On April 30, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate[1], has been validated and accepted for review.

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The application, covering commercially significant European markets[2], has now moved into a 210-day active assessment phase[3]. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines[4]. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after.

In Europe, there is currently no generally available commercial product for PET[5] imaging of glioma with 18F-FET ("FET-PET"), resulting in an acute and immediate need for a consistent, high-quality product [6]. Through this MAA, Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix’s glioblastoma therapy candidate TLX101-Tx (iodofalan 131I), which has been granted orphan drug designation in Europe and the U.S. The Phase 3 IPAX-BrIGHT[7] trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally[8] and is launching in multiple European countries.

Sied Kebir, MD, Head of Clinical Neuro-Oncology, University Hospital Essen, said: "In our day-to-day practice, one of the hardest questions we face is whether a change on conventional imaging reflects tumor progression or a treatment-related effect. PET imaging with ¹⁸F-FET can be used to help resolve this dilemma. The acceptance of this application is a welcome step toward broader, standardized patient access across Europe, and more timely and accurate decision-making."

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The acceptance of our European MAA represents a significant regulatory milestone for Telix and for TLX101‑Px. It supports a critical unmet need for widely accessible glioma imaging for both diagnostic evaluation and therapeutic decision‑making. Subject to regulatory approval, we are preparing to bring this powerful precision medicine product to market in both Europe and the United States, where our new drug application has recently been accepted[9]."

About glioma in Europe

In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year[10], with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors[11]. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting4. Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions[12]. With low survival rates and the need to make rapid decisions, precision imaging is paramount6. Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe and worldwide to receive greater clarity in their diagnosis and treatment decision making.

About TLX101-Px

TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine) is Telix’s PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix’s IPAX-2[13] and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi". Brand name and commercial launch are subject to final regulatory approval.

(Press release, Telix Pharmaceuticals, APR 30, 2026, View Source [SID1234664980])

On April 30, 2026 EnGeneIC Limited reported that the first patient has been dosed in its clinical trial evaluating EnGeneIC’s investigational EGFR-targeted EDV (EnGeneIC Dream Vector) therapy in patients with recurrent glioblastoma multiforme (GBM), an aggressive and currently incurable form of brain cancer.The trial is being led by Principal Investigator Dr. Mark Wong, Medical Oncologist at Westmead Hospital, one of Australia’s leading comprehensive cancer centres. Additional Australian recruitment sites will include the Kinghorn Cancer Centre, with further expansion planned to clinical sites in Singapore.

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"This first patient dosed milestone is a critical step forward for patients with recurrent glioblastoma, who typically have very limited treatment options once standard therapies have failed," said Dr. Mark Wong. "We look forward to assessing the safety and potential clinical benefit of this investigational therapy in a patient population with significant unmet medical need."

The investigational treatment consists of EGFR-targeted EnGeneIC Dream Vectors (EDVs) — bacterially derived, nanocell-based particles engineered to selectively bind to epidermal growth factor receptor (EGFR), which is frequently over-expressed in glioblastoma. The EDVs are loaded with the chemotherapeutic agent doxorubicin and the immune-modulating adjuvant α-galactosyl ceramide (α-GalCer).

This dual-payload design is intended to directly kill EGFR-expressing tumour cells while simultaneously activating a broad anti-tumour immune response, potentially converting an immunologically "cold" tumour into one capable of sustained immune recognition and attack.

In the clinical context, recurrent GBM remains highly resistant to conventional chemotherapy and immunotherapy, and EGFR-targeted EDVs offer a novel approach by combining targeted intracellular drug delivery with immune activation in a disease where both effective tumour penetration and immune engagement have historically been major challenges.

Dr. Jennifer MacDiarmid, Joint CEO and Director of EnGeneIC, commented "This clinical trial builds on spectacular overall survival outcomes currently observed in Compassionate Case Study patients with recurrent glioblastoma who had exhausted all available treatment options. Those results provided the strong clinical rationale to advance this EGFR-targeted EDV therapy into a formal clinical trial, allowing us to rigorously evaluate both its anti-cancer and immune-stimulating potential."

Patient recruitment is expected to continue across Australian and Singaporean sites in accordance with the trial protocol and applicable regulatory approvals.

About Glioblastoma

Glioblastoma multiforme is the most common and aggressive primary brain cancer in adults. Despite treatment with surgery, radiation and chemotherapy, recurrence is common and survival outcomes remain poor, highlighting the urgent need for new therapeutic approaches.

(Press release, EnGeneIC, APR 30, 2026, View Source [SID1234664995])

On April 30, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported positive clinical data from its Phase 2a study of namodenoson in patients with advanced pancreatic cancer.

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The data from the fully enrolled study demonstrate preliminary evidence of clinical activity, including durable disease stabilization in a heavily pretreated patient population, in addition to the previously reported favorable safety profile.

Key findings include:

● Stable disease observed in >30% of evaluable patients

● Prolonged treatment duration includes one patient extending beyond 16 months.

● 35% of patients remain on therapy and follow up

● Favorable safety and tolerability profile consistent with prior reports

The prolonged treatment duration observed in several patients suggests a potential for durable clinical benefit in this difficult-to-treat population.

"As we continue to analyse the data, we are encouraged by the emerging signal of durable disease stabilization observed in this study," said Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. "Importantly, a meaningful proportion of patients remain on therapy for extended periods, supporting the continued clinical development of namodenoson in pancreatic cancer."

As a substantial proportion of patients remain on treatment, full efficacy analyses, including progression-free survival and overall survival, top-line results are expected in the coming months and will be presented in a forthcoming clinical conference.

About Namodenoson

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

About Pancreatic Cancer Phase 2a Study

The Phase 2a study of namodenoson is an open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of namodenoson in this population. All patients receive oral namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. 20 evaluable patients were enrolled to the study. The primary objective of this trial is to characterize the safety profile of namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases.

(Press release, Can-Fite BioPharma, APR 30, 2026, View Source [SID1234664962])

On April 30, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate[1], has been validated and accepted for review.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The application, covering commercially significant European markets[2], has now moved into a 210-day active assessment phase[3]. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines[4]. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after.

In Europe, there is currently no generally available commercial product for PET[5] imaging of glioma with 18F-FET ("FET-PET"), resulting in an acute and immediate need for a consistent, high-quality product [6]. Through this MAA, Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix’s glioblastoma therapy candidate TLX101-Tx (iodofalan 131I), which has been granted orphan drug designation in Europe and the U.S. The Phase 3 IPAX-BrIGHT[7] trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally[8] and is launching in multiple European countries.

Sied Kebir, MD, Head of Clinical Neuro-Oncology, University Hospital Essen, said: "In our day-to-day practice, one of the hardest questions we face is whether a change on conventional imaging reflects tumor progression or a treatment-related effect. PET imaging with ¹⁸F-FET can be used to help resolve this dilemma. The acceptance of this application is a welcome step toward broader, standardized patient access across Europe, and more timely and accurate decision-making."

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The acceptance of our European MAA represents a significant regulatory milestone for Telix and for TLX101‑Px. It supports a critical unmet need for widely accessible glioma imaging for both diagnostic evaluation and therapeutic decision‑making. Subject to regulatory approval, we are preparing to bring this powerful precision medicine product to market in both Europe and the United States, where our new drug application has recently been accepted[9]."

About glioma in Europe

In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year[10], with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors[11]. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting4. Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions[12]. With low survival rates and the need to make rapid decisions, precision imaging is paramount6. Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe and worldwide to receive greater clarity in their diagnosis and treatment decision making.

About TLX101-Px

TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine) is Telix’s PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix’s IPAX-2[13] and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi". Brand name and commercial launch are subject to final regulatory approval.

(Press release, Telix Pharmaceuticals, APR 30, 2026, View Source [SID1234664980])

On April 30, 2026 Pliant Therapeutics (Nasdaq: PLRX) reported the dosing of the first participant in the FORTIFY Phase 1b open-label indication expansion clinical trial of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 is an oral, small molecule, dual selective inhibitor of the integrins αvβ8 and αvβ1.

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"We are pleased to announce this milestone for the FORTIFY trial and the expansion into solid tumor cohorts that we believe are supported by PLN-101095’s mechanism of action," said Bernard Coulie, M.D., Ph.D.., Chief Executive Officer of Pliant. "As a leader in integrin drug development, we look forward to exploring the full potential of this novel drug candidate."

FORTIFY – Phase 1b Clinical Trial Design

The primary objective of this trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of PLN-101095 when administered orally in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors. The expansion trial is enrolling three cohorts of patients with NSCLC, clear cell renal cell carcinoma, or one of a subset of tumors with high tumor mutational burden. Patients will be treated for 14 days with PLN-101095 as monotherapy dosed at 1,000 mg twice daily, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027.

PLN-101095 for the Treatment of Checkpoint Resistant Tumors

PLN-101095 is an oral, small molecule inhibitor of integrins αvβ8 and αvβ1. Activated transforming growth factor-β (TGF-β) has been shown to foster an immuno-suppressive tumor microenvironment (TME) that contributes to immune-checkpoint inhibitor (ICI) resistance and treatment failure in cancer.1 Blocking integrins αvβ8 and αvβ1 has been shown to prevent the activation of TGF-β and is expected to stimulate immune activation by increasing immune cell infiltration into the tumor microenvironment.2,3 PLN-101095 is currently being evaluated in Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT 06270706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 in combination with an anti-PD-1 monoclonal antibody (mAb) elicited a dose-dependent reduction in tumor volume and increased CD8+ T cell tumor infiltration in the tumor microenvironment compared with anti-PD-1 mAb therapy alone.4 In preclinical studies, PLN-101095 demonstrated monotherapy activity in reduction of tumor volume and increased cluster of differentiation (CD)8+ T cell infiltration.

(Press release, Pliant Therapeutics, APR 30, 2026, View Source [SID1234664996])