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DEP theranostic presented at international oncology meeting

On October 16, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported a copy of the poster that showcases the results from a study of DEP HER2-zirconium, Starpharma’s HER2-targeted radiodiagnostic candidate, which demonstrated a favourable biodistribution profile, with excellent imaging contrast between tumour and normal tissues, as well as rapid uptake and high levels of tumour accumulation in a HER2+ breast cancer model (Press release, Starpharma, OCT 16, 2023, View Source;mc_eid=bf52dd3418 [SID1234635975]). These results were announced by Starpharma in July 2023.

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The poster was presented over the weekend in Boston, US, at the AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), co-hosted by the American Association of Cancer Research (AACR) (Free AACR Whitepaper), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) from 11 to 15 October 2023.

Starpharma’s DEP HER2-zirconium is a radiodiagnostic product that belongs to the rapidly growing radiotheranostic market. DEP HER2-zirconium is designed to specifically diagnose, stage, and monitor HER2+ cancers with greater sensitivity, meaning that patients suffering from these cancers could be diagnosed earlier, more accurately, and monitored more closely during cancer treatment.

DEP® irinotecan IO/PARP combination data presented at AACR

On October 16, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported a copy of the DEP irinotecan combination data poster, showcasing the recently announced data for DEP irinotecan in combination with leading anticancer therapies, including immuno-oncology (IO) agents, in human colorectal cancer (CRC) models (Press release, Starpharma, OCT 16, 2023, View Source;mc_eid=bf52dd3418 [SID1234635974]). The data show that DEP irinotecan in combination with an IO agent or a PARP2 inhibitor demonstrated superior anti-tumour activity and significant survival benefit when compared to these agents delivered alone in multiple CRC models.

The poster was presented over the weekend in Boston, US, at the international oncology conference, AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), co-hosted by the American Association of Cancer Research (AACR) (Free AACR Whitepaper), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) from 11 to 15 October 2023.

This promising combination data, together with the recently released positive clinical results for DEP irinotecan, provide a strong rationale for clinical evaluation of DEP irinotecan with these leading classes of cancer drugs. These combinations are commercially important because they increase the potential market opportunities for DEP irinotecan and illustrate valuable synergies with successful product categories.

Immutep Announces Publication of Abstracts at ESMO Congress 2023

On October 16, 2023 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 the publication of abstracts with data from the TACTI-002 and INSIGHT-003 trials in 1st line non-small cell lung cancer (1L NSCLC) at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Immutep, OCT 16, 2023, View Source [SID1234635973]).

TACTI-002 is a Phase II trial evaluating the chemotherapy-free combination of eftilagimod alpha ("efti") and KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Rahway, NJ, USA) anti-PD-1 therapy, in 1L NSCLC. The TACTI-002 abstract published by ESMO (Free ESMO Whitepaper), which contains data based on a cut-off date of 31 March 2023, showed an excellent initial survival benefit across an all-comer PD-L1 patient population in 1L NSCLC as well as for patients in each PD-L1 Tumour Proportion Score (TPS) subgroup, including 38.8 months in TPS >50%, 23.4 months in TPS 1-49%, and 25.0 months in TPS >1% (the OS result in TPS >1%, a key area of focus for future development where efti has FDA Fast Track designation, was already reported on May 17, 2023).

Notably, new updated data from TACTI-002, including more mature Overall Survival (OS) results, will be presented by Dr. Enric Carcereny, Catalan Institute of Oncology, Badalona (ICO), during a Mini Oral session (#1312MO) at ESMO (Free ESMO Whitepaper) Congress 2023 on Saturday, October 21, 2023, at 9:05 AM CEST.

INSIGHT-003 is an investigator-initiated Phase I trial conducted by the Frankfurt Institute of Clinical Cancer Research IKF evaluating efti in conjunction with KEYTRUDA and doublet chemotherapy in non-squamous 1L NSCLC patients. The data in the INSIGHT-003 abstract, with a cut-off date of 18 April 2023, showed a promising 67% overall response rate. Additionally, a Trials in Progress (TiP) abstract on the EFTISARC-NEO trial evaluating efti in combination with radiotherapy and KEYTRUDA titled has been published.

Abstracts are available on the ESMO (Free ESMO Whitepaper) website, and the mini oral presentation & posters will be available on Immutep’s website following their presentation.

Presentation Details

Title: Combining the antigen-presenting cell activator eftilagimod alpha (soluble LAG-3) and pembrolizumab: overall survival data from the 1st line non-small cell lung carcinoma (NSCLC) cohort of TACTI-002 (Phase II)

Presenter: Dr. Enric Carcereny, Catalan Institute of Oncology, Badalona (ICO)
Date and Time: Saturday, October 21, 2023; 9:10 AM CEST
Mini Oral session – NSCLC, metastatic
Presentation #1312MO
Title: INSIGHT-003 evaluating feasibility of eftilagimod alpha (soluble LAG-3) combined with 1st line chemo-immunotherapy in metastatic non-small cell lung cancer (NSCLC) adenocarcinomas

Speaker: Dr. Akin Atmaca, Krankenhaus Nordwest (IKF)
Date: Monday, October 23, 2023
Poster presentation, #1042P
Title: Pembrolizumab in combination with eftilagimod alpha and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas – EFTISARC-NEO trial

Speaker: Dr. Katarzyna Kozak, Maria Skłodowska-Curie National Research Institute of Oncology
Date: Monday, October 23, 2023
Poster presentation, #1987TiP
Conference Call and Webcast:

Immutep will host a conference call and webcast to discuss the clinical data presented at ESMO (Free ESMO Whitepaper) 2023 and provide an overview on future clinical development plans for efti in 1st line non-small cell lung cancer. The event will feature Immutep CEO Marc Voigt, CSO Dr Frederic Triebel, CMO Dr Florian Vogl, and Christian Mueller, Senior Vice President Strategic Development. An open question & answer session with all presenters will conclude the event. A replay of the webcast will be available under the Events section of Immutep’s website.

Date/Time: Monday, October 23rd, at 8AM AEDT (Sunday, October 22nd, at 5PM ET)
Register: Link to register here
Questions: Investors are invited to submit questions in advance via [email protected].
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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-ƴ 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 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

Novocure Announces Presence at European Society for Medical Oncology (ESMO) Congress 2023

On October 15, 2023 Novocure (NASDAQ: NVCR) reported its participation in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 from October 20 – 24 in Madrid (Press release, NovoCure, OCT 15, 2023, View Source [SID1234635982]). Novocure will present three new posters on Tumor Treating Fields (TTFields) therapy, including an analysis of patient-reported health-related global and functional quality of life scores from the randomized phase 3 LUNAR clinical trial in metastatic non-small cell lung cancer (NSCLC).

The new analysis of data from LUNAR utilized The European Organization for Research and Treatment of Cancer Quality of Life questionnaire-C30. Analysis showed no statistically significant difference between patients who received TTFields therapy together with standard systemic therapies and patients who received standard systemic therapies alone in median time to deterioration for global health status (4.4 vs 4.0 months, P=0.91) and for all five functional scales: physical functioning (3.2 vs 4.2 months, P=0.58), role functioning (3.0 vs 2.8 months, P=0.59), emotional functioning (6.6 vs 5.7 months, P=0.96), cognitive functioning (3.7 vs 4.4 months, P=0.23), and social functioning (4.0 vs 3.9 months, P=0.66).

Highlights of Novocure’s presentations at the ESMO (Free ESMO Whitepaper) Congress 2023 also include global post-marketing surveillance data from patients with high-grade gliomas, confirming the well-tolerated safety profile of TTFields therapy in a subgroup of patients ages 70 and older in the real-world setting, which is consistent with data from Novocure’s EF-14 clinical trial. Another highlight is survey data from patients with glioblastoma (GBM) using TTFields therapy in the United States and DACH region (Germany, Austria and Switzerland), which showed that most patients were very satisfied or satisfied with TTFields therapy. Most said they would recommend TTFields therapy to a friend or acquaintance with GBM.

Novocure will also host an industry-sponsored symposium, titled The Evolving Role of TTFields Therapy in Solid Tumors, in Oviedo Auditorium, Hall 7, on Oct. 23 at 1 p.m. CEST.

"We are encouraged by new data supporting the use of TTFields therapy in the management of metastatic NSCLC and further validating the favorable safety and patient satisfaction profiles of TTFields therapy in patients with aggressive central nervous system tumors," said Pritesh Shah, Novocure’s Chief Growth Officer. "We look forward to sharing these insights with, and continuing to learn from, leading medical oncologists in Europe and worldwide."

Novocure’s full list of presentations at the ESMO (Free ESMO Whitepaper) Congress 2023 includes:

Post-marketing surveillance data from patients ≥70 years of age with central nervous system malignancies treated with Tumor Treating Fields (TTFields) therapy between 2011–2022. Presenter: Wenyin Shi. 12 p.m. CEST on Sunday, Oct. 22.
Tumor Treating Fields therapy for glioblastoma: Identifying needs and satisfaction of new and long-term users. Presenter: Eleni Batzianouli. 12 p.m. CEST on Sunday, Oct. 22.
Impact of TTFields therapy on global and functional health-related quality of life (HRQoL) in metastatic non-small cell lung cancer (mNSCLC) from the pivotal LUNAR study. Presenter: Joachim Aerts. 12 p.m. CEST on Monday, Oct. 23.
Symptom burden and health-related quality of life (HRQoL) in platinum-resistant or -refractory ovarian cancer (PROC): a systematic literature review (SLR). Presenter: Nikhila Indukuri. 12 p.m. CEST on Saturday, Oct. 21.
About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

CatalYm Presents Data at ESMO 2023 Expanding GDF-15’s Role in Checkpoint Therapy Resistance by Inhibition of Myeloid Immune Cell Activation

On October 15, 2023 CatalYm reported new preclinical data expanding the mechanistic understanding of how GDF-15 plays a key role in cancer therapy resistance (Press release, Catalym, OCT 15, 2023, View Source [SID1234635981]). The results will be presented in a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain on Sunday, October 22nd by CatalYm’s CSO, Dr. Christine Schuberth-Wagner. The data are the first to show that GDF-15 has an inhibitory effect on the activation of M1 macrophages. These specific myeloid lineage immune cells are central to the initiation of immune responses, including the secretion of pro-inflammatory cytokines and chemokines, presentation of antigens as well as direct antitumor cytotoxicity.

"The findings, therefore, provide additional support for the potential of GDF-15 neutralizing approaches as a critical component for treatment success in a broad range of anti-cancer regimens."

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The results support and expand on initial findings, recently published in Nature Communications, on pathways involved in the development of GDF-15 mediated therapy resistance in cancer cells. These data were the first to demonstrate a mechanistic link between GDF-15 and inhibition of the LFA-1/ICAM-1 cell adhesion axis in cancer, resulting in impaired infiltration of T cells into the tumor microenvironment.

"The ESMO (Free ESMO Whitepaper) data add to recently discovered mechanistic effects of GDF-15 impairing T cell infiltration into tumors and show the impairment of another important immune cell compartment by GDF-15, thereby expanding our understanding of its role in establishing tumor resistance to current cancer therapies. Interestingly, M1 macrophages are crucial for initiation of anti-tumoral immune responses and in parallel are active in tumor cell destruction by phagocytosis and oxidative stress," said Dr. Christine Schuberth-Wagner, Chief Scientific Officer at CatalYm. "The findings, therefore, provide additional support for the potential of GDF-15 neutralizing approaches as a critical component for treatment success in a broad range of anti-cancer regimens."

The preclinical data comprise in vitro analyses demonstrating that GDF-15 inhibits the polarization of M0 to M1 macrophages, indicated by a reduction of activation marker expression as well as MHC-II and Fcg-receptors. These phenotypic changes are accompanied by an altered cytokine expression and secretion profile. The activation was restored when GDF-15 was neutralized with CatalYm’s anti-GDF-15 antibody candidate, visugromab. In in vivo melanoma models, knock-out of GDF-15 led to an increase of counts and activation status of macrophages and antigen-presenting dendritic cells in tumor tissue. Overall, the results indicate that GDF-15 counteracts myeloid immune cell activation, supporting the generation of an immune-evasive tumor microenvironment, an important feature in therapy resistance.

CatalYm is investigating its GDF-15-neutralizing antibody visugromab in the GDFather (GDF-15 Antibody-mediaTed Human Effector Cell Relocation) trials in combination with the anti-PD-1 inhibitor nivolumab in patients with advanced solid tumors. Interim data from the Phase 2 (NCT04725474) trial recently presented at ASCO (Free ASCO Whitepaper) continue to demonstrate a very good safety and tolerability profile and promising durable, confirmed responses in major cancer indications, including non-small cell lung cancer (NSCLC), bladder cancer and hepatocellular carcinoma (HCC). The company expects to report mature data readouts for efficacy and safety from the core Phase 2a program as well as main biomarker-correlations before the end of 2023.

About Visugromab (CTL-002)

Visugromab is a monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by reenabling immune cell activation and tumor infiltration. Visugromab has already demonstrated a good safety profile and potent and durable anti-tumor efficacy in combination with anti-PD-1 treatment in advanced cancer patients The antibody is currently being investigated in ongoing Phase 2 studies in multiple solid tumor indications.