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 Dizal reported that it has entered into a global exclusive license agreement with AstraZeneca 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 China and the U.S. 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. Dizal recently announced results of the multinational Phase III WU-KONG28 study of Zegfrovy in first line NSCLC with EGFR exon20ins 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 China’s Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA). The China’s CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.

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 mutations as a disease driver. Roughly one in four patients with an EGFR-mutated NSCLC mutation has a tumor with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited.

Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: "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." 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."

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."

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.

About Zegfrovy

Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of Zegfrovy in the same indication. The sNDA for previously untreated NSCLC with EGFR exon20ins has been submitted to China Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA), supported by WU-KONG28 study results. The China’s CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.

In addition, Zegfrovy also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse events) were Grade 1/2 in nature and clinically manageable.

(Press release, Dizal Pharma, JUL 14, 2026, View Source [SID1234669213])

On July 14, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that IP Australia has issued a Notice of Acceptance for a new patent related to Anixa’s breast cancer vaccine technology.

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This patent, exclusively licensed from Cleveland Clinic, will provide protection for the Company’s novel approach to breast cancer treatment and prevention in Australia. The patent is titled, "Vaccine Adjuvants and Formulations," and the co-inventors are Dr. Justin Johnson and the late Dr. Vincent Tuohy, both of Cleveland Clinic.

The acceptance further expands the international scope of Anixa’s intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Australian patent complements patents issued in the United States and other key global jurisdictions, including Europe, China, and Japan, among others, and represents an important step toward potential future regulatory approvals and commercialization efforts outside the United States.

In a recently completed Phase 1 trial, at Cleveland Clinic and funded by the U.S. Department of Defense, the vaccine met all major primary endpoints, was safe and well tolerated, and generated protocol defined immune responses in more than 74% of participants. These results support continued clinical development of the Company’s novel preventive and therapeutic breast cancer vaccine.

"This newly accepted patent continues the broad international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue clinical development in the U.S., our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialization."

Breast cancer remains the most commonly diagnosed cancer among women worldwide, and while survival rates in Australia remain high, incidence rates have continued to increase. Despite significant advances in screening and treatment, there are currently no approved vaccines designed to prevent breast cancer.

Anixa’s breast cancer vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue, particularly in aggressive forms of the disease such as triple-negative breast cancer.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention. If successful, the technology could represent one of the first preventive vaccine approaches targeting breast cancer.

(Press release, Anixa Biosciences, JUL 14, 2026, View Source [SID1234669214])

On July 14, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that it has entered into a collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) to advance a Phase II clinical study evaluating a cadonilimab-based combination regimen for the perioperative treatment of locally advanced, resectable HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Cadonilimab is the world’s first PD-1/CTLA-4 bispecific antibody developed by Akeso.

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The study is being led by Dr. Yelena Janjigian, a globally renowned expert in gastrointestinal malignancies at MSKCC. It is now actively enrolling patients across the United States.

This Phase II study will generate robust clinical evidence to support the future initiation of an international multicenter Phase III trial of the cadonilimab combination regimen for the perioperative treatment of GC/GEJ adenocarcinoma.

Cadonilimab and ivonescimab, as first-in-class bispecific antibodies with breakthrough global clinical value, have garnered significant attention and recognition from the international medical community. These innovative IO 2.0 therapies are increasingly favored by global partners as the preferred backbone for combination regimens and novel treatment paradigms across a wide range of cancers. Their global therapeutic value continues to be scientifically explored and realized through ongoing clinical data and new studies.

Building on cadonilimab’s unique dual-target synergistic mechanism, this Phase II study is supported by strong evidence from the Phase III COMPASSION-15 trial and previous Phase II neoadjuvant studies in gastric/GEJ adenocarcinoma.

Gastric cancer is the fifth most common malignancy worldwide, with nearly one million new cases annually. For patients with locally advanced, resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma, standard perioperative FLOT chemotherapy achieves a 3-year overall survival rate of only 48%. Although the addition of PD-1 inhibitors to FLOT has become the new standard of care, the pathologic complete response (pCR) rate remains limited at approximately 19%, and nearly one-third of patients experience disease recurrence or death within two years. Dual PD-1/CTLA-4 inhibition has shown limited benefit due to overlapping toxicities and increased early mortality. A significant unmet medical need persists for more effective and better-tolerated treatment options.

As the first approved bispecific antibody for cancer immunotherapy, cadonilimab has demonstrated breakthrough clinical benefits across multiple pivotal studies and is now widely used in clinical practice. More than 12 registrational or Phase III studies of cadonilimab are currently underway globally, including two international multicenter registrational/Phase III trials led by Akeso.

In addition, Akeso is collaborating with INOVIO to explore a novel combination regimen using INOVIO’s DNA-based therapy for glioblastoma (GBM) at Dana-Farber Cancer Institute and Mass General Brigham. The Company continues to accelerate the global development of cadonilimab through strategic partnerships with leading therapeutics and institutions.

(Press release, Akeso Biopharma, JUL 14, 2026, View Source [SID1234669215])

On July 13, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL) ("Artelo" or the "Company), a clinical-stage pharmaceutical company focused on modulating lipid-signalling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, reported promising results from nonclinical studies in neuropathic pain with ART27.13, the Company’s proprietary peripherally restricted cannabinoid receptor agonist, currently in Phase 2 clinical development evaluating patients experiencing cancer-related anorexia cachexia syndrome (CACS).

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To determine whether ART27.13 has the potential to address neuropathic pain in cancer patients, researchers at Artelo investigated its proprietary dual cannabinoid agonist in a nonclinical model of paclitaxel-induced peripheral neuropathy, a debilitating side effect that affects approximately 60%-80% of patients receiving paclitaxel1.

Results demonstrated that repeated dosing with ART27.13 reduced neuropathic pain-associated behaviors (mechanical allodynia and thermal hyperalgesia) in both male and female paclitaxel-treated animals, supporting further exploration of the compound in oncology supportive care settings.

"Chemotherapy-induced peripheral neuropathy can significantly affect patient quality of life and may limit cancer treatment adherence," said George Warren, Ph.D., lead scientist at Artelo Biosciences and presenter of the pain study results at the International Cannabinoid Research Society (ICRS) 2026 Annual Symposium recently held in Dijon, France. "The results observed in this model suggest that ART27.13 may have broader applications in cancer supportive care beyond CACS. We have incorporated several pain endpoints into the Cancer Appetite Recovery Study (CAReS) trial and, we look forward to reviewing these upon study completion to determine if the analgesic potential of ART27.13 in a cancer setting translates into the clinic."

CACS affects up to 80% of patients with advanced malignancies2 and is associated with reduced treatment tolerance, diminished physical functioning and poorer clinical outcomes. There are currently no FDA-approved treatment options available for CACS. ART27.13 is being evaluated in the CAReS and interim results also presented at ICRS demonstrated encouraging trends across several clinically meaningful endpoints, including improvements in body weight and lean body mass, increased activity levels, and favorable safety profile at doses up to 1300 µg/day.

"Interim CAReS results, and the new data in neuropathic pain, suggests peripheral cannabinoid receptor modulation may influence multiple pathways associated with appetite regulation, metabolism, body composition and symptom management, particularly chemotherapy-induced neuropathic pain, in patients with cancer," said Professor Saoirse E. O’Sullivan, Vice President of Translational Science at Artelo Biosciences and presenter of the interim results from CAReS. "Importantly, the supportive care opportunity for ART27.13 may extend beyond appetite stimulation and weight maintenance, as demonstrated by additional research presented at ICRS."

"Despite its significant impact on patient outcomes and quality of life, CACS remains an area of substantial unmet medical need with limited therapeutic options available to patients and physicians," continued Professor O’Sullivan. "The trends observed in body composition and activity measures from CAReS are particularly encouraging given the profound impact these factors can have on patients living with CACS."

https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2026.1762734/full?utm_source
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About ART27.13
ART27.13 is a novel cannabinoid receptor agonist being developed as supportive care for people with cancer experiencing anorexia and cachexia. Administered orally once daily, the treatment goals with ART27.13 are to improve appetite, body weight, and activity levels while preserving muscle and elevating quality of life. Initially developed by AstraZeneca plc, ART27.13 selectively targets peripheral cannabinoid (CB1 and CB2) receptors to avoid the CNS side effects typically associated with some cannabinoids. While exhibiting a favorable safety profile at all doses in the CAReS trial, interim analysis from the blinded and randomized Phase 2 study demonstrated a mean weight gain of over 6% for participants that received the top dose of ART27.13 compared to a 5% loss in the placebo group. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to therapy. Currently, there areno FDA approved treatments for cancer anorexia cachexia syndrome.

About CAReS
The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in people with cancer experiencing anorexia and weight loss. Cancer-related anorexia, or the lack or loss of appetite in the person with cancer, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for people with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. Interim data from the Phase 2 portion of CAReS showed improvements in lean body mass, weight gain, and activity among patients treated with all doses of ART27.13, particularly at the highest dose, compared to the participants administered placebo. (ISRCTN registry: View Source)

(Press release, Artelo Biosciences, JUL 13, 2026, View Source [SID1234669183])