On July 14, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that the Australian Patent Office has allowed Patent Application No. 2021290439 entitled "Treatment of Advanced Metastatic Cancer."

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The patent complements Can-Fite’s rapidly advancing oncology pipeline. Namodenoson is currently being evaluated in a pivotal Phase 3 study for advanced hepatocellular carcinoma following FDA and EMA protocol agreement. In pancreatic cancer, the Company recently completed a Phase 2a clinical study demonstrating an excellent safety profile together with encouraging survival outcomes and durable disease stabilization and is planning a Phase 2b study evaluating Namodenoson in combination with gemcitabine.

"This patent allowance further strengthens our global intellectual property portfolio surrounding Namodenoson and reinforces the long-term value of our oncology franchise," said Pnina Fishman, Ph.D., Chairperson and Chief Scientific Officer of Can-Fite BioPharma. "Importantly, the patent supports two of our most advanced oncology programs—hepatocellular carcinoma and pancreatic cancer—and extends protection for our innovative therapeutic approach in a major international market."

Namodenoson selectively targets the A3 adenosine receptor (A3AR), which is highly expressed in inflammatory and cancer cells. Activation of A3AR has been shown to induce apoptosis of tumor cells while sparing normal tissues, contributing to the compound’s favorable safety profile demonstrated across clinical studies.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and enroll patients for a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety of the drug.

(Press release, Can-Fite BioPharma, JUL 14, 2026, View Source [SID1234669201])

On July 14, 2026 AstraZeneca reported it has entered into an exclusive license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy.

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Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

Approximately 80-85% of lung cancer patients globally have NSCLC. About 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR-mutated (EGFRm) NSCLC. Roughly one in four patients with EGFRm NSCLC has a tumour with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited.

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe."

Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: "As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China. Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion non-small cell lung cancer approved in the US and China for patients following prior systemic therapy."

Dizal recently announced positive results from the global WU-KONG28 Phase III trial of Zegfrovy in 1st-line NSCLC with exon 20 insertion EGFR mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.

Supported by these results, a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.

Sunvozertinib (Zegfrovy) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for NSCLC as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines for detailed recommendations.1

Financial considerations

AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy.

The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2026.

Notes

NSCLC
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.2 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.2-3 Approximately 75% of people are diagnosed with advanced NSCLC.4 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.5-7

Zegfrovy
Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

In addition, Zegfrovy also demonstrated encouraging anti-tumour activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon 20 insertions. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related treatment-emergent adverse events were Grade 1/2 in nature and clinically manageable.

(Press release, AstraZeneca, JUL 14, 2026, View Source [SID1234669180])

On July 14, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapies, reported the grant of a new patent (number 12,673,088) entitled "Combined Preparations for the Treatment of Cancer or Infection" by the United States Patent and Trademark Office (USPTO).

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This patent is the fourth in the series and follows the grant of the United States parent patent, first divisional patent, and second divisional patent announced in December 2020, March 2021 and June 2023, respectively.

The claims of the new patent build on the protection provided by the three previously granted patents and are directed to methods for the treatment of cancer by administering eftilagimod alfa in combination with an anti-PD-1 antibody or an anti-PD-L1 antibody, or fragments thereof. The expiry date of the patent is 20 January 2036.

This grant further expands Immutep’s intellectual property protection for eftilagimod alfa in combination with PD-1 pathway inhibitors, a key class of immunotherapies used in modern cancer treatment.

Marc Voigt, CEO of Immutep, said: "We are very pleased to add this fourth United States patent to our expanding patent portfolio covering eftilagimod alfa in combination with PD-1 pathway inhibitors. This represents a meaningful addition to our intellectual property estate. As we consider next steps for efti, this expanded IP estate supports future development pathways and business development opportunities."

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals and cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations including with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, JUL 14, 2026, View Source [SID1234669172])

On July 13, 2026 Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the U.S. Food and Drug Administration (FDA) has approved PADCEV (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor, Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant and adjuvant (before and after surgery) treatment for adult patients with muscle-invasive bladder cancer regardless of cisplatin eligibilityi. This now marks the first platinum-free regimen approved for adult patients with MIBC, regardless of cisplatin eligibility.

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The approval was based on results from the pivotal Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15), which were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU). This expanded indication builds on the November 2025 U.S. FDA approval of the combination for use as neoadjuvant and adjuvant treatment in cisplatin-ineligible adult patients with MIBC, based on results from the EV-303 Phase 3 clinical trial (also known as KEYNOTE-905) that were published in the New England Journal of Medicine.

Christopher Hoimes, DO, Director of the Bladder Cancer Program and Center for Cancer Immunotherapy at Duke Cancer Institute, and an EV-304 Principal Investigator
"For muscle-invasive bladder cancer, a comprehensive treatment approach is important; the neoadjuvant phase can help shrink the tumor and target undetectable cancer cells early before surgery, while the adjuvant phase can be critical in eliminating residual, undetectable cancer cells following surgery. These data from EV-304 and this approval show that by delivering this regimen across both the neoadjuvant and adjuvant phases, without platinum-based chemotherapy, we can significantly reduce the risk of recurrence and improve overall survival — offering a potential new standard of care for adult patients with muscle-invasive bladder cancer."

Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer
"Today’s approval marks a historic turning point for the treatment of muscle-invasive bladder cancer, providing adult patients with the first approved platinum-free combination regimen shown to significantly improve survival over the current standard of care – regardless of cisplatin-eligibility. PADCEV plus pembrolizumab has established itself as the standard of care for first line therapy of advanced stages of bladder cancer, and we’re thrilled to be able to provide this community a much-needed new treatment option in an earlier, potentially curative-intent setting."

Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas
"The approval of neoadjuvant and adjuvant PADCEV plus pembrolizumab expands the established impact of this combination and represents a critical leap forward in how muscle-invasive bladder cancer can be treated. By delivering a clinically meaningful survival benefit, with profound event-free survival and pathological complete response rates, this regimen is the first platinum-free treatment option in nearly 25 years to outperform standard of care chemotherapy, offering new hope to patients living with this disease."

In the EV-304 clinical trial, patients were randomized to receive surgery with neoadjuvant and adjuvant PADCEV plus pembrolizumab or surgery with neoadjuvant chemotherapy. PADCEV plus pembrolizumab was administered as a planned total of 9 cycles of PADCEV and 17 cycles of pembrolizumab split before and after surgery.ii PADCEV plus pembrolizumab demonstrated:

A 47% reduction in the risk of tumor recurrence, progression or death compared to patients treated with standard of care neoadjuvant gemcitabine and cisplatin (Hazard Ratio (HR) of 0.53; 95% Confidence Interval (CI), 0.41–0.70; 1-sided p<0.0001).ii
An estimated 79.4% of patients were event-free at two years, compared with 66.2% treated with standard of care.ii
A 35% reduction in the risk of death compared to neoadjuvant chemotherapy (HR of 0.65; 95% CI, 0.48-0.89; 1-sided p=0.0029).ii
A pathological complete response (pCR) rate of 55.8% compared with 32.5% with chemotherapy at the time of surgery (estimated difference 23.4%; 95% CI 16.7-29.8; 1-sided p<0.0001).ii
A safety profile consistent with prior experience with this combination, and no new identifiable safety signals. Grade ≥3 adverse events (AEs) due to any cause occurred in 75.7% of patients treated with neoadjuvant and adjuvant PADCEV plus pembrolizumab compared to 67.2% of patients treated with neoadjuvant chemotherapy.ii
About the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant gemcitabine-cisplatin chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab split before and after surgery.ii

The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause. Key secondary endpoints include OS and pCR rate.iii

For more information on the global EV-304 trial, go to clinicaltrials.gov.

About Muscle-Invasive Bladder Cancer
Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 people each year globally, including an estimated 85,000 people in the U.S.iii,iv MIBC represents approximately 30% of all bladder cancer cases.v The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery.vi Even after undergoing surgery to have their bladder removed, approximately half of patients with MIBC experience disease recurrence.vii

About PADCEV (enfortumab vedotin-ejfv)
PADCEV (enfortumab vedotin-ejfv) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.viii Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).i

PADCEV plus pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved for the treatment of adult patients with MIBC in the United States and for cisplatin-ineligible patients with MIBC in the European Union.

PADCEV plus pembrolizumab is also approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the United States, the European Union, Japan and a number of other countries around the world. PADCEV is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

(Press release, Astellas, JUL 13, 2026, View Source [SID1234670182])

On July 13, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported a collaboration with Ardigen S.A., an AI-driven computational partner for modern R&D recognized for pioneering the use of artificial intelligence (AI) and bioinformatics for precision medicine, to support VERAXA’s growing BiTAC pipeline of t cell engagers (TCEs) and antibody drug conjugates (ADCs). The collaboration is another milestone in VEREXA’s mission to integrate AI into its research and development, with the long-term goal to achieve success rates in drug development that exceed industry benchmarks.

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Current high-potency modalities, including TCEs and ADCs, are frequently limited by severe on-target, off-tumor toxicities, restricting therapeutic efficacy and leading to high failure rates in development. VERAXA’s BiTAC-TCEs and future BiTAC-ADCs utilize a Boolean "AND-gate" logic, requiring the co-expression of two distinct targets on the same cancer cell for activation. This innovative approach has the potential to significantly widen the therapeutic window by sparing healthy tissues and even systemic toxicity.

With the BiTAC platform, VERAXA believes that it can leverage the extensive body of existing preclinical and clinical data generated across the industry, particularly from programs that failed due to toxicity despite demonstrating promising efficacy. AI could enable the integration and analysis of such large datasets to identify improved dual-target combinations, refine therapeutic design, and potentially rescue previously challenging or "undruggable" targets. The partnership with Ardigen will initially focus on developing AI-enabled tools and models to guide the selection process of synergistic cancer target pairs for VERAXA’s growing BiTAC portfolio.

"We see enormous potential in the application of AI processes to help guide the development strategy of our proprietary BiTAC programs," commented Christoph Antz, Ph.D., CEO and Co-Founder of VERAXA. "Because of the nature of BiTACs, smart cancer target selection and thorough validation from the outset can have a transformative impact on future success rates and product profiles. This collaboration represents a strategic step forward in harnessing the power of AI to bring precision oncology therapies to patients faster."

(Press release, Veraxa Biotech, JUL 13, 2026, View Source [SID1234669184])