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 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 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.