On November 17, 2025 Accession Therapeutics Limited, a biopharmaceutical company developing next generation cancer immunotherapies, reported it has dosed the first patient in its Phase I clinical trial evaluating TROCEPT-01 (ATTR-01), the company’s lead drug candidate from its proprietary TROCEPT platform technology. The patient has now completed the cycle of treatment. This milestone marks a major step forward in the development of a potentially transformative treatment for solid tumours.

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TROCEPT-01 (ATTR-01) is a first-in-class, tumour-activated viral immunotherapy that, following systemic delivery, is designed to selectively generate a clinically validated checkpoint inhibitor within tumours. This approach, targeting αvβ6 integrin on epithelial tumours, optimises efficacy while minimising damage to healthy tissue. Preclinical studies have demonstrated strong anti-tumour activity across multiple solid tumour models, supporting its potential as a targeted therapy for aggressive cancers.

The ATTEST trial is an open label, dose-escalation and dose expansion study (View Source) designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TROCEPT-01 (ATTR-01) in patients with advanced carcinomas who have had at least one prior treatment course. The trial is being conducted at leading clinical sites across the UK. Additional trial sites will be activated as the study progresses, including in Spain where there is established expertise in the treatment of solid tumours.

Professor Adel Samson, Professor of Cancer Medicine and Immunotherapy at Leeds University School of Medicine and lead Investigator in the ATTEST study, said:
"As a clinician, I am very excited about the potential of TROCEPT-01 (ATTR-01) and the TROCEPT platform to increase clinical response rates through high tumour-localised production of anti-cancer drugs. This program is targeted at solid tumours where there is significant need for better treatment outcomes".

Bent Jakobsen, PhD FMedSci, CEO of Accession Therapeutics, said:
"Dosing the first patient in our TROCEPT-01 clinical trial is a pivotal moment for Accession Therapeutics and a testament to the dedication of our team and collaborators. In TROCEPT, we have created a unique, highly versatile platform that enables novel drugs to be made inside cancer cells. The platform gives us multiple opportunities to generate valuable products to transform outcomes for cancer patients. TROCEPT-01 (ATTR-01) has the potential to expand the indications where checkpoint inhibitors have been successful."

Professor Hardev Pandha, FRCP, FRACP, PhD, Medical Director of Accession Therapeutics, added:
"TROCEPT-01 (ATTR-01) represents a novel approach to target hard-to-treat cancers, and we are excited to advance this promising therapy into clinical development. We anticipate the clinical data will show that the virus gets to the tumours when given systemically, and that the drug is produced within the tumours. Our goal in the ATTEST study is to establish a strong safety profile while identifying early signals of efficacy to benefit patients with limited treatment options."

(Press release, Accession Therapeutics, NOV 17, 2025, View Source [SID1234660037])

On November 17, 2025 Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, reported the completion of enrollment in the ongoing Phase 1a clinical trial of BTX-9341, a potent and selective CDK4/6 degrader, for the treatment of advanced and/or metastatic HR+/HER2- breast cancer in patients who have previously received CDK4/6 inhibitor therapy either in the adjuvant or metastatic setting.

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The Phase 1a clinical trial began with dose escalation of BTX-9341 as a monotherapy, followed by a combination with fulvestrant. The primary objective of the Phase 1a trial is to assess safety, tolerability, pharmacokinetic and pharmacodynamic activity of BTX-9341 as a monotherapy and in combination with fulvestrant. Based on the recommended dose from Phase 1a, there will be a formal evaluation of efficacy in the dose expansion phase of the trial.

"Completing enrollment in the Phase 1a trial for BTX-9341 marks a significant step forward in advancing a very promising first-in-class treatment option for patients with HR+/HER2- breast cancer who have received prior CDK4/6 inhibitor therapy." said Dr. Leah Fung, Chief Executive Officer of Biotheryx. "We are deeply grateful to the patients, investigators, and our team who made this possible as we continue to work together towards the common goal of improving patient lives."

About BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of Cyclin E and CDK2 transcription, cell cycle arrest and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that limit the impact of inhibitors in second line HR+/HER2- breast cancer.

(Press release, BioTheryX, NOV 17, 2025, View Source;breast-cancer-302616179.html [SID1234660036])

On November 17, 2025 Lunit, a leading provider of AI for cancer diagnostics and precision oncology, and Labcorp, a global leader of innovative and comprehensive laboratory services, reported a collaborative initiative to accelerate innovation in digital pathology (DP) and artificial intelligence (AI) for oncology research and clinical care.

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The collaboration aims to leverage Labcorp’s extensive clinical and pathology expertise alongside Lunit’s cutting-edge AI algorithms to transform how tumor microenvironments are analyzed and interpreted. By combining high-resolution whole-slide imaging with AI-powered spatial profiling, the collaboration seeks to generate new insights that can enhance biomarker discovery and guide precision immuno-oncology strategies.

First Collaborative Studies Presented at SITC (Free SITC Whitepaper) and AMP

The first outcome of the collaboration was showcased at two leading scientific conferences:

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): Study demonstrated how AI-based spatial profiling and machine learning can identify immune-active subtypes of non-small cell lung cancer (NSCLC) tumors with the MET exon 14 skipping mutation, which are associated with improved immunotherapy outcomes. Using Lunit SCOPE IO, researchers analyzed more than 370 pathology slides to characterize immune phenotypes across different types of MET alterations, including exon 14 skipping, amplification, or no mutation (wildtype). Immune gene expression analysis further validated the AI-defined immune phenotypes and revealed key immune response pathways driving the inflamed phenotype, underscoring the predictive power of AI-based spatial profiling in MET-mutated NSCLC.
Association for Molecular Pathology (AMP): Study highlighted distinct tumor-immune microenvironments linked to different MET alterations in NSCLC, revealing immune-desert phenotypes in MET-amplified tumors, and inflamed phenotypes in those with MET exon 14 skipping tumors.
"Collaborating with Labcorp, one of the most respected leaders in diagnostics and clinical research, marks an important step toward expanding the real-world use of AI in oncology. These early studies show how AI can reveal meaningful, predictive biomarkers hidden within pathology slides," said Brandon Suh, CEO of Lunit. "It’s a clear example of how digital pathology and AI can work hand in hand to advance precision oncology understanding, bridging discovery research and real-world clinical care."

"Our collaboration with Lunit aims to turn complex pathology data into meaningful insights," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president and medical lead for oncology at Labcorp. "These studies demonstrate how AI-powered digital pathology can reveal patterns within tumors—ultimately helping to guide treatment decisions, inform biomarker development, and pave the way for more personalized cancer care."

Labcorp and Lunit plan to further broaden their collaboration by applying digital pathology AI to additional cancer types and genomic correlations.

(Press release, LabCorp, NOV 17, 2025, View Source [SID1234660035])

On November 17, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported positive Phase III results from the lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer. The study met its primary endpoint at a pre-planned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant versus standard-of-care endocrine therapy. lidERA is the first Phase III trial of a selective estrogen receptor degrader (SERD) to demonstrate a significant benefit in the adjuvant setting. The majority of breast cancer cases are diagnosed at an early stage.

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"Today’s results underscore the potential of giredestrant as a new endocrine therapy of choice for people with early-stage breast cancer, where there is a chance for cure," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "Given that ER-positive breast cancer accounts for approximately 70% of cases diagnosed, these findings – together with recent data in the advanced ER-positive setting – suggest that giredestrant has the potential to improve outcomes for many people with this disease."

Overall survival data were immature at the time of interim analysis, but a clear positive trend was observed. Giredestrant was well tolerated and adverse events were consistent with its known safety profile, with no unexpected safety findings observed. Data from lidERA will be presented at an upcoming medical meeting and shared with health authorities with the aim of bringing this potential treatment option to patients around the world.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence.

lidERA is the second positive Phase III readout for giredestrant following evERA Breast Cancer, which was presented at the European Society for Medical Oncology Congress 2025. The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels). This growing body of evidence supports the potential of giredestrant to meaningfully improve outcomes compared with standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.

Genentech’s extensive giredestrant clinical development program spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the lidERA Breast Cancer study
lidERA Breast Cancer [NCT04961996] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Over 4,100 patients were enrolled in the study.

The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers). Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety.

About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK) 4/6 inhibitor versus fulvestrant plus a CDK 4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)

(Press release, Genentech, NOV 17, 2025, View Source [SID1234660034])

On November 17, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported it will host a virtual Research and Development (R&D) Event from 11:00 am – 1:45 pm ET on Friday, December 5, 2025.

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Candel’s R&D Day will include presentations and panel discussions from its executive leadership, clinical investigators, scientific advisors, and key collaborators. The event will provide an extensive overview of the Company’s viral immunotherapy approach and oncology-focused pipeline. Click here to register for the event.

The R&D Day will include the following presentations:

Introduction to Candel Therapeutics:

Paul Peter Tak, MD, PhD, FMedSci, Candel’s President and CEO

Panel Discussion: Immuno-oncology: The next wave of innovation

Panelists:

James P. Allison, PhD, Nobel Laureate, Regental Professor and Chair of Immunology, and Founding Director of Scientific Programs for the James P. Allison Institute at the University of Texas MD Anderson Cancer Center

Carl H. June, MD, Richard W. Vague Professor in Immunotherapy and Director, Center for Cellular Immunotherapies and Parker Institute for Cancer Therapy, Perelman School of Medicine, University of Pennsylvania

Padmanee Sharma, MD, PhD, Professor of Genitourinary Medical Oncology and Immunology, and Director of Scientific Programs for the James P. Allison Institute at the University of Texas MD Anderson Cancer Center

Moderator: Yigal Nochomovitz, PhD, Citi Group

CAN-2409 for newly diagnosed localized prostate cancer

Glen Gejerman, MD, Co-chief of Urologic Oncology, Hackensack University Medical Center

Philip Kantoff, MD, Former Chair, Department of Medicine, Memorial Sloan Kettering Cancer Center, CEO, Convergent Therapeutics

Garrett Nichols, MD, MS, Candel’s Chief Medical Officer

Ron Tutrone, MD, National Director of Clinical Research, United Urology

Moderator: Oliver McCammon, LifeSci Capital

CAN2409: Roadmap to Biologics License Application (BLA)

Sue Stewart, JD, Candel’s Chief Regulatory Officer

Seshu Tyagarajan, PhD, Candel’s Chief Technical and Development Officer

Moderator: Andres Maldonado, PhD, HC Wainwright & Co.

CAN-2409: Pre-commercialization roadmap

Jonathan Mitchell, MSc, Partner, Globe Life Sciences

Jacqueline Poot, President, IDEA Pharma

Paul Peter Tak, MD, PhD, FMedSci, Candel’s President and CEO

Moderator: Andres Maldonado, PhD, HC Wainwright & Co.

CAN-2409 for immune checkpoint inhibitor refractory non-small cell lung cancer

Panelists:

Charu Aggarwal, MD, Professor of Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania

Roy Herbst, MD, PhD, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology, Yale Cancer Center

Dan Sterman, MD, Thomas and Suzanne Murphy Professor of Medicine and Cardiothoracic Surgery, NYU Langone Health

Moderator: John Newman, PhD, Canaccord Genuity

CAN-3110 for recurrent glioblastoma

Francesca Barone, MD, PhD, Candel’s Chief Scientific Officer

Henry Brem, MD, Professor of Neurosurgery, Johns Hopkins University

Moderator: Kemp Dolliver, Brookline Capital Markets

Registration for this virtual event and access to the live webcast and subsequent replay will be accessible under "Events and Presentations" on the Investors page of the Company’s website at www.candeltx.com or by clicking here.

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.

About CAN-3110

CAN-3110 (linoserpaturev) is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where CAN-3110 was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved mOS compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation.

(Press release, Candel Therapeutics, NOV 17, 2025, View Source [SID1234660033])