This section highlights FDA-related milestones and regulatory updates for drugs developed by BioLineRx (BLRX).
Over the past two years, BioLineRx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GLIX1, Soquelitinib, Glioblastoma, and motixafortide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
GLIX1 FDA Regulatory Events
GLIX1 is a drug developed by BioLineRx for the following indication: treatment of recurrent and progressive glioblastoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GLIX1
- Announced Date:
- May 22, 2026
- Indication:
- treatment of recurrent and progressive glioblastoma
Announcement
BioLineRx Ltd. announced that two abstracts featuring GLIX1 will be published at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting, which is being held May 29-June 2, 2026, in Chicago, IL.
AI Summary
BioLineRx Ltd. said two abstracts on GLIX1 will be presented at the ASCO 2026 Annual Meeting in Chicago from May 29 to June 2, 2026. One abstract, GLIX1: A first-in-class oral molecule targeting the DNA damage response by restoring TET2 activity, will be shown in a publication-only session on central nervous system tumors. The second, Synergistic antitumor activity of GLIX1, a small molecule TET2 activator, in combination with PARP inhibition across multiple cancers, will appear in a publication-only breast cancer session focused on metastatic disease.
GLIX1 is an oral, brain-penetrating drug designed to activate the TET2 pathway, which is often blocked in cancer. By restoring this pathway, GLIX1 may overwhelm cancer cells’ DNA repair ability and cause them to die. BioLineRx is developing GLIX1 with Hemispherian for glioblastoma and other solid tumors.
Read Announcement- Drug:
- GLIX1
- Announced Date:
- April 28, 2026
- Indication:
- treatment of recurrent and progressive glioblastoma
Announcement
BioLineRx announced that the first patient has been dosed in the first-in-human, Phase 1/2a study of GLIX1 for the treatment of recurrent and progressive glioblastoma (GBM) and other high-grade gliomas.
AI Summary
BioLineRx announced that the first patient has been dosed in the first-in-human Phase 1/2a study of GLIX1 for recurrent and progressive glioblastoma (GBM) and other high-grade gliomas. The patient was treated at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center. Northwestern University (led by Dr. Roger Stupp and Dr. Ditte Primdahl) and Moffitt Cancer Center (led by Dr. Patrick Grogan) will also take part in the study.
In preclinical models, including in vivo GBM models, GLIX1 showed strong anti-tumor activity, good blood–brain barrier penetration, and a favorable safety profile. The Phase 1 dose-escalation portion will enroll up to 30 patients receiving daily GLIX1 monotherapy to determine a maximum tolerated or recommended dose based on safety, PK/PD, and early signs of efficacy. Phase 1 data are expected in H1 2027. The planned Phase 2a expansion will explore newly diagnosed GBM and select other cancers, including combinations such as with PARP inhibitors, to inform further development. Hemispherian is advancing GLIX1 in partnership with BioLineRx.
Read Announcement
Soquelitinib FDA Regulatory Timeline and Events
Soquelitinib is a drug developed by BioLineRx for the following indication: For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Soquelitinib
- Announced Date:
- May 14, 2026
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc. announced today the presentation of final data from its randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting, which is taking place May 13-16, 2026 in Chicago.
AI Summary
Corvus Pharmaceuticals said final results from its randomized, blinded, placebo-controlled Phase 1 trial suggest that soquelitinib may help people with moderate-to-severe atopic dermatitis by calming inflammation and restoring immune balance. The company presented new data at the Society for Investigative Dermatology Annual Meeting in Chicago, including a late-breaking oral session.
In the study, patients taking 200 mg twice daily showed strong improvements in eczema severity, with no disease rebound and no need for rescue medicine during follow-up. The benefits also appeared to last after treatment stopped, pointing to possible drug-free remissions. Corvus said the data showed fewer inflammatory Th2 cells and cytokines, while persistent regulatory T cells, or Tregs, increased. These changes fit soquelitinib’s action as an ITK inhibitor and may help explain the durable responses seen in patients. The company said the findings support further study of soquelitinib as a potential new treatment for atopic dermatitis.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- January 20, 2026
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced positive results from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
AI Summary
Corvus Pharmaceuticals reported positive results from cohort 4 of a randomized, blinded, placebo-controlled Phase 1 trial of soquelitinib in moderate-to-severe atopic dermatitis. In the extended 8-week treatment, soquelitinib patients (n=12) had a mean 72% reduction in EASI at Day 56 versus 40% for placebo (n=10). Clinical responses deepened from Week 4 to Week 8: 75% of soquelitinib patients achieved EASI‑75, 25% achieved EASI‑90, and 33% reached IGA 0/1, compared with 20%, 0%, and 0% respectively in placebo. Separation from placebo began by Day 15 and widened through Day 56.
Safety was favorable: adverse events occurred in 41.7% of soquelitinib patients and 50% of placebo patients, all Grade 1–2, with no serious events or lab abnormalities. Activity was seen in patients previously treated with systemic therapies, including dupilumab and JAK inhibitors. Biomarkers showed reductions in IL‑4, IL‑5 and IL‑17 and increases in Treg cells, supporting an ITK‑based immune rebalancing mechanism. Corvus plans a Phase 2 trial in Q1 2026.Read Announcement
- Drug:
- Soquelitinib
- Announced Date:
- January 5, 2026
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc. confirms the planned announcement of the results from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis in the second half of January 2026.
AI Summary
Corvus Pharmaceuticals confirmed it will announce results from cohort 4 of its randomized, blinded, placebo-controlled Phase 1 trial of soquelitinib in patients with moderate to severe atopic dermatitis in the second half of January 2026. The company emphasized the timing for these data and the specific focus on cohort 4, which is part of the early-stage safety and activity assessment of the drug in this patient population.
Because the data release is imminent, Corvus said it is canceling all previously planned conference appearances, including its scheduled presentation at the J.P. Morgan 2026 Healthcare Conference on January 12. Soquelitinib is an investigational oral small-molecule ITK inhibitor that Corvus is developing for immune diseases, and the company is moving forward with clinical readouts while prioritizing the upcoming cohort 4 results.Read Announcement
- Drug:
- Soquelitinib
- Announced Date:
- December 8, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc. announced the presentation of final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma today in an oral session at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, which is taking place December 6-9, 2025 in Orlando, FL.
AI Summary
Corvus Pharmaceuticals presented final Phase 1/1b data for soquelitinib in an oral session at the 67th ASH Annual Meeting in Orlando. The trial enrolled 75 patients with various T cell lymphomas and tested twice-daily doses from 100 mg to 600 mg. The 200 mg twice-daily dose was chosen for expansion based on biomarker target coverage. No dose-limiting toxicities or major safety signals were seen across doses up to 600 mg.
In the 200 mg twice-daily cohort (N=36), median progression-free survival was 6.2 months and median overall survival was 28.1 months, results the company says compare favorably with existing therapies. Six patients in that cohort achieved complete responses. In a subgroup with 1–3 prior therapies and adequate lymphocyte counts (N=24), 9 patients responded (6 complete, 3 partial). These findings support an ongoing registration Phase 3 trial in relapsed/refractory PTCL and continued development in atopic dermatitis and other immune diseases.
Data also showed soquelitinib’s ITK inhibition shifts T cell differentiation toward Th1, reduces Th2/Th17 signals, and produced related biomarker changes in blood and tumor biopsies, supporting broader immune and inflammatory indications.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- June 25, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China.
AI Summary
Corvus Pharmaceuticals recently announced that the IND application submitted by its China partner, Angel Pharmaceuticals Ltd., has been approved by the Center for Drug Evaluation of the China National Medical Products Administration. This approval will allow Angel Pharma to begin a Phase 1b/2 clinical trial of soquelitinib, an investigational drug, for patients with moderate-to-severe atopic dermatitis in China.
The trial is designed to assess different dosing regimens over a 12‐week treatment period, with patient enrollment expected to start in the third quarter of 2025 and initial data available in 2026. This development builds on previous Phase 1 data, potentially offering a new treatment option for atopic dermatitis. The trial will help expand the clinical experience with soquelitinib and further explore its benefits for patients in China.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- June 11, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis will be presented today in a poster session at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, which is taking place June 11-14, 2025 in Barcelona.
AI Summary
Corvus Pharmaceuticals, Inc. announced that new preclinical data demonstrating the potential of its lead ITK inhibitor, soquelitinib, to treat systemic sclerosis will be presented at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona from June 11-14, 2025. The data, which has already garnered attention from the Emerging EULAR Network by being selected as a top 10 abstract, highlights soquelitinib’s potential to prevent lung damage, inflammation, and pulmonary hypertension associated with systemic sclerosis. Dr. Gonçalo Boleto from Centro Académico de Medicina de Lisboa in Portugal will present the findings in a poster session. While Corvus Pharmaceuticals is primarily focused on its development programs for peripheral T cell lymphoma and atopic dermatitis, these preclinical findings may pave the way for future clinical trials or partnerships exploring ITK inhibition in systemic sclerosis treatment.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- June 4, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
AI Summary
Corvus Pharmaceuticals, Inc. announced interim data from its Phase 1, randomized, double-blind, placebo-controlled clinical trial of soquelitinib for moderate to severe atopic dermatitis. The trial evaluated different dosing cohorts, with cohort 3 (200 mg twice daily) showing the most promising results. Patients in cohort 3 experienced earlier and deeper improvements, with a reduction in itch as early as day 8 and a 64.8% mean reduction in the Eczema Area and Severity Index (EASI) compared to 34.4% for placebo after 28 days. Overall, patients treated with soquelitinib showed statistically significant improvements compared to placebo, with meaningful reductions in itch and clear separation of effectiveness emerging by day 15. Building on these positive outcomes, enrollment has begun for an extension cohort using the same dose for an 8-week treatment period, looking to further enhance patient results.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- April 23, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis will be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting, which is taking place May 7-10, 2025 in San Diego, CA.
AI Summary
Corvus Pharmaceuticals, Inc. announced that new interim data from its Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis will be presented at the Society for Investigative Dermatology 2025 Annual Meeting in San Diego, CA. This trial is randomized, double-blind, and placebo-controlled, and the data will be shared through both an oral session and a poster presentation. The poster session is scheduled for May 8, 2025, while the oral presentation will take place on May 10, 2025.
The presentation will discuss the activity of soquelitinib, a selective ITK inhibitor, and its novel mechanism of action in treating atopic dermatitis. The company will also present details of these findings during its first quarter 2025 business update conference call and webcast, emphasizing promising developments in the treatment of this challenging skin condition.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- March 20, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
- Corvus Pharmaceuticals, Inc. announced that additional data from the Company's Phase 1/1b clinical trial of soquelitinib for the treatment of patients with T cell lymphoma (TCL) is being presented at the 16th Annual T-Cell Lymphoma Forum taking place March 20-22, 2025 in San Diego, CA.
AI Summary
Corvus Pharmaceuticals, Inc. announced that additional data from its Phase 1/1b clinical trial of soquelitinib for T cell lymphoma will be presented at the 16th Annual T-Cell Lymphoma Forum in San Diego, CA from March 20-22, 2025. The trial involved 25 patients treated with a 200 mg twice-daily dose, and the results showed promising signs of anti-tumor activity with a 39% overall response rate and a notable 26% complete response rate.
Dr. John Reneau from The Ohio State University Comprehensive Cancer Center will share the findings, including improvements in progression-free survival and reductions in T cell exhaustion. These encouraging outcomes support further clinical development of soquelitinib, reinforcing its potential as an effective treatment option for patients with T cell lymphoma.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- March 12, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has initiated a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease.
AI Summary
Corvus Pharmaceuticals announced that the National Institute of Allergy and Infectious Diseases (NIAID) has started a Phase 2 clinical trial of soquelitinib for treating Autoimmune Lymphoproliferative Syndrome (ALPS), a rare genetic disease. ALPS causes a harmful buildup of T cells that can lead to enlarged lymph nodes, spleen, and low blood counts, which make patients prone to serious complications. The study is led by Dr. V. Koneti Rao at the NIH Clinical Center and will evaluate the safety and effectiveness of soquelitinib in reducing these symptoms, using imaging and blood tests as primary measurements.
The trial will enroll up to 30 patients aged 16 and older, with two dosing groups being tested. Early preclinical results have shown that ITK inhibition with soquelitinib may rebalance the immune system by reducing dysfunctional T cells. This research offers hope for improved treatment options for ALPS patients.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- January 13, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
AI Summary
Corvus Pharmaceuticals announced new interim results from its randomized, double-blind, placebo-controlled Phase 1 trial of soquelitinib in patients with moderate to severe atopic dermatitis. The trial included data from two cohorts. In cohort 1, patients received 100 mg twice a day, and in cohort 2, patients received 200 mg once daily. The results showed a favorable safety profile with no significant adverse effects or abnormal lab results.
Importantly, clinically meaningful endpoints were met using FDA-accepted measures. About 26% of patients taking soquelitinib achieved an Investigator Global Assessment (IGA) score of 0 or 1, and 37% reached a 75% reduction in the Eczema Area and Severity Index (EASI 75), while no patients in the placebo group reached these targets. These promising interim results suggest soquelitinib could offer a convenient and effective oral treatment for atopic dermatitis, and further results will be reported in the second quarter of 2025.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- December 18, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals announced interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
AI Summary
Corvus Pharmaceuticals announced interim results from its randomized, double-blind, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. In the trial’s first cohort using the lowest dose (100 mg twice daily), the treatment showed a favorable safety profile with few mild adverse events and promising efficacy outcomes. Patients receiving soquelitinib experienced significant improvements in eczema severity, as demonstrated by notable reductions in Eczema Area and Severity Index (EASI) scores compared to placebo, with improvements evident as early as eight days into treatment. Additionally, analysis of cytokine levels revealed associations between clinical improvements and reductions in inflammatory markers such as IL-5, IL-17, IL-31, IL-33, and TSLP. These findings highlight the potential of soquelitinib as a new treatment option for atopic dermatitis and support the broader promise of ITK inhibition in managing immune-related diseases.
Read Announcement - Drug:
- Soquelitinib
- Announced Date:
- December 17, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals announce interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis tomorrow, December 18, 2024.
AI Summary
Corvus Pharmaceuticals announced that interim data from its randomized, double-blind, placebo-controlled Phase 1 clinical trial of soquelitinib will be shared on December 18, 2024. This trial is evaluating the drug in patients with moderate to severe atopic dermatitis. Soquelitinib, an investigational oral small molecule, is designed to selectively inhibit interleukin-2-inducible T cell kinase (ITK), which plays a role in immune cell function. The company plans to release the interim results through a press release and will present the data on a conference call and webcast. The event is scheduled for 8:00 a.m. ET / 5:00 a.m. PT, with access available via telephone or online through the Corvus Pharmaceuticals website. This announcement marks an important step in exploring new treatment options for patients suffering from atopic dermatitis.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- September 10, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that it has initiated a registrational Phase 3 clinical trial of soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).
AI Summary
Corvus Pharmaceuticals, Inc. announced that it has started a registrational Phase 3 clinical trial for soquelitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This new study is a randomized, controlled trial that will test the safety and effectiveness of soquelitinib compared to the standard chemotherapy options such as belinostat or pralatrexate. Soquelitinib, a potential first-in-class ITK inhibitor, is designed to target T cell lymphomas using a unique mechanism that may boost the body’s natural tumor-fighting abilities. The trial plans to enroll about 150 patients who have already undergone one to three previous treatments. It will take place at around 40 sites in the United States, Canada, Australia, and South Korea. The main goal is to improve progression-free survival, with other important outcomes including overall survival and the duration of tumor response.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- August 1, 2024
- Target Action Date:
- Q3 2024
- Estimated Target Date Range:
- July 1, 2024 - September 30, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals Soquelitinib registrational Phase 3 clinical trial in PTCL advancing toward initial enrollment in Q3 2024
AI Summary
Corvus Pharmaceuticals announced that its registrational Phase 3 clinical trial of soquelitinib in patients with relapsed or refractory peripheral T cell lymphoma (PTCL) is moving forward, with initial patient enrollment expected to begin in the third quarter of 2024. The trial targets adults who have undergone at least two previous lines of systemic therapy, addressing the unmet need for treatments in a patient group with limited effective options. The investigational oral drug, soquelitinib, has attracted strong interest from experienced investigators who specialize in T cell lymphomas. This Phase 3 study aims to further evaluate the safety and effectiveness of soquelitinib, offering a potential new treatment approach for PTCL patients. The advancement of this trial highlights Corvus Pharmaceuticals’ commitment to improving outcomes in a challenging disease area, where few approved therapies exist.
Read Announcement- Drug:
- Soquelitinib
- Announced Date:
- August 1, 2024
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
Corvus Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to soquelitinib for the treatment of adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) after at least two lines of systemic therapy.
AI Summary
Corvus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational drug, soquelitinib, for treating adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) who have received at least two lines of systemic therapy. This designation highlights the urgent need for new treatment options in PTCL, a condition where available therapies often fall short, providing limited benefit and carrying significant toxicity.
Fast Track Designation aims to speed up drug development and review by improving communication with the FDA and allowing parts of the application to be reviewed on a rolling basis. The decision underscores both the severe unmet medical need in this patient population and the potential of soquelitinib to address these critical challenges. The company is on track to begin patient enrollment in its Phase 3 registrational trial in Q3 2024.
Read Announcement
Glioblastoma FDA Regulatory Events
Glioblastoma is a drug developed by BioLineRx for the following indication: treatment of recurrent and progressive GBM and other high-grade glioma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Glioblastoma
- Announced Date:
- March 26, 2026
- Indication:
- treatment of recurrent and progressive GBM and other high-grade glioma
Announcement
BioLineRx Ltd announced the initiation of a first-in-human, Phase 1/2a study of GLIX1 for the treatment of recurrent and progressive GBM and other high-grade glioma (NCT07464925).
AI Summary
BioLineRx announced the start of a first-in-human Phase 1/2a study of GLIX1 (NCT07464925) for recurrent and progressive glioblastoma (GBM) and other high-grade gliomas. In preclinical work, GLIX1 showed strong anti-tumor activity across multiple GBM models, good penetration of the blood-brain barrier, and a favorable safety profile in toxicology studies. The program aims to move promising lab results into patients while carefully monitoring safety, drug levels, and early signs of benefit.
The study is led by experienced glioblastoma investigators, including Dr. Roger Stupp, with three leading centers participating. NYU Langone Health, led by Dr. Alexandra Miller, is first to open for enrollment, followed by Northwestern University (Drs. Stupp and Ditte Primdahl) and Moffitt Cancer Center (Dr. Patrick Grogan). Phase 1 plans to enroll up to 30 patients to establish a maximum tolerated or recommended dose based on safety, PK/PD and preliminary efficacy, with initial data expected in the first half of 2027. A Phase 2a expansion will test multiple cohorts, including newly diagnosed and recurrent GBM and combinations with other treatments.Read Announcement
Motixafortide FDA Regulatory Events
Motixafortide is a drug developed by BioLineRx for the following indication: For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- motixafortide
- Announced Date:
- May 30, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
BioLineRx Ltd. announced that a poster including new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination clinical trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3, 2025 in Chicago, Illinois.
AI Summary
BioLineRx Ltd. announced that a poster with new data from the pilot phase of its CheMo4METPANC Phase 2 clinical trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, from May 30 to June 3. The trial is testing a combination treatment for metastatic pancreatic cancer that includes the CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard chemotherapy agents gemcitabine and nab-paclitaxel. In the pilot study, four out of eleven patients stayed progression free for over one year. Two patients even underwent definitive treatment; one showed complete resolution of liver lesions and the other had a sustained partial response. The study also found increased CD8+ T-cell infiltration in tumors, suggesting that the treatment may boost the immune system’s ability to fight the cancer.
Read Announcement - Drug:
- motixafortide
- Announced Date:
- May 27, 2025
- Indication:
- For Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma
Announcement
BioLineRx Ltd provided a corporate update.
AI Summary
BioLineRx Ltd provided a corporate update focused on its strategic efforts in oncology and rare diseases. CEO Philip Serlin explained that after out-licensing their FDA-approved stem cell mobilization agent, APHEXDA®, to Ayrmid Ltd., the company has been actively evaluating new assets in its core areas. Serlin expressed optimism about announcing a significant transaction later this year, highlighting that APHEXDA is performing well under Ayrmid’s management—a development that is expected to bring long-term value to BioLineRx.
The update also noted the company’s ongoing clinical development initiatives, including progress in the CheMo4METPANC Phase 2b trial sponsored by Columbia University, which aims to advance treatments for pancreatic cancer. Overall, BioLineRx is leveraging its drug development and regulatory expertise to explore innovative opportunities and bring new therapies to market.
Read Announcement
