On April 14, 2026 GlycoNex, Inc. (4168, hereinafter referred to as GNX), clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the initiation of a first-in-human (FIH) Phase 1 clinical trial of GNX1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal cancers.

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This milestone marks GlycoNex’s transition into clinical-stage development for its proprietary glycan-targeting ADC platform and represents a significant step toward addressing high unmet need in gastric and other gastrointestinal malignancies.

The multi-center, multinational Phase 1 study in patients with advanced gastrointestinal cancers is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of GNX1021 and to establish a recommended dose range for subsequent clinical development. The first phase of the trial will be conducted in Japan and Taiwan. Patient enrollment in Japan is expected to begin in June 2026. GlycoNex plans to submit an Investigational New Drug (IND) application in Taiwan in June 2026, with enrollment anticipated to begin in the third quarter of 2026.

"PMDA approval to initiate our first-in-human study is a defining milestone for GlycoNex and a critical validation of our glycan-targeting platform," said Dr. Mei-Chun Yang, Chief Executive Officer of GlycoNex. "GNX1021 represents a differentiated approach to ADC development, designed to address tumor heterogeneity by targeting glycan structures broadly expressed across multiple cancer-associated proteins. We believe this unique mechanism, combined with the selective expression of the bLeB/Y antigen in gastrointestinal tumors, positions GNX1021 to potentially deliver meaningful clinical benefit, particularly in gastric cancer where new treatment options are urgently needed."

GNX1021 is an innovative ADC designed to target branched glycan antigens that are abnormally overexpressed on tumor cell surfaces. Unlike conventional targeted therapies that recognize a single protein epitope, GNX1021 exploits aberrant glycan structures across multiple tumor-associated membrane proteins, enabling multi-target engagement and potentially overcoming a key limitation of existing precision oncology agents.

GNX1021 targets the bLeB/Y antigen, which is highly expressed in epithelial tumors—including gastric, pancreatic, and colorectal cancers—while showing minimal expression in healthy human tissues. This unique targeting mechanism enables GNX1021 to identify cancer cells with high specificity, significantly improving the therapeutic index and patient safety.

In preclinical safety assessments, GNX1021 demonstrated a controlled and predictable safety profile in toxicology studies involving rats and cynomolgus monkeys. Results indicated a stable metabolic process with no significant drug accumulation or unanticipated damage to major organs. These findings not only validate the biosafety of GNX1021 but also provide robust scientific evidence to support its transition into human clinical trials.

Dr. Yang concluded: "We are encouraged by continued global interest in novel ADCs with differentiated targets. As GNX1021 advances through clinical development, we believe it has the potential to generate significant strategic partnering interest while, more importantly, advancing a new therapeutic approach for patients with difficult-to-treat cancers. Reflecting on recent global ADC licensing trends, drugs with unique targets that have reached Phase 1 clinical trials often command total deal values ranging from several hundred million to over a billion USD."

(Press release, GlycoNex, APR 14, 2026, View Source [SID1234664369])

On April 14, 2026 HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address cancer relapse, metastasis, and resistance, reported the preclinical poster presentation titled, Combination of the GCN2 activator HC-7366 with VEGFR-TKI results in greater efficacy than VEGFR-TKI alone or VEGFR-TKI/HIF-2i combinations in ccRCC which will be highlighted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego, California. The abstract is now available on the AACR (Free AACR Whitepaper) website.

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The poster will present data showing that HC-7366 enhanced the activity of multiple VEGFR-TKIs, including lenvatinib, cabozantinib, and axitinib in preclinical metastatic ccRCC models, with HC-7366 and VEGFR-TKI doublets outperforming the combination of HIF-2α inhibitor and VEGFR-TKI in several preclinical patient-derived xenograft models. The data further support HC-7366 as a potential strategy to overcome VEGFR-TKI resistance in metastatic ccRCC and provide rationale for clinical evaluation of HC-7366 and VEGFR-TKI combinations in ccRCC. These findings also support HiberCell’s recent initiation of a Phase 1b arm evaluating HC-7366 in combination with cabozantinib in metastatic ccRCC as part of its ongoing clinical study (NCT06234605).

"We’re excited to share these data, which demonstrate the preclinical combination potential of HC-7366 with VEGFR-TKIs, a key standard-of-care therapeutic class in ccRCC," said Nandita Bose, Ph.D., Chief Development Officer of HiberCell. "These findings build on the data presented at the 2024 AACR (Free AACR Whitepaper) Annual Meeting demonstrating the combination potential of HC-7366 with HIF-2α inhibitors and further support our ongoing clinical evaluation of HC-7366 in combination with all three major standard-of-care therapeutic classes in ccRCC: HIF-2α inhibitors, VEGFR-TKIs, and immune checkpoint inhibitors. Collectively, these data suggest HC-7366 may have the potential to emerge as a next-generation, novel therapeutic approach in ccRCC."

Poster Presentation Detail:

Title: Combination of the GCN2 activator HC-7366 with VEGFR-TKI results in greater efficacy than VEGFR-TKI alone or VEGFR-TKI/HIF-2i combinations in ccRCC

Session: Combination Targeted Therapy (Section 42)

Abstract Number: 6485

Date & Time: April 21, 2026, 2:00 pm – 5:00 pm

About HC-7366

HC-7366 is a first-in-class, first-in-human, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is one of the kinases of the integrated stress response (ISR) family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have antitumor and immunomodulatory activity as a monotherapy and in combination with varied SOC agents in preclinical models of both solid and liquid tumors. HC-7366 is currently under clinical development in Phase 1b studies in ccRCC and acute myeloid leukemia (AML).

(Press release, HiberCell, APR 14, 2026, View Source [SID1234664385])

On April 14, 2026 Renaissance Pharma Limited, an Essential Pharma company focused on development stage assets, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation for Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody in development for the treatment of high-risk neuroblastoma (HRNB), a rare paediatric cancer. The designation recognises the significant unmet medical need in HRNB and will support more frequent interactions with the FDA throughout development, as well as eligibility for accelerated and rolling review.

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The company also confirms it has received IND clearance from the FDA, enabling initiation of the SHINE Phase II/III clinical trial in relapse or refractory children with HRNB in the United States. The first commercial-scale Good Manufacturing Practice (GMP) batch of Daretabart (hu1418K322A) has also been successfully manufactured for use in the SHINE trial.

Daretabart (hu1418K322A) is being developed by Renaissance Pharma under an exclusive license agreement with St. Jude Children’s Research Hospital, a global leader in pediatric cancer research and treatment. The antibody targets GD2, a cell surface antigen highly expressed on neuroblastoma cells. By binding to GD2, Daretabart (hu1418K322A) is designed to enhance immune-mediated tumour cell killing, while incorporating novel structural modifications intended to improve tolerability profile.

The programme builds on encouraging Phase II data evaluating Daretabart (hu1418K322A) as part of first-line therapy and in the post-consolidation setting for patients with HRNB. The study demonstrated a three-year event-free survival (EFS) rate of 73.7% and an overall survival (OS) rate of 86.0%. These results were published in the Journal of Clinical Oncology in December 2021.

The successful manufacture of the first commercial-scale GMP batch marks a key operational milestone and underscores Renaissance Pharma’s commitment to ensuring reliable, high-quality supply as the programme advances. This achievement supports ongoing clinical development and represents an important step towards future commercial readiness.

Simon Ball, Interim CEO of Essential Pharma and Director of Renaissance Pharma Limited said: "Daretabart has the potential to make a real difference for children with high-risk neuroblastoma, a disease where outcomes remain deeply inadequate despite intensive treatment. FDA Fast Track Designation is an important external validation of that potential, and together with IND clearance and our ability to manufacture at commercial scale, reflects the strength and maturity of this programme. Having worked exceptionally hard behind the scenes for a number of months, it is with great excitement that we announce this update today. We are executing at pace, and look forward to sharing data from the SHINE trial as it progresses. Today’s news brings us another step closer to delivering Daretabart as a meaningful new treatment option for children facing this aggressive cancer."

(Press release, Essential Pharma, APR 14, 2026, View Source [SID1234664353])

(Press release, Essential Pharma, APR 14, 2026, View Source [SID1234664353])

On April 14, 2026 PanGIA Biotech, Inc. ("PanGIA Biotech" or "Company") reported that two research abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2026, taking place April 17–22 in San Diego, California. Both abstracts highlight ongoing development of the Company’s PanGIA Analysis System ("PAS"), a machine learning platform designed to support non-invasive cancer detection through advanced biomarker analysis.

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Reflecting the Company’s continuing research into expanding the capabilities of the PAS across early detection applications, the accepted abstracts include:

"Our mission is to enable earlier detection to help facilitate better patient outcomes, reducing patient mortality. The acceptance of these abstracts is a step in that direction," said Holly Magliochetti, CEO and Co-Founder of PanGIA Biotech. "Opportunities like presenting at AACR (Free AACR Whitepaper) allow us to contribute to the broader conversation shaping the future of cancer diagnostics."

As one of the world’s leading scientific forums for cancer research, the AACR (Free AACR Whitepaper) Annual Meeting brings together clinicians, researchers, and industry leaders to share advances in oncology and translational medicine.

The Company’s research builds on ongoing work to expand the analytical capabilities of the PAS platform and support multi-cancer early detection approaches.

"Presenting this work at AACR (Free AACR Whitepaper) provides an opportunity to share how PanGIA Biotech’s research and development applies machine learning to complex biomolecular signals in non-invasive samples," said Obdulio Piloto, PhD, co-founder and Chief Scientific Officer of PanGIA Biotech and co-author of the studies. "Our research continues to explore how these analytical approaches may support earlier and more scalable cancer detection."

(Press release, PanGIA Biotech, APR 14, 2026, View Source [SID1234664370])

On April 14, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that a clinical data abstract submitted by experts from Moffitt Cancer Center was presented at the 2026 Society of Interventional Radiology (SIR) Annual Scientific Meeting in Toronto, Canada.

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The abstract, entitled "What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer," was presented on April 13, 2026 by a multidisciplinary team of experts, including Dr. Mustafa Al-Roubaie, an Interventional Radiologist at Moffitt Cancer Center and member of RenovoRx’s Medical Advisory Board.

The abstract examined the effectiveness of local, targeted intra-arterial chemotherapy administration using RenovoRx’s patented TAMP (Trans-Arterial Micro-Perfusion) therapy platform. By delivering chemotherapy directly near the tumor site, TAMP helps to overcome the poor vascularity typical of solid tumors like locally advanced pancreatic cancer (LAPC), where intravenous chemotherapy is often less effective. Additionally, the abstract assessed the potential application of metabolic imaging, FDG (fluorodeoxyglucose) PET/CT, in evaluating therapeutic outcomes following targeted intra-arterial drug-delivery via TAMP in patients with refractory disease.

The study concluded that TAMP is a promising approach for localized delivery of chemotherapeutic agents for the treatment of solid tumors such as LAPC, offering the potential for enhanced therapeutic drug-delivery with reduced systemic toxicity. Metabolic imaging further demonstrated dramatic reductions in FDG avidity, suggesting treatment response even when tumor size changed minimally. Eight cycles of intra-arterial chemotherapy were administered over 2 months, using the TAMP therapy platform, which is enabled by the Company’s RenovoCath device. Post-treatment imaging results indicated that PET/CT may detect early treatment response before anatomical changes occur.

"Patients diagnosed with LAPC face a challenging prognosis, due in part to a dense, hypovascular stroma that can restrict the effectiveness of traditional systemic (namely intravenous) chemotherapy," said Dr. Al-Roubaie. "Systemic chemotherapeutic administration is often associated with considerable toxicity and suboptimal tumor penetration. The TAMP therapy platform aims to increase local drug concentration directly near the tumor site while reducing systemic exposure."

Dr. Al-Roubaie continued, "These findings support RenovoRx’s TAMP therapy platform and its ability for local intra-arterial chemotherapeutic delivery directly near the tumor site and the potential for reduced toxicity for patients. These findings may complement RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial evaluating the company’s lead drug-device product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) for the treatment of LAPC."

About RenovoCath
Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, APR 14, 2026, View Source [SID1234664386])