On August 20, 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 a late-breaking abstract has been accepted and selected as a Proffered Paper oral presentation at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place September 13-17 in Barcelona, Spain (Press release, Immutep, AUG 20, 2024, View Source [SID1234646012]).

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The oral presentation will detail results from the randomized Cohort A of the TACTI-003 (KEYNOTE-C34) Phase IIb trial evaluating eftilagimod alpha ("efti"), a proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with pembrolizumab versus pembrolizumab alone in recurrent or metastatic first line head and neck squamous cell carcinoma patients with any PD-L1 expression (CPS >1). Details of the presentation are as follows:

Title: Primary Results from TACTI-003: A Randomized Phase IIb Trial Comparing Eftilagimod Alpha (soluble LAG-3) Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with CPS ≥1
Speaker: Claus Andrup Kristensen, MD, PhD, Head of Section for Thoracic and Head and Neck Oncology, Rigshospitalet, Copenhagen, Denmark
Presentation #: LBA35
Category: Proffered Paper session: Head and neck cancer
Date & Time: Sunday, September 15, 2024; 10:25 – 10:35 am CET

Late-breaking abstracts are generally reserved for high-quality, new research findings from randomized phase II or phase III trials with implications for clinical practice or understanding of disease processes. Proffered papers are oral presentations of original data of superior quality, followed by expert discussion and perspectives.

About TACTI-003
The Two ACTive Immunotherapies-003 (TACTI-003) trial is an ongoing Phase IIb study (also known as KEYNOTE-C34) evaluating eftilagimod alpha (efti), Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The randomized Cohort A portion of the study is evaluating efti in combination with pembrolizumab as compared to pembrolizumab monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours, whereas Cohort B is evaluating efti in combination with pembrolizumab in patients with PD-L1 negative tumours (CPS <1).

The primary endpoint of the study is Objective Response Rate of evaluable patients according to RECIST 1.1. Secondary endpoints include Overall Survival, Objective Response Rate according to iRECIST, Progression Free Survival, and Duration of Response. For more information about the Phase IIb trial, visit clinicaltrials.gov (NCT04811027).

On August 20, 2024 Phigenix reported that United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,064,403, which relates to compositions and methods related to the use and administration of certain PAX2 inhibitors for treating drug-resistant breast cancer previously treated with an anti-estrogen receptor, anti-progesterone receptor, or an anti-her2 drug (Press release, Phigenix, AUG 20, 2024, https://www.phigenix.com/news/2024/8/20/phigenix-inc-receives-issuance-of-us-patent-covering-novel-therapeutic-for-treating-drug-resistant-breast-cancer [SID1234646009]). Dr. Carlton D. Donald, President and CEO of PHIGENIX, commented, "We are extremely pleased to receive this new patent as we continue to innovate new drugs for patients with hard-to-treat cancers."

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On August 20, 2024 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), the Company’s investigational B7-H3-targeted antibody drug conjugate (ADC) being evaluated for the treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy (relapsed or refractory) (Press release, GlaxoSmithKline, AUG 20, 2024, View Source [SID1234646008]). The Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy1.

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Extensive-stage small-cell lung cancer is aggressive with poor prognosis and significant need for new treatments. Today’s Breakthrough Therapy Designation supports our ambition to accelerate GSK’227 for these patients as part of our broader ADC programme focused on developing new treatment options with transformational and first-to-market potential."

Lung cancer is one of the most common cancers worldwide. In the US, approximately 15% of all lung cancers are small-cell. Of patients with small-cell lung cancer, 70% have extensive-stage disease meaning the cancer has spread throughout one or both lungs and/or to other parts of the body2. ES-SCLC is an aggressive and difficult-to-treat cancer with limited treatment options. The 5-year survival rate is approximately 3%2. Most patients with ES-SCLC relapse after initial treatment and the median overall survival with current standard-of-care treatments for relapsed ES-SCLC is 5-6 months3,4.

Earlier this year, GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of GSK’2275. FDA’s Breakthrough Therapy Designation is supported by data from the ongoing ARTEMIS-001 Phase 1 open-label, multi-centre trial of more than 200 patients evaluating the safety, tolerability, and preliminary anti-tumour activity in locally advanced or metastatic solid tumours, including relapsed or refractory ES-SCLC, conducted by Hansoh Pharma. Results from this trial will be presented at the 2024 World Conference on Lung Cancer taking place from 7-10 September in San Diego, California, USA. GSK plans to begin global phase 1/2 trials in 2H 2024 to support a registrational pathway for GSK’227.

About GSK5764227

GSK5764227, also known as HS-20093, is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully humanised anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload. HS-20093 is being developed by Hansoh Pharma for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumours in multiple phase I and II clinical trials in China, with GSK’s global Phase I trials for GSK5764227 set to begin in 2H 2024.

On August 20, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the first patient has joined its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence (RWE) study at Baylor Scott & White, the primary study site and largest not-for-profit health system in Texas (Press release, Exact Sciences, AUG 20, 2024, View Source [SID1234646006]). The multi-site study will enroll up to 25,000 patients, evaluating the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year period. Endeavor Health, a Chicago-area health system serving more than 1.4 million patients, will start enrolling patients this fall. The U.S. Food and Drug Administration (FDA) recently authorized an investigational device exemption (IDE) for the Exact Sciences MCED test, allowing its use in the Falcon Registry. This study will provide valuable insight to further inform the development and commercialization of the company’s future MCED test and support discussions with regulatory agencies, payers, and guideline bodies.

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"Exact Sciences is dedicated to advancing an MCED test, as it offers a highly promising way to make an impact on the burden of cancer," said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. "Too often, cancers go undetected until symptoms appear, resulting in diagnoses at advanced, less treatable stages. Early detection through screening improves outcomes, yet two-thirds of cancer cases and deaths are due to cancers that do not have recommended screening options. 1 Our collaboration with Baylor Scott & White and Endeavor Health is a crucial step forward and represents a tremendous opportunity to help transform cancer care."

To better understand the impact of MCED testing on patient care, the study will use a registry approach, tracking patient data over time to evaluate outcomes and improve future treatments. Up to 25,000 patients ages 50-80 with no history of cancer will participate in annual MCED testing for three years and two additional years of follow-up data collection. Data will also be collected for a comparator cohort of up to 50,000 patients, demographically and clinically similar to the study cohort but receiving standard care without the MCED test. The Exact Sciences MCED test features two high-performing biomarker classes known for their ability to identify cancer early, offering sensitivity and specificity that can detect aggressive cancers and those lacking current standard of care screening. 2

"With this important work, we aim to intercept cancer earlier than ever before," said Ronan Kelly, M.D., principal investigator of the MCED Falcon Registry Real-World Evidence study. Dr. Kelly is the director of oncology, Baylor Scott & White Charles A. Sammons Cancer Center at Baylor University Medical Center — Dallas, and chief of oncology, North Texas Division, Baylor Scott & White Health. "We are eager to do our part in the national effort to decrease cancer mortality by 50% over the next 25 years, as outlined in the U.S. government’s Cancer Moonshot initiative. This important study is helping advance proactive cancer detection efforts, and we are excited to help close gaps in existing cancer screening programs."

Cancer remains the second leading cause of death in the United States, with over 2 million new cases and approximately 611,000 deaths projected for 2024. 3 Advancing early detection through innovative approaches like MCED testing has never been more critical. Baylor Scott & White and Endeavor Health, located in distinct parts of the country and serving a diverse range of communities, will help reach a broad representative group of Americans and provide insights on the potential benefits of early detection across diverse populations.

"Implementing MCED testing and advancing preventative genomics are crucial steps in addressing the ‘last mile’ problem in health care," said Peter Hulick, M.D., the Janardan D. Khandekar, M.D., chair of personalized medicine and the director of the Mark R. Neaman Center for Personalized Medicine at Endeavor Health. "The Falcon Registry is a pivotal research study to meet the real-world challenges of implementation and aligns with the broader vision of the Davis Family Center for Preventive Genomics at Endeavor Health, which is to assist patients, their families, and caregivers in making better-informed decisions about early diagnosis, prevention strategies, and personalized treatment options."

The Exact Sciences MCED test is available to patients who have consented and enrolled in the Falcon Registry study. It has not been cleared or approved by the U.S. Food and Drug Administration or other notified regulatory authority. The test was developed and its performance characteristics validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The test is performed at Exact Sciences Laboratories. Exact Sciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.

On August 20, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it will present data from its FOCUS Phase 3 study at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, which convenes from September 13-17, 2024, in Barcelona, Spain (Press release, Delcath Systems, AUG 20, 2024, View Source [SID1234646005]).

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Poster Presentation Details

Title: Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results
Date: September 14, 2024
Time: 9:00 am
Location: Hall 6
Poster number: 1127P

The presentation will highlight the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in patients across six subgroups with unresectable metastatic uveal melanoma (mUM).