BioNTech, BioLineRx Unveil Clinical Data at ASCO 2026

Two biotechnology companies, BioNTech and BioLineRx, presented clinical data at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, highlighting advances in antibody-drug conjugates and glioblastoma treatments. BioNTech showcased a deep pipeline of antibody-drug conjugates and checkpoint inhibitor results, while BioLineRx announced the first patient dosed in a phase 1/2a trial of its glioblastoma candidate GLIX1.

BioNTech’s lead candidate, Trastuzumab Pamirtecan (BNT323/DB-1303), is a HER2-directed antibody-drug conjugate that the company plans to submit to the FDA as a Biologics License Application in 2026, pending regulatory feedback. In a phase 2 cohort of 145 patients with HER2-positive advanced endometrial cancer, the drug delivered a confirmed objective response rate of 47.9% and median progression-free survival of 8.1 months. Among patients with the highest HER2 expression (IHC 3+), the response rate exceeded 70%. The FDA already awarded the asset Fast Track and Breakthrough Therapy designations in 2023.

Beyond the lead ADC, BioNTech showcased two other conjugates: BNT326/YL202, a HER3-directed candidate in phase 1b/2 as monotherapy and in combination with Pumitamig for advanced solid tumors, and BNT324/DB-1311, a B7H3-directed ADC in phase 1/2a. A phase 3 study of the latter in metastatic castration-resistant prostate cancer is slated for 2026. Interim data from the phase 2 Rosetta Lung-02 study in non-small cell lung cancer and results from Gotistobart in platinum-resistant ovarian cancer also offered encouraging readouts.

Pumitamig, the company’s checkpoint inhibitor, is rapidly expanding its footprint. Five new pivotal studies have been launched in 2026 in partnership with Bristol Myers Squibb, covering triple-negative breast cancer, MSS colorectal cancer, gastric cancer, and two NSCLC settings. The Rosetta Lung-02 trial produced the third consistent dataset showing anti-tumor activity in combination with chemotherapy. BioNTech expects interim phase 3 analyses from the Pumitamig program later this year.

On the financial front, BioNTech held $19.6 billion in cash at the end of March and has initiated a $1 billion share buyback program over twelve months. Revenue guidance for 2026 stays at $2.3–2.6 billion. Management confirmed plans to run 15 active phase 3 trials by year-end, with seven late-stage data readouts scheduled for 2026.

BioLineRx reported that the first patient has been dosed in a phase 1/2a clinical trial of GLIX1 for the treatment of glioblastoma (GBM). New GLIX1 data demonstrated a potent anti-tumor effect in GBM across multiple in-vivo studies, including a temozolomide-resistant patient-derived xenograft model. The phase 1/2a trial was initiated in March 2026, with the first patient dosed at NYU Langone Health. Two additional cancer centers, Northwestern University and Moffitt Cancer Center, are participating in the study. The phase 1 part will recruit up to 30 patients with recurrent and progressive GBM to establish a maximum tolerated dose and/or recommended dose based on safety, PK/PD and preliminary efficacy. The phase 2a expansion is planned to include newly diagnosed GBM and select cancers, with GLIX1 as monotherapy or in combination with standard of care, including in combination with PARP inhibitors.

Two abstracts on GLIX1 were selected for publication during the ASCO annual meeting. BioLineRx also announced that enrollment is continuing in the CheMo4METPANC phase 2b clinical trial of motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy for metastatic pancreatic ductal adenocarcinoma. A prespecified interim/futility analysis is planned when 40% of progression-free survival events are observed, which the company continues to anticipate will occur in 2026.

BioLineRx reported APHEXDA sales for the first quarter of 2026 were $2.7 million, providing royalty revenues of $0.5 million. With $17.4 million on its balance sheet as of March 31, 2026, BioLineRx is maintaining its cash runway guidance into the first half of 2027.