On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported it will jointly present additional immunological data profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine (INTV) TG4050 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

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Comprehensive immunogenicity data confirm TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy.

Prof. Le Tourneau, MD, PhD, Medical Oncologist at Gustave Roussy, and Principal Investigator, commented: "These new immunological data provide compelling evidence confirming TG4050’s mechanism of action. They also offer a clear rationale for the sustained prevention of relapses, which is a critical outcome for long-term patient benefit."

Data presented at SITC (Free SITC Whitepaper) demonstrate that TG4050 in monotherapy induces a potent CD8+ T cell response consistent with durable anti-tumor immunity:

Vaccine-induced cytotoxic CD8+ T cells display effector phenotype biomarkers even one year after the end of treatment, suggesting potential long-term effector functions.
CD8+ T cells express high levels of cytotoxic and tissue-resident biomarkers, suggesting that these cells are effective at killing cancer cells and likely to be found not only in the blood but also in tissues, where they are designed to be able to scout for and eliminate tumor cells.
The abstract is available on both the new windowSITC and PDFTransgene websites. The poster presentation will take place on November 8 and will be available that day on both the SITC (Free SITC Whitepaper) and Transgene’s websites.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, said: "We are extremely proud to present new immunological data that further characterize the CD8+ T cell responses against the selected neoantigens. These translational data confirm that the vaccine selected neoantigens that induce an efficient immune response. TG4050 is currently being evaluated in the Phase II part of our ongoing Phase I/II study. The first immunogenicity data from this Phase II part are expected to be available in the second half of 2026."

Motoo Nishihara, Corporate EVP and CTO, at NEC, added: "These findings highlight the strong potential of NEC’s AI-driven platform in enabling the development of individualized neoantigen therapeutic vaccines. The confirmation of the mechanism of action and evidence of durable relapse prevention mark important milestones that reinforce our dedication to revolutionizing cancer treatment through cutting-edge AI innovation."

Transgene and NEC previously shared data (see PDFpress release) illustrating that CD8+ T cells specific to tumor neoantigens have been detected in patients treated with TG4050. These cells target multiple neoantigens encoded in the vaccine and their responses persist for up to two years after the start of the treatment.

New data provide key mechanistic insights into how TG4050 induces and sustains potent, CD8+ T cell responses in operable HNSCC* patients

Comprehensive immunogenicity data demonstrate TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, supporting its potential to reduce risk of relapse

Conference call scheduled on November 14 at 4 p.m. CET (in English). See details below.

Strasbourg, France & Tokyo, Japan, November 4, 2025, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, will jointly present additional immunological data profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine (INTV) TG4050 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

Comprehensive immunogenicity data confirm TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy.

Prof. Le Tourneau, MD, PhD, Medical Oncologist at Gustave Roussy, and Principal Investigator, commented: "These new immunological data provide compelling evidence confirming TG4050’s mechanism of action. They also offer a clear rationale for the sustained prevention of relapses, which is a critical outcome for long-term patient benefit."

Data presented at SITC (Free SITC Whitepaper) demonstrate that TG4050 in monotherapy induces a potent CD8+ T cell response consistent with durable anti-tumor immunity:

Vaccine-induced cytotoxic CD8+ T cells display effector phenotype biomarkers even one year after the end of treatment, suggesting potential long-term effector functions.
CD8+ T cells express high levels of cytotoxic and tissue-resident biomarkers, suggesting that these cells are effective at killing cancer cells and likely to be found not only in the blood but also in tissues, where they are designed to be able to scout for and eliminate tumor cells.
The abstract is available on both the new windowSITC and PDFTransgene websites. The poster presentation will take place on November 8 and will be available that day on both the SITC (Free SITC Whitepaper) and Transgene’s websites.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, said: "We are extremely proud to present new immunological data that further characterize the CD8+ T cell responses against the selected neoantigens. These translational data confirm that the vaccine selected neoantigens that induce an efficient immune response. TG4050 is currently being evaluated in the Phase II part of our ongoing Phase I/II study. The first immunogenicity data from this Phase II part are expected to be available in the second half of 2026."

Motoo Nishihara, Corporate EVP and CTO, at NEC, added: "These findings highlight the strong potential of NEC’s AI-driven platform in enabling the development of individualized neoantigen therapeutic vaccines. The confirmation of the mechanism of action and evidence of durable relapse prevention mark important milestones that reinforce our dedication to revolutionizing cancer treatment through cutting-edge AI innovation."

Transgene and NEC previously shared data (see PDFpress release) illustrating that CD8+ T cells specific to tumor neoantigens have been detected in patients treated with TG4050. These cells target multiple neoantigens encoded in the vaccine and their responses persist for up to two years after the start of the treatment.

Transgene will host a webcast (in English) to discuss the SITC (Free SITC Whitepaper) data on November 14, 2025, from 10:00 a.m. to 11:00 a.m. ET (4 p.m. to 5 p.m. CET).

Webcast link to English language conference call:
new windowView Source

(Press release, Transgene, NOV 4, 2025, View Source [SID1234659388])

On November 4, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies to help patients fight cancer, reported it will deliver three presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.

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Together, these presentations underscore Candel’s leadership in the development of novel therapeutics, harnessing multi-omics insights and artificial intelligence (AI) to define therapeutic strategies based on a deeper understanding of the tumor microenvironment and biomarkers of response in multiple solid tumors.

"Candel’s presentations at SITC (Free SITC Whitepaper) 2025 exemplify our innovative approach to the discovery and development of novel immunotherapies," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "By leveraging next-generation research tools we are working to generate deep biological insights that inform every stage of drug development, from bench to bedside and back. This iterative process allows us to refine how we develop a novel class of immunotherapies that have the potential to improve clinical outcome in patients with difficult-to-treat solid tumors."

Invited Faculty Presentation and Panel Discussion:

Paul Peter Tak, M.D., Ph.D., FMedSci, will present Candel’s positive phase 3 clinical trial data of CAN-2409 in patients with newly diagnosed, localized prostate cancer and discuss the next wave of innovation in immunotherapy during an invited faculty presentation and subsequent panel discussion. The Company plans to submit a Biologics License Application (BLA) for CAN-2409 in prostate cancer in the fourth quarter of 2026.

Title: Phase 3, Randomized, Placebo-Controlled Clinical Trial of CAN-2409 + Prodrug in Combination with Standard of Care Radiation Therapy for Newly Diagnosed, Localized Prostate Cancer with Curative Intent

Presenter: Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel Therapeutics
Session: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics
Date/Time: Friday, Nov. 7, 2025, 3:55 – 5:35 p.m.
Location: Potomac Ballroom – Gaylord National Resort and Convention

CAN-2409 in NSCLC Clinical Data:

Daniel Sterman M.D., Thomas and Suzanne Murphy Professor of Medicine and Cardiothoracic Surgery, NYU Langone Health and Principal Investigator, will present a poster based on integration of clinical and biomarker data from the phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV NSCLC who had progressed, despite immune checkpoint inhibitor (ICI) treatment (NCT04495153). Patients received two courses of intratumoral CAN-2409 combined with valacyclovir prodrug along with continued ICI treatment. Leveraging previously reported clinical data,1,2,3 Multi-Omics Factor Analysis (MOFA) was applied to integrate over 3,000 data points from flow cytometry and proteomics analysis of serial samples to provide a deeper understanding of the relationship between clinical and biological responses to CAN-2409.

Key findings include:

Patients with non-squamous (NSQ) histology exhibited greater expansion of effector and memory T cell populations following CAN-2409 treatment compared to patients with squamous (SQ) histology; latent immune signatures were associated with lack of response and poor outcome in patients with SQ histology
Robust systemic immune activation in NSQ patients was observed after the second CAN-2409 course, with increased CD8+ central memory T cells and elevated soluble granzymes associated with long-term survival
Improved immune activation after CAN-2409 administration was observed in patients with NSQ histology compared to those with SQ histology, and this was associated with prolonged overall survival
"The enhanced immune activation and improved survival observed after CAN-2409 administration in patients with non-squamous disease, support the rationale for a phase 3 clinical of CAN-2409 in this subgroup of patients," said Dr. Sterman.

enLIGHTEN Discovery Platform Preclinical Data:

Anne Diers, Ph.D., Vice President of Research at Candel Therapeutics, will present a poster on the third preclinical candidate based on the enLIGHTEN Discovery Platform. An AI approach was used to interrogate The Cancer Genome Atlas (TCGA) RNA sequencing data and identify potential therapeutic payloads to be deployed in the tumor microenvironment to treat specific indications. The resulting therapeutic candidate consists of the Alpha-201 vector expressing IL-12 and IL-15 and has been designed for the treatment of breast cancer.

Key findings include:

Evidence of infection and payload-dependent PBMC-mediated tumor cell killing in vitro, showing that the engineered virus can trigger immune cells to attack cancer cells
Significant tumor growth suppression (60.0% ± 12.6 vs. vehicle) in the EMT6 mouse model of breast cancer
Evidence of a synergistic interaction between IL-12 and IL-15 payloads, with the combination producing nominally greater effects than either cytokine alone
Increased frequency of circulating Ki67+ CD8+ T cells, natural killer cells, and conventional dendritic cells type 2, as well as upregulation of inflammatory response pathways, including IFN-gamma/alpha responses, upon treatment with Alpha-201 IL-12-15
"The enLIGHTEN platform provides a new, systematic approach to cancer immunotherapy development," said Francesca Barone, M.D., Ph.D., Chief Scientific Officer at Candel. "By rationally identifying optimal combinations of immune targets for specific tumor types and validating them using our viral vector engineering capabilities, we can design multimodal therapies with the potential to overcome the immunosuppressive tumor microenvironment."

About CAN-2409

CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

(Press release, Candel Therapeutics, NOV 4, 2025, View Source [SID1234659387])

On November 4, 2025 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined net revenues of $8.3 million during the third quarter of 2025. Year-to-date revenues for the first nine months of the year totaled $30.8 million, representing an increase of 12% over the first nine months of 2024.
Cumberland ended the quarter with approximately $66 million in total assets, $40 million in liabilities and $26 million of shareholders’ equity.
"We are very pleased to add an established, FDA approved brand to our commercial portfolio," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "We are also encouraged by the continued progress with our development programs designed to address a series of unmet medical needs in orphan patient populations. As we move into the final quarter of 2025, we remain focused on our mission of working together to provide unique products that improve the quality of patient care."

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RECENT COMPANY DEVELOPMENTS INCLUDE:
New Product Added to Commercial Product Portfolio
Cumberland recently announced arrangements with RedHill Biopharma Ltd. ("RedHill") to jointly commercialize Talicia, marking the latest addition to its commercial product portfolio. The FDA-approved oral capsule is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection and leading risk factor for gastric cancer.
Cumberland has formed a new company with RedHill, named Talicia Holdings, Inc. RedHill has assigned all its Talicia-related assets to the new company for a 70% ownership position. Cumberland will provide $4 million in investment capital over a two-year period and receive ownership of the 30% remaining shares. Cumberland and RedHill have equal board seats and voting rights in the new company, and these arrangements will enable Cumberland to participate in the value it helps create in the brand.
Through a co-commercialization agreement, Cumberland will assume responsibility for the distribution and sale of Talicia in the U.S. Cumberland will record Talicia product sales and equally share Talicia’s net revenues. Cumberland will also provide an annual investment to cover certain distribution, marketing and sales costs, and will lead the sales promotion for Talicia by leveraging its established field national sales division.

Talicia is the only all-in-one treatment containing omeprazole, amoxicillin and rifabutin, and is now recommended as a first-line therapy in the American College of Gastroenterology (ACG) clinical guidelines. Talicia is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.
International Agreements
During the third quarter, Cumberland announced the launch of Vibativ in Saudi Arabia. The product launch follows an agreement with Tabuk Pharmaceutical Manufacturing Company to introduce Vibativ into the Middle East. The arrangement provided Tabuk exclusive rights to distribute Vibativ in Saudi Arabia and Jordan, with the option to expand into other countries in the region. Tabuk has obtained the final approvals needed to commercialize Vibativ in Saudi Arabia.
In October 2025, Cumberland’s ibuprofen injection product received regulatory approval in Mexico. The Company previously announced its partnership with PiSA Farmaceutica, a well-established Mexican pharmaceutical firm. Under the agreement, PiSA is responsible for the registration and commercialization of the product for the Mexican market, while Cumberland provides regulatory support and the product supply.
Additionally, Cumberland previously announced that its Vibativ product received approval from the regulatory authorities in China, the world’s second-largest pharmaceutical market.
Vibativ 4-Vial Starter Pak Now Available for Vizient Providers
Cumberland recently announced the availability of the Vibativ (telavancin) 4-Vial Starter Pak through a new supply arrangement with Vizient Inc., making it accessible to their healthcare providers nationwide.
As the country’s largest provider-driven healthcare performance improvement company, Vizient serves more than 65% of the nation’s acute care providers, including 97% of academic medical centers and 35% of the non-acute market. Through this agreement, Vizient members now have access to Vibativ’s new 4-vial configuration, which supports flexible treatment initiation in both inpatient and outpatient settings for this potentially life-saving therapy.
Vibativ Added to Premier National Group Purchasing Agreement
In October 2025, Cumberland announced that Vibativ was added to a national group purchasing agreement with Premier, Inc. The product additional allows Premier members to purchase Vibativ, in the 12-vial carton and 4-vial Starter Pak. Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,350 U.S. hospitals and 325,000 other providers and organizations. With expanded access, Premier member healthcare providers now have greater flexibility in ordering Vibativ for both inpatient and outpatient settings.

Ifetroban Clinical Studies
In June 2025, breakthrough findings from Cumberland’s Phase II FIGHT DMD trial, evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy ("DMD"), were presented at the Parent Project Muscular Dystrophy Annual Conference. The findings demonstrated that high-dose ifetroban delivered a 5.4% improvement in cardiac function in patients with DMD. The presentation also included additional biomarker data indicating reduced cardiac damage, which correlated with the clinical findings. These results position ifetroban as a potential treatment for DMD cardiomyopathy – the leading cause of death in these patients and a critical unmet medical need affecting 90% of DMD patients.
The top-line FIGHT DMD study findings were also selected for a late-breaking presentation at the Muscular Dystrophy Association’s Clinical & Scientific Conference in March 2025. In June 2025, Cumberland completed the comprehensive analysis of the study results, finalized its clinical study report and submitted it to the FDA, along with a request for an end-of-Phase 2 meeting. Cumberland then began interaction with the FDA to determine the remaining development requirements.
Meanwhile, Cumberland has been evaluating its ifetroban product candidate in a Phase II clinical program in patients with Systemic Sclerosis. Enrollment in the study was completed this year, and Cumberland is monitoring the clinical sites in preparation to lock the database and begin evaluating the results.
In addition, Cumberland has a Phase II clinical study, the FIGHTING FIBROSIS trial, underway in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. Patient enrollment is now well underway in medical centers across the U.S. The study design includes both an interim safety analysis, as well as an interim efficacy analysis.

FINANCIAL RESULTS:
Net Revenue: For the third quarter of 2025, net revenues were $8.3 million and included $1.2 million for Kristalose, $3.2 million for Sancuso, $2.6 million for Vibativ and $0.9 million for Caldolor.
Year-to-date 2025 net revenues were $30.8 million. Year-to-date net revenues by product were $7.4 million for Kristalose, $8.6 million for Sancuso, $6.7 million for Vibativ and $3.8 million for Caldolor.
Operating Expenses: Total operating expenses were $10.3 million for the third quarter of 2025 and $32.3 million for the first nine months of the year.
Net Income (Loss): Year-to-date net loss was approximately $1.4 million and the third quarter net loss was approximately $1.9 million.
Adjusted Earnings: The adjusted loss for the third quarter of 2025 was $0.8 million, or $0.06 per share. Adjusted earnings for the first nine months of 2025 was $1.9 million, or $0.13 per diluted share.
Balance Sheet: On September 30, 2025, Cumberland had approximately $66 million in total assets, including $15 million in cash and cash equivalents. Liabilities totaled $40 million, including $5 million on the Company’s credit facility. Total shareholders’ equity was $26 million on September 30, 2025.

EARNINGS REPORT CALL:
A conference call will be held today, November 4, 2025, at 4:30 p.m. Eastern Time to provide a Company update and discuss the financial results.
The link to register is View Source
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting: View Source

(Press release, Cumberland Pharmaceuticals, NOV 4, 2025, View Source [SID1234659384])

On November 4, 2025 Catalent, Inc., a leading global contract development and manufacturing organization, reported new innovations from its SMARTag antibody-drug conjugate (ADC) technology platform. The company announced preclinical efficacy and tolerability data demonstrating the potential of CAT-09-833, a SMARTag ADC targeting MUC1, for the treatment of platinum-resistant ovarian cancer. The company also introduced SMARTag Enhanced Conjugates, a new class of ADCs that combines different payload types to benefit more patients by amplifying efficacy without compromising safety.

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The updates were presented at the 16th World ADC San Diego conference in a session in the Translational Medicine track entitled "SMARTag Enhanced Conjugates: Novel Payload Combinations to Enhance ADC Efficacy & Payload Delivery." The presentation was made by Ayodele Ogunkoya, Ph.D., Bioconjugation Group Leader, Catalent. World ADC provides a leading opportunity for Catalent to spotlight its ADC technologies and services to more than 1,400 ADC biopharma attendees actively seeking new partnerships and solutions.

"There is a growing appreciation for the role that ADCs may play in ovarian cancer treatment. The MUC1 tumor-associated antigen, which is highly expressed in ovarian tumors, demonstrates expression complementary to that of other ovarian ADC targets, such as folate receptor alpha," said Penelope Drake, Ph.D., Head of R&D Bioconjugates, Catalent. "Our novel antibody offers a unique way to access this target with an ADC, and the data thus far suggest that CAT-09-833 has a promising preclinical profile. We look forward to seeing the molecule advance and learning more about its potential to help cancer patients."

Catalent’s new SMARTag Enhanced Conjugates incorporate both cytotoxic and non-cytotoxic payloads to create unique dual- and triple-payload ADCs that can be optimized to the specific biology of the target tumor to amplify the effect of the cytotoxic payload without compromising safety. They are enabled by the SMARTag platform, which allows for a tunable drug-to-antibody ratio (DAR). Catalent presented data from a xenograft model demonstrating that the use of certepetide as a non-cytotoxic payload can yield improved ADC efficacy and broaden the distribution of the ADC cytotoxic payload and antibody in the tumor microenvironment. Certepetide is an internalizing RGD (iRGD) cyclic peptide that Catalent licensed (along with its analogs) from Lisata Therapeutics, Inc. for use with its SMARTag technology platform, with a goal of selectively targeting and penetrating solid tumors with ADCs more effectively.

Mike Blank, General Manager, Catalent, said, "We have a history of innovation dating back to 2008 when we spun the SMARTag technology out of the Bertozzi lab at UC Berkeley. Since then, we have made continuous progress on expanding the capabilities of the platform and understanding the design elements that underpin a successful ADC. We believe the new SMARTag Enhanced Conjugates represent the latest innovation in ADCs, allowing for the creation of an entirely new class of molecules that we hope will expand the scope of treatable cancer indications, reaching—and ultimately helping—more patients in need."

(Press release, Catalent, NOV 4, 2025, https://www.catalent.com/catalent-news/catalents-smartagadc-pipeline-and-new-enhanced-conjugates-offering-featured-at-16th-world-adc-san-diego/ [SID1234659383])

On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Single Intratumoral Drug Injection Yields Complete Response (CR) in Metastatic Breast Cancer (MBC) Bone Lesions", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Wednesday, December 10, 2025.

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The abstract presents preliminary clinical data from a recently completed Phase 2a trial (NCT05280067) performed at the University of British Columbia evaluating ZetaMet (Zeta-BC-003) for safety and efficacy for the treatment of MBC lytic bone lesions in Stage 4 breast cancer patients. Phenotypes treated within the study, TNBC, HR+, HR+/HER2+, and HERS2+/HR-. Each patient underwent a single fluoroscopy-guided injection of ZetaMet while under sedation. All achieved a complete response (CR), ceased tumor activity, with no serious adverse events (SAEs), adverse events (AEs), or skeletal-related events (SREs) and many demonstrated a reconstitution of trabecular bone, which further underscores the potential of ZetaMet to not only halt disease progression but restore skeletal integrity.

The findings build on prior compassionate use cases published in peer-reviewed journals with two-year follow-up, reinforcing ZetaMet’s potential to prevent SREs and improve overall survival. The abstract will be published in SABCS 2025 Proceedings and featured in Clinical Cancer Research.

With the trial now complete and comprehensive analyses underway, this presentation at SABCS will represent the most detailed data release to date. A full report of the findings will also be submitted to Health Canada (HC) and the U.S. Food and Drug Administration (FDA) to inform future planning discussions.

Presentation Details:

Abstract Number: 3549
Presentation Number: PS1-13-18
Presentation Title: Single Intratumoral Drug Injection Yields Complete Response in Metastatic Breast Cancer Bone Lesions: Results from Phase 2a Trial
Poster Presentation: Wednesday, December 10, 2025, 12:30-2:00pm CST
"The promising Phase 2a findings for ZetaMet mirror our earlier peer-reviewed results, reinforcing the strength of our clinically validated strategy in treating metastatic breast cancer." said Joe C. Loy, CEO of Zetagen Therapeutics. "We observed that both treated and adjacent non-treated lesions within the same vertebral body achieved complete response, with no signs of tumor activity and no skeletal-related events—all using the same drug concentration validated in our preclinical studies—strongly affirming the scientific foundation of our approach".

About ZetaMet (Zeta-BC-003)
ZetaMet (Zeta-BC-003) is the first-of-its-kind, synthetic, small-molecule, administered intratumorally to minimize off target toxicity, delivered via a proprietary controlled-release carrier intended to resolve metastatic breast cancer bone lesions, inhibit pain while regenerating bone, with the potential to increase survival rates.

The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet.

Zetagen with FDA and Health Canada (HC) approval via the Expanded Access (Compassionate Use) program has treated eight (8) patients with ZetaMet (Zeta-BC-003) with results published multiple peer-reviewed journals.

Peer-reviewed 2-year follow up clinical data published in 2023 on ZetaMet (Zeta-BC-003) demonstrated resolution of seven (7) lytic lesions (radiated and non-radiated), reduction in pain, significant attrition of opioid pain medication (4-fold), prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.[i] To view this publication via open access, go to: View Source

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659381])