On April 14, 2026 Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies in the EMEA region, reported that it has signed an exclusive agreement with LEO Pharma A/S to commercialize LOQTORZI (toripalimab) in select regions in Central and Eastern Europe (CEE).

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Under the terms of the agreement, Er-Kim will serve as the exclusive commercial partner for LOQTORZI in the following markets: Bulgaria, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia.

This PD-1 inhibitor is an intravenous immunotherapy that harnesses the body’s immune system to identify and attack cancer cells. In the European Union, the treatment is indicated for two distinct, hard-to-treat malignancies:

Nasopharyngeal Carcinoma (NPC): A rare and aggressive cancer of the head and neck. The therapy is used in combination with cisplatin and gemcitabine for adults with recurrent (non-resectable) or metastatic NPC as a first-line option, or as a monotherapy for those who have previously undergone chemotherapy.
Oesophageal Squamous Cell Carcinoma (OSCC): For patients with advanced, recurrent, or metastatic OSCC that cannot be removed by surgery. In these cases, it is used in combination with cisplatin and paclitaxel.
Cem Zorlular, Chief Executive Officer of Er-Kim, said, "Advancements in immunotherapy are fundamentally changing the outlook for patients with nasopharyngeal carcinoma and oesophageal squamous cell carcinoma, but innovation only matters when it reaches the people who need it. By leveraging our deep infrastructure and relationships in Central and Eastern Europe, we are pleased to partner with LEO Pharma to bridge this access gap and bring LOQTORZI to oncology patients throughout the CEE region."

"We are committed to advancing cancer care by making innovative treatments available to this vulnerable group of patients who face limited options. Er‑Kim’s regional knowledge makes them a strong partner to bring LOQTORZI to new markets in Central and Eastern Europe," said Jean Monin, Executive Vice President of the Critical Care Business Unit at LEO Pharma A/S. "Together, we can make a difference for the patients and healthcare professionals we serve."

In 2025, LEO Pharma A/S was granted exclusive distribution and sales rights for LOQTORZI in the European Union (EU), the European Economic Area (EEA), as well as Switzerland and the United Kingdom, while TopAlliance Biosciences remains the Marketing Authorisation Holder (MAH).

(Press release, Erkim Pharmaceuticals, APR 14, 2026, View Source [SID1234664387])

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])

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 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the first patient has been dosed with TLX101-Tx (¹³¹I-iodofalan) in Telix’s pivotal IPAX BrIGHT trial1, marking the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, an aggressive form of brain cancer.

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The patient was dosed at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. IPAX BrIGHT is assessing the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone. The global, multicenter, open-label study will enroll patients with radiographically confirmed recurrent glioblastoma at first recurrence.

Telix’s commitment to advancing care for patients with glioblastoma is driven by the significant unmet need in this space. In the past 25 years, only two drugs have been approved by the United States Food and Drug Administration (FDA) for glioblastoma2, and no standard treatment currently exists for recurrent disease. Patients therefore face limited treatment options after initial therapy. TLX101-Tx offers a novel approach by targeting the L-type amino acid transporter 1 (LAT1), a transporter that enables the radiopharmaceutical to cross the blood-brain barrier and delivers therapy directly to the tumor.

IPAX BrIGHT expands upon promising data from earlier trials in the recurrent glioblastoma setting, including IPAX-13, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis4. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx were consistent and confirmatory to IPAX-1, with a median OS of 12.4 months from initiation of treatment and 32.2 months from initial diagnosis5. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx.

Professor Gan, Director of Cancer Clinical Trials at Austin Health, said, "Based on the prior safety profile and early efficacy data for TLX101-Tx in the IPAX-1 and IPAX-Linz studies, I am pleased to continue to explore this therapeutic modality in the first radiopharmaceutical pivotal trial in recurrent glioblastoma, where there are currently few effective treatment options."

Dr. David N. Cade, Group Chief Medical Officer, Telix, added, "Through the IPAX BrIGHT trial, we aim to offer a new option for patients affected by glioblastoma. This registration-enabling study represents a major step forward in our mission to improve therapeutic options in neuro-oncology. With very limited innovation in treatment in recent decades, TLX101-Tx has the potential to become a first-in-class therapy that meaningfully improves patient outcomes."

The IPAX BrIGHT study has received regulatory approval in Australia, Austria, Belgium and the Netherlands with approval being sought in additional jurisdictions. Telix’s investigational PET6 imaging agent for glioma, TLX101-Px (floretyrosine F 18) will be used for patient selection in IPAX BrIGHT, as well as assessing metabolic tumor response according to PET RANO 1.07.

About TLX101-Tx

TLX101-Tx (131I-iodofalan) is a systemically administered radiopharmaceutical therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101-Tx utilizes a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. In addition to the IPAX-1 and IPAX-Linz studies, TLX101-Tx is also under investigation in the IPAX-2 Phase 1 study in combination with post-surgical standard of care treatment in patients with newly diagnosed glioblastoma8. TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction.

About glioblastoma

Glioblastoma (GBM), is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.9. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients10, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, APR 14, 2026, View Source [SID1234664384])

On April 14, 2026 4D Path, a company dedicated to personalizing cancer care through a novel, physics-informed approach to predicting tumor response to therapy, reported a collaboration with Daiichi Sankyo (TSE: 4568) to develop next-generation predictive biomarkers in an antibody drug conjugate (ADC) clinical development program.

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ADCs are among the most promising therapeutic classes in oncology, yet there remains a significant unmet need for scalable biomarkers that predict which patients are most likely to benefit from increasingly complex regimens and combination therapies. This collaboration brings together 4D Path’s ability to compute biologically grounded, physics-informed treatment predictive biomarkers from routine pathology specimens with the ADC innovation leadership of Daiichi Sankyo.

Under the collaboration, 4D Path will apply its proprietary Q-Plasia OncoReader (QPOR) platform to standard Hematoxylin and Eosin (H&E)-stained tumor biopsy slides to compute interpretable, quantitative biomarkers associated with cell-cycle deregulation and tumor microenvironment dynamics. These biomarkers will be evaluated for their ability to identify patients most likely to benefit from the select ADC, helping enable more precise, non-invasive, and cost-effective patient selection, potentially improving response rates and accelerating clinical trials.

This approach is designed to be compatible with both retrospective analyses of archived clinical specimens and prospective evaluation in ongoing and future studies.

"While the introduction of ADCs has improved outcomes for patients, more advanced biomarkers that are predictive of response to these agents is needed. 4D Path’s novel approach to utilizing biological and physical characteristics from routine H&E-stained biopsy slides to predict benefit from ADCs has the potential to improve outcomes, helping patients get the right therapy at the optimal time in their disease course," said Lee Schwartzberg, medical oncologist and Scientific Advisory Board member, 4D Path.

The collaboration is expected to also generate functional mechanistic insights into tumor-specific patterns of response and resistance—helping illuminate how biological context may interact with ADC designs. By transforming routine pathology images into actionable, physics-informed collective tumor state variables, the agreement aims to enrich translational understanding while supporting more personalized and effective treatment strategies.

"The deep precision medicine focus of this collaboration in digital pathology brings in 4D Path’s QPOR platform-derived pan-cancer insights identifying patients likely to respond to treatment, by one-shot computation of cell cycle and tumor microenvironment dynamics from routine tissue images. Additionally, this will potentially shed light on tumor specific biological understanding of response and resistance, enriching knowledge of the relative impact of targets, linkers, and payloads on outcomes and accelerating precision ADC treatments," said Satabhisa Mukhopadhyay, Ph.D., co-founder and chief scientific officer at 4D Path.

This collaboration underscores the industry-wide shift toward AI-driven, image-based biomarkers that can be deployed at scale using standard-of-care specimens—supporting faster, more confident treatment decisions and improving the probability of success in clinical development.

(Press release, Daiichi Sankyo, APR 14, 2026, https://www.businesswire.com/news/home/20260408304934/en/4D-Path-Announces-Collaboration-with-Daiichi-Sankyo-to-Advance-AI-Driven-Predictive-Biomarkers-for-an-Antibody-Drug-Conjugate-Program [SID1234664383])