Mabwell Announces First-Patient Dosing for Novel CDH17-Targeting ADC 7MW4911

On November 25, 2025 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that the first patient has been dosed in the Phase I/II clinical trial of its independently developed novel CDH17-targeting antibody-drug conjugate (ADC) (R&D code: 7MW4911) for advanced solid tumors.

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This Phase I/II clinical trial (CTR20254163) aims to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of 7MW4911 in patients with advanced solid tumors. Previously, 7MW4911 had received IND clearance from FDA to initiate a Phase I/II clinical trial for advanced colorectal cancer and other advanced gastrointestinal tumors (NCT07216560).

7MW4911 is a novel CDH17-targeting ADC developed by Mabwell based on its proprietary IDDC platform. It is composed of a highly specific CDH17 monoclonal antibody capable of efficient internalization into tumor cells, a novel cleavable linker with high plasma stability, and a proprietary DNA topoisomerase I inhibitor payload, MF-6, specifically designed to overcome the multidrug resistance.

Preclinical studies demonstrated that 7MW4911 exhibited potent antitumor activity in CDX/PDX models of various gastrointestinal tumors. In multidrug-resistant models, its antitumor effect was significantly superior to MMAE/DXd-based ADCs, and it was able to reverse tumor progression following treatment with such ADCs, highlighting its advantage in treating resistant tumors. Relevant research findings have been published in the 2025 AACR (Free AACR Whitepaper) and the internationally renowned journal Cell Reports Medicine (July 2025).

(Press release, Mabwell Biotech, NOV 25, 2025, View Source [SID1234660948])

CytomX Therapeutics to Present at Upcoming December Investor Conferences

On November 25, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that management will participate in the following investor conferences in December.

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8th Annual Evercore Healthcare Conference
Date: Tuesday, December 2, 2025
Fireside Chat: 1:45 p.m. ET
Location: Coral Gables, FL

Piper Sandler 37th Annual Healthcare Conference
Date: Thursday, December 4, 2025
Fireside Chat: 1:00 p.m. ET
Location: New York, NY

A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

(Press release, CytomX Therapeutics, NOV 25, 2025, View Source [SID1234660933])

Citius Oncology to Exhibit at the 67th American Society of Hematology (ASH) Annual Meeting

On November 25, 2025 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported it will exhibit at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, taking place December 6–9, 2025, in Orlando, Florida.

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The Citius Oncology team will be located at Booth #265 in the ASH (Free ASH Whitepaper) Exhibit Hall to discuss LYMPHIR (denileukin diftitox-cxdl), its novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (r/r) Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Company representatives will be available throughout the meeting to engage with physicians, researchers and the broader CTCL and oncology communities.

"We look forward to showcasing LYMPHIR at ASH (Free ASH Whitepaper) 2025 and engaging directly with the oncology community," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma. "This event offers a great platform to meet with CTCL stakeholders to discuss how LYMPHIR’s clinical profile may offer an important treatment option for patients with cutaneous T-cell lymphoma."

The ASH (Free ASH Whitepaper) Annual Meeting is the world’s premier event in malignant and non-malignant hematology, bringing together more than 25,000 clinicians, scientists, and industry leaders from around the globe. The meeting features cutting-edge research, expert education sessions, and an expansive exhibit hall showcasing the latest advances in hematologic innovation.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA in August 2024.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

(Press release, Citius Oncology, NOV 25, 2025, View Source [SID1234660949])

Immuneering to Present at the Piper Sandler 37th Annual Healthcare Conference

On November 25, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive and helping them thrive, reported that management will present at the Piper Sandler 37th Annual Healthcare Conference in New York City. Participating will be Ben Zeskind, Co-founder and Chief Executive Officer, Igor Matushansky M.D., Chief Medical Officer, Harold "E.B." Brakewood, Chief Business Officer and Mallory Morales, CPA, Chief Accounting Officer, Treasurer.

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Format: Company Presentation and 1×1 investor meetings.

Presentation time: December 4, 11:10-11:30 a.m. ET, Staten Island Track (Kennedy 1, 4th Floor).

The presentation will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

(Press release, Immuneering, NOV 25, 2025, View Source [SID1234660934])

Prestige Biopharma and Biosidus Enter Exclusive License Agreement for Tuznue® Commercialization in Latin America

On November 25, 2025 Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, reported an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina, with decades of experience in biosimilar development and commercialization, for the commercialization of Tuznue (trastuzumab) across Latin American markets, including Argentina, Mexico, Bolivia, and Paraguay.

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Tuznue is a biosimilar to Herceptin (trastuzumab), approved for the treatment of breast cancer and metastatic gastric cancer. Prestige Biopharma received European Commission (EC) marketing authorization for Tuznue in September 2024. This approval marks a major milestone for the company’s biosimilar portfolio, signaling progress in expanding access to cost-effective treatments across key global markets.

Under the agreement, Biosidus secures exclusive rights to market and distribute Tuznue in Argentina, Mexico, Bolivia, and Paraguay, leveraging its extensive commercial network and deep expertise in biosimilar adoption. Prestige Biopharma will be responsible for the production and supply of the drug substance through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia.

Lisa S. Park, CEO of Prestige BioPharma, commented: "We are pleased to announce our strategic partnership with Biosidus for Argentina and other key markets in Latin America. With its proven track record and deep regional expertise, Biosidus represents an ideal partner for the successful manufacturing and commercialization of our lead biosimilar. We are confident that this collaboration will further enhance the global value and reach of our biosimilar portfolio."

Mariano Elizalde, CEO of Biosidus, said: "We are proud to partner with Prestige Biopharma to introduce Tuznue in selected markets across Latin America. This agreement strengthens our Biosimilars portfolio and our commitment to expand access to biotechnological medicines in Latin America. Together with Prestige Biopharma, we are confident in offering patients and healthcare professionals a quality and affordable therapeutic option".

About Tuznue
Tuznue is a biosimilar of Herceptin (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC).

(Press release, Prestige BioPharma, NOV 25, 2025, View Source [SID1234660950])