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HUTCHMED Highlights Pivotal Phase II Data for Fanregratinib in Intrahepatic Cholangiocarcinoma Presented at ESMO Gastrointestinal Cancers Congress 2026

On June 25, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma ("ICC") will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

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Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

"The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure," said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. "The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology."

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title:

Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial

Lead Author:

Jianming Xu, Chinese PLA General Hospital, Beijing, China

Session:

Rapid oral session on innovation

Presentation Number:

343RO

Date & Time:

Saturday, July 4, 2026, 9:00 am CEST

Location:

Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, JUN 25, 2026, View Source [SID1234668950])

European Commission Approves PADCEV(enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) as the First and Only Approved Perioperative Treatment Option for Cisplatin-Ineligible Patients with Resectable Muscle-Invasive Bladder Cancer

On June 24, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the European Commission has granted Marketing Authorization for PADCEVTM (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the European Union (EU). The approval establishes the first and only approved perioperative (neoadjuvant and adjuvant) treatment option for this patient population in the EU.

The approval is based on results from the Phase 3 EV-303 clinical trial (KEYNOTE-905), in which perioperative enfortumab vedotin plus pembrolizumab significantly improved Event-Free Survival (EFS) and Overall Survival (OS) compared with surgery alone in patients with MIBC who were ineligible for or declined cisplatin-containing chemotherapy.1 The combination reduced the risk of tumor recurrence, progression, or death by 60% (Hazard Ratio (HR) 0.40, 95% CI, 0.28-0.57; p<0.0001)1 and reduced the risk of death by 50% (HR 0.50, 95% CI: 0.33-0.74; p=0.0002).1

The safety profile was consistent with the known profiles of the individual medicines, and no new safety signals were observed. The most common (≥30%) adverse events related to treatment with the combination were pruritus (itching), alopecia, diarrhea, fatigue, and anemia.1

Results from the trial were recently published in The New England Journal of Medicine.1

Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas
"For patients with muscle-invasive bladder cancer who are unable to receive cisplatin-based chemotherapy, perioperative treatment options have historically been limited. This approval establishes the first approved perioperative treatment option for these patients in Europe and represents an important advance for patients facing this disease. We remain committed to improving outcomes for people living with bladder cancer through continued innovation across different stages of the disease."

Christof Vulsteke, M.D., Ph.D., Head of Integrated Cancer Center Ghent (IKG, Belgium) and Clinical Trial Unit Oncology Ghent and EV-303 Principal Investigator
"Despite surgery with curative intent, many patients with muscle-invasive bladder cancer experience disease recurrence. The EV-303 results demonstrated clinically meaningful improvements in both event-free and overall survival, supporting perioperative enfortumab vedotin plus pembrolizumab as an important new treatment option for cisplatin-ineligible patients in Europe."

Alex Filicevas, Executive Director, World Bladder Cancer Patient Coalition
"For patients living with muscle-invasive bladder cancer, the possibility of the cancer returning after surgery can be a source of significant uncertainty and concern for them and their families. But patients who are unable to receive cisplatin-based chemotherapy have historically faced limited treatment options beyond surgery. This approval represents important progress for the bladder cancer community and a significant advance for patients affected by this disease."

Bladder cancer remains a significant health burden across Europe, with nearly 200,000 people diagnosed each year.2 MIBC accounts for up to 30% of all bladder cancer cases.3 Up to half of patients with MIBC are ineligible to receive cisplatin-containing chemotherapy. Until now, there have been no approved perioperative treatment options for these patients, despite a substantial risk of disease recurrence following surgery.4

Enfortumab vedotin plus pembrolizumab is already approved in Europe as a first-line treatment for patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.5 This approval expands the use of the combination into earlier-stage, resectable MIBC for patients who are ineligible for cisplatin-containing chemotherapy, extending its use from advanced disease into a curative-intent treatment setting.

Astellas is working closely with regulatory authorities and health technology assessment bodies across the European Union to support patient access following the approval.

Astellas has already reflected the impact of the EC approval in its financial forecast for the current fiscal year ending March 31, 2027.

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.6 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).6

Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved in the United States as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the European Union, the combination is approved for the treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.

About the EV-303/KEYNOTE-905 Trial
The EV-303 trial (also known as KEYNOTE-905) is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab or neoadjuvant and adjuvant pembrolizumab versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant pembrolizumab (arm A), surgery alone (arm B) or neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab (arm C). Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.

The primary endpoint of this trial is EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on imaging, blinded independent central review (BICR), and/or biopsy or death due to any cause. Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm B.

For more information on the global EV-303 trial, go to clinicaltrials.gov.

(Press release, Astellas, JUN 24, 2026, View Source [SID1234670179])

VERAXA Biotech Expands R&D Hub in Heidelberg as Innovative BiTAC™-TCE and ADC Programs Advance Towards Clinical Development

On June 24, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported that the Company has moved into additional laboratory space at its existing R&D site in Heidelberg, Germany, based on a previously signed long-term lease agreement. The expansion enables the company to accommodate for currently planned team additions in its R&D department, the installation of laboratory equipment and the build-up of the final R&D infrastructure needed for planned development activities.

VERAXA is pursuing a growing portfolio of proprietary and partnered drug development programs from early, discovery stage toward early clinical development. At the heart of VERAXA’s R&D activities is the Company’s novel BiTAC strategy and its application to drive a portfolio of BiTAC-TCE and BiTAC-ADC development programs. The BiTAC therapeutic strategy is designed to unlock a new level of precision in cancer treatment by using two complementary precursors and enabling a tumor-restricted activation of the desired therapeutic effect.

"Securing the necessary space for our growing R&D organization was vital as we expand both internal drug development activities and plan ahead for an increased level of research activities within therapeutic alliances," said Torsten Bürgermeister, Chief Financial Officer of VERAXA. "We were able to avoid any disruption of our R&D operations at our existing site in the Heidelberg biopharmaceutical cluster, which continues to provide us with a rich academic research environment and offers multiple touchpoints with some of the world’s leading research organizations in medical oncology."

(Press release, Veraxa Biotech, JUN 24, 2026, View Source [SID1234668949])

TScan Therapeutics to Participate in the H.C. Wainwright 4th Annual Cell Therapy Virtual Conference

On June 24, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported that the Company will participate in a fireside chat at the H.C. Wainwright 4th Annual Cell Therapy Virtual Conference on Tuesday, June 30, 2026 at 11:30 a.m. Eastern Time.

A webcast of the fireside chat will be available on the "Events and Presentations" section of the Company’s website at ir.tscan.com. An archived replay of the webcast will be available on the Company’s website for 90 days following the event.

(Press release, TScan Therapeutics, JUN 24, 2026, View Source [SID1234668948])

Calidi Biotherapeutics Presents New Data on CLD-501, Its In Situ T-Cell Engager Candidate Targeting TROP-2 at the T-Cell Engager Therapeutic Summit

On June 24, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported data at the T-cell Engager Therapeutic Summit in San Diego, California. The Company presented data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment ("TME"). The poster is available here.

"The data presented at today’s summit shows the advances we have made with the RedTail platform and our progress in addressing a central challenge in immuno-oncology: how to deliver tumor-specific T-cell engagers effectively in solid tumors" said Calidi Chief Executive Officer Eric Poma, PhD. "The data highlights the ability of the RedTail platform to functionally overexpress complex biologics including cytokines and T-cell engagers, and profoundly alter the tumor microenvironment to allow for T-cell-mediated tumor cell destruction."

RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist ("IL-15 SA"), a known CD8⁺ T-cell, NK cell, and gamma delta (γδ) T-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.

Data presented at the T-Cell Therapeutic Engager meeting showcased RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits immune cell infiltration and T-cell activity. By remodeling the TME and driving T-cell activation in concert with expression of a T-cell engager, RedTail is designed to overcome these historical limitations.

The Company is developing CLD-501, a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor / on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the TME, limiting off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

Calidi Biotherapeutics continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, JUN 24, 2026, View Source [SID1234668947])