On September 14, 2023 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that Ryvu’s licensee, the Menarini Group, will expand development of MEN1703 (SEL24) by initiating a new Phase II study in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in addition to continued translational work in other hematologic indications (Press release, Ryvu Therapeutics, SEP 14, 2023, View Source [SID1234635168]).

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"We are excited to begin this Phase II study with our partner Menarini to address the critical unmet need in DLBCL," said Pawel Przewiezlikowski, co-founder, largest shareholder, and CEO of Ryvu Therapeutics. "The extensive preclinical evidence of MEN1703 activity in multiple types of lymphomas sets a promising foundation for evaluating the molecule’s potential in DLBCL, and we look forward to seeing this program continue to advance in the clinic."

The Phase II study, which will explore the activity of MEN1703 in combination with standard-of-care therapy in DLBCL and as a single agent, is being initiated based on strong preclinical activity of MEN1703 in lymphoma. MEN1703 has completed Phase II studies in relapsed/refractory AML, including an expansion cohort in IDH-mutated AML. The studies demonstrated an acceptable safety profile and early signs of single agent activity. Based on these data, development of MEN1703 will continue with focus on DLBCL and potentially other indications. AML will be deprioritized given the existing data and competitive landscape.

Under the terms of the license agreement executed in 2017, Menarini is the global development and commercial licensee. Ryvu remains a strategic partner through the existing Joint Steering Committee and will become an operational partner as part of an amended agreement to enable Ryvu to execute clinical studies on behalf of Menarini. Menarini will continue to be responsible for all research and development costs, including full reimbursement to Ryvu for study execution; the license and financial terms of the original agreement remain unchanged.

"DLBCL is an aggressive and difficult-to-treat type of non-Hodgkin lymphoma, and these patients have limited therapeutic options and face challenges in achieving sustained remissions," said Elcin Barker Ergun, CEO of the Menarini Group. "We are pleased to advance MEN1703 into clinical development and look forward to exploring its therapeutic potential in DLBCL as well as evaluating it in other promising indications."

About MEN1703 (SEL24)

MEN1703 (SEL24) is a clinical-stage program discovered and developed by Ryvu Therapeutics and licensed to the Menarini Group. MEN1703 is a first-in-class, dual PIM/FLT3 kinase inhibitor with a unique activity profile. By design, this profile may provide responses to treatment that are more durable than current options and address a disease that has progressed following FLT3 inhibition. Preclinical data suggests therapeutic potential in both hematological malignancies and in solid tumors. Ryvu has granted the Menarini Group an exclusive worldwide license to further research, develop, manufacture and commercialize MEN1703 (SEL24).

More information on the study at: View Source

On September 14, 2023 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported that renowned dermato- oncology key opinion leader and study investigator, Professor Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, will give an oral presentation on the findings from his RESMAIN study investigating the efficacy of resminostat as a maintenance treatment for cutaneous T-cell lymphoma, at the EORTC Cutaneous Lymphoma Tumor Group Annual Meeting at the Leiden University Medical Center, the Netherlands, September 21-23 (Press release, 4SC, SEP 14, 2023, https://www.pressetext.com/news/20230915007 [SID1234635167]).

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Title: RESMAIN: Results of a multicenter, randomized, double blind, placebo controlled trial to evaluate resminostat for maintenance treatment in advanced stage Mycosis fungoides or Sézary syndrome

Presenting Author: Professor Rudolf Stadler, University Hospital Johannes Wesling, Ruhr University Bochum, Minden, Germany

Date and Time: Saturday September 23rd, 9:10am CET

Location: Leiden University Medical Center, the Netherlands, Room: O-143

4SC will host a webinar to present an analysis of the findings showcased at the EORTC CLTG Annual Meeting on Wednesday 4th October. Clinical experts, Professor Rudolf Stadler and Professor Julia Scarisbrick, will discuss the results and there will be the opportunity to ask questions during a Q&A session moderated by 4SC’s Chief Executive Officer, Jason Loveridge.

Title: Presentation by Professor Rudolf Stadler and Professor Julia Scarisbrick on recent new positive data from the RESMAIN study

Date and Time: Wednesday 4th October, 3.00pm CET

Register and submit questions:View Source

Jason Loveridge, Ph.D., Chief Executive Officer of 4SC, commented: "Our pivotal RESMAIN study was conducted at more than 50 clinical centers across Europe and by Yakult Honsha in Japan, investigating the efficacy of resminostat as a maintenance treatment for cutaneous T -cell lymphoma. Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor which is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body’s immune response to cancer. We look forward to presenting the results of the trial for the first time during this prestigious conference and our live webinar in October."

On September 14, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported the U.S. Food and Drug Administration (FDA), because of resource constraints, requires additional time to complete the Priority Review of Iovance’s Biologics License Application (BLA) for lifileucel (Press release, Iovance Biotherapeutics, SEP 14, 2023, View Source [SID1234635166]). The BLA is seeking accelerated approval of lifileucel for patients with advanced melanoma. The FDA extended the new target action date for a decision under the Prescription Drug User Fee Act (PDUFA) to February 24, 2024, but agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date.

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The FDA recently notified Iovance that they had insufficient resources to review a recent response to an information request for the ongoing BLA review prior to the planned late-cycle review meeting scheduled for September 11, 2023. In a meeting with the FDA held on September 14, 2023, the FDA acknowledged the resource constraints and agreed to work closely with Iovance to expedite the remaining review.

The overall BLA process continues under Priority Review with several recent positive status updates. The FDA reiterated there are no major review issues, and there are no plans to hold an advisory committee meeting. In addition, all pre-approval inspections of clinical sites. internal and external manufacturing and testing facilities have been successfully completed. The FDA is also engaged and has expressed no concerns on the status of the TILVANCE-301 confirmatory trial in frontline advanced melanoma, which remains on track to be well underway by the PDUFA date.

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "While the resource constraints at FDA have extended our PDUFA date, Iovance and FDA remain engaged to complete the review process as quickly as possible. We appreciate FDA management’s efforts to expedite the remaining review so that we can bring lifileucel to critically ill patients with no other FDA approved options after current standard of care. We are confident in the potential for lifileucel to redefine the treatment paradigm for these patients. With the strength of our clinical data, manufacturing capabilities, and commercial readiness efforts, Iovance is well positioned to rapidly serve the U.S. melanoma community immediately following an approval."

Lifileucel, if approved, will be the first and only TIL therapy for patients with advanced melanoma, as well as the first one-time cell therapy for a solid tumor cancer. Lifileucel is an individualized therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.

The FDA accepted the BLA for lifileucel in May 2023 under Priority Review and previously granted a Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel in advanced melanoma. The extension of the PDUFA date does not impact the Priority Review status or RMAT designation.

The BLA submission for lifileucel is supported by positive data from the C-144-01 clinical trial in patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. If lifileucel receives accelerated approval, the randomized Phase 3 TILVANCE-301 trial in frontline advanced melanoma can serve as the confirmatory study to support full approval. TILVANCE-301 is expected to be well underway at the time of approval.

On September 14, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported its abstract has been accepted for poster presentation at the 2023 CTOS Annual Meeting being held November 1-4, 2023 in Dublin, Ireland (Press release, Moleculin, SEP 14, 2023, View Source [SID1234635165]).

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Details of the presentation are as follows:

Title: A Phase 1b/2 Study of Liposomal Annamycin (ANN) in Subjects with Previously Treated Soft-Tissue Sarcomas (STS) with Pulmonary Metastases
Presenter: Brian Andrew Van Tine, MD, PhD, Professor of Medicine, Washington University School of Medicine
Category: Medical & Pediatric Oncology and Trials
Date: Thursday, November 2, 2023

For more information about the CTOS, please visit the conference website, here.

On September 14, 2023 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported that it is hosting an Investor Day beginning at 1:00 p.m. ET today in New York City, expected to conclude by approximately 4:00 p.m. ET (Press release, LabCorp, SEP 14, 2023, View Source [SID1234635164]). The event will highlight the company’s go-forward strategy from Labcorp Chairman & CEO Adam Schechter, followed by business overviews and a longer-term financial outlook by members of the leadership team.

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"Labcorp is the world’s largest laboratory service provider focused on science, technology and innovation," said Adam Schechter, chairman and CEO of Labcorp. "Today, we are excited to share our roadmap for strong growth and shareholder value across Diagnostics Laboratories and Biopharma Laboratory Services. We believe that our focus on customers and our ability to execute with scale and operational excellence will drive strong profitable growth and further differentiate Labcorp."

Webcast Information
A live webcast of the event will be available through the Labcorp Investor Relations website beginning at 1:00 p.m. ET. A replay of the webcast and a copy of presentation materials will be available on the Investor Relations section of the Company’s website at View Source