On August 27, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company specializing in the treatment of primary and metastatic liver cancers, reported the publication of a retrospective study by independent investigators in the Annals of Surgical Oncology (Press release, Delcath Systems, AUG 27, 2024, View Source [SID1234646117]). The study, titled "Hepatic and Overall Progression-Free Survival After Percutaneous Hepatic Perfusion (PHP) as First-Line or Second-Line Therapy for Metastatic Uveal Melanoma," was conducted by researchers at Moffitt Cancer Center in Tampa, Florida. The 30-patient study reported that Delcath’s HEPZATO KIT (melphalan/Hepatic Delivery System (HDS)) provided better disease control in the liver and improved progression-free survival in patients with hepatic metastases from uveal melanoma, compared to both immunotherapy and other liver-directed therapies.

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Key Findings from the Study:

Overall Survival (OS): The study reported median OS of 22.4 months for patients treated with HEPZATO KIT as a first-line therapy (N=17) and 18.4 months as a second-line therapy (N=6).
Hepatic Progression-Free Survival (hPFS): Patients receiving HEPZATO KIT as first-line therapy had a median hPFS of 17.6 months (N=17), compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. When used as a second-line therapy, HEPZATO KIT resulted in a median hPFS that was not reached (N=6), showing better outcomes than immunotherapy (14.7 months, N=5) and other liver-directed therapies (7.5 months, N=3) in this patient cohort.

Progression-Free Survival (PFS): The median overall PFS was 15.4 months (N=17) for patients receiving HEPZATO KIT as first-line therapy, compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. In the second-line setting, HEPZATO KIT resulted in a median PFS of 22.2 months (N=6), compared to 14.7 months (N=5) for immunotherapy and 7.5 months (N=3) for other liver-directed therapies, reflecting longer disease control in this group.

Jonathan Zager, MD Chief Academic Officer and Director of Regional Therapies at Moffitt Cancer Center, remarked, "The findings from this study reaffirm the critical role of melphalan/HDS in managing liver-dominant metastatic uveal melanoma. These results highlight the potential benefits melphalan/HDS offers to patients, particularly in the context of first- and second-line treatments. My team is committed to further exploring the potential of combining melphalan/HDS with systemic therapies to continue improving patient outcomes."

On August 27, 2024 JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported that the National Medical Products Administration (NMPA) of China has approved the supplemental Biological License Application (sBLA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (r/r MCL) (Press release, JW Therapeutics, AUG 27, 2024, View Source [SID1234646134]). This is the third marketing approval on Carteyva submitted by JW Therapeutics, and is the first cell therapy product approved in China for the treatment of patients with r/r MCL. Carteyva was granted, by NMPA, Breakthrough Therapy Designation in Mar 2022, as well as Priority Review in Dec 2023.

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MCL is a heterogeneous B cell non-Hodgkin lymphoma which is currently incurable with existing therapies[1]. MCL, associated with a poor prognosis, mainly occurs in elderly men who were not diagnosed until advanced stage[2]. Significant progress has been made in the last decade as the treatment paradigm has shifted from traditional chemoimmunotherapy toward targeted therapies such as bruton tyrosine kinase inhibitors (BTKi). Despite the use of BTKi in r/r MCL has improved their survival outcomes, many patients will ultimately relapse with shortened remission durations (6~10 months) [3]. Notwithstanding the above, there are still unmet medical needs for a safe, effective novel approach to overcome the limitations of current treatments of r/r MCL.

The sBLA was supported by the clinical results from a single-arm, multi-center, pivotal study on Carteyva in adult patients with r/r MCL in China. In the study, patients with r/r MCL who had been treated with a CD20-targeting antibody, anthracycline or bendamustine, or BTKis were included. After being treated with lymphodepleting chemotherapy, patients received Carteyva (100×106 CAR+ T cells). As of August 7th, 2023, a total of 59 patients received Carteyva infusion. Of 59 efficacy evaluable patients, Carteyva demonstrated remarkable clinical responses achieving high rates of objective response rate (ORR) and complete response rate (CRR) (best ORR 81.36%, best CRR 67.80%) and the incidence of severe (grade ≥ 3) cytokine release syndrome (CRS) was 6.8%, the incidence of severe (grade ≥ 3) neurotoxicity (NT) was 6.8%.

Sophia Yang, Senior Vice President and Head of Regulatory, Research & Development of JW Therapeutics, noted: "We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of patients with r/r MCL have achieved complete remission after treatment with Carteyva, and the overall safety data demonstrated that the treatment was generally well-tolerated. Carteyva becomes the first commercial CAR-T cell product for the treatment of r/r MCL in China."

References

The consensus of the diagnosis and treatment of mantle cell lymphoma in China (2016 version). Chin J Hematol.2016, 37(9):735-741.
Herrmann A, Hoster E, Zwingers T, et al. Improvement of Overall Survival in Advanced Stage Mantle Cell Lymphoma[J]. Journal of Clinical Oncology, 2009, 27(4):511-518.
Burkart M, Karmali R. Relapsed/Refractory Mantle Cell Lymphoma: Beyond BTK Inhibitors. J Pers Med. 2022 Mar 1;12(3):376.

About Relmacabtagene Autoleucel Injection

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva has been approved by the China National Medical Products Administration (NMPA) for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBLC) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma ("r/r MCL") after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors ("BTKi"), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

On August 27, 2024 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, reported that Dr. Mahesh V. Patel, President and Chief Executive Officer, will present and meet with investors at the H.C. Wainwright 26th Annual Global Investment Conference being held in-person and virtually on September 9-11, 2024 (Press release, Lipocine, AUG 27, 2024, View Source [SID1234646118]).

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Presentation Details

Time: Available from 7:00 a.m. EDT onwards
Date: Monday, September 9, 2024
Webcast Link: View Source

Investors can register for the conference here. Those interested in arranging a 1×1 meeting with Lipocine should contact their H.C. Wainwright representative.

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 27, 2024 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, reported that Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss will share updates during fireside chats at three upcoming investor conferences (Press release, Mannkind, AUG 27, 2024, View Source [SID1234646119]):

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2024 Wells Fargo Healthcare Conference in Boston
Wednesday, September 4
11:00 a.m. Eastern Time

Morgan Stanley 22nd Annual Global Healthcare Conference in New York
Friday, September 6
7:00 a.m. Eastern Time

H.C. Wainwright 26th Annual Global Investment Conference in New York
Tuesday, September 10
9:30 a.m. Eastern Time

Links to access live audio webcasts of the sessions will be available on MannKind Corporation’s website at: View Source An archived, recorded version will also be available on the website for approximately 30 days following each conference.