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.

On August 26, 2024 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on Thursday, September 5, at 2:35 p.m. Eastern Time (Press release, Veracyte, AUG 26, 2024, View Source [SID1234646102]).

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days after the live presentation broadcast.

On August 26, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that management will participate in the H.C. Wainwright 26th Annual Global Investment Conference being held September 9th – 11, 2024 at the Lotte New York Palace Hotel in New York City (Press release, Anixa Biosciences, AUG 26, 2024, https://ir.anixa.com/news/detail/1048/anixa-biosciences-to-present-at-the-h-c-wainwright-26th-annual-global-investment-conference [SID1234646088]).

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Anixa’s presentation will be available on-demand to registered attendees via the conference platform beginning Monday, September 9, 2024, at 7:00 AM Eastern Time. A webcast of the Company’s presentation can also be accessed at View Source and on the investor relations section of Company’s website at View Source

Management will be participating in one-on-one meetings with investors throughout the conference in New York City. To request a meeting, please contact [email protected].

On August 26, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an orally available investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), for adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy, including BTK inhibitor (BTKi) and B-cell lymphoma 2 (BCL2) inhibitor (Press release, BeiGene, AUG 26, 2024, View Source [SID1234646089]).

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The FDA’s Fast track designation is aimed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.

"When disease progression for patients on BTK inhibitors occurs, there is a need for BTK-targeting agents with a different mode of action given the centrality of this pathway in CLL/SLL. BTK-protein degradation with our BTK CDAC (BGB-16673) may address this unmet need," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology. "The FDA’s Fast Track Designation supports our goal of efficiently developing BGB-16673 for these patients, the first investigational drug from our CDAC platform. We believe BGB-16673 strengthens our hematology leadership and complements BRUKINSA (zanubrutinib), the backbone for our investigational hematology pipeline. BGB-16673 is the most advanced BTK degrader in the clinic and is well-suited to become an important therapy for patients progressing after BTKi who have limited options."

The designation was requested based on the potential for BGB-16673 to address an unmet medical need for patients CLL/SLL whose disease has progressed. Data from ongoing first-in-human Phase 1/2 (NCT05006716) presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress in June highlighted the tolerable safety and promising efficacy in heavily pretreated patients with R/R CLL/SLL. More than 300 patients have been treated to date in 15 countries across the BGB-16673 global clinical development program.

About Chronic Lymphocytic Leukemia

A life-threatening cancer of adults, chronic lymphocytic leukemia (CLL) is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues.1,2 CLL is the most common type of leukemia in adults, accounting for about one-third of new cases of leukemia.2,3 Approximately 20,700 new cases of CLL will be diagnosed in the U.S. in 2024.3

About BGB-16673

BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC) designed to induce degradation of wildtype and multiple mutant forms of BTK, including those that commonly confer resistance to BTK inhibitors in patients who experience progressive disease.

On August 26, 2024 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for "a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer" has been approved (Press release, Mabwell Biotech, AUG 26, 2024, View Source [SID1234646105]). The corresponding Phase III clinical study has been initiated and is currently in the enrollment stage. As of the announcement, 9MW2821 has been approved for three pivotal clinical trials.

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9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell, and it is the first of its kind in China to initiate clinical trials on the same target, with more than 400 subjects enrolled in the clinical studies for multiple indications. The results of existing clinical studies have demonstrated outstanding therapeutic efficacy and safety profile. The pivotal Phase III clinical study, "an open-label, randomized Phase 3 study to evaluate 9MW2821 vs investigator’s choice of chemotherapy in subjects with locally advanced or metastatic urothelial cancer who have previously received PD-(L)1 inhibitor and platinum-containing chemotherapy", is currently in the enrollment stage.

About Urothelial Carcinoma
Bladder cancer, a form of urothelial carcinoma, stands out among its various subtypes for its significant impact on public health. The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) reports that bladder cancer is the ninth most common malignant tumor in incidence and ranks thirteenth in mortality among all malignant tumors. According to The Global Cancer Statistics published by the International Agency for Research on Cancer (IARC) in 2022, there were approximately 614,000 new cases and 220,000 deaths from bladder cancer worldwide. The Disease Burden of Malignant Tumors in China 2022, released by the National Cancer Center in February 2024, reported 92,900 new cases and 41,400 deaths from bladder cancer in China, placing it eleventh and thirteenth globally in terms of new incidences and mortality, respectively. As a prevalent cancer in China, urothelial carcinoma is characterized by a propensity for metastasis, a high recurrence rate, and a short survival time in its advanced stages. It represents a significant disease burden and poses a serious threat to the survival and quality of life of those affected.

About 9MW2821
9MW2821 is a site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using ADC platform, and the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. As the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data in cervical cancer (CC), esophageal cancer (EC) and breast cancer, 9MW2821 has been granted Fast Track Designation by FDA in 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC); 9MW2821 has also been granted Orphan Drug Designation by FDA for the treatment of EC, and Breakthrough Therapy Designation by CDE of NMPA, for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

9MW2821 achieves site-specific modification of antibody through proprietary conjugation technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.