On March 9, 2026 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM:HCM; HKEX:13) reported an update regarding TAZVERIK (tazemetostat), an oncology therapy licensed from Epizyme, Inc. ("Epizyme"), an Ipsen ("Ipsen") company, in China. Epizyme is the Marketing Authorization Holder of TAZVERIK in the Chinese mainland, for which HUTCHMED Limited (a subsidiary of the Company) acts as the domestic agent/licensee. Ipsen has informed HUTCHMED that it is voluntarily withdrawing TAZVERIK in the US. As a result, steps have been taken to initiate the market withdrawal and product recall in China. Consequently, HUTCHMED Limited has initiated a withdrawal and product recall from the Chinese mainland, Hong Kong and Macau, and is discontinuing all active tazemetostat clinical trials. Existing patients should consult their treating physicians immediately to discuss their treatment options.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab ("R²") vs R² in follicular lymphoma). As informed by Ipsen, following a review of emerging data from SYMPHONY-1, the study Independent Data Monitoring Committee advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing TAZVERIK effective immediately, including both for follicular lymphoma ("FL") and epithelioid sarcoma (ES).

Ipsen has announced that, in addition to withdrawing TAZVERIK from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrollment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs. Ipsen is working with the US Food and Drug Administration ("US FDA") on the next steps to execute the withdrawal of TAZVERIK and provide all necessary information to complete this process.

The safety and wellbeing of patients is HUTCHMED’s top priority. In alignment with this commitment, HUTCHMED Limited has promptly informed healthcare professionals, the China National Medical Products Administration ("NMPA"), the Hong Kong Department of Health and the Macau Health Bureau of this development. Upon becoming aware of this information, HUTCHMED Limited immediately placed the product on hold, suspending all sales and shipments, and notified healthcare institutions to cease prescribing it and pharmacies to stop dispensing it. HUTCHMED Limited has also immediately notified clinical trial sites in China to discontinue the use of tazemetostat. Furthermore, HUTCHMED Limited is also actively cooperating with regulatory authorities to determine the appropriate next steps for the withdrawal and recall of TAZVERIK in the Chinese mainland, Hong Kong and Macau.

TAZVERIK is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme. TAZVERIK monotherapy was approved by the US FDA in 2020 under the US FDA accelerated approval program. TAZVERIK received conditional approval from the NMPA for the treatment of FL as an imported drug. This approval pathway incorporates the evaluation of overseas trial data, references overseas regulatory approvals, and bridging study data to adapt foreign trial results to the Chinese population. Continued registration of TAZVERIK is subject to continuing obligations, including reporting of changes in foreign regulatory status, new safety signals and new evidence affecting the benefit-to-risk profile to patients.

The withdrawal is not expected to impact the Company’s financial guidance. In 2025, HUTCHMED sales of TAZVERIK were US$2.5 million.

(Press release, Hutchison China MediTech, MAR 9, 2026, View Source [SID1234663363])

On March 9, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Korean Ministry of Intellectual Property (MOIP) has issued a Notice of Allowance for a new patent related to Anixa’s breast cancer vaccine technology. This patent, exclusively licensed from Cleveland Clinic, will provide composition of matter protection for the Company’s novel approach to breast cancer treatment and prevention in South Korea. 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.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Korean patent complements patents issued in the United States and other key global jurisdictions, and represents an important step toward potential future regulatory approvals and commercialization efforts outside the United States.

"This newly allowed 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. In our recently completed Phase 1 clinical trial conducted at Cleveland Clinic, the vaccine met all major primary endpoints, was safe and well tolerated, and generated immune responses in 74% of participants, supporting continued clinical development of this novel preventive approach."

While the breast cancer survival rate is high in South Korea, the incidence rate has been increasing rapidly. In addition, unlike Western nations, the onset of breast cancer tends to occur earlier in life in South Korea. Breast cancer remains the most commonly diagnosed cancer among women worldwide, and currently there are no approved vaccines to prevent the disease.

Anixa’s 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, MAR 9, 2026, https://www.prnewswire.com/news-releases/anixa-biosciences-receives-notice-of-allowance-from-korean-ministry-of-intellectual-property-moip-for-patent-covering-breast-cancer-vaccine-technology-302707370.html [SID1234663381])

On March 9, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported a collaboration with Etcembly Ltd, a biotechnology company applying advanced machine learning to T cell receptor (TCR) discovery and engineering.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Highlights:

AI-enabled collaboration to engineer KKLC1-targeting TCRs for Zelluna’s TCR-NK platform
Builds on successful engineering of MAGE-A4 TCR underpinning ZI-MA4-1, approved for clinical testing in February 2026
Expands pipeline with validated solid tumour antigen expressed across multiple difficult-to-treat cancers
AI-guided in silico engineering to enhance specificity, potency and development efficiency
The collaboration will focus on the engineering of high-affinity, tumour-specific TCRs targeting KKLC1, a validated cancer antigen found in multiple difficult-to-treat solid tumours. The engineered receptors will be fully owned by Zelluna and developed for use within Zelluna’s proprietary TCR-NK platform. In-vitro data demonstrating safety, specificity and functional activity is now expected in Q4 2026.

This collaboration builds on Zelluna’s successful engineering of a T cell receptor (TCR) designed to recognise the cancer antigen MAGE-A4. This receptor is the targeting module of the company’s lead product candidate ZI-MA4-1, which in February 2026 received approval from the UK Medicines and Healthcare products Regulatory Agency (UK MHRA) to initiate clinical testing. By engineering receptors targeting KKLC1, Zelluna is expanding its product portfolio beyond MAGE-A4 and can thereby address a broader spectrum of solid cancers and patients.

"Our lead product candidate ZI-MA4-1 is built on an affinity enhanced receptor that recognises cancer cells with the MAGE-A4 protein. We developed this receptor in our first highly successful collaboration with Etcembly," said Luise Weigand, Chief Scientific Officer of Zelluna. "We are now delighted to continue our collaboration on our next programme targeting KKLC1. By combining artificial intelligence with our cell therapy platform, we aim to develop highly precise and potent treatments for solid cancers."

"Our first collaboration with Zelluna demonstrated what AI-guided TCR engineering can achieve: a clinically approved receptor in a fraction of conventional timelines. We are excited to apply EMLy again to expand Zelluna’s pipeline and address cancers that desperately need new treatment options" commented Michelle Teng, Founder and CEO of Etcembly.

(Press release, Zelluna Immunotherapy, MAR 9, 2026, View Source [SID1234663398])

On March 9, 2026 ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review. The request did not include the initiation or design of any new clinical trials. ImmunityBio submitted the requested information in February 2026. After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data. The company subsequently resubmitted the sBLA for patients with papillary-only NMIBC, including updated long-term follow-up data, and the Agency has acknowledged receipt of the filing. The long-term safety and efficacy results for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors have been published in The Journal of Urology.

"As far back as 2007, IL-15 was identified by leading scientific and medical organizations, including the NCI, NIH, FDA, AACR (Free AACR Whitepaper), and ASH (Free ASH Whitepaper), as the number one ranked immunotherapy molecule with the potential to cure cancer," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "The mechanism of action of ANKTIVA’s IL-15 superagonist activity was affirmed by the FDA’s approval of ANKTIVA in 2024 for BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The long-term data in papillary disease alone demonstrate prolonged disease-free survival and durable bladder preservation, consistent with ANKTIVA’s IL-15-based mechanism of action."

Dr. Soon-Shiong added, "We welcome FDA Commissioner Dr. Makary’s recent statements in The New England Journal of Medicine highlighting the importance of a "plausible mechanism of action" as an emerging regulatory pathway. The mechanism of action of ANKTIVA, which was recognized in the NCI’s 2007 report and reaffirmed in the FDA-approved 2024 package insert, embodies the principles underlying this approach."

Based on the IL-15 mechanism of action and results from the QUILT 3.055 study, the Saudi Food and Drug Authority (SFDA) recently approved ANKTIVA in combination with checkpoint inhibitors for patients with second-line and later metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after standard therapies, including checkpoint inhibitor treatment. In this setting, multiple randomized studies of investigational agents compared with docetaxel chemotherapy have failed to demonstrate improved outcomes, underscoring the significant unmet need among patients who experience relapse or progression after checkpoint inhibitor therapy. Notably, the recent randomized PRAGMATICA-LUNG (SWOG S2302) trial in the same disease setting, which compared pembrolizumab plus ramucirumab versus docetaxel, did not demonstrate improved survival compared with docetaxel, reporting a median overall survival of approximately nine months with docetaxel chemotherapy.

ImmunityBio plans to present the clinical data supporting the SFDA approval of the chemotherapy-free regimen of ANKTIVA plus checkpoint inhibitors, which demonstrated nearly double the median overall survival historically observed with docetaxel chemotherapy. The Company also intends to continue discussions with the FDA and other global regulatory authorities regarding potential treatment options for patients with second line and later metastatic NSCLC who have exhausted currently available standards of care, including checkpoint inhibitors.

About the Papillary Indication: The sBLA submission for BCG-unresponsive NMIBC papillary disease is supported by long-term results from the QUILT 3.032 Phase 2/3 trial (Cohort B) in 80 patients with high-grade papillary-only NMIBC. As published in The Journal of Urology (Chang et al., 2025), the study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2% (95% confidence interval: 46.6-68.2%). Patients treated with intravesical ANKTIVA plus BCG demonstrated a 96.0% disease-specific survival (DSS) rate at 36 months, with median DSS not yet reached. Progression-free survival (PFS) was 94.9% at 12 months and 83.1% at 36 months, indicating durable prevention of progression to muscle-invasive disease. Bladder preservation remained high, with cystectomy-free survival of 92.2% at 12 months and 81.8% at 36 months, meaning over 80% of patients avoided radical cystectomy through three years of follow-up. These results highlight the potential of ANKTIVA plus BCG to provide durable bladder-sparing outcomes and a chemotherapy-free immunotherapy alternative for patients with high-risk papillary NMIBC.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, MAR 9, 2026, View Source [SID1234663364])

On March 9, 2026 Caris Life Sciences (NASDAQ: CAI), a leading patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported the launch of a novel, proprietary Caris AI Insights signature for pancreatic cancer included in the Caris Molecular Tumor Board Report. The Caris Molecular Tumor Board Report is an innovative tumor profiling report that provides an additional tumor biology resource and is available upon request with no additional tissue sampling required when ordering MI Cancer Seek.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Caris Life Sciences continues to advance precision oncology by integrating multimodal real-world datasets, available with its proprietary CodeAI platform, enabling the creation of Caris AI Insights, an engine that utilizes Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS), and clinical data to generate deeper biological understanding and more actionable insights for clinicians and researchers.

By harnessing AI across its comprehensive real-world datasets, comprised of over 550,000 patients, Caris researchers are building next-generation multimodal models that accelerate biomarker discovery, enhance therapeutic decision-making, and support the development of more personalized cancer treatments.

This signature, designed to support first-line treatment selection for patients with pancreatic ductal adenocarcinoma (PDAC), leverages Caris’ WES and WTS to provide biologically informed insights that may help clinicians personalize therapy decisions in one of the deadliest and most treatment-challenging cancers.

FOLFIRINOX and gemcitabine/nab-paclitaxel (gem/nab-p) are the most commonly used first-line regimens for advanced PDAC, yet limited actionable biomarker guidance exists for therapy selection. As a result, treatment selection often relies on clinical factors rather than tumor biology, exposing patients to potentially unnecessary toxicity with limited benefit.

"Caris AI Insights for PDAC represents a meaningful step forward in bringing molecular intelligence to a disease where clinicians have historically had to make difficult treatment decisions with limited biological guidance," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "By harnessing the power of WES and WTS, this Caris AI Insights signature identifies complex molecular patterns that may predict differential benefit between standard first-line regimens. This is exactly the type of advancement to improve patient care that our comprehensive platform was built to deliver."

The PDAC signature provides clinicians with risk categorization (standard or high risk) and treatment recommendations between FOLFIRINOX and gem/nab-p, based on molecular patterns associated with differential benefit. The report includes a Kaplan-Meier plot for patients treated with either regimen, matching the predictions to the clinicians’ patients to advise likely responses.

Caris received FDA approval in November 2024 for MI Cancer Seek, a tissue-based assay that is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.

A future publication is expected this year, highlighting how Caris AI Insights for pancreatic cancer identified a significant subset of patients who may be candidates for treatment de-escalation, as well as those more likely to benefit from a more intensive regimen and those who likely need the more intensive therapy.

(Press release, Caris Life Sciences, MAR 9, 2026, View Source [SID1234663382])