On August 27, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that data from a Phase 1 study of ZL-1218, the company’s anti-CCR8 antibody, will be presented in a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain (Press release, Zai Laboratory, AUG 27, 2024, View Source [SID1234646139]). The preliminary results from the ongoing dose-escalation clinical trial (NCT05859464) will highlight the potential of ZL-1218 to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment (TME) of advanced solid tumors.

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"The reduction of suppressive tumor-associated regulatory T cells by ZL-1218 offers promise to re-stimulate the immune attack on advanced solid tumors. We look forward to sharing preliminary results from our Phase 1 study at ESMO (Free ESMO Whitepaper) 2024."

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ZL-1218 is a humanized monoclonal antibody with an enhanced Fc region that targets CCR8, a chemokine receptor selectively expressed on tumor-associated regulatory T cells (Treg) and may enhance antitumor immune response by depletion of CCR8+ Treg cells via antibody-dependent cellular cytotoxicity activity. ZL-1218 offers potential as a novel therapeutic to treat solid tumors. Enrollment is ongoing in the global Phase 1 study of ZL-1218 as a single agent and in combination with pembrolizumab in patients with advanced solid tumor malignancies.

"The ability to overcome the complexities of the tumor microenvironment are critical to improving patient outcomes in cancer immunotherapy," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "The reduction of suppressive tumor-associated regulatory T cells by ZL-1218 offers promise to re-stimulate the immune attack on advanced solid tumors. We look forward to sharing preliminary results from our Phase 1 study at ESMO (Free ESMO Whitepaper) 2024."

Details regarding the Zai Lab poster presentation at ESMO (Free ESMO Whitepaper) 2024 are as follows:

Title: Preliminary Clinical PK and PD analysis of a Phase 1 Study of ZL-1218, a humanized anti-CCR8 IgG1 antibody, in patients with advanced solid tumors

Presentation Number: 1008P

Presenter: Oriol Mirallas, Medical Oncology Specialist, Vall d’Hebron Institute of Oncology, Barcelona, Spain

Date: Saturday, September 14, 2024

Location: Fira Barcelona Gran Via

On August 27, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will present at the H.C. Wainwright 26th Annual Global Investment Conference being held from September 9-11, 2024 in New York (Press release, Adicet Bio, AUG 27, 2024, View Source [SID1234646138]).

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Details of the event are as follows:
Date: Tuesday, September 10, 2024
Time: 2:30 p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

On August 27, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will participate in the upcoming Morgan Stanley 22nd Annual Global Healthcare Conference in New York, NY Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will participate in the upcoming Morgan Stanley 22nd Annual Global Healthcare Conference in New York, NY.

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Guardant Health’s management is scheduled to participate in a fireside chat on Thursday, September 5th at 11:30 a.m. ET. Interested parties may access live and archived webcasts of the sessions on the "Investors" section of the company website at: www.guardanthealth.com..

Guardant Health’s management is scheduled to participate in a fireside chat on Thursday, September 5th at 11:30 a.m. ET. Interested parties may access live and archived webcasts of the sessions on the "Investors" section of the company website at: www.guardanthealth.com.

On August 27, 2024 Pillar Biosciences, Inc., the leader in Decision Medicine, reported the global launch of oncoReveal Nexus, a research-use-only (RUO) next-generation sequencing (NGS) kit designed to enable laboratories with a rapid, targeted solution for solid and hematological malignancies to help accelerate the delivery of targeted therapy (Press release, Pillar Biosciences, AUG 27, 2024, View Source [SID1234646136]).

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A team at New York’s Memorial Sloan Kettering Cancer Center (MSK), will be the first to utilize oncoReveal Nexus, which will be branded MSK-REACT. MSK has already received NYS DOH approval for clinical implementation of MSK-REACT, enabling a more streamlined NGS workflow to help patients get on the right therapy sooner.

oncoReveal Nexus assesses key driver genes for both hematological and solid tumor malignancies in one multiplex reaction. The assay has a fully automatable workflow that can be performed by any clinical laboratory, batching up to eighty-one patient samples in a single Illumina MiSeq sequencing run, using as little as 2.5 ng DNA per patient sample. With a sample-to-report time within 2-3 days after DNA isolation, a laboratory deploying this panel will be able to quickly assess key driver alterations prior to initiating the laboratory process for comprehensive genomic profiling (CGP), enabling more rapid time-to-treatment and laboratory cost savings.

"For the last few years, industry dialogue surrounding NGS testing has been about whether to use small panel targeted sequencing or CGP. We firmly believe that both NGS approaches are extremely complementary, have very specific benefits, and can be leveraged together to maximize laboratory efficiencies while improving overall patient outcomes," said Dan Harma, Chief Commercial Officer, Pillar Biosciences. "The launch of our oncoReveal Nexus panel at MSK to help accelerate the delivery of precision medicine really underscores our belief in this model and our company’s approach to the market."

At MSK, the newly developed and rapid panel is expected to help accelerate genomic results in parallel with the more comprehensive CGP assay MSK-IMPACT test for both solid and hematologic malignancies. In validation studies, the teams have noted 100 percent concordance between oncoReveal Nexus and MSK-IMPACT, providing a level of confidence that this approach will provide both clinical and workflow benefits.

On August 27, 2024 Legend Biotech (NASDAQ: LEGN), a subsidiary of GenScript Biotech Corporation (hereinafter referred to as "GenScript"), a global leader in life sciences research and manufacturing services, reported that they have received approval from the China National Medical Products Administration (NMPA) for its cell therapy product, ciltacabtagene autoleucel (cilta-cel) (Press release, Legend Biotech, AUG 27, 2024, View Source [SID1234646135]). This groundbreaking treatment is approved for use in adult patients with relapsed or refractory multiple myeloma (MM) who have previously undergone at least three prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent. The approval of cilta-cel provides a novel treatment for patients in China who have not benefit from traditional therapies.

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Cilta-cel is a gene-modified autologous chimeric antigen receptor T cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA). It is administered via intravenous infusion. Cilta-cel features a unique CAR structure composed of two BCMA-targeting, heavy-chain, single-domain antibodies. This design allows cilta-cel to bind the BCMA-expressing myeloma cells, and induce activation and proliferation of T cells to eliminate tumor.

Legend Biotech CEO Ying Huang stated: "The approval of cilta-cel in China market marks a key milestone and will bring significant benefits to many patients. Moving forward, we will continue to pursue our goal of curing patients, expand our clinical research, and enhance the accessibility of this innovative product to benefit more patients."

Ongoing Commitment to Cell Therapy Market and Innovation Strategy

The approval of cilta-cel is not only a significant milestone of GenScript and Legend Biotech but also a response of their unwavering commitment to innovation-driven development. Sherry Shao, GenScript’s rotating CEO, said, "Innovation has always been at the heart of GenScript’s growth strategy. As the global biopharmaceutical field advances rapidly and patient needs deepen, we recognize that only through relentless innovation and unwavering dedication to cell and gene therapy can we drive the industry forward with outstanding products and services. Congratulations to Legend Biotech on its achievements. We are confident that Legend Biotech will continue to lead in cell therapy, exploring new frontiers and delivering groundbreaking innovations to the industry."

The approval is based on the outstanding results of the CARTIFAN-1 (NCT03758417) multi-center confirmatory Phase II clinical trial. This study evaluated the efficacy and safety of cilta-cel in patients with relapsed or refractory multiple myeloma.

Results from a median follow-up of 37.29 months showed that among 58 patients analyzed for efficacy, the overall response rate (ORR) was 87.9%, with very good partial response (VGPR) or better achieved in 86.2%, and complete response (CR) or stringent complete response (sCR) reached 79.3%. The median duration of response (mDOR) was 32.56 months, median progression-free survival (mPFS) was 30.13 months, and the median overall survival (mOS) was not reach the point.

Cilta-cel has demonstrated excellent clinical efficacy in trials, offering early and durable responses as well as longer PFS survival benefits in patients who failed multiple prior lines of treatment. This innovative and safe therapy represents a significant benefit for multiple myeloma patients.

This approval of cilta-cel not only highlights the technological strength of Legend Biotech but also enhances the market growth potential of GenScript and reinforces its leading position in the biotech industry. This important progress will lead the way for GenScript to continuously invest and explore in the cell therapy field, accelerate the translation of breakthrough therapies from the lab to clinical practice, and expedite the development and commercialization of innovative drugs and therapies.

With over twenty years of dedicated development and investment in the life science industry and cell and gene therapy, GenScript has built a solid foundation in these areas. GenScript is actively expanding the boundaries of life sciences and strengthening collaborations with global research institutions, medical organizations, and industry partners. By integrating resources and leveraging synergies, GenScript aims to accelerate the rapid development of the biotech industry and provide more and better treatment options for patients worldwide.