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 iTeos Therapeutics, Inc. (Nasdaq: ITOS) ("iTeos"), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported that interim data from GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK, assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer, will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, being held September 13-17, 2024 in Barcelona, Spain (Press release, iTeos Therapeutics, AUG 20, 2024, View Source [SID1234646013]).

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Late Breaking Oral Presentation Details
Title: Interim Analysis of GALAXIES Lung-201: Phase 2, Randomized, Open-label Platform Study of Belrestotug Plus Dostarlimab in Patients (pts) With Previously Untreated Locally Advanced/Metastatic (LA/M) PD-L1 High (TPS >/=50%) Non-Small Cell Lung Cancer (NSCLC)
Abstract Number: LBA52
Session Title: Proffered Paper Session: NSCLC Metastatic
Date / Time: September 14, 2024 at 8:30 am CEST / 2:30 am ET

The ESMO (Free ESMO Whitepaper) website indicates that all late-breaking abstracts will be published on the ESMO (Free ESMO Whitepaper) website on the day of the presentation at 00:05 am CEST.

On August 20, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI) reported it will halt the registration-intended PRECISION1 trial of nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. An analysis by the Independent Data Monitoring Committee demonstrated that the study was unlikely to exceed an efficacy threshold necessary to support an accelerated approval, the key goal of this Phase 2 study (Press release, Aadi Bioscience, AUG 20, 2024, View Source [SID1234646015]). The approximately 25 patients in PRECISION1 who are still benefiting from nab-sirolimus will be eligible for transition to a planned expanded access protocol, and a complete analysis of the PRECISION1 trial will be provided at a later date.

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Aadi will now focus on preserving cash while maximizing its commercial business. Aadi’s marketed product, FYARRO, is the only preferred treatment for patients with advanced malignant PEComa, a rare and aggressive cancer. In the second quarter of this year, FYARRO delivered sales of $6.2M.

To further preserve cash runway, Aadi will pause new enrollment, but continue dosing previously enrolled patients, in two, ongoing Phase 2 trials of nab-sirolimus for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NETs). Both studies have enrolled sufficient patients (n=20 and n=10 for EEC and NETs, respectively) to assess initial efficacy signals later this year. Aligned to these pipeline adjustments, the Company is reducing its Research & Development workforce by 80%. Together these actions extend cash runway into at least 2H 2026.

"We are humbled by the effort of the investigators, support staff, and most importantly, the patients and their families who took part in PRECISION1. While nab-sirolimus showed monotherapy activity in the study population, the trial fell short of delivering what we believe would be required to support an accelerated approval in the broad TSC1/TSC2 inactivating mutations indication. We look forward to providing the full trial analysis at a later date," said David Lennon, President and CEO of Aadi Bioscience. "I want to thank the dedicated Aadi employees who worked tirelessly on this trial and are negatively impacted by this outcome. Given the change in the development pipeline, we have taken the necessary steps to immediately preserve cash runway, and have hired an advisory firm to explore all options to maximize value for shareholders."

On August 20, 2024 PDX Pharma reported the company was granted a new U.S. Patent (US12059500) on August 13, 2024, marking the third U.S. patent for our ARAC technology! ARAC is based on our innovative Pdx-NP nanoparticle platform, which co-delivers antigen release agents and immune checkpoint inhibitors to elicit a potent anti-tumor immune response (Press release, PDX Pharmaceuticals, AUG 20, 2024, View Source [SID1234646304]). The key claims in this patent include PD-L1 antibody-conjugated Pdx-NP loaded with "any" cancer therapeutics. This new addition to our patent portfolio not only extends our protection but also strengthens our commitment to advancing the ARAC pipeline. We are incredibly proud of this achievement, made possible by our dedicated team members and inventors, Drs. Moataz Reda and Worapol (Boom) Ngamcherdtrakul, along with our OHSU collaborator and PDX Pharma’s CEO, Dr. Wassana Yantasee. Stay tuned for more exciting updates!

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On August 19, 2024 Kelun reported that the new drug application (NDA) for the core product sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) based on the positive results from the pivotal OptiTROP-Lung03 study has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK) (Press release, Kelun, AUG 20, 2024, View Source [SID1234645995]).

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OptiTROP-Lung03 is a multi-center, randomized, pivotal clinical study that evaluates sac-TMT monotherapy 5mg/kg every other week (Q2W) as an intravenous injection versus docetaxel for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) who failed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy. At a pre-specified analysis, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) and progression-free survival (PFS) compared with docetaxel.

Lung cancer mainly includes non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which NSCLC is the most common pathological type, accounting for about 80%-85% of all lung cancers. The molecular typing of NSCLC patients in China is different from that of Western populations, and EGFR mutation is a common variant gene type, accounting for about 40%-50% of lung adenocarcinoma patients in China [1]. According to the 2024 CSCO guidelines, EGFR-TKIs are the preferred treatment for stage IV EGFR-mutant NSCLC [2]; platinum-containing chemotherapy is the main first-line chemotherapy regimen after resistance to EGFR-TKIs; and existing treatment regimens are ineffective in those who have failed EGFR-TKIs and platinum-containing chemotherapy. Single-agent chemotherapy is the current standard of care for this population, and docetaxel is the most commonly used single-agent chemotherapy, with an ORR of 3.2%-10.8%, a median PFS of only about 2 months, and a median OS of about 6-8 months [3,4,5,6,7]. For patients with locally advanced or metastatic EGFR-mutated NSCLC who have failed treatment with EGFR-TKIs and who have failed platinum-containing chemotherapy, the existing treatment regimens are less efficacious, there is a large unmet clinical need, and new drugs are urgently needed to improve patient survival.

Kelun-Biotech has filed the Application for sac-TMT for injection for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC who failed after treatment with an EGFR-TKI and platinum-based chemotherapy.

The Application is the second NDA for sac-TMT that has been accepted by the NMPA. On August 14, 2024, it was announced on the official website of the CDE that the Application was planned to be included in the priority review and approval process of the CDE. Previously, an NDA for sac-TMT in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) was accepted by the NMPA.

Dr. Junyou Ge, CEO of Kelun-Biotech, said, "It is a great honor to have the second NDA of SKB264 accepted. Kelun-Biotech has always adhered to an innovation-driven development strategy, actively exploring cutting-edge technologies and new approaches to the treatment of major diseases. In response to unmet medical needs, we are committed to the original innovation of new drugs with differentiated advantages and international potential. By enhancing our end-to-end innovative drug development capabilities, we continuously improve the efficiency and success rate of drug research and development, and make every effort to move forward our clinical research progress. We are dedicated to continuously exploring and rapidly validating the clinical value of core projects. The company will always be guided by a caring heart, striving for excellence, and contributing to the great global oncology health cause."