On December 10, 2025 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, reported the presentation of new data from the expanded 3mg/kg every 6 week (Q6W) Phase 1 dosing study for ragistomig, a bispecific 4-1BB X PD-L1 antibody, in a poster at the European Society for Medical Oncology – Immuno-Oncology Congress 2025 (ESMO-IO 2025) by co-developer ABL Bio. The poster (Poster 257P), presented by Gerald Falchook, MD, Director of the Sarah Cannon Research Institute (SCRI) at HealthONE Denver, showed the new Q6W schedule demonstrated consistent monotherapy antitumor activity with improved immunological endpoints and tolerability.

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"We are very pleased by the impressive ragistomig Phase 1 dose expansion data presented today at ESMO (Free ESMO Whitepaper)-IO, indicating that the prior Q2W schedule demonstrated meaningful clinical activity, and that the new Q6W dosing interval provides comparable efficacy with a more favorable safety profile. The study achieved its objective by extending the therapeutic window and supports the advancement of ragistomig into combination studies. We are particularly encouraged by the improved safety profile, with only 5% of patients experiencing ≥ Grade 3 liver function elevation, while maintaining comparable immune-mediated activity. These observations, combined with comparable confirmed responses and durable immune engagement, underpins our optimism that ragistomig has the potential to make an important contribution to more effective treatment outcomes for patients with relapsed/refractory solid tumor cancers," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.

"Ragistomig was designed to overcome resistance in patients who relapsed after treatment with checkpoint inhibitors, a multi-billion dollar pillar of cancer treatment. The ragistomig data presented at ESMO (Free ESMO Whitepaper)-IO build on the promising results presented at ASCO (Free ASCO Whitepaper) 2024. This program aligns well with our strategy to partner with innovators around the world to advance transformative and potentially breakthrough therapies. We are enthusiastic to collaborate with our partner, ABL Bio, to initiate combination studies," said Sean Fu, PhD, Chief Executive Officer of NovaBridge.

ESMO-IO Meeting information:

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Title: Phase 1 Clinical Trial of Ragistomig (ABL503/TJ-L14B: PD-L1 × 4-1BB bispecific antibody) Q6W Dosing Balances Favorable Safety and Sustained Efficacy Through Extended Immunologic Memory and Reinvigoration of CD8+ T Cells
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Abstract #688/Poster 257P
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Date and Time: Wednesday, December 10th at 5:15 PM GMT
A copy of the poster will be available here after the session. To review an overview of the Phase 1 dose escalation data, click here.

Ragistomig Phase 1 Monotherapy Q6W Data (per October 22, 2025 data cut-off):

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Ragistomig demonstrated comparable anti-tumor efficacy for the Q6W dose schedule compared to the Q2W regimen (58.8% disease control rate (DCR) at Q6W compared to 64.3% at Q2W)
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Ragistomig exhibited a favorable and improved safety profile, with 1/20 Grade ≥3 liver function test elevations (LFT), no treatment discontinuations due to treatment emergent adverse events (TEAEs) and no reported cytokine release syndrome (CRS)
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Overall immune cell activity was consistent between the Q6W and Q2W dosing. Immune cell pharmacodynamics with the Q6W dosing demonstrated expansion of effector memory and CD8+ T cells, with attenuated Treg expansion, indicating durable immune engagement
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The data suggest evaluation of the ongoing 5 mg/kg Q6W dosing cohort and evaluation of ragistomig in future combination studies
Patient Characteristics:

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20 heavily pre-treated subjects received 3 mg/kg Q6W ragistomig. In this group, 100% were previously treated with immuno-oncology therapies and 70% had previously received ≥3 lines of systemic treatment and exhausted all available standard treatment options
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Dosing is underway in 10 patients who are receiving 5 mg/kg Q6W ragistomig
Efficacy Results, based on 17 evaluable patients receiving 3 mg/kg Q6W v. 14 evaluable patients with 3 mg/kg Q2W

ABL503 monotherapy
efficacy profiile

3 mgkg Q6W
(N=17)

3 mg/kg Q2W
(N=14)

Objective Response Rate, n (%)

2 (11.8%)

4 (28.6%)

Disease Control Rate, n (%)

10 (58.8%)

9 (64.3%)

Complete response

0 (0%)

1 (7.1%)

Partial response

2 (11.8%)

3 (21.4%)

Stable disease

8 (47.1%)

5 (35.7%)

Progressive disease

7 (41.2%)

5 (35.7%)

Safety Data, based on 20 evaluable patients receiving 3 mg/kg Q6W v. 15 evaluable patients with 3 mg/kg Q2W

o
An improved safety profile was observed with the 3 mg/kg Q6W regimen
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The 3 mg/kg Q6W regimen was identified as an optimal potential regimen for combination strategies
o
1/20 subjects (5%) experienced ≥Grade 3 LFT elevation at Q6W dosing v. 40% at Q2W dosing
o
TEAEs ≥Grade 3 were 50% at the Q6W (10/20) v. 66.7% (10/15) at 3 mg/kg Q2W. In the Q6W dose, these TEAEs, including LFT elevations, decreased platelet count, anemia and decreased neutrophil count, were recovered within 3-14 days (with or without treatment interventions), with no discontinuations
o
No cases of CRS were reported with either dosing schedule
Immunology Data:

o
Effector and memory CD8+ T cell subsets were increased, with comparable fold-changes between dosing groups, suggesting that immune mediated pharmacodynamic activity may contribute to efficacy
o
CTLA+ Treg frequencies remained near baseline in the Q6W group, suggesting a more favorable effector-to-regulatory balance
About Ragistomig

Ragistomig (also known as ABL503) is a differentiated novel bispecific that integrates a single-chain, Fc-silent PD-L1 segment as a tumor engager and 4-1BB segment as a conditional T cell activator. It was developed using ABL Bio’s "Grabody-T" bispecific antibody platform technology to overcome resistance to PD-(L)1 inhibition and stimulate 4-1BB activation only in the presence of PD-L1 expressing tumor cells, to minimize the risk of off-tumor toxicity. Preclinical studies demonstrated that the bispecific antibody showed better anti-tumor activity than its single-agent components. A Phase 1 dose expansion study (NCT04762641) is currently being conducted in the U.S. and South Korea. The study was designed with a primary endpoint of defining the dose-limiting toxicity and adverse event profile of ragistomig, as well as to observe the objective response rate, pharmacokinetic and immunogenicity profiles and other secondary endpoints.

Ragistomig (also known as ABL503) is being jointly developed with ABL Bio

ASCO 2024: the 2024 American Society for Clinical Oncology Annual Meeting; Q6W: every six weeks

(Press release, NovaBridge Biosciences, DEC 10, 2025, View Source [SID1234661348])

On December 10, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported that data utilizing its RaDaR 1.0 assay for the detection of molecular residual disease (MRD) will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 9–12, 2025, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

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NeoGenomics will present new data from the SURVIVE HERoes Phase III trial and the CLEVER study, both of which used RaDaR 1.0 circulating tumor DNA (ctDNA) testing to evaluate molecular residual disease and recurrence risk. These findings reinforce the growing role of tumor-informed ctDNA approaches in early breast cancer research and recurrence monitoring.

Presentation details

The first study, titled "5-year outcomes and ctDNA findings in the CLEVER trial targeting disseminated dormant tumor cells," investigates long-term recurrence biology in patients with high-risk breast cancer and shows that positive ctDNA frequently precedes clinical recurrence. Five-year follow-up data demonstrate that RaDaR-detected ctDNA was present in most patients with disseminated tumor cells, often months before relapse. These findings reinforce the potential role that sensitive ctDNA testing can play in monitoring molecular residual disease during periods of ongoing long-term risk. Investigators from the University of Pennsylvania will present on Thursday, Dec. 11, 2025, 7:00 AM–8:30 AM CST. [PD5-02]

The SURVIVE Phase III randomized case-control trial, presented as "Reevaluating Follow-Up in Early Breast Cancer, guided by Liquid Biopsy: the SURVIVE Study (NCT05658172)," investigates whether the use of the RaDaR assay in liquid-biopsy guided follow-up may enable earlier detection of recurrence and improve overall survival. Investigators from the University Hospital Ulm, Germany, presenting on behalf of recruiting centers across Germany, will share the current status on Friday, Dec. 12, 2025, 12:30 PM–2:00 PM CST. [PS5-08-13]

The SURVIVE HERoes Phase III trial, presented as "The SURVIVE HERoes study NCT06643585: Targeting molecular relapse in breast cancer," is an ongoing therapeutic intervention arm of the SURVIVE trial, which evaluates an emerging strategy for treating patients at the point of molecular relapse, when ctDNA is detectable when using the RaDaR assay despite no radiographic evidence of disease. The study examines whether earlier intervention in HER2-positive or HER2-low early breast cancer can improve long-term outcomes. Positive study results could help establish a new, molecularly guided, individualized surveillance and treatment approach. Investigators from the University Hospital Ulm will present on Friday, Dec.12, 2025, 12:30 PM–2:00 PM CST. [PS5-07-28]

"The findings presented at this year’s SABCS conference demonstrate how RaDaR-detected ctDNA can provide invaluable and actionable information to care teams as they monitor patients following their initial breast care treatment," said Tony Zook, Chief Executive Officer. "These studies represent an important step in building the evidence needed to integrate MRD insights into the routine oncology care that community oncologists and their patients deserve."

(Press release, NeoGenomics Laboratories, DEC 10, 2025, View Source [SID1234661364])

On December 10, 2025 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported the latest clinical data at the annual European Society for Medical Oncology ("ESMO") Immuno-Oncology Congress, December 10-12, 2025, in London.

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The data from patients with PD-1 inhibitor-resistant metastatic melanoma treated with NUC-7738 in combination with pembrolizumab continue to demonstrate clinical activity and a favorable safety profile. All patients had progressive disease prior to starting treatment. Clinical activity includes two partial responses (one confirmed) and seven cases of stable disease, notably including one ongoing stable disease converting to a complete metabolic response with no detectable active disease. These results further reinforce the initial findings presented at the ESMO (Free ESMO Whitepaper) Congress 2024.

As of the most recent analysis, nine patients have been treated in the Expansion Cohort, which is part of the planned enrollment of up to 28 additional patients. Combined with the 12 patients previously treated in the Dose Confirmation Cohort, this will provide a total combination dataset comprising up to 40 patients. No new safety signals have been observed, and several patients remain on therapy with ongoing disease control, including one unconfirmed partial response and durable stable disease.

"We are very pleased to share the continued progress from this study," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "The clinical activity and favorable safety profile of NUC-7738 support its potential to offer meaningful benefit for patients with advanced melanoma who have exhausted current treatment options."

Mr. Griffith added: "These findings support continued enrollment and further clinical advancement as we move toward a potential registrational pathway."

One of the study participants, who achieved complete metabolic response, was recently featured in the UK Channel 4 documentary series Cancer Detectives: Finding the Cures, which also profiled Professor Sarah Blagden, the study’s lead investigator and Professor of Experimental Oncology at the University of Oxford.

Details of NuCana’s presentation at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 are as follows:

Abstract Title: A Phase 2 expansion study of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant cutaneous melanoma (NuTide:701)

Poster Number: 321TiP

Date: Wednesday, December 10, 2025

Presenting Author: Dr Miranda J. Payne

All regular abstracts accepted for presentation at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 have been published online via the ESMO (Free ESMO Whitepaper) website on Thursday, December 4 at 12:05 p.m. CET (Wednesday, December 3 at 6:05 p.m. ET). All accepted abstracts will be published online in the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Immuno-Oncology and Technology (IOTECH).

More information regarding the 2025 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress can be found at: View Source

(Press release, Nucana, DEC 10, 2025, View Source [SID1234661349])

On December 10, 2025 InduPro, Inc., a biotechnology company defining membrane protein spatial relationships to create novel therapeutics for the treatment of cancer and autoimmune diseases, reported a strategic equity investment and research collaboration with Sanofi. The agreement with Sanofi includes the right of first negotiation for InduPro’s bispecific PD-1 agonist program, which is currently in preclinical development for the treatment of autoimmune and inflammatory disorders.

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"We are thrilled to collaborate with Sanofi to advance toward the clinic our bispecific PD-1 agonist program. Sanofi’s know-how and global leadership position in autoimmune and inflammatory diseases make them the ideal partner to bring this exciting first-in-class molecule forward," said Prakash Raman, Ph.D., Chief Executive Officer of InduPro. "In addition, we welcome Sanofi’s strategic equity investment into InduPro, which further reinforces the strength of our collaboration."

Under the terms of the agreement, InduPro and Sanofi will collaborate on preclinical and IND-enabling research activities with funding from Sanofi, which will also make an undisclosed equity investment in InduPro.

InduPro therapeutically targets cell surface proteins in a variety of disease contexts by leveraging inherent or induced protein proximity. Through precise mapping of protein neighborhoods using its proprietary, high resolution proximity labeling technology, the Company is discovering novel co-target pairs that are highly selective for specific disease biology. Targeting these unique pairings via induced proximity provides a novel mechanism for influencing the cellular signaling pathways that are critical for impacting disease. InduPro’s approach relies on a unique discovery engine to generate potential first-in-class and best-in-class novel therapeutic candidates across multiple indications and modalities.

(Press release, InduPro, DEC 10, 2025, View Source [SID1234661365])

On December 10, 2025 Privo Technologies, Inc., reported that the first patient has been dosed in its first-in-human clinical trial evaluating PRV131, a nanoengineered intratumoral cisplatin injectable for the treatment of T1–T3 oral squamous cell carcinoma (OSCC).

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The Phase 1/2 Dose Escalation and Dose Optimization Run-In Study (Arm 3 of CLN-004) is designed to refine dosing by evaluating safety, preliminary efficacy, tolerability, and pharmacokinetics of PRV131 across selected dose levels as a neoadjuvant therapy. With the intention of debulking tumors prior to surgery, the goal of PRV131 is to improve surgical outcomes, preserve oral tissue, and reduce the morbidity associated with traditional surgical approaches.

The trial has now opened at the first clinical site, where the inaugural patient received treatment with PRV131, marking a key milestone in the development of novel locoregional therapies for head and neck cancer.

About PRV131

Built on Privo’s proprietary PRV Platform technology, PRV131 is a nanoengineered intratumoral injectable suspension designed to deliver high-concentration cisplatin directly into solid tumors while minimizing systemic exposure. This inaugural dosing represents an important expansion of the PRV program beyond topical and intraoperative patches (e.g., PRV111 and PRV211) toward intratumoral delivery of cisplatin for patients with oral cavity malignancies. PRV131 is engineered to address significant unmet needs in oral cavity cancer by:

Shrinking or debulking tumors prior to surgery to improve functional and cosmetic outcomes
Delivering high intratumoral drug concentration while limiting off-target toxicity
Potentially preserving form and function of the oral cavity, which can be severely impacted by standard surgical interventions
Preclinical studies have demonstrated that PRV131 can shrink or eliminate several solid tumor types, including squamous cell carcinomas, while generating durable responses. In companion animal studies conducted in dogs with large, naturally occurring tumors, PRV131 reduced tumor volumes by over 80% with no observed systemic toxicity.

"We are incredibly pleased to begin dosing patients with PRV131 in this first-in-human study," said Dr. Manijeh Goldberg, PhD, Founder and CEO of Privo Technologies. "Patients with oral cavity cancer often face invasive surgeries that can dramatically affect their ability to speak, eat, and live comfortably. PRV131 is designed to shrink tumors directly at the site, helping preserve critical oral structures and maintain function, offering the potential for meaningful improvements in quality of life. This milestone represents an important step in our mission to transform local cancer treatment with precise, targeted, nanoengineered chemotherapy."

(Press release, Privo Technologies, DEC 10, 2025, View Source [SID1234661350])