Tislelizumab

Beijing-based Huahui Health has initiated a first-in-human trial of HH160, a potential first-in-class trispecific antibody engineered to block PD-1, CTLA-4, and VEGF-A within a single molecule. The trial’s relevance lies in whether simultaneous triple blockade — combining dual checkpoint inhibition with anti-angiogenic activity in one construct — can improve on the toxicity and efficacy profile of combining three separate agents, a question that has grown more pressing as PD-1/CTLA-4 combinations become standard of care in several tumor types. BeOne Medicines (Nasdaq: ONC), which agreed in April 2026 to pay USD 20 million upfront for a global exclusive option to license HH160 in a deal valued at up to approximately USD 2.02 billion, is listed as a collaborator and study director. The Phase I study (NCT07623369) follows a two-part sequential design, with Part 1 consisting of dose escalation across patients with advanced solid tumors to establish the maximum tolerated dose, and Part 2 a safety expansion cohort in selected tumor types. The specific tumor types include non-small cell lung cancer (NSCLC), hepatocellular carcinoma, colorectal cancer, and additional indications to be determined by emerging data. HH160 is administered by intravenous infusion every three weeks. The trial is open-label and non-randomized, according to the trial record. Enrollment is planned for approximately 56 participants with eligible tumor types spanning a broad range of solid malignancies, including gastroesophageal adenocarcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, endometrial carcinoma, cervical cancer, ovarian cancer, small cell lung cancer, triple-negative breast cancer, and urothelial carcinoma. Patients with active leptomeningeal disease, uncontrolled brain metastases, or significant bleeding risk are excluded. Primary completion is expected by August 2028. HH160’s hexavalent architecture with silent Fc HH160 was constructed by fusing anti-PD-1 and anti-CTLA-4 nanobodies to the N- and C-termini of the heavy chain of an anti-VEGF-A human IgG1 antibody, forming a symmetrical hexavalent molecule with two binding sites per target, according to a preclinical abstract presented at the AACR Annual Meeting (Cancer Research, 2025). The Fc region is silenced — attenuating effector functions — a design choice that in the checkpoint inhibitor field is generally employed to prevent Fc-mediated depletion of PD-1- or CTLA-4-expressing T cells. The use of nanobody-based domains for the checkpoint arms is mechanistically notable. Nanobodies, derived from single-domain camelid antibody fragments, are substantially smaller than conventional Fab regions, enabling a more compact and potentially more manufacturable multi-specific architecture. The anti-VEGF-A conventional IgG1 backbone provides the structural scaffold. Huahui Health developed HH160 on its proprietary PolyBoost multispecific antibody platform, which the company describes as enabling this type of multi-arm construction. The rationale for combining these three targets rests on complementary mechanisms: PD-1 and CTLA-4 blockade act at distinct stages of the T cell activation cycle, while VEGF-A inhibition addresses the immunosuppressive and pro-angiogenic tumor microenvironment. The most direct clinical-stage comparator is cadonilimab (AK104, Akeso), a PD-1×CTLA-4 bispecific antibody approved in China for cervical cancer, which demonstrated that dual checkpoint blockade in a single molecule is clinically feasible and potentially safer than ipilimumab-based combinations. HH160 adds VEGF-A blockade to this framework, a design also being explored by Akeso with ivonescimab (PD-1×VEGF bispecific), which has reported Phase III data in NSCLC. The BeOne partnership, announced in April 2026, gives BeOne the right to exercise its option following Phase I data readout, positioning the company to potentially integrate HH160 into a broader solid tumor portfolio that already includes the PD-1 inhibitor tislelizumab. The immunogenicity study components built into the Phase I protocol will also be closely watched, given that multi-specific formats with nanobody-derived domains can present distinct immunogenic profiles relative to conventional monoclonal antibodies. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Copyright © 2026. AllSci Corp. All rights reserved.

Presentations highlight ANKTIVA®-based approaches in non-small cell lung cancer (NSCLC) and non-muscle invasive bladder cancer (NMIBC) CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. ( NASDAQ: IBRX ), a commercial-stage immunotherapy company, today announced two poster presentations and one online publication at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2, 2026, in Chicago. The presentations span two randomized Phase 3 trials in advanced NSCLC and a matched adjusted indirect comparison (MAIC) in BCG unresponsive non-muscle invasive bladder cancer (NMIBC), and collectively evaluate ANKTIVA ® (nogapendekin alfa inbakicept-pmln), the company’s IL-15 receptor agonist immunotherapy designed to activate natural killer (NK) cells, CD4+ and CD8+ T cells, and memory T cells, across multiple solid tumor indications. “ASCO provides an important opportunity to share emerging clinical and translational data that continue to deepen our understanding of how ANKTIVA-based immunotherapy may restore immune function and rescue or reinvigorate the response to checkpoint inhibitors,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “ANKTIVA is the first FDA-approved immunotherapy designed to stimulate NK cells, CD4+ and CD8+ T cells, and memory T cells, which are the very immune cells that are depleted in patients with lymphopenia and that are critical to mounting an effective anti-tumor response. Growing long-term survival data across bladder, lung and other solid tumors are beginning to put in focus a compelling hypothesis: that restoring immune competence and addressing lymphopenia may be as a fundamental to cancer care as targeting the tumor itself. These findings reinforce our conviction that the future of immunotherapy lies in activating and amplifying the immune system, not suppressing it.” Presentation highlights include: ASCO 2026 Annual Meeting Poster Presentations - Sunday, May 31st (9am-12pm)​ Poster Title: Phase 3 trial ResQ201A of nogapendekin alfa inbakicept (NAI) plus tislelizumab and docetaxel vs. docetaxel monotherapy for advanced or metastatic NSCLC resistant to ICI therapy ​Poster Board: 455a​m Abstract: #TPS8671​ Presenter: Andreas Saltos (Affiliation: Moffitt) Poster Title: Efficacy outcomes in first line (1L) non–small cell lung cancer (NSCLC) with maintenance of immune competence: QUILT‑2.023 randomized phase 3 study of IL‑15R agonist nogapendekin alfa inbakicept (NAI) with checkpoint inhibitor (CPI) ± chemotherapy Poster Board: 378​ Abstract: #8588​ Presenter: John Wrangle (Affiliation: MUSC) Online Publication Only Abstract Title: A matched adjusted indirect comparison (MAIC) of NAI+BCG & pembrolizumab in patients with BCG unresponsive NMIBC with CIS ± papillary disease – Will be published on at 5:00 PM EDT on May 21, 2026 About ANKTIVA ® (nogapendekin alfa inbakicept-pmln) The interleukin-15 (IL-15) cytokine 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. ANKTIVA® is a first-in-class IL-15 receptor 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. About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield ™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor superagonist, ANKTIVA ® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the clinical development of ANKTIVA® (nogapendekin alfa inbakicept-pmln), the potential benefits of ANKTIVA-based immunotherapy in non-small cell lung cancer (NSCLC) and non-muscle invasive bladder cancer (NMIBC), future regulatory submissions and approvals, commercialization plans and market potential, and the company's strategic vision for restoring immune competence in cancer patients. These forward-looking statements are based on ImmunityBio's current expectations and beliefs and are subject to uncertainties and factors that could cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, but are not limited to: the risk that clinical trials may not demonstrate adequate safety and efficacy to support regulatory approval or may be delayed or terminated; the risk that regulatory authorities may not approve ANKTIVA for additional indications or may impose restrictions on its use; the risk that the company may not successfully commercialize ANKTIVA or achieve market acceptance; competition from other therapies; manufacturing and supply chain risks; intellectual property risks; and the company's ability to obtain additional funding to support its operations. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026 as well as its Form 10-Q filed with the SEC on May 7, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Contacts ImmunityBio Contacts: Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045 Sarah.Singleton@ImmunityBio.com