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 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
•
Abstract #688/Poster 257P
•
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
o
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 NEC Bio Therapeutics reported results from the Phase I basket clinical trial of an orally administered cancer vaccine, NECVAX-NEO1, used in combination with checkpoint inhibitors (CPIs) for treating patients with solid tumors. The findings are being presented in a poster at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in London, United Kingdom, from December 10 to 12, 2025.

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NECVAX-NEO1 is a personalized bacteria-based oral DNA therapeutic vaccine, developed using AI prediction of the most immunogenic patient-specific neoepitopes. This vaccine is designed to activate a patient’s immune system, prompting a T-cell response that can precisely target and eliminate tumor cells based on an individual’s unique neoantigens.

In the phase I study, 6 patients with melanoma, renal cell cancer, or head and neck cancer, who have been on CPI treatment for at least three months, were treated with NECVAX-NEO1. The safety run-in phase showed no treatment-related toxicities, allowing a dose increase. Clinically, 83% of the patients achieved stable disease at the end of 24 weeks of treatment, which was followed by a 12 week follow-up period. In all patients immunogenic neoepitopes used in the vaccine, were detected, as demonstrated by ELISPOT analysis.

Regarding the results of the clinical study, Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, commented, "Our clinical Phase I data are demonstrating promising immune responses in treated cancer patients. The translational biomarker data are in line with the clinical data so that we are presenting a consistent data set. The progress is encouraging as we advance two additional clinical studies in 3 European countries in both early- and later-stage cancer settings. We look forward to further evaluating NECVAX-NEO1 as a potential treatment option for cancer patients with hard-to-treat tumors."

Motoo Nishihara, Corporate Executive Vice President and CTO of NEC Corporation, further commented, "We are proud to present the progress of the NECVAX-NEO1 trial, which demonstrates safety as well as signs of immunogenicity and early efficacy. NECVAX-NEO1 is the first oral cancer vaccine asset to be clinically developed by NEC. The results of this trial are a testament to our proprietary AI predictive software that supports immunological and clinical readouts. This development aligns closely with NEC’s broader mission to deliver global healthcare solutions using state-of-the-art technologies developed in-house."

Details of the poster are below:

Poster title: NECVAX-NEO1, a bacteria-based personalized neoepitope vaccine combined with PD-1/PD-L1 checkpoint inhibition in a phase I, open-label, multicenter study: safety, immunogenicity and early efficacy signals. NCT05354323

Authors: D. Vaitiekus, E. Juozaityte, L. Puzauskienė, S. Tulyte-Kirzova, L. Gatijatullin, M. Platten, I. Poschke, I.Hülsmeyer, A. Kuhn, A. Aranguren, H. Lubenau, R. Stratford, T. Clancy, H. Fontenelle, B. Simovski, Y. Yamashita, C. Chaput, A. Meiser, V. Urbonas

Poster Number: 258P

(Press release, NEC, DEC 10, 2025, View Source [SID1234661347])

On December 10, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 727,969 shares of common stock of the Company originally issued in February 2025 at an exercise price of $6.63 per share and 316,360 shares of common stock of the Company originally issued in August 2025 at an exercise price of $6.3219 per share. The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to effective registration statements on Form S-1 (File No. 333-286276) and Form S-3 (File No. 333-290418). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $6.5 million, before deducting financial advisory fees.

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Roth Capital Partners and Maxim Group LLC are acting as the Company’s financial advisors for this transaction.

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 2,610,823 shares of common stock, at an exercise price of $6.63 per share and will be exercisable upon shareholder approval and for a term of five years from the date of shareholder approval.

The transaction is expected to close on or about December 11, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Moleculin, DEC 10, 2025, View Source [SID1234661346])

On December 10, 2025 Kazia Therapeutics Limited ("Kazia" or the "Company") reported new data from two presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) providing compelling mechanistic and early clinical evidence supporting the activity of paxalisib, the Company’s brain-penetrant dual PI3K/mTOR inhibitor, across both HER2-positive metastatic breast cancer and triple-negative breast cancer (TNBC).

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The results, originating from advanced liquid biopsy profiling, immune phenotyping, and early clinical readouts, highlight paxalisib’s potential to disrupt highly aggressive circulating tumor cell (CTC) clusters, reverse epigenetically-driven resistance pathways, and reinvigorate exhausted T- and B-cell populations, thereby enhancing responsiveness to immunotherapy.

Paxalisib Disrupted Drivers of Metastasis: Vim+/Snail+/NRF2+ CTC Clusters in HER2+ Disease Ex Vivo

In HER2-positive metastatic breast cancer, a population in which nearly all patients eventually relapse despite HER2-directed therapies, investigators observed that even patients who were radiographically responding continued to harbor substantial burdens of therapy-resistant CTC clusters—a key driver of metastatic spread.

Poster Presentation: PS2-10-02 : Liquid Biopsy Tracking of PI3K–mTOR Residual Disease Signatures in Metastatic HER2+ Breast Cancer

Key findings:

•
Paxalisib reduced single CTCs by 42% and CTC clusters by 78% ex vivo, including large clusters (≥5 cells), which are strongly associated with metastatic progression.

•
CTC clusters expressed a highly aggressive mesenchymal phenotype marked by Vimentin⁺/Snail⁺/NRF2⁺, which paxalisib significantly disrupted.

•
Patients with poor clinical response demonstrated impaired cytotoxic function (reduced Granzyme B and Perforin) and expanded exhausted T-cell populations, while paxalisib treatment activated cytotoxic, interferon, chemokine, and inflammatory pathways in samples from these patients, supporting a more immunologically "hot" tumor environment.

"These findings reveal an important biological gap left by existing HER2+ directed therapies," said Prof. Sudha Rao, QIMR Berghofer. "CTC clusters persist even in responding patients, and paxalisib is the first agent we have observed that can directly dismantle this highly aggressive and clinically relevant compartment."

TNBC Phase 1b Trial: Early Clinical Data from First Patient Show Robust Suppression of CTC Clusters and Reversal of T-Cell Exhaustion

Early longitudinal biomarker data from the first patient treated in the PaxPlus-ABC Phase 1b study (paxalisib + pembrolizumab + chemotherapy) indicate that paxalisib has had measurable biological activity after only a single cycle.

Poster Presentation: PS5-08-04: A phase 1b, multi-centre, open-label, randomized study to evaluate the safety, tolerability, and clinical activity of combining paxalisib with olaparib or pembrolizumab/chemotherapy in patients with advanced breast cancer

Highlights from first patient include:

•
Marked reduction in CTC clusters following the first cycle of paxalisib.

•
Epigenetic reprogramming of CTCs toward less aggressive phenotypes, confirmed through digital pathology and Nanostring profiling.

•
Significant reduction of exhausted CD8 T cells, with revitalization of cytotoxic and antigen-presentation pathways.

•
CT imaging has demonstrated overall primary tumor volume reduction from baseline 14mm x 11mm (154mm2) to 12mm x 3 mm (36mm2)

•
Notably, a temporary interruption of paxalisib (necessitated by a chemotherapy-related adverse event) resulted in a rapid resurgence of CTC clusters. Resumption of paxalisib after a short 3-week pause restored suppression of CTC clusters, indicating that pembrolizumab alone could not control these metastatic drivers and highlighting paxalisib’s unique mechanistic role.

Pembrolizumab Alone May Not Control CTC Burden; A Mechanistic Opportunity for Paxalisib

Across HER2+ and TNBC ex-vivo datasets, a consistent theme emerges:

•
Pembrolizumab monotherapy does not meaningfully reduce CTC burden, and in TNBC, CTC clusters increased when paxalisib was withheld.

•
Paxalisib directly targets mesenchymal, metastatic, and epigenetically resistant CTC clusters.

•
It also reinvigorates immune effector cells, potentially overcoming the cytotoxic dysfunction and exhaustion that limit checkpoint inhibitor efficacy.

This mechanistic direct suppression of metastasis-initiating cells plus restoration of immune function positions paxalisib as a potentially transformative immunotherapy-enhancing agent.

Expanding Opportunity Across Breast Cancer: HER2+, TNBC, BRCA-Mutated, and Beyond

Because mesenchymal CTC clusters and T-cell exhaustion are shared resistance mechanisms across multiple breast cancer subtypes, paxalisib’s effects are highly relevant beyond TNBC.

Emerging data suggest:

•
In HER2+ patients, despite targeted therapy, residual disease persists in the form of aggressive CTC clusters—a new therapeutic window for paxalisib.

•
In TNBC, paxalisib’s epigenetic and immunologic effects provide a strong rationale for combination with pembrolizumab, PARP inhibitors, and chemotherapy.

•
In BRCA-mutated and homologous recombination–deficient tumors, PI3K/mTOR inhibition may synergize with synthetic lethal strategies such as olaparib.

"Kazia’s recent clinical and translational findings point to a unifying biology across breast cancer subtypes," said Dr. John Friend, CEO of Kazia Therapeutics. "Paxalisib appears capable of disrupting metastatic machinery that is not adequately addressed by current HER2-targeted therapies, checkpoint inhibitors, or chemotherapies. We believe these discoveries meaningfully expand the potential utility of paxalisib beyond our current development programs."

For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC, [email protected], +1-201-786-8795.

(Press release, Kazia Therapeutics, DEC 10, 2025, View Source [SID1234661345])