On October 23, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology platform, reported new three-year immune and clinical outcome data for personalized cancer vaccine EVX-01 in patients with advanced melanoma.

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The data demonstrates EVX-01 inducing an immune response in all patients, with 89% of its personalised vaccine antigen targets inducing a tumor-specific immune response in treated patients. Further, sustained T-cell responses were observed, with preserved magnitude and breadth of the specific immune response, during the third year of the phase 2 trial in which EVX-01 was administered as monotherapy.

The new data also shows that all patients maintained their clinical response observed at two-year follow-up with no tumor progression observed through the third year of EVX-01 treatment alone. The data will be presented in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 held in Madrid, Spain, tomorrow.

The new findings supplement the unprecedented two-year data presented at ESMO (Free ESMO Whitepaper) in 2025, showing a 75% Objective Response Rate with 25% of patients obtaining a complete response.

"We are delighted to announce yet another set of strong immune and clinical data for EVX-01. The 89% target precision documented in the trial is another confirmation that AI-Immunology identifies and selects the most therapeutically relevant vaccine targets. Thus, the new data supports both EVX-01 as a promising personalized cancer vaccine and our platform as a validated technology for discovery and design of novel treatments," says Birgitte Rønø, CSO and COO of Evaxion.

"What makes these three-year findings particularly compelling is not only the durability of clinical responses, but also the sustained strength and breadth of vaccine-induced T-cell immunity. These results offer an exciting glimpse into the future of precision oncology, where we can harness the unique biology of each patient’s tumor to train the immune system to recognize and target cancer with remarkable specificity. The prospect of translating this highly personalized immune response into long-lasting disease control represents an important step forward and offers renewed hope for patients facing advanced cancer", says Professor Muhammad Adnan Khattak, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, Australia, key opinion leader and one of the trial’s investigators.

Building on convincing two-year results
In addition to promising response rates, the two-year data from the trial also showed a durable clinical benefit, with 92% of patients still responding at two years of follow-up and no relapses observed.

54% of patients had a deepened response following initiation of EVX-01 treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial.

EVX-01 induced an immune response in all patients, with 86% of the vaccine neoantigens generating potent specific T-cell responses as measured at the two-year follow-up. Analyses of additional samples collected during the one-year extension phase further increased this neoantigen hit-rate to 89%.

Evaxion maintains a cash runway extending well into the second half of 2027.

About the phase 2 trial
The phase 2 trial investigated EVX-01 in patients with advanced melanoma. Each patient enrolled in the trial received a unique vaccine designed and manufactured based on their individual biology.

In the first two-years, patients received EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab). KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Six out of 12 responders continued in the trial’s one-year extension, where they received EVX-01 as stand-alone therapy.

Webinar on October 29, 2026
Evaxion will host a webinar featuring key opinion leader and trial investigator, Professor Muhammad Adnan Khattak, on October 29, 2026, at 15.30 CET/10.30am EDT.

The webinar can be attended through registration via this link.

In the webinar, Professor Khattak will present the three-year clinical and immune data from the EVX-01 phase 2 trial in patients with advanced melanoma. The presentation will highlight clinical outcomes, durability of responses and vaccine-induced immune responses following three years of follow-up. The presentation will be followed by a Q&A session, with participants encouraged to submit questions.

Poster presentation details

Poster title: EVX-01, a personalized cancer vaccine, induces sustained T-cell responses and durable disease control in advanced melanoma after three-year of follow-up
Presentation#: 2006P
Location: Poster Area – Hall 5
Topic: Investigational immunotherapy
Date/Time: October 24, 2026, at 12:00 – 12:45 CET
Presenter: Professor Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia
About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancer tumors. It is currently being evaluated as a treatment of advanced melanoma and is Evaxion’s lead clinical asset.

Designed with our AI-Immunology platform, EVX-01 is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumor-specific neoantigens.

(Press release, Evaxion, OCT 23, 2026, View Source [SID1234673706])

On October 23, 2026 Enterome SA, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted in vivo immune therapies, reported final data from the Phase 1/2 AUDREY study of OncoMimics EO4010 in combination with nivolumab, with or without bevacizumab, in patients with mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC) previously treated with standard chemotherapy and anti-VEGF or anti-EGFR therapy. The data show that EO4010 expands CD8 T cells directed at the tumor-associated antigens it mimics in most patients, and that fast and high-level expansion of these tumor-targeting CD8 T cells is associated with longer overall survival.

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The data are being presented on 25 October 2026 in a poster at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain (Abstract 859P), by presenting author Dr. Elena Élez Fernandez, Vall d’Hebron University Hospital, Barcelona.

"pMMR metastatic colorectal cancer remains one of the most difficult settings for immunotherapy. The consistent expansion of tumor-directed CD8 T cells in these patients, and its association with survival, support continued investigation of this approach in a controlled study," said Dr. Elena Élez Fernandez, Vall d’Hebron University Hospital, Barcelona, Spain, presenting author.

"In this pretreated population of patients with pMMR colorectal cancer, EO4010 rapidly expanded CD8 T cells recognizing the peptides of EO4010 in every patient, and in most patients, these CD8 T cells cross-reacted with the tumor-associated antigens that EO4010 mimics. The speed and level of CD8 T-cell expansion have now been shown to be associated with overall survival. This encouraging signal from a small Phase 1/2 trial, together with the data pointing to BIRC5 as the epitope driving it as well as the good tolerability we observed with EO4010 treatment, gives us clear support for the continued clinical evaluation of EO4010 in pMMR mCRC," said Jan Fagerberg, MD, Chief Medical Officer of Enterome.

"Since the war on cancer began, researchers have been frustrated by the disease’s ability to evade the body’s immune system. These data presented at the ESMO (Free ESMO Whitepaper) conference confirm and extend to solid tumors what we reported this year with another OncoMimics candidate, EO2463, in blood cancer. CD8 T cells raised by OncoMimics are associated with patient outcomes. In short, we have shown that OncoMimics therapeutic intervention is teaching the patients’ immune systems how to recognize their cancer," said Pierre Belichard, Chief Executive Officer of Enterome.

"With clinical signals now in three programs across glioblastoma, lymphoma and colorectal cancer, we believe the OncoMimics platform has shown potentially disruptive therapeutic promise as it is now validated in both blood and solid cancers. Further studies are needed to determine the magnitude and duration of effect of OncoMimics and this is the basis of our ongoing discussions with partners and investors on the next stage of development for the portfolio."

The Phase 1/2 AUDREY trial treated 25 patients with unresectable pMMR mCRC whose disease had progressed after oxaliplatin, irinotecan, fluoropyrimidines and anti-VEGF or anti-EGFR therapy. Twenty patients received EO4010 plus nivolumab (Cohorts 1 and 2) and five patients received EO4010 plus nivolumab and bevacizumab (Cohort 3). Patients in Cohorts 1 and 2 had received a median of three prior lines of systemic treatment for metastatic disease. pMMR tumors account for the large majority of mCRC and generally do not respond to checkpoint inhibitors alone.

Key data presented at ESMO (Free ESMO Whitepaper):

Tolerability: EO4010 in combination with nivolumab, with or without bevacizumab, was well tolerated. The most common treatment-related adverse event was local administration site reaction (84% of patients). The only related grade 3 events were two local administration site reactions, and there were no grade 4 or 5 events.
Immune response: EO4010-induced expansion of CD8 T cells specific for the EO4010 peptides and for their tumor-associated antigen targets was detected in 100% and 84% of patients, respectively. Expansion was fast, with 81% and 71% of patients positive after two to three administrations (weeks 5-6), and durable, with specific CD8 T cells still detectable at 10 months of follow-up.
Clinical activity: Disease control was achieved in 6 of 25 patients (24%), with a median duration of disease control of 5.5 months, including one partial response with 47% shrinkage of liver metastases and 34% shrinkage of lung metastases lasting 8.7 months. Median overall survival was 11.3 months (95% CI 7.1–not reached) in Cohorts 1 and 2, with a median follow-up of 16.8 months, and was not reached in Cohort 3 (95% CI 9.7–not reached; median follow-up 12.0 months).
Association with survival: In Cohorts 1 and 2, faster and higher expansion of tumor-targeting CD8 T cells was associated with longer overall survival in univariate analyses. Across all cohorts, patients with expansion at week 5 of CD8 T cells specific for BIRC5, or for the EO4010 peptide EO2317 that mimics BIRC5, lived longer than patients without such expansion (BIRC5: HR 0.27, 95% CI 0.08–0.91, log-rank p=0.024; EO2317: HR 0.15, 95% CI 0.03–0.69, log-rank p=0.005; n=21 evaluable patients). All p-values are nominal. Exploratory analyses indicate that anti-cancer treatments received after the study do not account for the survival signal.
Earlier this year, Enterome reported at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress and the Pan Pacific Lymphoma Conference (PPLC) that EO2463-induced CD8 T-cell expansion was associated with objective response, complete response and progression-free survival in patients with indolent non-Hodgkin lymphoma. Enterome expects to present further EO2463 data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2026.

ESMO Congress 2026 Presentation Details

Title: EO4010 (EO) multi-target peptide immunotherapy: tumor directed CD8 T cell expansion kinetics and association to survival in patients (pts) with treated mismatch repair proficient (pMMR) metastatic colorectal carcinoma (mCRC). Study EOCRC2-22/AUDREY (NCT05589597)

Abstract: 859P | Poster Display Session Colon Cancer, Sunday 25 October 2026, 12:00–12:45 PM CET, Poster Area Hall 5 – Copy of the poster is available here.

Congress: ESMO (Free ESMO Whitepaper) Congress 2026, Madrid, Spain, 23–27 October 2026

Presenting author: Dr. Elena Élez Fernandez, Vall d’Hebron University Hospital, Barcelona, Spain

e-Poster: available to registered delegates on the ESMO (Free ESMO Whitepaper) 2026 Virtual Congress Platform from Friday 23 October 2026, 08:00 CEST

AUDREY (EOCRC2-22; NCT05589597) is an open-label, multicenter Phase 1/2 study conducted in Europe and the United States evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO4010 in combination with nivolumab (Cohorts 1 and 2) and with nivolumab plus bevacizumab (Cohort 3) in HLA-A2 positive patients with unresectable pMMR mCRC previously treated with oxaliplatin, irinotecan, fluoropyrimidines and anti-VEGF or anti-EGFR therapy. Twenty-five patients were treated; the data presented at ESMO (Free ESMO Whitepaper) are the final study data.

EO4010 is an off-the-shelf OncoMimics active immunotherapy composed of five synthetic microbial-derived peptides (EO2317, EO2318, OMP10, OMP11 and OMP12) designed to mimic CD8 T-cell epitopes of the tumor-associated antigens BIRC5 (survivin), FOXM1, UBE2C, CDC20 and KIF2C, which control the cell cycle and are upregulated in metastatic colorectal cancer, plus the helper peptide UCP2. This multi-target approach is intended to expand in vivo pre-existing memory CD8 T cells that cross-react with the tumor antigens, broaden target coverage and obviate antigen escape.

OncoMimics are designed to teach the immune system to recognize and defend against cancer. They consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or lineage markers (e.g. as observed in B cell lymphomas). These peptides induce a fast and potent in vivo expansion of effector-memory CD8 T-cells, naturally primed by gut bacteria, and cross-reactive with TAAs/B cell markers, thereby eliciting cytotoxic responses against tumor cells. Because they are recognized as foreign entities by the immune system, OncoMimics help overcome the self-tolerance that limits the ability of many cancer immunotherapies to trigger rapid, potent, and durable endogenous immune responses. The synthetically produced OncoMimics peptides are selected and designed in silico by mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple highly immunogenic peptides specifically designed to broaden target coverage, mitigate tumor heterogeneity and obviate the cancer’s ability to escape the therapeutic intervention.

(Press release, Enterome, OCT 23, 2026, View Source [SID1234673705])

On October 23, 2026 Convergent Therapeutics Inc., a clinical-stage biotechnology company developing next-generation radiopharmaceuticals for the treatment of cancer, reported compelling results from Part 2 of the Phase 2 CONVERGE-01 study evaluating Ac-225 rosopatamab tetraxetan (CONV01-α) in patients with Lu-PSMA-naïve, androgen pathway modulator-resistant (APMR) prostate cancer. In the study, CONV01-α demonstrated potent anti-tumor activity, including deep prostate specific antigen (PSA) responses following a two-dose regimen, with a favorable safety profile.

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In the study, CONV01-α achieved a PSA50 response rate of 84% and a PSA90 response rate of 26% demonstrating substantial anti-tumor activity in patients with rapidly progressing disease. Treatment was well tolerated, with clinically manageable hematologic toxicity at the target dose and no renal or hepatic toxicity or high-grade xerostomia observed. Direct Actinium-225 dosimetry also demonstrated the feasibility of measuring radiation exposure in normal organs, with reassuring absorbed-dose estimates that provide additional support for the favorable safety and tolerability profile observed to date.

"The depth of PSA responses observed with only two doses of Ac-225 rosopatamab tetraxetan, together with its favorable safety profile, offers a particularly compelling option for patients with metastatic castration-resistant prostate cancer (or APMR) who have not yet received Lu-PSMA, a population for whom novel treatment options are needed," said Praful Ravi, MB, BChir, MRCP, Medical Director of Genitourinary Theranostics at Dana-Farber Cancer Institute. "The patient-friendly two-dose regimen also has the potential to substantially reduce treatment burden, allowing patients to resume their usual activities and family lives at home without prolonged radiation-related isolation."

The study findings build on previously reported Phase 2 results in patients treated with Lu-PSMA therapy and reinforce the potential of CONV01-α as a differentiated treatment option across multiple stages of advanced prostate cancer.

"These results reinforce our conviction that CONV01-α has the potential to become an important treatment option across the prostate cancer therapy continuum," said Philip Kantoff, M.D., Co-Founder and Chief Executive Officer of Convergent Therapeutics. "Demonstrating substantial anti-tumor activity in patients both before and after Lu-PSMA treatment underscores the significant opportunity for targeted alpha therapies in a disease where curative options remain limited. We look forward to continuing CONVERGE-01, further exploring its potential in this earlier treatment setting and advancing our development plans to bring this promising therapy to patients."

ESMO program details:

Abstract Title: CONVERGE-01: Ac-225 Rosopatamab Tetraxetan (CONV01-α) in Patients with Androgen Pathway Modulator Resistant Prostate Cancer (APMR)
Abstract Number: 2266P
Format: Poster Presentation
Location: IFEMA, Madrid
Date and Time: October 23, 2026, 3:15 pm CEST
Presenter: Praful Ravi, MB, BChir, MRCP, Medical Director of Genitourinary Theranostics at Dana-Farber Cancer Institute

About CONV01-α
CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of mCRPC, uses a humanized monoclonal antibody (rosopatamab) directed against PSMA, a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling precise short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

(Press release, Convergent Therapeutics, OCT 23, 2026, View Source;in-Lu-PSMA-Nave-Prostate-Cancer-at-ESMO-Congress-2026 [SID1234673704])

On October 23, 2026 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) reported that SystImmune’s parent company Sichuan Biokin Pharmaceutical, Ltd. (Biokin) announced positive results from a prespecified interim analysis of the randomized Phase 3 PANKU-Breast01 study (NCT06343948) evaluating izalontamab brengitecan (iza-bren), an investigational, potentially first-in-class, dual-targeting EGFRxHER3 bispecific antibody-drug conjugate (ADC), versus chemotherapy in patients with unresectable locally advanced, recurrent or metastatic hormone receptor-positive (HR+)/HER2-negative (HER2-) breast cancer who have failed at least one prior line of chemotherapy. Results will be presented today in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Annual Congress taking place October 23–27 in Madrid, Spain, and simultaneously published in The Lancet.

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With a median follow-up for progression-free survival (PFS) of 15.2 months, results showed iza-bren (n=190) reduced the risk of disease progression or death, the study’s primary endpoint, by 59%, with median PFS vs. chemotherapy (n=193) of 8.2 months vs. 4.0 months as assessed by Blinded Independent Central Review (BICR) [HR: 0.41; 95% CI: 0.33-0.53, p<0.0001]. Overall survival, a key secondary endpoint of the study, was immature at the time of interim analysis. Confirmed objective response rate (cORR) by BICR was 40.5% with iza-bren vs. 20.2% with chemotherapy, and median duration of response (mDOR) was 6.9 months vs. 4.2 months, respectively.

"While there have been advances in the treatment landscape for HR-positive, HER2-negative advanced breast cancer, options can become increasingly limited as patients progress through available therapies, with most ultimately relying on chemotherapy," said Professor Binghe Xu, Academician of the Chinese Academy of Engineering, Cancer Hospital Chinese Academy of Medical Sciences. "PANKU-Breast01 provides encouraging evidence for a new therapeutic approach. Unlike other ADCs, izalontamab brengitecan is designed to target both EGFR and HER3, and the reduction in the risk of disease progression or death suggests it could offer patients a meaningful new treatment option."

The safety profile for iza-bren was manageable and no new safety signals were identified. Grade ≥3 treatment-related adverse events (TRAEs) were predominantly hematologic in nature. TRAEs were manageable with supportive care, and only 1.6% of patients discontinued iza-bren treatment due to TRAEs. Adjudicated interstitial lung disease (ILD) occurred in two (1.1%) patients with iza-bren (Grade 1 or 2).

"The 59% reduction in progression or death we see with iza-bren represents a substantial advance for patients who have limited treatment options after prior chemotherapy," said Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. "This Phase 3 data, combined with our positive results in triple-negative breast cancer, demonstrates that our dual EGFRxHER3-targeting approach can meaningfully address the biology of multiple breast cancer subtypes and represents an important step towards more effective, precision-based treatment strategies."

"The positive PANKU-Breast01 results are an important validation of iza-bren’s potential as an innovative scientific approach to overcome disease resistance and the limitations of currently available treatment options," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "Together with the clinical benefit iza-bren has shown in other tumor types, these data position iza-bren as a potentially first-in-class dual-targeting ADC therapy with the potential to become a new standard of care across the cancer treatment paradigm."

Iza-bren has demonstrated clinical benefit in five Phase 3 trials across five distinct indications, including previously-treated HR+/HER2-negative breast cancer, previously-treated EGFR-mutated non-small cell lung cancer, nasopharyngeal carcinoma after prior treatment, previously-treated esophageal squamous cell carcinoma, and advanced triple-negative breast cancer, underscoring iza-bren’s broad therapeutic potential in areas of critical unmet need. Iza-bren has also received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for previously-treated advanced EGFR-mutated NSCLC.

The PANKU-Breast01 study is sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China. Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement.

About izalontamab brengitecan (iza-bren)

Izalontamab brengitecan (iza-bren, BL-B01D1) is a bispecific antibody-drug conjugate (ADC) that targets both EGFR and/or HER3, antigens that are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Upon target binding and internalization, iza-bren’s therapeutic novel Topo1i payload is released, causing cytotoxic stress that leads to cancer cell death. Iza-bren’s dual mechanism of action also blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb.

(Press release, Bristol-Myers Squibb, OCT 23, 2026, View Source;Breast-Cancer-in-Phase-3-PANKU-Breast01-Study/default.aspx [SID1234673703])

On October 23, 2026 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported that the companies presented data at the 2026 European Society for Medical Oncology Annual Congress (ESMO 2026) demonstrating synergy between GLIX1 and multiple PARP inhibitors (PARPi) in homologous recombination (HR)-proficient ovarian cancer cell lines and in an in vivo patient-derived xenograft (PDX) model.

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"These preclinical findings extend the rationale for GLIX1 beyond glioblastoma, where we have already enrolled three dose-level patient cohorts in our Phase 1/2a clinical trial," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, the in vivo results further strengthen the rationale for combining GLIX1 with PARP inhibitors, demonstrating meaningful anti-tumor activity in an HR-proficient ovarian cancer model even at reduced doses of both agents. We are very encouraged by these findings and look forward to further exploring GLIX1/PARP inhibitor combinations, including the planned addition of an ovarian cancer arm in the expansion phase of our ongoing clinical trial."

"GLIX1 is designed to restore TET2 activity and drive tumor-selective DNA damage," said Dr. Adam Robertson, Ph.D., Chief Scientific Officer of Hemispherian AS and presenting author of the abstract. "These findings suggest GLIX1 could remove the HR-deficiency requirement for PARPi activity, thereby both improving and broadening the use of PARP inhibitors in ovarian cancers, and we look forward to building on this work."

Presentation Details:

Title: GLIX1, a TET2 Activator Targeting the DNA Damage Response, Synergizes with PARP Inhibitors in Ovarian Cancer Cell Lines

Category: Gynecological Cancers

Presentation #: 1435eP

Presentation type: e-Poster

Location: e-Poster Area, Hall 25

Summary:

Ovarian cancer remains difficult to treat, particularly in HR-proficient tumors, where PARP inhibitors have shown limited activity. GLIX1 is a first-in-class small molecule that activates TET2, an enzyme that is suppressed in cancer and normally drives DNA demethylation. By restoring TET2 activity, GLIX1 is designed to induce tumor-selective single-stranded DNA breaks through base excision repair, which could overcome the PARP inhibitor requirement for HR deficiency.

GLIX1 was combined with three PARP inhibitors (olaparib, veliparib and niraparib) across a panel of HR-proficient ovarian cancer cell lines, supporting a mechanism-driven class effect. The combination produced reproducible synergy with all three agents, with ZIP synergy scores ranging from 10.9 to 43.2 (olaparib: 15.4–43.0; veliparib: 10.9–43.2; niraparib: 12.2–39.8). Cells treated with the combination also showed upregulation of p21, consistent with activation of the DNA damage response.

The poster also presents results from a 28-day study in an HR-proficient ovarian cancer patient-derived xenograft (PDX) model (OV0250). The low-dose combination of GLIX1 (50 mg/kg daily) and olaparib (10 mg/kg daily) demonstrated statistically significant tumor growth inhibition versus vehicle control, and greater antitumor activity than either GLIX1 (250 mg/kg daily) or olaparib (50 mg/kg daily) administered alone at their respective optimal doses. The combination also demonstrated tumor growth inhibition comparable to cisplatin.

Additional tumor-exposure measurements demonstrated GLIX1 penetration into ovarian tumor tissue following oral administration, with tumor-to-plasma concentration ratios of approximately 50%. Plasma and tumor GLIX1 concentrations were measured one hour after dosing in a representative animal from each of the two GLIX1 monotherapy groups.

These data support synthetic lethality between GLIX1 and PARP inhibition and indicate that GLIX1 may remove the HR-deficiency requirement for PARP inhibitor activity. Such a combination, when applied clinically, may improve and broaden the use of PARPi in ovarian cancers. GLIX1 is currently being evaluated in a Phase 1/2a clinical trial in glioblastoma, with plans to include an ovarian cancer arm in the expansion phase (NCT07464925).

About GLIX1

GLIX1 is a first-in-class, orally administered, brain-penetrant small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway, which is commonly suppressed in cancer. Activating TET2 with GLIX1 is designed to overwhelm the DNA repair capacity of cancer cells, resulting in tumor-selective cell death. GLIX1 is being developed by BioLineRx and Hemispherian AS for the treatment of glioblastoma and other solid tumors.

About Ovarian Cancer

Ovarian cancer is the deadliest gynecologic malignancy in the United States, with an estimated 21,000 new cases and over 12,000 deaths projected in 2026. Standard first-line treatment consists of cytoreductive surgery and platinum-based chemotherapy, with PARP inhibitors used as maintenance therapy in selected patients, particularly those with BRCA-mutated or homologous recombination (HR)-deficient disease. However, PARP inhibitors are markedly less effective in patients with HR-proficient tumors, which account for approximately 50% of high-grade serous ovarian cancers and are associated with primary platinum resistance and shorter survival. This leaves a substantial and currently underserved patient population in need of new treatment strategies capable of extending the benefits of PARP inhibitors.

(Press release, BioLineRx, OCT 23, 2026, View Source [SID1234673702])