On June 15, 2026 Akeso, Inc. (HKEX: 9926) reported that the first patient has been enrolled in the Phase Ib/II clinical study (AK138D1-202) evaluating its internally developed next-generation HER3 antibody-drug conjugate (ADC), AK138D1, as either monotherapy or in combination with ivonescimab for the treatment of advanced breast cancer.

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HER3 is broadly expressed across various solid tumors, including breast, ovarian, colon, gastric, lung, skin, and pancreatic cancers, affecting millions of patients globally. While traditional HER3-targeted ADCs have demonstrated therapeutic potential in combination settings, their clinical utility has historically been constrained by dose-limiting toxicities.

AK138D1 is a next-generation, differentiated HER3-targeting ADC developed in-house by Akeso. Leveraging a unique, innovative design, AK138D1 is engineered to reduce uptake in normal tissues, thereby minimizing off-target toxicities and widening the therapeutic window. Furthermore, its design prevents the clustering of ADC molecules on the tumor surface, enhancing deep tissue penetration and uniform distribution to overcome the "binding site barrier". Early-stage clinical studies conducted in China and Australia have demonstrated that AK138D1 exhibits robust anti-tumor activity in solid tumors and breast cancer, coupled with an excellent safety profile, notably characterized by low hematologic toxicity and the absence of interstitial lung disease (ILD). This compelling balance of efficacy and safety overcomes common limitations of conventional ADCs, establishing a foundation for AK138D1 to be explored in diverse combination therapeutic regimens.

The AK138D1-202 study focuses on the two major breast cancer subtypes with the greatest unmet need: hormone receptor-positive, HER2-negative (HR+/HER2-) disease, which accounts for approximately 65% of all breast cancers, and triple-negative breast cancer (TNBC), which represents 10-20% of cases. The trial enrolls patients across multiple treatment lines from treatment-naïve to heavily pretreated, and includes diverse PD-L1 expression levels. Breast cancer remains the most common cancer among women worldwide, with an estimated 2.3 million new cases diagnosed annually. Substantial unmet needs persist in both first-line and later-line settings for HR+/HER2- breast cancer and TNBC.

Early data from AK138D1 studies have already shown meaningful efficacy and a strong safety profile in breast cancer. Concurrently, a Phase III study of ivonescimab-based combination therapy in first-line TNBC is ongoing. The combination of AK138D1 and ivonescimab is poised to emerge as a highly differentiated "IO2.0 + ADC2.0" therapeutic strategy for advanced breast cancer.

As IO+ADC combinations become a cornerstone of global oncology research, Akeso is strategically and efficiently building a comprehensive global portfolio of these next-generation therapies, leveraging its proprietary leadership in bispecific and multispecific antibody platforms.

On the IO front, Akeso stands as the only company globally with two approved bispecific antibodies for oncology, spearheading the advancement of IO2.0 therapies. Regarding its ADC pipeline, Akeso’s development of AK146D1 (a Trop2/Nectin4 bispecific ADC) and AK138D1, among other innovations, aims to resolve the toxicity-related limitations of current ADCs and propel the field into the "ADC2.0" era.

About AK138D1

Injectable AK138D1 is a HER3-targeted antibody-drug conjugate (ADC), with a fully humanized anti-HER3 IgG1 antibody, patritumab. It is conjugated to the topoisomerase I inhibitor DXd through a cleavable linker, MC-AAA (maleimide-alanine-alanine-alanine). After binding to HER3 on tumor cells, the ADC is internalized into the tumor cells, where the linker is cleaved, releasing the membrane-permeable DXd. This leads to DNA damage and subsequent cell apoptosis. Early study results have shown that AK138D1 possesses potent biological activity and a favorable safety profile. A phase II clinical trial is currently ongoing to investigate AK138D1 combined with cadonilimab and ivonescimab in patients with solid tumors. This regimen is a critical part of Akeso’s IO2.0 + ADC 2.0 combination approach.

(Press release, Akeso Biopharma, JUN 15, 2026, View Source;adc2-0-strategy-302800044.html [SID1234668743])

On June 15, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported that the first patient has been enrolled in its Phase 1 clinical trial evaluating IDE892, a potential best-in-class methylthioadenosine (MTA)-cooperative inhibitor of PRMT5, in combination with IDE397, a potential first-in-class and best-in-class inhibitor of MAT2A, in MTAP-deleted solid tumors, with a focus on NSCLC and pancreatic cancer. In preclinical studies, dual inhibition of PRMT5 and MAT2A with the combination of IDE892 and IDE397 resulted in potent anti-tumor activity in MTAP-deleted tumor models, including complete and durable responses at well-tolerated doses below those required for monotherapy activity.

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"We are excited to begin enrolling this Phase 1 combination trial evaluating IDE892 in MTAP-deleted pancreatic cancer and non-small cell lung cancer. We designed IDE892 with potential best-in-class properties, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding intended to maximize its therapeutic window and favorable drug-like properties to enable rational combinations with IDE397 and pan-RAS inhibitors. This trial exemplifies our clinical development strategy of enabling rational combinations to deliver deeper and more durable responses for MTAP-deleted pancreatic cancer and lung cancer patients where there are currently no approved treatment options," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Loss of MTAP leads to the accumulation of MTA and increased dependence on PRMT5 and MAT2A, two key enzymes involved in methylation and RNA splicing. In MTAP-deleted tumors, this biology establishes a robust synthetic lethal vulnerability that underpins the mechanistic rationale for combining IDE892 and IDE397. IDEAYA also entered into a clinical collaboration with Roche evaluating IDE892 in combination with RG6505, Roche’s Phase 1 pan-RAS inhibitor, in MTAP-deleted pancreatic ductal adenocarcinoma (PDAC) to target the genetic co-alterations of MTAP and KRAS in this indication. Next, IDEAYA is advancing a third proprietary program for MTAP-deleted solid tumors targeting CDKN2A, the most common co-alteration of MTAP, through ongoing preclinical toxicology studies to support an investigational new drug (IND) application in the first half of 2027.

MTAP deletion is estimated to occur in approximately 15% of all solid tumors, including 15-20% of NSCLC and up to 40% of pancreatic cancer. There are no approved therapies for MTAP-deleted cancers, highlighting the significant unmet need and opportunity for new precision therapies for these patients.

(Press release, Ideaya Biosciences, JUN 15, 2026, View Source [SID1234668742])

On June 15, 2026 TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the study of its TBS-2025 VISTA inhibiting antibody for the treatment of molecularly defined subsets of AML and other blood related cancers. The IND is being filed following detailed feedback and guidance from the FDA on the IND filed in February 2026.

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"We are excited to be the first company to advance a VISTA-inhibiting antibody for investigation in hematologic cancers, targeting molecularly defined subsets of AML, including those with NPM1 and in the future, FLT3-ITD mutations, two of the most common mutations present in approximately 60-70% of patients with AML. We also plan to include patients with relapsed/refractory (r/r) high-risk myelodysplasia (MDS), where VISTA expression, like in AML, generally correlates with low response rates and poor survival outcomes," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "Currently, there are no approved or effective treatment options for these patient populations, representing a significant unmet medical need."

Dr. Craig Tendler, Chief Medical Officer consultant overseeing the TBS-2025 development program and Board member of TuHURA Biosciences, added, "The FDA provided valuable feedback and comprehensive guidance on trial design, which we incorporated into our proposed Phase1b dose optimization trial. Our plan is to combine the Phase 1b with the Phase 2 study for a combination study design that is much more efficient and could potentially save 4-6 months in development time. We look forward to FDA’s written responses anticipated to be received next month and, depending on the responses, are targeting initiating the Phase 1b/2 trial of TBS-2025 in the second half of 2026."

The Phase 1b portion of the study will examine the safety and potential efficacy of monotherapy dose levels in relapsed/refractory (r/r) AML patients, most of whom will harbor the NPM1 mutation and have failed to respond or relapsed after menin inhibitor therapy. In the planned protocol, if a safe and biologically effective dose is identified, the Company will review the data with the FDA to discuss the potential to expand the study at a recommended Phase 2 dose determined in the Phase 1b, to pursue a potential accelerated approval pathway, a development path similar to that of menin inhibitors in this molecular subset of patients with r/r mutNPM1 AML.

It is anticipated that the Phase 2 portion of the study will explore the potential of TBS-2025 to improve complete response rates and duration of response when used in combination with menin inhibitors in patients with mutNPM1 r/r AML.

About TBS-2025
TBS-2025 is a unique VISTA-inhibiting monoclonal antibody. VISTA is a novel checkpoint expressed on quiescent (resting) T cells and highly expressed on myeloid cells, notably myeloid derived suppressor cells (MDSCs). Scientific evidence demonstrates that mutNPM1 has demonstrated the mutation drives the expression of VISTA on leukemic blasts, which is reported to be the primary mechanisms by which AML escapes recognition by the patient’s immune system, resulting in low response rates of short duration following current therapies, including recently approved menin inhibitors. When VSIR, the gene that encodes for VISTA, is removed in murine models of mutNPM1 AML, an immune response is observed and survival is enhanced. Similarly, in a murine model of AML, TBS-2025 resulted in an increase in survival comparable to intensive chemotherapy regimen that is currently used in front line treatment of patients with AML. When combined with intensive chemotherapy, survival was markedly improved. Collectively, these data underscore the potential for TBS-2025 in the treatment of patients with AML

TBS 2025 was initially investigated in a large Phase 1 trial as either monotherapy (n=24) or in combination with pembrolizumab (n=15) among patients with advanced, therapy refractory cancers, including breast, lung, colorectal, and ovarian cancer. The purpose of the study was to investigate its safety profile and determine the recommended Phase 2 dose for solid tumors. The drug demonstrated a favorable safety profile even at the highest dose level of 1,000mg administered every two weeks. Safety and pharmacokinetic data from this trial was helpful in designing the Phase 1b segment of the planned trial in AML.

(Press release, TuHURA Biosciences, JUN 15, 2026, View Source [SID1234668741])

On June 15, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) seeking approval of ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. The FDA has not identified any filing review issues at this time and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027. "The FDA’s acceptance of our BLA for ozekibart is a monumental milestone for Inhibrx and, more importantly, for the chondrosarcoma community," said Mark Lappe, Chief Executive Officer of Inhibrx. "Chondrosarcoma is an aggressive and devastating bone cancer and there are currently no approved therapies for patients suffering from this disease. We look forward to working closely with the FDA during this review process to potentially bring this first-in-class targeted therapy to patients as quickly as possible."

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The BLA is supported by positive results from the ChonDRAgon study, a randomized, blinded, placebo-controlled, registrational trial of ozekibart in patients with metastatic or unresectable conventional chondrosarcoma, which met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68; P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a blinded, randomized trial for chondrosarcoma, a disease with no approved systemic options.

If approved, ozekibart would become the first commercial product for Inhibrx and the first-ever approved systemic therapeutic for patients with unresectable or metastatic conventional chondrosarcoma.

About Chondrosarcoma
Chondrosarcoma is a rare type of cancer that primarily develops in the cartilage cells of bones, most commonly affecting the pelvis, hip, and shoulder. It stands as the second most common primary bone malignancy. When the disease becomes unresectable or metastatic, the prognosis is historically poor because the tumors are largely unresponsive to traditional oncology treatments, leaving surgical resection as the only effective management strategy for localized disease.

About ozekibart (INBRX-109)

Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated the ChonDRAgon study, a randomized, blinded, placebo-controlled, registrational trial of ozekibart in metastatic, unresectable conventional chondrosarcoma. The trial enrolled a total of 206 patients across 67 different sites worldwide. The primary objective of the trial was the evaluation of the efficacy of ozekibart as measured by median PFS, assessed by central real-time independent radiology review per RECIST 1.1. Secondary objectives were the evaluation of overall survival, median PFS by investigator assessment, quality of life, objective response rate, duration of response, disease control rate, safety and tolerability, pharmacokinetics and anti-drug antibodies to ozekibart.

Key enrollment criteria in order for patients to qualify for inclusion in the trial were grade 2 or 3 unresectable or metastatic conventional chondrosarcoma. Patients received either ozekibart or placebo every three weeks at a randomization of 2:1, stratified by the line of therapy, grade and IDH1/2 mutation status.

Patients randomized to the placebo arm were allowed to crossover to receive ozekibart upon confirmation of progression as reported by central independent radiology review.

The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options.

The benefit of ozekibart was consistent across all pre-specified subgroups, including patients with IDH-wild-type and IDH-mutant tumors. Other key secondary endpoints, including disease control rate (54% vs 27.5%), and delay to deterioration in pain and physical function, further supported the clinical benefit observed with ozekibart.

Ozekibart was generally well tolerated, with a manageable safety profile. The most common treatment-related adverse events were fatigue, constipation, and nausea. Hepatotoxicity, a known risk for this mechanism of action, occurs during the first treatment cycle and is in patients with underlying hepatic impairment. One hepatotoxicity-related fatal event occurred early in the study, prior to the implementation of mitigation measures. Over the course of the ChonDRAgon study, this risk was effectively mitigated by excluding patients with severe liver impairment and by implementing close monitoring during early treatment cycles, allowing for prompt management of liver enzyme elevations. This approach resulted in a low overall incidence of treatment-related hepatic adverse events, 11.8% compared to 4.5% in the placebo arm, the majority of which were Grade 1 or 2 in severity.

In addition to the registrational trial in chondrosarcoma, Inhibrx is advancing ongoing expansion cohorts, evaluating ozekibart in combination with irinotecan-based regimens in Ewing sarcoma and colorectal cancer. Encouraging early signals support further exploration of ozekibart’s potential in these difficult-to-treat tumor types with high unmet medical need.

(Press release, Inhibrx, JUN 15, 2026, View Source [SID1234668740])

On June 15, 2026 Lonza and Antharis Therapeutics, Inc., a biopharmaceutical company developing next-generation antibody-based therapeutics for oncology, reported an exclusive, target-specific licensing agreement to develop novel dual-payload ADCs targeting gastrointestinal (GI) cancers.

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Antharis Therapeutics utilizes cutting-edge proprietary antibody engineering and target biology expertise to develop next-generation therapeutic monoclonal antibodies (mAbs), bispecifics and ADCs, designed to address unmet medical needs in oncology. Through this agreement, Antharis will integrate its proprietary antibody engineering and target biology expertise with Lonza’s clinically validated, site-specific ADC technologies.

Under the terms of the agreement, Antharis will secure rights to Lonza’s dual-payload ADC technology platform, which will be combined with Antharis’ proprietary discovery and development capabilities to advance highly differentiated, next generation ADC programs for multicancer applications.

The collaboration will initially support Antharis’ lead ADC program, about to enter the clinic, targeting GI cancers, and reflects the shared commitment of Antharis and Lonza to developing first-in-class and best-in-class, biology-driven ADCs with potential for overcoming multi-drug resistance and increasing overall survival rates.

Jan Vertommen, Vice President of Commercial Development, Advanced Synthesis, Lonza, said: "This licensing agreement highlights an exciting new innovation based on Lonza’s proprietary dual payload technology. We are excited to combine our platform with Antharis’ deep expertise in antibody engineering and target biology to evaluate its potential to advance next generation ADCs. We are pleased to see this collaboration applied within Antharis’ ambitious and scientifically rigorous ADC programs."

Raphael Ribeiro Pinaud, CEO of Antharis Therapeutics, said: "This collaboration represents a major strategic milestone for Antharis. By combining Lonza’s clinically validated ADC technology platform with Antharis’ antibody engineering, target biology and translational expertise, we are well positioned to advance next-generation dual-payload ADCs. We believe this collaboration creates a powerful and highly differentiated approach to oncology drug development."

Under the terms of the agreement, Antharis will retain full responsibility for research, clinical development, manufacturing and commercialization of the ADCs, while Lonza will manufacture components related to its proprietary payload and linker technologies. Lonza will be eligible to receive upfront, potential milestone payments and royalty payments on net sales.

(Press release, Lonza, JUN 15, 2026, View Source [SID1234668739])