On October 20, 2025 Archivel Farma reported the outcome of RUTIVAC study in Bladder Cancer.

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The RUTI vaccine, developed and produced in-house by Archivel Farma, was tested in a phase I trial involving 40 patients with high-risk non-muscle-invasive bladder cancer at Hospital Universitari Germans Trias i Pujol. Administered prior to standard BCG therapy, RUTI enhanced the immune response, reducing tumor recurrence and progression, and improving patient survival over five years.

The vaccine generated stronger CD4⁺ and CD8⁺ T-cell responses and increased cytokine production, without promoting immunosuppressive T-regulatory cells. Importantly, RUTI was well tolerated with only mild injection-site reactions.
These promising results, published in European Urology, suggest that RUTI could enhance the current standard of care for bladder cancer, paving the way for larger trials to confirm its clinical benefits. Read in View Source

Archivel Farma has been both, sponsor and RUTI supplier for this study. We extend our sincere thanks and congratulations to our partners, IrsiCaixa and the Germans Trias i Pujol Research Institute (IGTP), for their dedication and excellent work.

(Press release, Archivel Farma, OCT 20, 2025, View Source [SID1234656810])

On October 20, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class antibodies for cancer immunotherapy, reported a poster at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting on updated clinical results and positive antitumoral activity of BT-001 in patients with advanced refractory tumors.

The data show that intra-tumoral (IT) BT-001 injection in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) intravenous (IV) anti-PD-1 therapy KEYTRUDA (pembrolizumab[1]), was well tolerated and showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions.

Translational analyses reveal increased T cell chemoattractants in the blood and infiltration of activated CD8+ T cells and macrophages in tumors after treatment with BT-001 in combination with pembrolizumab. Significant tumor shrinkage (≥30% decrease in longest diameter) was observed in five of 16 injected lesions (in three patients with melanoma and one patient with sarcoma). Four patients had tumor shrinkage of non-injected lesions.

Long-lasting partial responses (PRs) were observed in a patient with melanoma resistant to anti-PD-1/anti-CTLA-4 combination therapy and in a heavily pre-treated, PD-L1 negative leiomyosarcoma patient.

These immune-mediated tumor shrinkages are consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active ones. The overall data support further development of BT-001 across a range of solid tumors to improve responses to cancer immunotherapies.

Prof. Celeste Lebbé, Dermatologist and Venereologist, Head of Dermatology Department at Hospital Saint-Louis, Paris, commented: "Many cancer patients fail to respond to existing treatments, emphasizing the urgent need for new approaches. BT-001 represents a promising new class of immunotherapy, capable of inducing a potent local immune response through the expression of GM-CSF and an anti-CTLA-4 antibody. These clinical data provide compelling proof of concept, highlighting the relevance of this oncolytic virus in transforming cold tumors into immunologically active ones. Whether administered alone or in combination with pembrolizumab, BT-001 offers the potential to expand treatment options with a favorable safety profile across multiple tumor types."

Dr. Alessandro Riva, Chairman and CEO of Transgene, said: "We are pleased to jointly present these clinical data on BT-001 at ESMO (Free ESMO Whitepaper) 2025, demonstrating encouraging antitumor activity in patients with solid, refractory solid tumors. These updated results confirm BT-001’s mechanism of action as a single agent administered via intra-tumoral injection and show early signs of clinical benefit, including lesion shrinkage and stable disease. With a favorable safety profile – both alone and in combination with pembrolizumab – BT-001 could represent an effective option to enhance responses to immune checkpoint inhibitors (ICI) in patients with limited treatment alternatives. Together with our partner BioInvent, we will continue to explore its safety and efficacy and share further data as it becomes available."

Andres McAllister, MD, PhD, Chief Medical Officer at BioInvent, added: "By combining BT-001 with pembrolizumab, we are building upon the promising data generated by BT-001 as a single agent. Targeting the PD-1/PD-L1 pathway in addition to BT-001’s mechanism of action is expected to further stimulate and restore the patient’s immune system, which should result in improved antitumoral activity and patient outcome. We are pleased to pursue clinical development opportunities with clinicians and further demonstrate the potential of this novel oncolytic virus."

Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO platform armed to express GM-CSF and BioInvent’s full-length anti-CTLA-4 monoclonal antibody, to elicit a strong and effective anti-tumoral response in solid tumors.

The poster titled: "Updated clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered in combination with pembrolizumab in patients with advanced solid tumors.", can be accessed at the websites for the ESMO (Free ESMO Whitepaper) conference, Transgene and BioInvent.

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(Press release, Transgene, OCT 20, 2025, https://www.bioinvent.com/en/press/transgene-and-bioinvents-armed-oncolytic-virus-bt-001-shows-positive-local-abscopal-and [SID1234656826])

On October 20, 2025 Valink Therapeutics Inc. ("Valink"), a private biotechnology company developing next-generation oncology therapeutics with a focus on bispecific antibody-drug conjugates (bsADCs) and complementary modalities for improved patient outcomes, reported the closing of a $11.8 million funding round and the expansion of its U.S. presence, with headquarters in Cambridge, Massachusetts. Proceeds from the financing will be used to advance Valink’s pipeline of first-in-class treatments designed to deliver enhanced efficacy, safety and precision in the treatment of cancer and other diseases.

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Valink’s bsADC technology aims to address key limitations of current ADCs by integrating novel targeting strategies with improved payload delivery. The company is also exploring complementary therapeutic modalities to broaden its impact across multiple cancer indications.

The financing was led by European venture capital fund redalpine, with participation from new investors LongeVC and Oxford Science Enterprises. Existing investors, including RV Invest, p53 Invest, and Hoxton Ventures also contributed to the round.

"We are grateful to redalpine and our syndicate of new and existing investors for their confidence in our vision and strategy," said Arne Scheu, DPhil, Co-founder and Chief Executive Officer of Valink Therapeutics. "This financing strengthens our position as a leader in next-generation bispecific ADCs and supports the advancement of our oncology pipeline toward key milestones. Our V-gate approach and proprietary drug discovery engine expand the frontier of antibody drug conjugates, offering the potential for first-in-class medicines to address areas of high unmet need in oncology and beyond."

"At redalpine, we back technologies that reshape paradigms. Valink’s discovery platform and V-gate approach represent a compelling advancement on traditional ADC strategies – unlocking new therapeutic possibilities by fusing programmable biology and a novel framework for target synergy," said Michael Sidler, redalpine founding partner and member of Valink Therapeutics board of directors. "We’re excited to lead this round and support Valink’s mission to address real-world disease biology with precision and adaptability."

(Press release, Valink Therapeutics, OCT 20, 2025, View Source [SID1234656842])

On October 20, 2025 CIS BIOPHARMA AG, a company pioneering new cancer targets, reported that the company will present an abstract & poster about its lead ADC called CBO-001 at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) -AACR- NCI-EORTC- AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, CIS BIOPHARMA, OCT 20, 2025, View Source [SID1234657093]).

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The AACR (Free AACR Whitepaper)-NCI-EORTC will be held October 22-26, 2025, at the Boston Hynes Convention Center in Boston, Massachusetts. The poster highlights preclinical data on CBO-001, a proprietary antibody-drug conjugate (ADC) developed by CIS BIOPHARMA. "We are excited to share our preclinical data at this year’s AACR (Free AACR Whitepaper)-NCI-EORTC meeting, demonstrating exceptional efficacy of our L1CAM ADC in several cancer indications, with outstanding results in small-cell lung cancer and ovarian cancer," says Dominik Brücher, Ph.D., Chief Technology Officer of CIS BIOPHARMA AG.

"The superior pre-clinical efficacy of this emerging cancer target versus standard-of-care and other emerging targets such as B7H3 and DLL3 in SCLC, positions us in a unique competitive situation, also envisioning combination strategies with these. Our overall goal with CBO-001 is to develop therapeutic options with superior overall survival for patients with SCLC, OC and other L1CAM positive malignancies."

On October 20, 2025 Arvinas, Inc. (Nasdaq: ARVN), reported new patient-reported outcomes (PRO) data from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant, which are being presented in a mini oral session at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Vepdegestrant is a novel investigational PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for estrogen receptor 1 (ESR1) mutated, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine-based therapy.

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In the VERITAC-2 clinical trial, patients with ESR1-mutated disease treated with vepdegestrant reported a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains compared to those who received fulvestrant. These findings complement previously reported clinical efficacy and safety data from the VERITAC-2 clinical trial, reinforcing vepdegestrant as a potential treatment option for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.

"These new data highlight the potential of vepdegestrant to provide significant improvements across important measures for patients with ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second-line setting," said John Houston, Ph.D., Chairperson, President and Chief Executive Officer of Arvinas. "In addition to a statistically significant improvement in progression-free survival, patients receiving vepdegestrant had statistically significant and clinically meaningful benefits in patient-reported outcomes as compared to fulvestrant while being treated for their cancer. These data from the VERITAC-2 clinical trial reflect Arvinas’ goal of striving to pair scientific innovation with improved patient outcomes."

In patients with ESR1-mutated disease, vepdegestrant demonstrated a reduced risk of deterioration compared to fulvestrant which was statistically significant in several PRO domains including overall health status, pain severity, and functioning (including role, cognitive, emotional, and social functioning), and vepdegestrant consistently showed reduced risk of deterioration versus fulvestrant across all PRO domains.

We believe these data support vepdegestrant’s opportunity to be a potential best-in-class therapy for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine therapy.

Also presented at ESMO (Free ESMO Whitepaper) 2025 were results from the TACTIVE-N Phase 2 clinical trial (NCT05549505), which evaluated neoadjuvant vepdegestrant in postmenopausal women with ER+/HER2– localized breast cancer. The results presented showed that neoadjuvant vepdegestrant demonstrated biological and clinical activity in this treatment-naïve, predominantly ESR1 wild-type population of postmenopausal women with ER+/HER2- localized breast cancer.

Additional detail on Arvinas and Pfizer’s presentations at ESMO (Free ESMO Whitepaper) 2025:

Title: Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)− advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial
Presenting Author: Dr. Mario Campone
Presentation Number: 489 MO
Presentation Type: Mini oral session
Session: Breast cancer, metastatic
Date: October 20, 2025
Time: 11:25-11:30 AM CEST

Title: TACTIVE-N: phase 2 study of neoadjuvant vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, or anastrozole in postmenopausal ER+/human epidermal growth factor receptor 2 (HER2)- localized breast cancer (BC)
Presenting Author: Dr. Peter A. Fasching
Presentation Number: 293MO
Presentation Type: Mini oral session
Session: Breast cancer, early stage
Date: Sunday, October 19, 2025
Time: 10:45-10:50 AM CEST

About the VERITAC-2 Clinical Trial

The Phase 3 VERITAC-2 clinical trial (NCT05654623) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with a CDK4/6 inhibitor plus endocrine therapy. The trial enrolled 624 patients, 270 of whom had ESR1m positive disease, at 213 sites in 25 countries.

Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. Overall survival is the key secondary endpoint.

About Vepdegestrant

Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. Vepdegestrant is being developed as a potential monotherapy for estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant for its use as a monotherapy in the treatment of adults with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option.

(Press release, Arvinas, OCT 20, 2025, View Source [SID1234656811])