Half-year interim report

On August 14, 2024 Evotec reported its half-year interim report 2024 (Presentation, Evotec, AUG 14, 2024, View Source [SID1234647164]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Q2 2024 quarterly report

On August 14, 2024 Oncopeptides reported its second quarter 2024 results (Presentation, Oncopeptides, AUG 14, 2024, View Source [SID1234646759]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Half-Year Report 2024

On August 14, 2024 MediGene reported its half-yearly 2024 results (Presentation, MediGene, AUG 14, 2024, View Source [SID1234645981]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Novocure Highlights TTFields Therapy in Treatment of Non-Small Cell Lung Cancer at 2024 World Conference on Lung Cancer

On August 14, 2024 Novocure (NASDAQ: NVCR) reported its participation in the upcoming International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC) from September 7 – 10, 2024 in San Diego, California (Press release, NovoCure, AUG 14, 2024, View Source [SID1234645937]). Novocure will take part in presentations and symposia throughout the event and will exhibit several posters exploring the use of Tumor Treating Fields (TTFields) therapy in the treatment of lung cancer, including a new post-hoc analysis of data from the LUNAR trial in metastatic non-small cell lung cancer (NSCLC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are eager to share these exciting new analyses with the lung cancer community," said Nicolas Leupin, MD, Novocure’s Chief Medical Officer. "TTFields therapy offers significant potential for the treatment of this prevalent disease. With multiple regulatory reviews underway, there is no better time to examine the promise of TTFields use in the treatment of NSCLC."

The new post-hoc analysis evaluated survival data from the phase 3 LUNAR clinical trial, as well as a data from a simulation study, to assess the effect of body mass index (BMI) on overall survival (OS) and the feasibility of delivering TTFields at a therapeutic intensity to patients of varying BMIs. Investigators did not identify a difference in OS benefit between patients with a BMI <25 kg/m2 compared a BMI >25 kg/m2. Additionally, data from the simulation-based study suggests TTFields can be delivered to the lungs in therapeutic dose and a corresponding clinical benefit observed in patients across a range of BMIs.

The LUNAR trial was designed to evaluate the use of TTFields therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer, following progression on or after platinum-based therapy. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful extension in OS for patients treated with TTFields and standard systemic therapies, as well as a pronounced extension in OS for patients randomized to receive physician’s choice immune checkpoint inhibitor together with TTFields. Novocure has submitted these data to regulatory agencies for approval and anticipates treating patients in late 2024.

Novocure’s presence at the 2024 WCLC will include:

Sunset Seminar: Women in Thoracic Oncology, hosted by Women Leaders in Oncology (WLO), sponsored by Novocure, on September 8, 2024, at 6:00 p.m. UTC-7
Impact of BMI on TTFields in Patients with mNSCLC: Post-hoc Analysis from the Phase 3 LUNAR Study and Simulation Model Data. Poster P1.098B.04 displayed in the Exhibit Hall on September 8, 2024, at 12:00 p.m. UTC-7
Treatment of Non-Small Cell Lung Carcinoma (NSCLC) Cells With Tumor Treating Fields (TTFields) and DNA-Dependent Protein Kinase (PK) Inhibitors. E-Poster EP.03F.04
Tumor Treating Fields (TTFields) Induce Pro-Inflammatory Phenotype Skewing of Macrophages. E-Poster EP.03G.03

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. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these 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.

ABOUT LUNAR

LUNAR tested the safety and effectiveness of TTFields therapy when used together with either an immune checkpoint inhibitor (ICI) or docetaxel for the treatment of patients diagnosed with metastatic NSCLC following progression on or after the use of platinum-based therapy. Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median overall survival (OS) of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with an ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.

Accutar Biotechnology Receives FDA Fast Track Designation for AC699 in ER+ / HER2- Breast Cancer

On August 14, 2024 Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, reported that the US Food and Drug Administration (FDA) has granted the investigation of AC699 a Fast Track designation for the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression on or after at least 1 line of endocrine-based therapy (Press release, Accutar Biotechnology, AUG 14, 2024, View Source;Breast-Cancer [SID1234645936]). AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α currently in a Phase 1 trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ER-positive/HER2-negative subtype is the most common subtype of breast cancer (~70%), and mutations in the estrogen receptor 1 (ESR1) gene are common (20-40%) among ER-positive/HER2-negative patients who received endocrine therapy in the metastatic setting. AC699 has demonstrated objective response rate (ORR) of 50% in patients with an ESR1 mutation, in an ongoing Phase 1 trial, presented at ASCO (Free ASCO Whitepaper) 2024.

"Receiving Fast Track designation for AC699 from the FDA highlights their recognition of the serious and life-threatening nature of this malignancy, the critical unmet medical needs not fully addressed by existing therapies, and the potential of AC699 to fill in the gap," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "We look forward to working closely with the FDA to optimize and expedite the development program."

The FDA’s Fast Track process is designed to facilitate the development and expedite the review of novel drugs intended to treat serious conditions and address significant unmet medical needs. Companies that receive Fast Track designation are eligible for more frequent meetings and communications with the FDA during clinical development and potentially accelerated approval and priority review, if relevant criteria are met. For more information on Fast Track Designation, please visit the FDA’s website at View Source

About AC699 and the Phase 1 Study (AC699-001)

AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α. In preclinical studies, AC699 has demonstrated potent and selective protein degradation of ERα wildtype and mutants with favorable pharmacological properties, as well as promising anti-tumor activities in ER-positive animal tumor models.

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC699 treatment in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer (NCT05654532). Additional information on this clinical trial can be found on www.clinicaltrials.gov.