On March 26, 2026 CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapeutics for oncology, immunology, inflammation, and other key disease areas, reported encouraging clinical progress for CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody.

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "Based on the latest clinical data for CS2009, we are confident in its potential to transform treatment paradigms across a broad spectrum of tumor types. Driven by its unique molecular design, CS2009 offers key mechanistic differentiation. To date, approximately 200 patients have been enrolled, demonstrating an outstanding safety profile with no observation of the severe toxicities commonly associated with combination regimens containing CTLA-4 and PD-(L)1 inhibitors.

In terms of efficacy, CS2009 has delivered compelling results across multiple indications: as a monotherapy in first-line NSCLC, it achieved an ORR of 90% in patients with PD-L1 TPS ≥ 50%. Significant benefits were also observed in historically difficult-to-treat ‘cold tumors’, including IO-pretreated advanced NSCLC, non-clear cell renal cell carcinoma (nccRCC), and soft tissue sarcoma (STS). Furthermore, Phase II studies evaluating CS2009 in combination with standard chemotherapy for first-line NSCLC, CRC, and other indications have yielded high objective response rates.

We look forward to presenting additional Phase I and Phase II data at this year’s ASCO (Free ASCO Whitepaper) and/or ESMO (Free ESMO Whitepaper) congresses. Currently, we are engaged in advanced partnership discussions with several global multinational pharmaceutical companies and aim to initiate multiple Phase III MRCT by the end of 2026."

Rapid Patient Enrollment with Phase I/II Data Supporting Favorable Safety and Efficacy

The global multi-center Phase I/II clinical trial for CS2009 is actively ongoing in Australia and China, and its Investigational New Drug (IND) application for Phase II has been approved by the U.S. Food and Drug Administration (FDA). As of mid-March 2026, a total of 113 patients with advanced solid tumors have been enrolled in Phase I, with a median follow-up of approximately six months. 85 patients have been enrolled in Phase II.

1. Phase I Data Reinforces an Excellent Safety Profile:

CS2009 demonstrates a favorable safety and tolerability profile across all six dose levels evaluated, with no dose-limiting toxicities (DLTs) observed and the maximum tolerated dose (MTD) not reached.
The incidence of Grade ≥3 TRAEs was 23%; Grade ≥3 immune-related adverse events (irAEs) was 12.4%; and Grade ≥3 VEGF-related TRAEs was 4.4%. No excessive toxicities that typically occurred in combination therapies containing CTLA-4 and PD-(L)1 were observed.
2. Broad Antitumor Activity Observed in Heavily-Pretreated NSCLC and "Cold Tumors":
Antitumor activity was observed across all dose levels, with robust efficacy signals in multiple tumor types.

At the 30 mg/kg, Q3W, CS2009 monotherapy achieved an ORR of 25% (6/24) and a DCR of 58.3% (14/24) in AGA-negative, later-line NSCLC patients.
Across dose levels, CS2009 monotherapy resulted in an ORR of 40% and a DCR of 100% in patients with nccRCC (n=5).
Across dose levels, CS2009 monotherapy resulted in an ORR of 33.3% and a DCR of 66.7% in patients with STS (n=9).
Phase II Data Reveal Transformative Potential of CS2009: 90% ORR with Monotherapy in First-Line NSCLC and Excellent Tolerability in Combination Regimens for First-Line NSCLC and CRC

The global multi-center Phase II clinical trial employs a multi-cohort parallel expansion design to evaluate the efficacy and safety of CS2009 monotherapy and combination therapy across 15 cohorts in 9 solid tumor types, including NSCLC, CRC, extensive-stage small cell lung cancer (ES-SCLC), cervical cancer (CC), gastric or gastroesophageal junction cancer (GC/GEJC), esophageal squamous cell carcinoma (ESCC), platinum-resistant ovarian cancer (PROC), triple-negative breast cancer (TNBC), and hepatocellular carcinoma (HCC).

1. Monotherapy Shows Striking Efficacy in First-line NSCLC:
CS2009 monotherapy (20 mg/30 mg, Q3W) achieved an ORR of 90% (9/10) and a DCR of 100% (10/10) in first-line NSCLC patients with PD-L1 TPS≥50% (n=10).

2. Combination Therapies Demonstrate Favorable Tolerability and Promising Efficacy
Safety data from multiple cohorts of CS2009 combined with standard chemotherapy showed that the combinations were well-tolerated across tumor types, with CS2009 without increasing the incidence or severity of chemotherapy-related adverse events. Initial potent antitumor activity was observed with combination treatment in first-line NSCLC and first-line CRC.

Efficient and Clearly-Defined Global Development Strategy

CStone plans to initiate the first set of Phase III global MRCTs for CS2009 by the end of 2026, focusing on indications including NSCLC, CRC, and SCLC.

Additional Phase I and Phase II clinical data for CS2009 are expected to be presented at the 2026 ASCO (Free ASCO Whitepaper) and/or ESMO (Free ESMO Whitepaper) Annual Meetings.

About CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

CS2009, an innovative trispecific antibody designed and developed by CStone, with the potential to be first- or best-in-class. It combines three clinically validated targets—PD-1, VEGFA, and CTLA-4—and exerts multidimensional antitumor effects through synergistic actions. Specifically, anti-PD-1 activity reverses T cell exhaustion, anti-CTLA-4 activity promotes T cell activation and proliferation, while anti-VEGFA activity blocks tumor angiogenesis and improves the tumor micro-environment (TME). In the TME, anti-PD-1 and anti-CTLA-4 activities are significantly enhanced by crosslinking with VEGFA. Meanwhile, CS2009 preferentially blocks PD-1 and CTLA-4 on double-positive tumor-infiltrating T cells while minimizing interference with CTLA-4 regulation in peripheral T cells.

(Press release, CStone Pharmaceauticals, MAR 26, 2026, View Source [SID1234663954])

On March 26, 2026 Keymed Biosciences (HKEX: 02162) reported its 2025 annual results. The year marked the company’s 10th anniversary and a pivotal year in its transition from R&D to commercialization.

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Revenue Leaps Forward, Supporting Long-Term Stable Growth

Since its founding in 2016, Keymed has built a pipeline of over 50 programs, with more than 10 in clinical development, three indications successfully launched, six core technology platforms continuously upgraded, over 10 external partnerships established, and planned production capacity exceeding 100,000 liters.

In terms of financial performance, the company achieved a significant revenue increase. Total revenue in 2025 was approximately RMB 720 million, a 67% year-on-year increase. This included around RMB 310 million from sales of the core product Kangyueda and approximately RMB 410 million from collaboration income. The company maintained steady R&D investment, with R&D expenses of approximately RMB 720 million. As of December 31, 2025, cash reserves stood at approximately RMB 1.96 billion, providing ample funding to support core pipeline development and long-term business growth.

Core Product Commercialization in Full Swing, Continuous Expansion of Indication Footprint

As of the date of this announcement, the new drug applications of Kangyueda for the treatment of moderate-to-severe atopic dermatitis (AD) in adults, chronic rhinosinusitis with nasal polyps (CRSwNP) and seasonal allergic rhinitis (SAR) have been approved by the National Medical Products Administration (NMPA). Since January 2026, all launched indications of Kangyueda and both of its packaging forms (vials and pre-filled auto-injector pens) have been included in the National Reimbursement Drug List of China, significantly enhancing affordability and accessibility for Chinese patients.

During the Reporting Period, revenue for sales of Kangyueda amounted to approximately RMB310 million. In January 2026, the new drug applications for Stapokibart for the treatment of adolescents with moderate-to-severe AD were accepted by the NMPA. Simultaneously, we are advancing a Phase III clinical study to evaluate the efficacy and safety of Stapokibart in child subjects with moderate-to-severe AD, and as of the date of this announcement, patient enrollment is in progress. Additionally, in 2025, we continuously proceeded with a Phase III clinical study of Stapokibart injection in patients with prurigo nodularis (PN). This clinical study has completed the patient enrollment in April 2025.

Global Partnerships Accelerate, Milestone Payments Validate Pipeline Value

In 2025, the company advanced several core pipeline programs through out-licensing deals, accelerating clinical development and unlocking overseas value for early-stage assets at an accelerated pace. Multiple business development achievements continued to validate the company’s platform innovation potential and diverse partnership model, providing sustained momentum for subsequent in-house R&D and pipeline advancement.

CMG901 (AZD0901, Claudin 18.2 ADC), a first-in-class Claudin 18.2 ADC globally, has received Fast Track and Orphan Drug Designations from the FDA, as well as Breakthrough Therapy Designation from the CDE. Following its out-licensing to AstraZeneca for global development, multiple global Phase III clinical trials are being rapidly advanced. In February 2026, the first subject was dosed in this clinical trial, triggering a milestone payment subject to the terms and conditions of the license agreement. In early March 2026, KYM Biosciences Inc. (a 70% non-wholly-owned subsidiary of the Group) received the relevant milestone payment totaling US$45 million.
CM336 (BCMA x CD3 bispecific antibody) was out-licensed to Ouro Medicines for global development (excluding Greater China). Open-label, multi-country basket studies are underway in the United States and Australia for relapsed/refractory autoimmune hemolytic anemia (AIHA), primary immune thrombocytopenia (ITP), and other autoimmune cytopenias, with the first cohort of patients having completed dosing. Basket studies have also been initiated for active, autoantibody-positive Sjögren’s syndrome and idiopathic inflammatory myopathy. In January 2026, CM336 was granted Fast Track Designation (FTD) by the FDA for the treatment of AIHA and ITP.
In March 2026, Ouro Medicines announced that Gilead Sciences would acquire Ouro Medicines through a merger. The Merger Agreement provides for an upfront payment at Closing of US$1,675 million, subject to customary adjustments, and contingent milestone payment of up to US$500 million, for a maximum total of US$2,175 million. It is expected that based on the Company’s equity interest in Ouro Medicines, the Group will receive an initial payment of approximately US$ 250 million, and contingent milestone payment of up to approximately US$ 70 million, for a maximum total of approximately US$320 million. The final consideration receivable by the Group is subject to the achievement of relevant milestones as well as the shareholders agreement amongst the Ouro Medicines shareholders.

CM355 (CD20 x CD3 bispecific antibody) : In January 2025, the company entered into a license agreement with Prolium, granting exclusive rights for global development in non-oncology indications and for oncology indications outside Asia. Keymed and its partner InnoCare received a combined upfront and near-term payment of $17.5 million, and are eligible for milestone payments and tiered royalties totaling up to $502.5 million, as well as a minority equity interest in Prolium. As of the date of this announcement, Prolium announced the initiation of dosing in healthy subjects in a single dose-escalation study of CM355/PRO-203, and expects to initiate an international multi-center Phase I/II clinical study for the treatment of systemic sclerosis (SSc) in the second quarter of 2026, and will also initiate therapeutic studies for other B-cell-driven severe autoimmune diseases within 2026. Additionally, in an investigator-initiated exploratory study, 5 patients with refractory advanced systemic lupus erythematosus (SLE) (all accompanied by lupus nephritis) are undergoing treatment evaluation.
CM313 (CD38 antibody) : In January 2025, the company entered into an exclusive license agreement with Timberlyne Therapeutics for global development (excluding Greater China), receiving $30 million in upfront and near-term payments, and became the largest shareholder of Timberlyne.
Promising Pipeline Data Highlights Best-in-Class Potential

CM512 (TSLP x IL-13 bispecific antibody) : The Phase I study has met all study endpoints. Data showed a half-life of up to 70 days, supporting the potential for extended dosing intervals. Notably, 50% of patients in the 300 mg group achieved EASI-75 at Week 6 post-first dose, compared to 7% in the placebo group. At Week 12, EASI-75 and EASI-90 response rates in the 300 mg dose group reached 58.3% and 41.7%, respectively, versus 21.4% and 0% in the placebo group. At Week 24, response rates remained stable across all endpoints and were significantly superior to placebo. Multiple Phase II studies for CM512 have been initiated across indications including chronic rhinosinusitis with nasal polyps (CRSwNP), moderate-to-severe atopic dermatitis (AD) in adults, moderate-to-severe asthma, moderate-to-severe chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria (CSU). Notably, the Phase II study in CRSwNP has completed enrollment of 120 target patients.
CM336 (BCMA x CD3 bispecific antibody) : Data from the Phase II dose-expansion cohort in relapsed/refractory multiple myeloma (RRMM) showed an objective response rate (ORR) of 95.2% in the target dose group, with a ≥ complete response (≥CR) rate of 76.2%, a minimal residual disease (MRD) negativity rate of 100%, and a 12-month progression-free survival (PFS) rate of 95.2%. The Phase III study was initiated in the second half of 2025.
In 2025, we continuously proceeded with a Phase I/II clinical study to assess CM336 injection for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). As of July 2025, in the Phase II dose-expansion stage, only 4.7% of subjects experienced Grade 2 cytokine release syndrome (CRS) events, with no immune effector cell-associated neurotoxicity syndrome (ICANS) events occurring. The objective response rate (ORR) in the target dose group was 95.2%, the rate of complete response (CR) or better was 76.2%, the minimal residual disease (MRD) negativity rate was 100%, and the 12-month progression-free survival rate was 95.2%. Concurrently, in the second half of 2025, we initiated a Phase III clinical study to evaluate CM336 monotherapy versus investigator’s choice (standard of care, SOC) in RRMM patients who previously have received at least second-line treatment.

Other Pipeline Programs Progressing Steadily:

CM518D1 (CDH17 ADC) : Initiated a Phase I/II clinical trial for advanced solid tumors.
CM383 (Aβ protofibril antibody) : Completed patient enrollment in a Phase Ib study for Alzheimer’s disease.
CM559 (N3pG Aβ antibody): A Phase I clinical study in healthy male subjects for the treatment of early Alzheimer’s disease was initiated in 2025, with the first subject enrolled in September.
CM326 (TSLP antibody) : Led by CSPC Pharmaceutical Group, clinical studies for multiple indications are underway. A Phase III clinical study for moderate-to-severe asthma completed enrollment of the first subject in March 2026, and a Phase III clinical study for CRSwNP was initiated in February 2026.
CM350 (GPC3 x CD3 bispecific antibody) : Phase I/II study in advanced solid tumors is in dose-escalation phase.
CM369/ICP-B05 (CCR8 antibody) : Phase I dose-escalation trials continue in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma.
Innovative Technology Platforms Continue to Evolve, Forward-Looking Positioning in Chronic Disease

The company has established a diverse set of technology platforms, including Antibodies Discovery Platform, KeyMedSTAR (Keymed Superior Topo1i ADC Reagents) ADC Platform, TCE Bispecific Antibodies Platform, VESIR (VEhicle for siRNA Delivery) Oligonucleotide Platform, Small Molecule Platform and KeyCND (Keymed Central Nervous System Delivery) – Blood-Brain Barrier-Penetrating Antibody Delivery Platform. Leveraging iterative and synergistic platform innovation capabilities, the company continues to efficiently generate high-quality, high-potential innovative medicines, pioneering a blue ocean in the broader chronic disease treatment landscape.

Talent and Organization Continuously Optimized, High-Standard Capacity Development Accelerates

As of December 31, 2025, the company had 1,625 full-time employees, including a commercialization team of over 400 and a drug discovery and clinical operations team of over 430, providing strong talent support for product commercialization and R&D. The Chengdu manufacturing facility currently has three pilot production lines and three commercial production lines, achieving a total capacity of 21,800 liters. A newly added 24,000-liter stainless steel production line has completed installation and commissioning and is about to come into operation. All facilities are designed in compliance with NMPA and FDA cGMP standards, with total planned capacity exceeding 100,000 liters in the future.

The 2025 annual results comprehensively demonstrate the company’s transformative progress in proprietary R&D, clinical advancement, and commercial operations, as well as its broad prospects across diversified technology platforms, innovative partnership-driven global expansion, and value realization on the world stage, underscoring the sustained and steady momentum fueled by original innovation. Keymed will continue to uphold its "patient-centric" philosophy, address unmet clinical needs, and remain committed to proprietary R&D and differentiated innovation, delivering high-quality, affordable innovative therapies to patients, while creating sustainable, long-term value for shareholders, partners, and society.

(Press release, Keymed Biosciences, MAR 26, 2026, View Source [SID1234663953])

On March 26, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported its 2025 annual results, highlighting a year of comprehensive, strategic leaps across all facets of its business.

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Commercial Operations Enter a New Phase of Growth

In 2025, Akeso achieved record commercial sales revenue of RMB3,033.1 million, a 51.48% year-on-year increase. All approved products and indications are now included in China’s National Reimbursement Drug List (NRDL). The strong commercial growth in 2025 was fueled by strong clinical validation and widespread adoption by both healthcare professionals and patients.

By the end of 2025, several high-impact indications were added to the latest NRDL, including:

Ivonescimab: 1L PD-L1(+) NSCLC
Cadonilimab: 1L gastric cancer and 1L cervical cancer
Other products: Multiple indications for penpulimab, ebdarokimab and ebronucimab
With stable pricing for core first-line (1L) indications and improved hospital access, Akeso’s commercial platform is positioned for a transformative 2026.

Advanced Clinical Development of IO 2.0 Bispecifics

Ivonescimab (PD-1/VEGF):

As the world’s first and only approved PD-1/VEGF bispecific antibody, ivonescimab solidified its global leadership in 2025 by iterating upon existing Standards of Care (SOC) to reshape the oncology landscape. Ivonescimab has benefited approximately 70,000 patients to date.

Ivonescimab’s IO 2.0 value is anchored by a series of landmark Phase III victories: in the HARMONi-2 study, ivonescimab achieved a head-to-head win against pembrolizumab in 1L PD-L1(+) NSCLC, establishing a new "chemo-free" standard. Additionally, the HARMONi-A study marked it as the first immunotherapy to reach dual PFS and OS positivity in EGFR-TKI resistant NSCLC, while HARMONi-6 demonstrated its superiority over tislelizumab (anti-PD-1 monoclonal antibody) in combination with chemotherapy in 1L squamous NSCLC, successfully overcoming traditional anti-VEGF contraindications for squamous histology.

Currently, the U.S. FDA has accepted the BLA from our partner Summit Therapeutics for ivonescimab plus chemotherapy in nsq-NSCLC following third-generation EGFR-TKI failure. As the only commercialized PD-1/VEGF bispecific globally, ivonescimab has secured two approved lung cancer indications in China (both NRDL-listed) with another sNDA under review for the first-line treatment of advanced squamous NSCLC. The Company’s expansive global development program now encompasses 15 Phase III trials, including 5 global studies and 7 head-to-head studies against PD-1/L1 therapies, targeting critical 1L indications, IO-resistant, and "cold" tumors.

Cadonilimab (PD-1/CTLA-4):

Cadonilimab (PD-1/CTLA-4) is the world’s first and only approved bispecific antibody of its class. With approximately 120,000 patients treated to date, it has demonstrated "all-comer" clinical benefits across multiple tumor types. Its exceptional efficacy in treating challenging cases, such as IO-resistant and "cold" tumors, has solidified its status as a cornerstone therapy in the IO 2.0 era.

Akeso is advancing 12 registrational or Phase III clinical trials for cadonilimab globally, covering more than 10 major cancer types and spanning the full treatment lifecycle and clinical scenarios. Furthermore, the Company is spearheading two international registrational studies: a head-to-head Phase III trial against nivolumab in first line gastric cancer, and a registrational trial for IO-resistant hepatocellular carcinoma (HCC). These high-efficiency global studies aim to address significant unmet medical needs, further unlocking cadonilimab’s global therapeutic value.

Oncology Therapy Matrix Continues to Expand

Akeso is pioneering the IO 2.0 + ADC 2.0 strategy, expanding its portfolio from bispecifics into trispecifics and TCE platforms. the Company is fast-tracking the global development of its next-gen ADCs, such as the bispecific Trop2/Nectin4 AK146D1, and the HER3 AK138D1. By combining these with its core IO assets (cadonilimab and ivonescimab), Akeso aims to address the narrow therapeutic windows associated with traditional ADCs. With AK150 (trispecific) now in the clinic and more trispecific/multispecific antibodies and TCE bispecific/multispecific antibodies approaching clinical entry, Akeso is rapidly building a formidable, next-generation oncology matrix.

Paradigm Shift in Bispecific Excellence: Continuous Expansion of the Oncology Portfolio

Akeso is methodically extending its IO 2.0 leadership into the emerging ADC 2.0 landscape, thereby operationalizing its integrated "IO 2.0 + ADC 2.0" platform thesis while systematically advancing bispecific antibody expertise into higher order trispecific/multispecific antibodies and TCE platforms. In the area of IO, Akeso remains the sole global player with two approved immuno-oncology bispecifics, a distinction that confers both first-mover clinical validation and a proprietary data moat in dual-check point/dual-pathway blockade. On the ADC front, the Company’s next-generation candidates, notably bispecific ADC AK146D1 and novel ADC AK138D1, are purpose-engineered to overcome the narrow therapeutic window that chronically plagues current ADCs, advancing the field into ADC 2.0.

Phase II trials combining these proprietary ADCs with cadonilimab and ivonescimab are now underway, with global expansion planned. Both IO bispecifics are also being explored broadly with external high-potential ADCs. Meanwhile, the Company’s first trispecific antibody, AK150, is in clinical development, with more trispecific/multispecific and TCE assets approaching the clinic.

Immune and CNS Diseases Enter the Dual-Target Era

Beyond building global competitiveness in oncology, Akeso has created a powerful new growth engine in immune-related diseases. Leveraging its bispecific and multispecific antibody platforms, the Company is advancing a pipeline of novel candidates in autoimmune, respiratory, allergy, and CNS indications, including AK139, AK152 (siRNA), KF111 (siRNA), and KF115 (siRNA), alongside commercial-stage products like ebdarokimab, gumokimab and manfidokimab. This layered portfolio is rapidly strengthening Akeso’s global presence beyond oncology.

AI-Powered R&D and Cutting-Edge Platforms

Building atop its globally competitive command in monoclonal and bispecific antibody development, Akeso has executed a deliberate expansion into frontier therapeutic modalities by embedding AI end-to-end across the entire R&D and manufacturing continuum – from discovery and cell-line/process development through to smart manufacturing. The outcome is a tightly orchestrated portfolio of differentiated platforms: the Tetrabody antibody technology platform, the AI-powered drug R&D platform, the Dual-Shield ADC technology platform, the Dual-Lock T-cell engager (TCE) technology platform, the Tissue-Smart siRNA/mRNA technology platform, and the cell therapy technology platform. These assets collectively solidifies Akeso’s global innovation edge, unlocking 0-to-N breakthroughs across multiple high-barrier domains where conventional therapeutic modalities have historically stalled.

Akeso continues to iterate and scale its AI-powered, integrated drug discovery platform, which now provides comprehensive coverage across the entire R&D lifecycle for both antibody and nucleic acid therapeutics, while extending into additional frontier modalities. At its core lies a proprietary AI technology matrix that fuses high-precision structure prediction, immunogenicity prediction, fully automated humanization, and one-step sequence optimization. This closed-loop, data-rich architecture enables end-to-end precise engineering from sequence design to clinical development, significantly accelerating the efficient and high throughput development of innovative therapies.

Dr. Michelle Xia, Founder, Chairwoman, President, and CEO of Akeso, commented:

"2025 marked a definitive strategic leap for Akeso across commercialization, global clinical expansion, and our broadening multi-platform innovation ecosystem. We achieved over 50% sales revenue growth. This success provides a powerful springboard for continued commercial and clinical execution in 2026.

We are now pioneering a shift in therapeutic paradigms. Leveraging our leadership in IO bispecifics, we are expanding into ‘IO 2.0 + ADC 2.0,’ including bispecific ADCs, trispecifics, and TCE platforms. Beyond oncology, we are bringing the immense therapeutic benefit of bispecific antibodies to immunology, respiratory, and CNS diseases, all powered by our integrated AI discovery engine.

Our vision to bring transformative and life saving medicine to every patient on Earth is coming to fruition. With over ten products in international trials, including studies that includes ivonescimab and cadonilimab, we are advancing our mission to deliver world-class medicines to patients worldwide. By integrating global talent, capital, and R&D resources, and integrating AI into our research and development efforts, we are building a robust institutional framework to sustain Akeso’s long-term leadership in innovation in the global biopharmaceutical industry."

(Press release, Akeso Biopharma, MAR 26, 2026, View Source [SID1234663952])

On March 26, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported 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).

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GLIX1 is an oral small molecule with a novel mechanism of action applicable to a broad range of cancers. By restoring TET2 activity, GLIX1 selectively targets DNA damage repair in cancer cells only. GBM was selected as the first indication for GLIX1 due to the low level of TET2 activity in this aggressive brain cancer, for which there remains a high unmet medical need for novel and more effective treatments. In extensive preclinical studies, including in-vivo GBM models, GLIX1 demonstrated potent anti-tumor activity and excellent blood-brain-barrier penetration, combined with a favorable safety profile in toxicology studies.

Three renowned academic centers will ultimately participate in this clinical trial. The first center ready to start enrolling patients is NYU Langone Health, led by Dr. Alexandra Miller. This will be followed by Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, and by Moffit Cancer Center, led by Dr. Patrick Grogan.

"The initiation of this study represents the culmination of many months of tireless work on behalf of our team and the team of our collaboration partner, Hemispherian AS, as well as a pivotal moment in our mission to identify and advance innovative drugs to treat diseases with significant unmet needs," stated Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1 has a very compelling profile supporting this Phase 1/2a study and, to that end, we look forward to initial data in the first half of 2027."

Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center at the Perlmutter Cancer Center, NYU Langone Health, stated, "I am pleased to be the first investigator able to enroll patients into this critical study, which brings new hope to patients who are in desperate need of innovative and novel treatment options."

Dr. Roger Stupp, Medical Director of the Malnati Brain Tumor Institute at Northwestern University in Chicago, and lead investigator of the study, added, "GLIX1 is a promising innovative molecule with impressive pre-clinical data, and I could not be more excited to participate in this study. The protocol will rigorously assess the safety of an agent with an entirely novel mechanism of action, with the potential to ultimately integrate well and synergize with the current treatments. We urgently need breakthrough innovations for our patients suffering from glioblastoma, one of the most aggressive and difficult malignancies to treat."

Phase 1/2a clinical trial design (NCT07464925)

The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade glioma. The objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial are anticipated in H1 2027.

The Phase 2a expansion part of the trial is planned to include various population cohorts, including GBM (newly diagnosed and/or recurrent), as well as additional cancers with/without standard of care (e.g., PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.

(Press release, BioLineRx, MAR 26, 2026, View Source [SID1234663951])

On March 26, 2026 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIR TM and ADAPTIR-FLEX TM platform technologies, reported financial results for the year ended December 31, 2025 and provided a business update highlighting recent clinical progress, pipeline expansion and capital strategy.

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"2025 was a year of meaningful progress across our clinical programs, pipeline strategy and capital position," said Marvin White, President and Chief Executive Officer of Aptevo Therapeutics. "Most importantly, recently reported mipletamig data continue to demonstrate encouraging remission outcomes together with a favorable safety profile, including no cytokine release syndrome observed in frontline patients treated to date. These results support the potential for mipletamig to enhance frontline AML treatment alongside existing standard-of-care therapy."

White continued, "During the year we also expanded our CD3 pipeline, introduced our first trispecific programs and strengthened our access to capital to support continued execution. As I transition into the role of Executive Chair and Jeff Lamothe assumes the responsibilities of President and Chief Executive Officer, I am confident in the Company’s ability to build on this momentum."

Highlights

Aptevo entered 2026 with momentum:

Mipletamig Clinical Performance: Mipletamig in triplet combination therapy continues to outperform standard of care ven/aza 1 in unfit frontline patients with acute myeloid leukemia (AML). This further validates a differentiated safety profile, including no cytokine release syndrome in frontline patients, suggesting it is additive to the current standard of care

Expanded CD3 portfolio: the addition of three new multispecific candidates, leveraging the Company’s proprietary application of its differentiated CRIS7-derived CD3 binding domain, including the introduction of its first two trispecific assets

These additions emphasize the breadth and modularity of the ADAPTIR and ADAPTIR-FLEX platforms and position the Company to address a wider range of tumor targets and combination strategies across immune-oncology

Strengthened Financial Capacity: In 2026, the Company established a $60 million equity line facility, providing additional access to capital, subject to market conditions and the Company’s capital deployment strategy. If fully utilized, this facility, together with current resources, is expected to support operations into 2029.

Encouraging Frontline AML Data

Updated interim results from 28 evaluable frontline AML patients 2 treated with mipletamig in combination with ven/aza demonstrate an emerging clinical profile that is additive in combination with standard of care. The triplet regimen delivered an 86% clinical benefit rate, including a 79% CR/CRi (vs. 66% ) 1 remission rate and a 61% complete remission rate (vs.37%) 1.

Among patients achieving remission, 55% reached measurable residual disease-negative status. Notably, 35% of remissions occurred in patients with TP53 mutations, a high-risk biomarker typically associated with poor prognosis.

Importantly, no cytokine release syndrome has been observed in frontline patients treated to date. Outcomes from the mipletamig triplet compare favorably with historical results reported for the ven/aza doublet and support the potential for mipletamig to enhance frontline AML therapy for older and/or unfit patients.

"Mipletamig continues to demonstrate encouraging remission outcomes together with a consistently favorable safety profile," said Dirk Huebner, M.D., Chief Medical Officer of Aptevo Therapeutics. "The absence of cytokine release syndrome in frontline patients underscores the potential advantage of our differentiated CD3 design in combination treatment settings."

Huebner added, "Four patients treated to date have proceeded to allogeneic stem cell transplant, representing the most favorable treatment outcome in AML and an uncommon achievement in the older and/or unfit frontline population."

A Differentiated CD3 Platform

During 2025 Aptevo expanded its CD3 portfolio with three new multispecific candidates, including the Company’s first two trispecific drug candidates designed to address complex solid tumor microenvironments.

All programs leverage Aptevo’s proprietary CRIS-7-derived CD3 binding domain, designed to promote targeted T-cell activation while reducing systemic immune overstimulation. Clinical experience with mipletamig, now evaluated in more than 120 patients across three trials, provides early validation of this design approach.

The Company now has a five-molecule CD3 portfolio spanning hematologic malignancies and solid tumors, including programs targeting AML, prostate cancer and Nectin-4-expressing tumors.

Capital Strategy and Financial Flexibility

Aptevo ended 2025 with $21.6 million in cash and cash equivalents, compared with $8.7 million at December 31, 2024, and expects current resources to support operations into the fourth quarter of 2026.

In 2026, the Company also established a $60 million equity line with Yorkville Advisors Global, LP. The equity line provides financing flexibility and allows Aptevo to access capital opportunistically based on its needs and market conditions. The Company is not required to utilize the full capacity of the facility and continues to evaluate additional strategic and non-dilutive funding opportunities.

1 DiNardo et al. N Engl J Med 2020;383:617-29
2 Total frontline patients include 4 from the completed dose escalation trial and 24 from the ongoing RAINIER dose optimization trial

2025 Summary Financial Results

Cash Position: Aptevo had cash and cash equivalents as of December 31, 2025, totaling $21.6 million.

Research and Development Expenses: Research and development expenses was $14.5 million and $14.4 million for the years ended December 31, 2025, and 2024, respectively. The increase was primarily due to increased mipletamig and employee costs and was offset by lower costs on ALG.APV- 527 as we concluded the dose escalation trial.

General and Administrative Expenses: General and administrative expenses increased by $1.6 million, to $11.8 million for the year ended December 31, 2025, from $10.2 million for the year ended December 31, 2024. The increase is primarily due to higher employee, consulting, and legal costs.

Other Income Net: Other Income, net was $0.3 million for the year ended December 31, 2025, and other income, net was $0.5 million for the year ended December 31, 2024. The change was primarily due to lower interest and rental income.

Net Loss Attributable to Common Shareholders: For the years ended December 31, 2025, and 2024, Aptevo had a net loss of $26.0 million and $24.1 million, respectively. The Company recorded a dividend deemed attributable to down round feature of common warrants of $1.6 million in 2025. The basic and diluted net loss per share for the year ended December 31, 2025, was $87.27 per share, compared to $31,460.23 per share for the corresponding period in 2024.

Dividend Attributable to Down Round Feature of Warrants: This non-cash amount reflects the impact of reducing the exercise price of the Company’s June 2025 warrants from the original $58.50 per share to $19.01 per share, the lowest price at which we sold common shares after issuance of such common warrants due to contractual requirements of the warrants. The exercise price was further adjusted to the floor price of $11.70 as a result of additional shares of common stock sold in January 2026. The $1.6 million recorded in the year ended December 31, 2025, reflects dividend deemed to common shareholders and it increases net loss attributable to common shareholders to $27.5 million for EPS purposes.

(Press release, Aptevo Therapeutics, MAR 26, 2026, View Source [SID1234663950])