karmann, MD PhD, Chief Medical Officer at AdvanCell. "Our Phase 1 results enable us to evaluate optimal dosing regimens that support a precision treatment strategy aligned with tumor biology and individual response, underscoring our commitment to deliver better clinical outcomes and quality of life for patients living with metastatic prostate cancer."

"As ADVC001 enters Phase 2, I am eager to begin enrollment in this study," said Aaron Hansen, MD, Principal Investigator at the Princess Alexandra Hospital. "ADVC001 has demonstrated a highly promising safety and efficacy profile in Phase 1, supporting its investigation in multiple settings. The adaptive dosing and the ability to treat with more than six cycles offer the potential to meaningfully improve clinical benefit and are a step towards more personalized treatment for patients with prostate cancer."

AdvanCell plans to present additional details on the TheraPb Phase 2 expansion trial design at a major oncology conference in the first half of 2026.

US Food and Drug Administration (2025, August) "Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development – Guidance for Industry (Draft Guidance)"

(Press release, Advancell, DEC 2, 2025, View Source [SID1234661070])

On December 2, 2025 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported that it will showcase its latest research through 100 abstracts and presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, taking place in Orlando, Florida and virtually from December 6-9. SCRI’s expansive network is represented by more than 50 researchers who serve as first authors and co-authors across over 15 research locations.

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A comprehensive list of SCRI abstracts and presentations at this year’s Annual Meeting & Exposition can be found here.

"This year’s ASH (Free ASH Whitepaper) Annual Meeting & Exposition marks a milestone for SCRI, with the largest number of accepted abstracts and presentations in our history," said David Spigel, MD, Chief Scientific Officer, SCRI. "This achievement reflects not only the significance of the research, but also the meaningful collaboration and unwavering commitment of the investigators across our network, all united to advance the science that transforms care for people facing blood cancers and blood disorders."

Noteworthy Presentations

Β-Thalassemia & Sickle Cell Disease

Haydar Frangoul, MD, MS, SCRI at TriStar Centennial Children’s Hospital, will present "First Results of Exagamglogene Autotemcel in Pediatric Patients Aged 5-11 Years with Transfusion-Dependent Β-Thalassemia or Sickle Cell Disease with Recurrent Severe Vaso-Occlusive Crises" in an oral presentation on Saturday, December 6 at 4:00 p.m. EST in OCCC – Chapin Theatre (W320).
Dr. Frangoul is also first author on an oral presentation titled, "Enhanced CD34+ Cell Mobilizations, Collections, and Comparable Safety Profile with Fixed Dose versus Weight-Based Plerixafor Dosing in Patients with Sickle Cell Disease Receiving Autologous CD34+ Base-Edited Hematopoietic Stem Cells in the Ongoing BEACON Study" on Monday, December 8 at 5:30 p.m. EST in Hyatt – Regency Ballroom R.
Leukemia

Nosha Farhadfar, MD, SCRI at Methodist Healthcare, is first author on an oral presentation alongside Stephen Strickland, MD, MSCI, SCRI, and Alireza Eghtedar, MD, SCRI at Colorado Blood Cancer Institute, titled, "Promising Results from an Ongoing Phase I Multicenter Study of Senti-202, a First-In-Class, CD33 and/or FLT3 & Not Endomucin, Selective Off-The-Shelf Logic Gated CAR NK Cell Therapy in Adults with Relapsed/Refractory Acute Myeloid Leukemia" on Monday, December 8 at 5:45 p.m. EST in OCCC – Valencia Room W415BC.
Lymphoma

Jeff Sharman, MD, SCRI at Willamette Valley Cancer Institute & Research Center I The US Oncology Network, serves as first author alongside co-authors John Burke, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, and Shachar Peles, MD, SCRI at Florida Cancer Specialists & Research Institute I The US Oncology Network, on an oral presentation titled, "Fixed Treatment Duration Subcutaneous Mosunetuzumab Monotherapy in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Interim Results from The Phase II MorningSun Study" on Saturday, December 6 at 9:45 a.m. EST in OCCC – Tangerine Ballroom F2.
Dr. Burke is first author alongside co-author Dr. Sharman on an oral presentation titled, "Fixed-Duration Subcutaneous Mosunetuzumab, with Maintenance Therapy, in Patients with Previously Untreated High-Tumor Burden Follicular Lymphoma: Longer Follow-Up and Exploratory Circulating Tumor DNA Analysis of The Phase II MorningSun Study" on Saturday, December 6 at 3:15 p.m. EST in OCCC – Tangerine Ballroom F2.
Other

James Essell, MD, SCRI at OHC I The US Oncology Network, is first author on an oral titled, "Remote Therapeutic Monitoring Reduces Hospitalization due to Infection in Patients Being Treated for Hematological Malignancy" on Saturday, December 6 at 10:30 a.m. EST in OCCC – W230.
Dr. Farhadfar will deliver "Safety and Feasibility of 0.6 mg/kg Every 4 Weeks Dosing of Axatilimab in Patients Treated in the AGAVE-201 Study" in an oral presentation on Saturday, December 6 at 2:15 p.m. EST in OCCC – W331.
In addition to scientific presentations, SCRI researchers will participate in and lead ASH (Free ASH Whitepaper) Annual Meeting & Exposition sessions, including:

Hans Lee, MD, SCRI, will moderate the session, Multiple Myeloma: Pharmacologic Therapies: Advances in Treatment Strategies for Relapsed/Refractory Multiple Myeloma, on Saturday, December 6 at 2:00 p.m. EST in OCCC – West Hall D1.
Dr. Burke will present "Engagement of Community Physicians in Clinical Trials" during the session, How Can Community-Based and Academic Hematologists Foster Clinical Trial Participation as Part of Patient Care? on Sunday, December 7 at 9:40 a.m. EST in Hyatt – Plaza Int’l HIJK.
Additional Poster Presentations with SCRI First Authors

Saturday, December 6

"Real-World Treatment Patterns, Factors Associated with Discontinuation and Toxicity Across Covalent BTK Inhibitors in First-Line Tx of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma," Dr. Burke, 5:30 p.m. – 7:30 p.m. EST, OCCC – West Halls B3-B4.
Sunday, December 7

"First-Line Consolidation with Cemacabtagene Ansegedleucel in Patients with Large B-Cell Lymphoma and Minimal Residual Disease after Response to Standard Therapy: The Pivotal, Randomized, Open‑Label Phase 2 ALPHA3 Study" and "Correlation Between Real-World Progression-Free Survival and Overall Survival among Patients with First-Line Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Receiving Covalent Bruton Tyrosine Kinase Inhibitors or B-Cell Lymphoma 2 Inhibitors," Dr. Burke, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.
"Asciminib in Chronic Myeloid Leukemia in Chronic Phase: Efficacy and Safety Results of the Phase 2 ASC2ESCALATE Trial in the Cohort of Patients with 1 Prior Tyrosine Kinase Inhibitor," M. Yair Levy, MD, SCRI at Texas Oncology I The US Oncology Network, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.
Monday, December 8

"Diverse Preferences for Treatment Options in Relapsed/Refractory Follicular Lymphoma: Survey Results from Patients in The United States," "Optimizing Processes for Adverse Event Management for Bispecific Antibodies for Diffuse Large B-Cell Lymphoma in Community Practice: Insights from a Quality Improvement Initiative," and "A First-In-Human Phase 1 Trial of LY4152199, A B-Cell Activation Factor Receptor T-Cell Engager Bispecific Antibody, in Patients with Previously Treated B-Cell Malignancies" Krish Patel, MD, SCRI, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.

(Press release, Sarah Cannon Research Institute, DEC 2, 2025, View Source [SID1234661069])

On December 2, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that at least twelve abstracts highlighting Signatera will be shared at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9-12.

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The presentations encompass aggregated data from more than 50,000 patients in real-world evidence and prospective clinical studies, demonstrating the prognostic and predictive power of Signatera across diverse breast cancer subtypes and settings. These include real-world studies of Signatera adoption and clinical impact at Yale, Houston Methodist and other leading institutions. Additional highlights include:

Signatera Genome study

In a real-world cohort of 227 patients with triple-negative, HR+/HER2- and HER2+ breast cancers, during surveillance Signatera Genome detected recurrence with a sensitivity and specificity of 100%.

Patients who were Signatera-positive within 3 months of surgery were at a significantly higher risk of distant disease recurrence (HR: 13.1, 95% CI: 1.4-122.1, P = 0.005).
Signatera positivity at any time post-definitive treatment was associated with significantly worse distant recurrence-free survival (HR: 221.2, 95% CI: 131.0-373.4, P <0.0001).
LEADER trial

This phase 2 randomized study aims to evaluate the efficacy of adding the CDK4/6 inhibitor, ribociclib, to adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer who test Signatera-positive during surveillance.

Patients with sustained MRD negativity remained disease-free during extended followup (12−month NPV: RFS=99%, DRFS=100%).
MRD-positive patients initiating ribociclib achieved high rates of ctDNA decrease or clearance, translating to delayed onset of distant recurrence (18.6 vs 5.4 from treatment start).
"We are proud to share our largest dataset for SABCS thus far, featuring the value of Signatera in risk stratification, the early detection of molecular relapse and treatment response monitoring," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "The findings from these prospective clinical studies and real-world evidence add important context on how Signatera can provide personalized insights and optimize treatment across all breast cancer subtypes and indications, and the new data with Signatera Genome offer even greater promise for MRD testing."

The full list of presentations at SABCS includes:

December 10, 4:30 PM CT | RF3-04 (Oral Presentation)
Presenter: Heather A. Parsons
Tumor-informed circulating tumor DNA analysis to assess molecular residual disease for prognosis and prediction of benefit from palbociclib in the PALLAS trial

December 10, 5:00 PM CT | PS2-09-04
Presenter: Julia Foldi
Predicting outcomes for patients with mixed ductal/lobular carcinoma of the breast based on circulating tumor DNA positivity patterns

December 10, 5:00 PM CT | PS2-10-03
Presenter: Devora Isserfoff
Impact of Circulating Tumor DNA (ctDNA) monitoring on Patient Anxiety and Clinician Decision-Making in Early-Stage Breast Cancer (PACE-ctDNA)

December 10, 5:00 PM CT | PS2-08-21
Presenter: Amy J. Xu
Circulating tumor DNA (ctDNA) Dynamics in Early-stage Breast Cancer Patients (pts) with Brain Metastases

December 10, 5:00 PM CT | PS2-08-12
Presenter: Julia Foldi
Age-associated divergence in breast cancer: clinical, molecular, and genomic insights from a large real-world cohort

December 10, 5:00 PM CT | PS2-09-20
Presenter: Daniel Stover
Circulating Tumor DNA Dynamics and Anatomical Patterns of Relapse Following Curative Therapy in Early-Stage Breast Cancer

December 10, 5:00 PM CT | PS2-07-26
Presenter: Wassim McHayleh
Clinical performance of Signatera Genome assay for predicting recurrence in patients with breast cancer

December 11, 7:00 AM CT | PD6-07 (Poster Spotlight)
Presenter: Mark Jesus Magbanua
ctDNA dynamics is most predictive of response in treatment-sensitive response-predictive subtypes of breast cancer: Results from the I-SPY2 trial

December 11, 7:00 AM CT | PD5-01 (Poster Spotlight)
Presenter: Arielle J. Medford
Personalized circulating tumor DNA (ctDNA) testing, intervention, and temporal dynamics in ER+/HER2- early-stage breast cancer (LEADER)

December 11, 7:00 AM CT | PD9-01 (Poster Spotlight)
Presenter: Steffi Oesterreich
Comprehensive Genomic Landscape of Invasive Lobular Carcinoma Reveals Distinct Molecular Subtypes

December 11, 12:30 PM CT | PS3-01-05
Presenter: Banu Arun
Prevalence and Characterization of Germline CDH1 Mutations in a Large Real-World Breast Cancer Cohort

December 11, 5:00 PM CT | PS4-02-25
Presenter: Minhal Zaidi
Single Institution experience of longitudinal post-surgical circulating tumor DNA monitoring in patients with HER2+ breast cancer

(Press release, Natera, DEC 2, 2025, View Source [SID1234661068])