Request Demo

Last update 16 Sep 2026

Bevacizumab

Last update 16 Sep 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Bevacizumab(Genetical Recombination), rhuMAb-VEGF, 贝伐单抗

+ [18]

Target

VEGF-A

Action

inhibitors

Mechanism

VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors), Angiogenesis inhibitors

Therapeutic Areas

NeoplasmsNervous System DiseasesCongenital Disorders+ [10]

Active Indication

Neurofibromatosis 2Unresectable Hepatocellular CarcinomaHepatocellular Carcinoma+ [184]

Inactive Indication

Acidemia, IsovalericAcute Basophilic LeukemiaAcute Eosinophilic Leukemia+ [319]

Originator Organization

Genentech, Inc.

Active Organization

National Cancer Institute

The University of Texas MD Anderson Cancer CenterRoche Registration GmbH

+ [27]

Inactive Organization

Sanofi-Synthelabo, Inc.

Pharma Mar SA

The Case Comprehensive Cancer Center

+ [56]

License Organization

Roche Korea Co., Ltd.

Immune-Onc Therapeutics, Inc.

Roche Holding AG

+ [5]

Drug Highest PhaseApproved

First Approval Date

United States (26 Feb 2004),

Colonic CancerRectal Cancer

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States)

Structure/Sequence

Sequence Code 41632H

Source: *****

Sequence Code 41637L

Source: *****

3,630

Clinical Trials associated with Bevacizumab

NCT07729098

/ Not yet recruitingPhase 1IIT

Safety And Efficacy of Intra-aRterial BEV (IA-BEV) as an Adjunctive Treatment During Middle Meningeal Artery Embolization (MMAE) in Non-Surgical Chronic Subdural Hematoma (cSDH) Patients

This is a Phase 1, open-label, single-center, dose-escalation study evaluating the safety and tolerability of intra-arterial bevacizumab (IA-BEV) given as an adjunct to middle meningeal artery embolization (MMAE) in adults with non-surgical chronic subdural hematoma (cSDH). Up to 18 participants who are already scheduled to undergo MMAE as standard of care will receive a single dose of bevacizumab, delivered directly into the middle meningeal artery immediately before embolization, during the same procedure. Three dose levels (2.0, 3.5, and 5.0 mg/kg) will be tested using a standard 3+3 dose-escalation design to identify the maximum tolerated dose. The study will also collect imaging and blood biomarker data to help understand which patients may benefit most from this combined treatment approach.

Start Date01 Jan 2027

Sponsor / Collaborator

University of Maryland Baltimore

TCTR20260721004

/ Not yet recruitingPhase 4IIT

Efficacy and Regimen of Bevacizumab Augmentation in Glaucoma Surgeries: A Randomized Clinical Trial across Trabeculectomy, Glaucoma Drainage Device, MIBS at Mettapracharak Hospital (Wat Rai khing)

Start Date01 Jan 2027

Sponsor / Collaborator-

NCT07797283

/ Not yet recruitingPhase 3

A Phase 3, Double-Blind, Randomized, Controlled Study of INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1 (MAESTRA 3)

The purpose of this study is to evaluate INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1.

Start Date01 Dec 2026

Sponsor / Collaborator

Incyte Corp.

100 Clinical Results associated with Bevacizumab

100 Translational Medicine associated with Bevacizumab

100 Patents (Medical) associated with Bevacizumab

21,152

Literatures (Medical) associated with Bevacizumab

31 Dec 2026·mAbs

A novel insulin-like growth factor II-based masking domain for conditional activation of therapeutic antibodies

Article

Author: Shi, Lihua ; Cho, Minseon ; Nishida, Motohiko ; Chiu, Mark L. ; Zhang, Di

Systemic target engagement constrains the therapeutic index of many antibody drugs, particularly in inflammatory disease and immuno-oncology. Protease-cleavable masking can localize activity to disease sites, but existing approaches often tradeoff masking strength, reversibility, and developability. Here, we evaluated the insulin-like growth factor II (IGF-II) as a compact, structurally defined steric masking domain for protease-dependent conditional activation of therapeutic antibodies. IGF-II masking domains, including a receptor-silent variant (IGF-II-s), were engineered as N-terminal fusions to therapeutic antibodies via protease-cleavable linkers and characterized using antigen-binding and cell-based functional assays. IGF-II masking attenuated anti-TNFα binding and neutralization potency in a protease-dependent manner and activity was largely restored following cleavage. In vivo, an MMP2/9-cleavable masked anti-TNFα antibody retained efficacy comparable to adalimumab and infliximab in a collagen antibody-induced arthritis model, yet, unlike the reference antibodies, did not measurably reduce survival in a Listeria monocytogenes infection challenge model at the dose tested. IGF-II-s showed no detectable IGF receptor binding and provided stronger masking than native IGF-II. This generalized approach was demonstrated across multiple antibodies, enabling efficient protease-dependent conditional activation of trastuzumab (anti-HER2), an anti-IL-1β antibody, and bevacizumab (anti-VEGF). Together, these results established an engineered IGF-II-based masking domain as a versatile, IGF-II receptor-silent platform enabling protease-dependent conditional activation of therapeutic antibodies, with potential to improve safety and expand therapeutic windows.

31 Dec 2026·mAbs

Rapid expression of therapeutic antibodies in mammalian cells via mRNA transfection

Article

Author: Gillard, Marianne ; Marcellin, Esteban ; Gunter, Helen ; Chavalparit, Thornwit ; Mercer, Timothy ; Barry, Craig

Messenger RNA (mRNA) has emerged as a powerful tool for protein expression in clinical settings, yet its potential as a platform for biologics manufacturing remains underexplored. Here, we evaluate transient mRNA transfection in Chinese hamster ovary (CHO) cells as a rapid and versatile system for protein production. Using reporter mRNAs, we optimize transfection efficiency and benchmark performance against industry-standard plasmid transfection and stable cell line methods. We demonstrate that co-transfection of heavy and light chain mRNAs enables the efficient synthesis, assembly and secretion of the monoclonal antibody bevacizumab with high fidelity. Compared to conventional approaches, mRNA transfection drives rapid and predictable protein expression, reducing cell incubation times and enabling sequential or conditional expression. These features highlight mRNA as a flexible and efficient platform for transient expression, providing a foundation for accelerating the development and manufacturing of biologics.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of atezolizumab and bevacizumab as first-line systemic therapy in unresectable hepatocellular carcinoma in Malaysia

Article

Author: Chaiyakunapruk, Nathorn ; Patikorn, Chanthawat ; Sulaiman Shah, Audi Adawiah ; Wong, Yoke Fui ; Mohamed, Rosmawati

AIM:

This study aims to evaluate the cost-effectiveness of atezolizumab plus bevacizumab as first-line systemic therapy for unresectable hepatocellular carcinoma (uHCC) in Malaysia, compared with the current standard treatments in the Malaysian Ministry of Health (MOH) to inform public healthcare decision‑making.

MATERIALS AND METHODS:

A cost-effectiveness analysis was conducted from the MOH perspective, following the national pharmacoeconomic guidelines (2019). The study compared atezolizumab plus bevacizumab with sorafenib and lenvatinib, respectively, using a partitioned survival model to project health outcomes and costs over a lifetime horizon. Clinical efficacy data were sourced from published trials and network meta-analyses. Cost inputs reflected local healthcare resource use and prices, using 2024 Malaysian Ringgit values inflated via the Consumer Price Index for Health. Costs and outcomes were discounted at 3% annually. Deterministic and probabilistic sensitivity analyses were performed to assess the impact of key parameter uncertainties on the results.

RESULTS:

Atezolizumab plus bevacizumab provided the highest quality-adjusted life years (QALYs) and life years compared to sorafenib and lenvatinib. Sorafenib was dominated by lenvatinib due to lower QALYs and higher costs and excluded from further analysis. Compared to lenvatinib, atezolizumab plus bevacizumab yielded 0.873 additional QALYs and RM 44,863 additional cost, resulting in an incremental cost-effectiveness ratio (ICER) of RM 51,399 per QALY gained (∼0.906 GDP/capita at Malaysia's 2024 GDP/capita RM 56,734).

CONCLUSIONS:

Atezolizumab plus bevacizumab is cost-effective compared to lenvatinib and sorafenib across willingness-to-pay (WTP) values of one to three times Malaysia's GDP per capita. These findings provide evidence to inform public health policy that expanding funding and adoption of atezolizumab plus bevacizumab is likely to improve health outcomes cost-effectively.

1,688

News (Medical) associated with Bevacizumab

22 hours ago

·www.biospace.com

Ivonescimab Monotherapy Demonstrates a Statistically Significant & Clinically Meaningful Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in Akeso’s HARMONi-2 Study Conducted in China

Ivonescimab Reduced the Risk of Death by 27% Compared to Pembrolizumab HARMONi-2 Demonstrated an Improvement in Median Overall Survival of 8.2 Months PD-L1 High Expression Subgroup: Hazard Ratio = 0.58 Summit is Conducting Global Phase III HARMONi-7 Study in Patients with PD-L1 High-Expressing NSCLC Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced that updated data, including overall survival (OS), from the randomized, double-blind Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab is being presented at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) in Seoul, Republic of Korea. The HARMONi-2 presentation entitled, Overall Survival Analysis From HARMONi-2: Ivonescimab vs Pembrolizumab as First-Line Treatment for PD-L1-Positive NSCLC, evaluated ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 Score >1%). HARMONi-2 (AK112-303) is a single-region, multi-center Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. The trial results will be presented by Professor Caicun Zhou, MD, PhD, Chief Physician and Director of the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University School of Medicine, and President of IASLC, on Tuesday September 15, 2026. Clinically Meaningful Efficacy In this protocol-specified interim analysis of OS, a secondary endpoint in the HARMONi-2 study, ivonescimab monotherapy demonstrated a statistically significant and clinically meaningful improvement compared to pembrolizumab monotherapy, achieving a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.95; p=0.009). A clinically meaningful benefit was demonstrated across important clinical subgroups, including those with PD-L1 low expression (PD-L1 Score 1-49%) and PD-L1 high expression (PD-L1 Score ≥ 50%), along with those with squamous and non-squamous histologies. In this analysis, ivonescimab continued to demonstrate an acceptable and manageable safety pro the HARMONi-2 study, which was consistent with previous Phase III studies of ivonescimab. No additional safety signals were noted in the HARMONi-2 study in this current data cut with longer treatment duration (median of 14 cycles of ivonescimab vs. 10 cycles of pembrolizumab) compared to the previous data cut. Global Phase III HARMONi-7 StudyBased on the primary analysis results of HARMONi-2, Summit initiated the global HARMONi-7 study (NCT06767514) in early 2025. HARMONi-7 is a randomized, double-blind, multi-regional Phase III clinical trial evaluating ivonescimab monotherapy to pembrolizumab monotherapy in the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 Score > 50%). The study is currently recruiting, with a target enrollment of 780 patients globally. The co-primary endpoints of HARMONi-7 are PFS and OS. The HARMONi-2 study is being conducted by Akeso in China, where ivonescimab is approved and commercially available for indications in NSCLC. Ivonescimab remains investigational and is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) and increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso. There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026. HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026. HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering. HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC. HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC. Five Phase III ivonescimab clinical trials have read out to date, all five with positive data. Four of these five studies are in NSCLC, and one is in biliary tract cancer (BTC). In addition to Summit’s positive HARMONi study, Akeso has had positive read-outs in three single-region (China), randomized Phase III clinical trials in NSCLC, HARMONi-A, HARMONi-2, and HARMONi-6, including a statistically significant overall survival benefit in all three studies. Akeso has also reported a statistically significant OS benefit in the single-region (China), randomized Phase III HARMONi-GI1 trial in advanced BTC. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. HARMONi-GI1 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced BTC. Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK. References: Xiong A, Wang L, Chen J, Wu L, Liu B, Yao J, et al. Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China. Lancet. 2025;405(10481):839-849. doi:10.1016/S0140-6736(24)02722-3. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalImmunotherapy

23 hours ago

·www.prnewswire.com

Sapience Therapeutics Announces FDA Acceptance of Investigational New Drug Application for ST316 in Familial Adenomatous Polyposis (FAP)

Sept. 14, 2026 -- Sapience Therapeutics, Inc., a clinical-stage biotechnology company dedicated to developing first-in-class peptide therapeutics targeting the underlying oncogenic and immune mechanisms driving cancer and pre-cancerous disease, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company an Investigational New Drug (IND) application for ST316 (IND 184073) for the treatment of familial adenomatous polyposis (FAP), a rare inherited disorder associated with the development of hundreds to thousands of precancerous colorectal polyps and a significantly increased risk of colorectal cancer. ST316 has previously received Orphan Drug designation from the FDA for the treatment of familial adenomatous polyposis. "We are pleased to reach this important regulatory milestone for ST316," said Barry Kappel, Chief Executive Officer of Sapience Therapeutics. "ST316's unique mechanism of action is designed to selectively inhibit oncogenic β-catenin activity while avoiding the toxicities associated with broader Wnt pathway inhibition. The favorable safety and tolerability profile observed with ST316 monotherapy in the Phase 1 clinical study strengthens the potential of this differentiated approach, particularly in FAP, where long-term treatment requires a high bar for safety and tolerability. Together with supportive preclinical activity in FAP models of disease, we believe ST316 has the potential to become an important new therapeutic option for patients with this serious inherited condition." ST316 has already demonstrated encouraging clinical activity in an ongoing Phase 2 expansion study in second-line metastatic colorectal cancer (2L mCRC). As presented at AACR 2026, and based on an April 13, 2026 data cutoff, 15 patients had been enrolled and treated with ST316 in combination with standard of care (FOLFIRI and bevacizumab), with a confirmed objective response rate (ORR) of 47%, including seven confirmed partial responses, and a disease control rate (DCR) of 93%. These results compare favorably to historical outcomes for FOLFIRI and bevacizumab in 2L mCRC patients, which have demonstrated an 11% ORR. Responses were observed across multiple patient subgroups, including those with RAS-mutated and RAS wild-type tumors, liver metastases, and prior bevacizumab exposure. In the 23-patient Phase 1 monotherapy portion of the study, ST316 demonstrated a favorable safety and tolerability profile, as previously disclosed at AACR 2026. These results provide clinical validation of β-catenin/BCL9 pathway antagonism in humans and support the rationale for evaluating ST316 in other β-catenin-driven diseases, including FAP, where the pathway is uniformly activated. Familial adenomatous polyposis (FAP) is a rare inherited condition, characterized by the development of numerous adenomatous polyps in the colon and rectum, typically resulting from mutations in the APC gene. Without intervention, individuals with FAP face a near-certain lifetime risk of developing colorectal cancer. Current management strategies rely heavily on intensive surveillance and prophylactic surgery, underscoring the need for effective medical therapies that can reduce disease burden and delay or prevent surgical intervention. FAP affects an estimated 1 in 5,000 to 10,000 individuals in the United States, according to the National Organization for Rare Disorders, and there are currently no FDA-approved medical therapies for the condition. ST316 is Sapience Therapeutics' first-in-class β-catenin antagonist designed to selectively inhibit the oncogenic activity of β-catenin through blockade of its interaction with BCL9, a critical transcriptional co-activator in the Wnt/β-catenin signaling pathway. This selective mechanism is designed to spare normal Wnt-dependent processes such as intestinal stem cell renewal and bone homeostasis, the mechanistic basis for the dose-limiting gastrointestinal and bone toxicities seen with broad Wnt pathway inhibitors. Consistent with this rationale, ST316 has not been associated with any gastrointestinal or bone-related adverse events leading to dose reduction, interruption, or discontinuation among the 38 patients treated to date in the Phase 1 monotherapy (n=23) and Phase 2 FOLFIRI and bevacizumab combination cohort of the study (n=15). Aberrant β-catenin signaling is a key driver of numerous cancers and pre-cancerous diseases, including familial adenomatous polyposis (FAP). ST316 is currently being evaluated in an ongoing Phase 2 dose expansion study in second-line metastatic colorectal cancer (2L mCRC) in combination with standard-of-care therapy. ST316 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of FAP. Sapience Therapeutics, Inc. is a privately held, clinical-stage biotechnology company focused on discovering and developing peptide therapeutics to address oncogenic and immune dysregulation that drive cancer. With in-house discovery capabilities, Sapience has built a pipeline of therapeutic candidates called SPEARs™ (Stabilized Peptides Engineered Against Regulation) that disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable. Sapience can also direct cargo to cell surface targets with their new class of molecule called SPARCs™ (Stabilized Peptides Against Receptors on Cancer), enabling delivery of radioisotope payloads such as α-particles to cancer cells. The company's lead programs, ST316, a first-in-class antagonist of β-catenin, and lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, are currently being evaluated in fully enrolled Phase 2 clinical trials. The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugClinical ResultIND

16 Sep 2026

·www.globenewswire.com

TME PHARMA CEO MESSAGE

TME PHARMA CEO MESSAGE Berlin, Germany, September 16, 2026, 8.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for brain cancer and eye diseases, today publishes a message from its CEO for the shareholders. Dear Shareholders,As I look back on the recent period, one clear feeling dominates: remained confidence in the path we are taking. We fully understand that many of you are eager to see concrete decisions. When reaching a decisive phase, waiting can naturally feel long. However, as you know, thorough negotiations and strategic choices do not happen overnight. As we move through a pivotal phase for TME Pharma, I would like to share an update on our strategic approach, our financial discipline, and our commitment to long-term value creation.Our focus remains squarely on securing an outcome that properly reflects the significant potential of our lead asset, NOX-A12. Executive Alignment & Capital DisciplineMy management philosophy across the entities I lead is rooted in absolute alignment with long-term shareholders. We strictly control overhead, and my personal compensation framework is structured to lower cash consumption and to emphasize long-term upside tied directly to company performance and share price appreciation. Furthermore, through direct personal investments and capital contributions, my priority has consistently been to protect existing shareholders from unnecessary dilution wherever possible. Since June 2025, our disciplined cost-reduction strategy has proven essential. By streamlining our burn rate, we successfully extended our financial runway into the second quarter of 2027. Through the use of standard bond financing, we have maintained a very limited level of dilution since December 2024. This deliberate approach was executed to ensure that TME Pharma retained the independence and time needed to negotiate from a position of strength. Capitalizing on Market DynamicsOur capital management strategy was designed to ensure the company was well-positioned as biotech sector sentiment and deal-making dynamics improved. We are observing increasingly positive momentum in the industry, marked by renewed capital flows and strategic demand for clinical-stage assets. TME Pharma is structured to leverage these favorable market conditions for the benefit of our shareholders. Ongoing Strategic Partnering for NOX-A12Following our announcement on August 24, 2026, we are continuing our evaluation process. In our discussions with potential partners, our primary focus is to safeguard long-term success. This entails ensuring that the upcoming Phase 2 GLORIA trial is effectively executed under a robust regulatory strategy. In addition, we focus on securing favorable financial terms for our shareholders; a licensing agreement must generate value for shareholders throughout the process so that, in the event of a successful market launch of NOX-A12, we can ultimately benefit from a substantial percentage of peak sales capacity. We are working diligently to conclude this final assessment phase and look forward to updating the market as soon as a definitive decision has been reached and formal agreements are finalized. Future additional activities In addition to our developments with our biotech assets, among which NOX-E36 remains a promising asset, I will continue to apply my knowledge and expertise as an investor to create value for TME Pharma shareholders in other areas as well. TME Pharma is a holding company, making it ideally suited to expand its activities and assets. We believe that communication with our shareholders is important, but since we only present financial reports on a semi-annual basis, we will choose, if there is enough to report, to keep you informed of developments more frequently through this channel. Thank you for your continued support and shared vision as we execute these critical strategic milestones. Sincerely, Diede van den OudenChief Executive Officer, TME Pharma N.V. For more information, please contact:TME Pharma N.V.Diede van den Ouden, CEOir@tmepharma.comwww.tmepharma.com About TME Pharma TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. TME Pharma has currently 2 main assets for development: NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The Company is currently seeking opportunities to secure the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include: Raising funds from alternative sourcesPursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the CompanyLeveraging tax loss carry forwards Further information can be found at: www.tmepharma.com. About the GLORIA Study The GLORIA (NCT04121455) ‘ready to go’-study is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). About the OPTIMUS Study OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients. Disclaimer Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law. Attachment ENG_TME PHARMA CEO MESSAGE

Orphan DrugPhase 2License out/inFast Track

100 Deals associated with Bevacizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D06409	Bevacizumab	L01XC07	DB00112

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Neurofibromatosis 2	Japan	Chugai Pharmaceutical Co., Ltd.	19 Jun 2026
Unresectable Hepatocellular Carcinoma	Japan	Chugai Pharmaceutical Co., Ltd.	25 Sep 2020
Hepatocellular Carcinoma	United States	Genentech, Inc.	29 May 2020
Recurrent Glioblastoma	United States	Genentech, Inc.	29 May 2020
Recurrent Primary Peritoneal Carcinoma	United States	Genentech, Inc.	14 Nov 2014
Ovarian Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	22 Nov 2013
Glioma	Japan	Chugai Pharmaceutical Co., Ltd.	14 Jun 2013
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	26 Sep 2011
Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	18 Sep 2009
Metastatic Renal Cell Carcinoma	United States	Genentech, Inc.	31 Jul 2009
Glioblastoma	United States	Genentech, Inc.	05 May 2009
Ganglioglioma	Japan	Chugai Pharmaceutical Co., Ltd.	18 Apr 2007
Non-squamous non-small cell lung cancer	United States	Genentech, Inc.	11 Oct 2006
Fallopian Tube Carcinoma	European Union	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Iceland	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Liechtenstein	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Norway	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	European Union	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	Iceland	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	Liechtenstein	Roche Registration GmbH	12 Jan 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	Phase 3	United States	National Cancer Institute	27 Jan 2026
Recurrent Endometrial Cancer	Phase 3	United States	National Cancer Institute	27 Jan 2026
Mesodermal Mixed Tumor	Phase 3	United States	NRG Oncology	12 Mar 2025
Mesodermal Mixed Tumor	Phase 3	Japan	NRG Oncology	12 Mar 2025
Ovarian Carcinosarcoma	Phase 3	United States	NRG Oncology	12 Mar 2025
Ovarian Carcinosarcoma	Phase 3	Japan	NRG Oncology	12 Mar 2025
Advanced Hepatocellular Carcinoma	Phase 3	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	28 Oct 2024
Advanced Head and Neck Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Head and neck cancer metastatic	Phase 3	United States	National Cancer Institute	13 Mar 2023
Hypopharyngeal Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05908786 (CTgov)	Phase 1/2	Hepatocellular Carcinoma	62	Atezolizumab+Bevacizumab (Atezolizumab + Bevacizumab)	wqkhponqqu = qnivoleybl myluqczkzp (cvejayetdd, duuqmnzylj - jnszocmsnh) View more	-	15 Sep 2026
				Atezolizumab+Bevacizumab+Tiragolumab (Atezolizumab + Bevacizumab + Tiragolumab)	wqkhponqqu = dpenvnbfkf myluqczkzp (cvejayetdd, yearzjfdjk - mofydyocqc) View more
WCLC2026	Not Applicable	RIT1-A77G \| ARID1A \| RIT1-M90I ... View more	3	pembrolizumab	yqooifqzkf(pxmjhkudwe) = jiacavpkrs qcaibdbxgg (pekfpvowpx )	Negative	12 Sep 2026
				Lazertinib/placebo and osimertinib/placebo (RIT1 amplified LUAD with bone metastasis)	yqooifqzkf(pxmjhkudwe) = apwwqjeryx qcaibdbxgg (pekfpvowpx )
WCLC2026	Not Applicable	Non-Small Cell Lung Cancer First line EGFR-mutant \| PD-L1 high/low/negative/unknown	63	atezolizumab+bevacizumab+carboplatin+paclitaxel	iupyrpjmhw(homrxyldkg) = interstitial lung disease incidence was notably low at 4.8% (3/63; Grade 1/2/3: 1/1/1) with no Grade 4/5 events pdvjhjmfat (mgqgimltfi ) View more	Positive	12 Sep 2026
				atezolizumab+bevacizumab+carboplatin+paclitaxel (first-line)
NCT04958811 (WCLC2026)	Phase 2	PD-L1 positive Lung Cancer PD-L1-positive \| KRAS \| STK11 ... View more	20	Atezolizumab 1200mg IVBevacizumab 15mg/kg IVTiragolumab 600mg IV + Atezolizumab 1200mg IVBevacizumab 15mg/kg IVTiragolumab 600mg IVIV + Atezolizumab 1200mg IVBevacizumab 15mg/kg IVTiragolumab 600mg IVIV	kwktxoqllz(ivfrflhqdo) = hmzfhneaie kdvqeowhib (ldkxsohadm, 6 - 38) View more	Negative	12 Sep 2026
WCLC2026	Not Applicable	Second line driver-gene-negative	56	Bevacizumab, nab-paclitaxel, and platinum (carboplatin or cisplatin)	fqppmdyhvm(wbrszeoeau) = ysrgxqlyse hknfvgtmhp (ddrwkhxptf, 34.0 - 59.3) View more	Positive	12 Sep 2026
WCLC2026	Not Applicable	Non-Small Cell Lung Cancer EGFR alterations \| CTNNB1 mutations	97	EGFR-TKI monotherapy	mihpicbgyc(zmpamzjvbo) = zutiqblktb gxopsqshhz (tmrbmtpnel, 42.55 - 74.54) View more	Positive	12 Sep 2026
				EGFR-TKIs+antiangiogenic therapy	eibqicjptx(ymzfcpfuhy) = gtwrsinyay bqhcbyzbxh (jpgvowrbxf, 20.8 - 21.6)
NCT05665348 (PRODIGE 81-FFCD 2101-TRIPLET HCC, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 2/3	Advanced Hepatocellular Carcinoma First line	226	Atezolizumab + Bevacizumab + Ipilimumab	gbagypwclm(bswzkrhnzh) = 3% of patients in the atezolizumab plus bevacizumab group experienced acute renal failure ujiwvhmqsg (ukaxdwukuc ) View more	Negative	01 Aug 2026
				Atezolizumab + Bevacizumab
NCT04516278 (CTgov)	Phase 3	Diabetic macular oedema \| Retinal Vein Occlusion \| Wet age-related macular degeneration ... View more	197	bevacizumab	ekiyobledl = kynkusvdai dvhtxqlapl (snkmbyrjft, levtknixtm - heypxznokq) View more	-	17 Jul 2026
NCT01871571 (CTgov)	Phase 2	Rectal Adenocarcinoma	17	laboratory biomarker analysis+leucovorin calcium+bevacizumab+oxaliplatin+fluorouracil	vsqoqbcaod = rmxoxrtpoo owwmnhjprb (hvixrjjkdo, ldlpqcdfxz - fwqbthmdaq) View more	-	01 Jul 2026
ASCO_Breakthrough2026	Not Applicable	EGFR Mutation Lung Cancer EGFR-mutated	119	Carboplatin+Pemetrexed+Bevacizumab	zribyvcmam(szhypdykvt) = Distinct safety profiles were identified: thrombocytopenia and hepatic dysfunction occurred more frequently with CPemB, whereas febrile neutropenia, rash, and peripheral neuropathy were more common with ABCP. ghfvmcelyn (yshpgaptqo ) View more	Positive	25 Jun 2026
				Atezolizumab+Bevacizumab+Carboplatin+Paclitaxel

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis