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])

On October 20, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported the presentation of data from two pivotal Phase 3 trials – RATIONALE-307 and 312 – offering new evidence of the benefits of its PD-1 inhibitor, TEVIMBRA (tislelizumab), at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress (ESMO 2025) in Berlin, Germany, October 17-21. The results reinforce TEVIMBRA’s consistent and durable efficacy across lung cancer subtypes, including non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (ES-SCLC). In addition, the first clinical data from BeOne’s investigational HPK1 inhibitor, BGB-26808, as a single agent and in combination with TEVIMBRA, will be presented, highlighting promising antitumor activity and a generally manageable safety and tolerability profile in patients with advanced solid tumors.

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"The results presented at ESMO (Free ESMO Whitepaper) 2025 strengthen the evidence base for TEVIMBRA in lung cancer, with consistent survival benefit across subtypes. We’re also encouraged by clinical activity from our investigational HPK1 inhibitor, BGB-26808, which supports our TEVIMBRA-based combination strategy," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "With TEVIMBRA’s recent European approval in perioperative resectable NSCLC and our diversified, combination-rich pipeline, we are advancing next-generation options for people with lung cancer."

New Data Builds on Strong Evidence Base for TEVIMBRA in Lung Cancer Treatment

The European Commission’s approvals of TEVIMBRA in lung cancer are based on five randomized Phase 3 studies from the RATIONALE program. At ESMO (Free ESMO Whitepaper) 2025, BeOne will present new data from two of these trials, further substantiating TEVIMBRA’s efficacy across lung cancer settings, including NSCLC and ES-SCLC, with a consistent safety profile.

RATIONALE-307 (NCT03594747): Long-term data show TEVIMBRA plus chemotherapy significantly improved overall survival over chemotherapy alone across different subgroups of patients with locally advanced or metastatic squamous NSCLC, including patients with stage IV disease, irrespective of PD-L1 expression. These survival benefits were observed even in the presence of high in-study crossover from chemotherapy to TEVIMBRA, a factor that typically reduces the observed benefit of treatment1. TEVIMBRA plus chemotherapy demonstrated a generally well-tolerated safety profile with no new safety signals even at the longer follow-up. The most common Grade 3 or 4 treatment-related adverse events (TRAEs) were associated with chemotherapy and included decreased neutrophil counts, neutropenia and leukopenia. (poster #1858, Oct. 18, 12:00-12:45 PM CEST).

A post-progression analysis from RATIONALE-307 also suggests that continued TEVIMBRA monotherapy may help extend survival in select patients whose disease progresses in a slower, more localized way (poster #1871​, Oct. 18, 12:00-12:45 PM CEST).
RATIONALE-312 (NCT04005716): Three-year data confirmed long-term efficacy and safety of first-line TEVIMBRA plus chemotherapy in ES-SCLC, with meaningful and sustained improvements in overall survival in both the intent-to-treat population and PD-L1-expressing subgroups, and no new safety signals identified. The most common Grade 3 or 4 TRAEs for TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, thrombocytopenia, and decreased white blood count (poster #2765, Oct. 18, 12:00-12:45 PM CEST).
Pipeline Momentum: Early Findings from HPK1 Inhibitor BGB-26808

Preliminary findings from the Phase 1a dose-escalation trial (NCT05981703) assessing BGB-26808, a novel, second-generation HPK1 inhibitor, as monotherapy and combined with TEVIMBRA showed encouraging antitumor activity in the combination arm. The combination arm achieved an unconfirmed objective response rate (ORR) of 15.4%, including one complete response and seven partial responses. Safety was manageable in patients with advanced, metastatic, and unresectable solid tumors. Grade 3 or 4 TRAEs with single-agent BGB-26808 were reported in 21.8% of patients and in 21.2% of patients in the combination arm (poster #1564, Oct. 19, 12:00-12:45 PM CEST).

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 22 registration-enabling studies. TEVIMBRA is approved in 47 markets, and more than 1.7 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, OCT 20, 2025, View Source [SID1234656827])

On October 20, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported on the positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the annual European Society Medical Oncologists meeting in Berlin, Germany.

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An interim efficacy analysis from the ongoing trial with ENV-105, a first-in-class CD105 antagonist, is being tested for safety and early efficacy in men with metastatic prostate cancer resistant to standard hormone therapy. Despite progression on prior hormonal therapies, the trial showed clinical benefit when combining ENV-105 with hormone therapy, apalutamide, in 86% of treated patients. All responders remained progression-free for at least four months and half remained progression-free beyond one year. Notably, seven of nine evaluable patients experienced a reduction in PSA levels from baseline.

"The positive safety profile and initial clinical benefit we’ve seen through our extensive interim analysis validates the comprehensive mechanism of action studies that preceded this clinical study, demonstrating how ENV-105 restores a patient’s ability to respond to hormone therapy," said Dr. Neil Bhowmick, CSO of Kairos Pharma.

Edwin Posadas, Director of the Experimental Therapeutics Program and the Medical Director of the Center for Uro-Oncology Research Excellence at the Cedars-Sinai Cancer Institute, leads the randomized Phase 2 trial that is currently accruing up to 100 patients at Cedars-Sinai Medical Center, City of Hope Cancer Center, and the Huntsman Cancer Institute. The 13.7 median PFS (progression free survival) achieved by imaging with the ENV-105 and apalutamide combination reported would suggest an improvement over current alternatives of chemotherapy and radioligand therapy, in terms of disease control as well as tolerability. Kairos Pharma seeks to provide a safe and effective therapy with ENV-105 for the over 3 million men with hormone-resistant prostate cancer worldwide.

(Press release, Kairos Pharma, OCT 20, 2025, View Source [SID1234656843])