On March 5, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that it will present a poster on updated data from the ongoing randomized Phase I trial of TG4050 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) (Press release, Transgene, MAR 6, 2024, View Source [SID1234640809]). The AACR (Free AACR Whitepaper) will take place in San Diego, California, USA, from April 5 to 10, 2024.

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Poster details

Title: Personalized vaccine TG4050 induces polyepitopic immune responses against private neoantigens in resected HPV negative head and neck cancers

· Session title: Late-Breaking Research: Clinical Research 3

· Poster and abstract number: LB401

· Date and Time: Wednesday April 10, 2024, 9:00 a.m. – 12:30 p.m. PDT

· Location: Poster Section 52, Board number 2

· Authors : A. Lalanne, C. Jamet, JP Delord, C. Ottensmeier, C. Le Tourneau, A. Tavernaro, G. Lacoste, B. Bastien, M. Brandely, B. Grellier, E. Quemeneur, Y. Yamashita, O. Kousuke, N. Yamagata, Y. Tanaka, K. Onoguchi, I. G. Pait, B. Malone, O. Baker, P. Brattas, M. Gheorghe, R. Stratford, T. Clancy, K. Bendjama, O. Lantz

The abstract will be available on the AACR (Free AACR Whitepaper) website April 5, 2024, at 3:00 p.m. ET / 9:00 p.m. CET.

TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) and machine learning (ML) expertise. TG4050 is being evaluated in a randomized multicenter Phase I clinical trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Transgene and NEC plan to continue the development of TG4050 in this indication with a Phase II extension of the trial expected to start in 2024. TG4050 is being jointly developed by Transgene and NEC.

On March 5, 2024 Cartesian Therapeutics, Inc. (NASDAQ:RNAC) (the "Company"), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, reported that its management expects to participate in the following investor conferences in March (Press release, Cartesian Therapeutics, MAR 6, 2024, View Source [SID1234640806]):

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A presentation at the 2024 Leerink Partners Global Biopharma Conference at 8:40 a.m. ET on Wednesday, March 13, 2024 in Miami, FL
A fireside chat at the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference at 11:00 a.m. ET on Tuesday, March 26, 2024

A live webcast of the presentation and fireside chat are expected to be accessible in the Events section of the Company’s website at www.cartesiantherapeutics.com, where an archived replay of the events will also be available for a limited time.

On March 5, 2024 Bayer reported its annual report 2023 (Presentation, Bayer, MAR 5, 2024, View Source [SID1234642168]).

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On March 6, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of an abstract highlighting the preclinical evaluation of the bispecific antibody zenocutuzumab (Zeno) for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 taking place in San Diego, CA April 5-10, 2024 (Press release, Merus, MAR 5, 2024, View Source [SID1234640874]).

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The abstract describes Zeno’s activity in preclinical models representing different tumor types expressing high neuregulin 1 (NRG1) levels. High NRG1 expression is associated with poorer prognosis in certain cancers and resistance to standard therapies. The anti-tumor efficacy of Zeno in vivo against a panel of 28 patient-derived xenograft (PDX) models representing different tumor types was examined. The results show that Zeno significantly inhibited tumor growth in seven high-NRG1-expressing PDX models representing multiple different tumor types.

Presentation Details:

Title: Zenocutuzumab, a HER2xHER3 bispecific antibody, is effective in cancer models with high NRG1 expression.
Session Category: Experimental and Molecular Therapeutics
Session: Antibody-Drug Conjugates and Bispecific Antibodies
Date: Monday, April 8, 2024
Time: 9:00 am-12:30 p.m. PT
Location: Poster Section 23
Poster #: 14
Abstract #: 1903

The full abstract is available on the AACR (Free AACR Whitepaper) website. The poster will be available on the Merus website at the start of the session.

Zeno is being investigated in the phase 1/2 eNRGy trial and Early Access Program which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. Based on recent productive and collaborative discussions with the U.S. Food & Drug Administration, we believe we will have sufficient clinical data in the first half of 2024 to support potential Biologics License Application submissions in NRG1+ non-small cell lung cancer and NRG1+ pancreatic cancer.

About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.

On March 5, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported safety and initial efficacy data from the first ever 90mg dosing of eftilagimod alpha (efti) in combination with weekly paclitaxel in patients from the safety lead-in (N=6) of the AIPAC-003 Phase II/III trial (Press release, Immutep, MAR 5, 2024, View Source [SID1234640856]).

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Updated safety data from patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC) treated with this innovative immuno-oncology (IO)-chemotherapy combination reveal no treatment-emergent serious adverse events. Additionally, all treatment-emergent adverse events during the safety observation period to date have been of mild severity.

Initial efficacy reports show these six MBC patients, who exhausted all endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, exhibited encouraging results achieving a 50% overall response rate, including one complete response and two partial responses, and a 100% disease control rate overall with the remaining three patients having stable disease as best response.

Acknowledging the early nature of these results, efti with paclitaxel historically has shown a dose-dependent effect in MBC and has in some cases also led to stable disease patients becoming partial responders after six months. The biologically active 30mg efti dose, previously the highest dose of efti ever tested, has demonstrated a stronger immune response and greater efficacy than lower dosing levels (1mg, 6mg) in multiple clinical trials.

The ongoing randomized Phase II portion of the trial, which will include up to 58 evaluable patients, is focused on whether 90mg efti dosing is safe and more efficacious than 30mg dosing. This portion of the trial has enrolled 23 patients to date. Importantly, the determination of the optimal biological dose in AIPAC-003 is directly tied to the FDA’s Project Optimus initiative and is relevant for the entire efti program.

Further updates from AIPAC-003 will be provided in CY2024. For more information on the trial, please visit clinicaltrials.gov (NCT05747794).

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-y and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).