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.

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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 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the first patient has been successfully dosed in a Phase Ⅱ clinical study evaluating Opamtistomig (LBL-024), the company’s core investigational PD-L1/4-1BB bispecific antibody, for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

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ESCC ranks as the seventh most common cancer in China, characterized by insidious onset and poor prognosis. Although immune checkpoint inhibitors combined with chemotherapy have improved objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to chemotherapy alone, median OS remains only 12-17 months. This underscores the limitations of current treatment approaches and the urgent need for improved outcomes, highlighting the necessity to explore more effective innovative strategies to address this significant clinical challenge.

Opamtistomig is a uniquely engineered bispecific antibody designed to simultaneously block PD-1/L1-mediated immune suppression and selectively activate the 4-1BB co-stimulatory pathway. By restoring T-cell functionality and expanding effector T-cell populations within the tumor microenvironment, Opamtistomig has the potential to deliver more potent and durable anti-tumor activity than PD-1/PD-L1 blockade alone, particularly in difficult-to-treat and immunotherapy-resistant tumors. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

The open-label, multi-center Phase Ⅱ clinical study is led by Professor Shen Lin of Beijing Cancer Hospital and is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig administered in patients with ESCC.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "ESCC is highly prevalent with poor prognosis in China. While immune-chemotherapy combinations have shown progress, the overall survival benefit remains very limited, necessitating breakthrough solutions. The dosing of the first ESCC patient with Opamtistomig marks a critical milestone in our clinical strategy for this core pipeline asset. We anticipate it will overcome current immunotherapy limitations, delivering both higher response rates and prolonged survival benefits for patients."

About ESCC
China is a region with a high incidence of esophageal cancer, accounting for approximately 50% of the newly diagnosed and fatal cases of esophageal cancer worldwide. Esophageal cancer is broadly classified into ESCC and esophageal adenocarcinoma, of which squamous cell carcinoma represents the predominant subtype in China. According to 2022 data published by the International Agency for Research on Cancer (IARC) of the World Health Organization, ESCC ranked seventh among all cancers in China in terms of incidence, with an estimated 224,000 new cases and approximately 187,000 deaths recorded annually. Early-stage esophageal cancer typically presents with no obvious clinical symptoms, and the majority of patients are diagnosed at a locally advanced stage or with distant metastases. As a result, prognosis remains poor, with a five-year survival rate of only 10.0% to 30.0%.

About Opamtistomig (LBL-024)
Opamtistomig (LBL-024) is a potential first-in-class bispecific antibody that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, and it holds promise to become the first approved therapy specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC)—a rare malignancy with substantial unmet clinical need.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig features a 2:2 molecular format, incorporating two binding domains each for PD-L1 and 4-1BB with an optimized affinity ratio. This unique design enables dual functionality: reversing PD-L1–mediated immune suppression while selectively enhancing T-cell activation, resulting in a potent and synergistic anti-tumor immune response.

In two ongoing clinical studies in China, Opamtistomig has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. Given the absence of a globally accepted standard of care for EP-NEC, these results support the advancement of a single-arm pivotal study toward potential accelerated approval.

Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Beyond EP-NEC, Opamtistomig has received clinical trial approvals across multiple tumor types with high unmet medical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Encouraging clinical activity has already been observed in NSCLC, SCLC, BTC, OC, and other indications, underscoring Opamtistomig’s potential as a broad-spectrum immuno-oncology therapy.

(Press release, Nanjing Leads Biolabs, MAR 9, 2026, View Source [SID1234663380])

On March 9, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported that the first patient has been enrolled in its Phase 1 clinical trial evaluating IDE892, an investigational MTA-cooperative PRMT5 inhibitor being developed for patients with MTAP-deleted solid tumors, including non-small cell lung cancer and pancreatic cancer. The trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of IDE892 as a monotherapy agent and in combination with IDE397, IDEAYA’s MAT2A inhibitor, in mid-2026. Dual inhibition of IDE892 and IDE397 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.

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"We are excited to have enrolled the first patient in our Phase 1 clinical trial evaluating IDE892 in patients with MTAP-deleted solid tumors, including non-small cell lung cancer and pancreatic cancer. We designed IDE892 with potential best-in-class properties, including specific biophysical and pharmacokinetic properties that we believe will maximize its therapeutic window and clinical efficacy, both as a monotherapy agent and as a combination partner with our MAT2A inhibitor, IDE397. Next, we look forward to advancing our first-in-class CDKN2A-defiency program to progress our broader corporate strategy of enabling wholly owned rational combinations targeting MTAP-deletion," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE892 was designed to be a potential best-in-class PRMT5 inhibitor, with ~1,400-fold selective binding to MTA-PRMT5 versus SAM-PRMT5 complexes and observed single-digit nano-molar potency in endogenous MTAP-deleted cell lines, and greater than 50-fold potency differential in MTAP-deleted versus MTAP wild type HCT116 isogenic cell lines. In addition, IDE892 inhibited the arginine dimethylation of a key PRMT5 substrate involved in mRNA splicing, spliceosome protein SmB (SmB-SDMA), with pico-molar potency in MTAP-deleted cell lines with greater than 100-fold potency differential versus an MTAP wild type cell line. IDE892 has demonstrated monotherapy regressions in MTAP-deleted preclinical models, and durable complete responses in combination with IDE397.

Loss of MTAP leads to the accumulation of methylthioadenosine (MTA) and increased dependence on PRMT5 and MAT2A, two key enzymes involved in methylation and RNA splicing. In MTAP-deleted tumors, this biology establishes a robust synthetic lethal vulnerability that underpins the mechanistic rationale for combining IDE892 and IDE397. In preclinical studies, dual inhibition of PRMT5 and MAT2A with the combination of IDE892 and IDE397 resulted in potent anti-tumor activity in MTAP-deleted tumor models, including complete and durable responses at well-tolerated doses below those required for monotherapy activity.

IDEAYA has also advanced its CDKN2A-deficiency program and is on track to select a potential first-in-class development candidate in H2 2026 with a target IND in H1 2027. IDEAYA has demonstrated robust monotherapy efficacy with its CDKN2A lead in multiple preclinical models, including in a KRAS mutation pancreatic model. IDEAYA plans to evaluate its CDKN2A-deficiency program preclinically as a monotherapy agent, and in combination with assets in its MTAP-deletion portfolio and potentially other RAS and KRAS targeted assets. CDKN2A-defiency is common in cancer, with a prevalence of over 80% in pancreatic cancer (M. Schutte, et al., Cancer Research, 1997; IDEAYA analysis, TCGA) and is typically co-deleted in MTAP-deletion solid tumors and a common co-alteration with KRAS mutations, particularly in pancreatic cancer, creating rational combination opportunities with MTAP-deletion and KRAS targeted therapies, respectively.

As part of IDEAYA’s strategic prioritization of its proprietary MTAP-deleted pipeline, including IDE397 and IDE892, and the advancement of its CDKN2A-deficiency program, the company has deprioritized its clinical combination activities with Trodelvy and will be concluding enrollment in the ongoing Phase 1/2 trials with Gilead. Based on preliminary data from these trials supporting the mechanistic rationale for the combination in MTAP-deleted cancers, IDEAYA may evaluate additional combinations between IDE397 and other TOP1 payload ADCs in this setting, including IDE034, its B7H3/PTK7 bispecific TOP1 ADC.

MTAP deletion is estimated to occur in 15–20% of non-small cell lung cancer, up to 40% of pancreatic cancer, and approximately 15% of all solid tumors, and is commonly co-deleted with CDKN2A due to the proximity of the two genes on chromosome 9p21. There are no approved therapies for patients with MTAP deletion, highlighting the significant unmet need and important new opportunities for precision therapies.

(Press release, Ideaya Biosciences, MAR 9, 2026, View Source [SID1234663379])

On March 9, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that an abstract was accepted for oral presentation in the Practice-changing, Paradigm-shifting Clinical Trials in Urology session, as part of the American Urological Association (AUA) 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026. The presentation will feature new data from the Company’s phase 3 clinical trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in patients with intermediate- to high-risk localized prostate cancer.

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Presentation Details:

Aglatimagene – Localized Prostate Cancer

Abstract Title: Extended follow-up shows accumulating benefit for patients treated with CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) in men with localized prostate cancer: update from PrTK03 randomized phase 3 clinical trial
Presentation Type: Plenary
Presenter: Mark G. Garzotto, M.D., Professor of Urology and Radiation Medicine, Oregon Health & Science University, Chief, Urology Section, Portland VA Medical Center
Session Title: P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology
Session Date/Time: Friday, May 15, 2026; 11:30 AM – 11:40 AM ET
Location: Hall D, Walter E. Washington Convention Center, Washington, D.C.
Full abstracts will be released by AUA on date and time of presentation. Details from the presentation will be available following the event on the Candel website at View Source

(Press release, Candel Therapeutics, MAR 9, 2026, View Source [SID1234663378])

On March 9, 2026 Xilio therapeutics presented its corporate presentation.

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(Presentation, Xilio Therapeutics, MAR 9, 2026, View Source [SID1234663375])