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.

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 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported dosing of the first patient in the HIGHLIGHT 1 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy (Press release, Astellas, AUG 27, 2024, View Source [SID1234646103]).

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Breast cancer is the most common cancer in women globally, with approximately 2.3 million new cases in 2022.1 Hot flashes and night sweats, also known as VMS, are recognized as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer. Approximately 77% of breast cancers can be treated with adjuvant endocrine therapies,2 most commonly tamoxifen and aromatase inhibitors, and up to 97% of breast cancer patients experience hot flashes or night sweats.3

Marci English, Vice President, Head of BioPharma Development, Astellas
"VMS can adversely affect quality of life, as well as compliance with treatment, for patients with breast cancer taking adjuvant endocrine therapy. We are excited to get the HIGHLIGHT 1 study underway, as currently there are no approved treatments for moderate to severe VMS that can be used by these patients."

About HIGHLIGHT 1
HIGHLIGHT 1 (NCT06440967) is a randomized, placebo-controlled, double-blind, Phase 3 clinical study to assess the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at up to 100 sites globally. The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. Patients will be treated for 52 weeks with a final evaluation at 55 weeks.

About Fezolinetant
Fezolinetant is an investigational oral, nonhormonal medicine in clinical development for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. The safety and efficacy of fezolinetant have not been established in this patient population. VMS are also known as hot flashes or night sweats. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the brain’s temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.4,5,6 There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.