On February 22, 2024 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported that data will be highlighted in three separate poster presentations at the 2024 Miami Breast Cancer Conference (MBCC), held on March 7 – 10, 2024 at the Fontainebleau, Miami Beach, FL (Press release, PreludeDx, FEB 22, 2024, View Source [SID1234640402]).

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"We are excited to share data regarding our novel biosignature for invasive Stage I, II breast cancer test for radiation therapy, as well as clinical utility data on our DCISionRT test for DCIS at the prestigious MBCC conference," said Dan Forche, President and CEO of PreludeDx. "We look forward to connecting with colleagues and sharing our vision for future early-stage breast cancer products, as well as advancing collaboration opportunities."

PreludeDx MBCC Posters to Be Presented

Title: A Novel Biosignature for Early-Stage Invasive Breast Cancer to Predict Radiotherapy Benefit and Assess Recurrence Risk for Patients Treated with Breast-Conserving Surgery
Presenter: Troy Bremer, PhD, Chief Scientific Officer, PreludeDx
Date: Thursday, March 7, 5:30 – 6:30 p.m. and Friday, March 8, 4:45 – 6:00 p.m. ET

Title: Impact on Radiation Therapy Recommendation and Treatment Modality for Patients with Ductal Carcinoma in Situ Using the 7-Gene Biosignature: Analysis of the PREDICT Study
Presenter: Chirag S. Shah, MD, Co-Director of Breast Radiation Oncology, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH
Date: Thursday, March 7, 5:30 – 6:30 p.m. and Friday, March 8, 4:45 – 6:00 p.m. ET

Title: Limitations in the Application of Clinicopathologic Factors Alone in Predicting Radiation Benefit for Women with Low-Risk DCIS after Breast Conserving Surgery: The Impact of a 7-Gene Biosignature Based on 10-year Ipsilateral Breast Recurrence (IBR) Rates
Presenter: Frank A. Vicini, MD, FASTRO, Radiation Oncologist at Michigan HealthCare Professionals, member of NRG Oncology
Date: Thursday, March 7, 5:30 – 6:30 p.m. and Friday, March 8, 4:45 – 6:00 p.m. ET

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

On February 22, 2024 AbbVie Inc. (NYSE: ABBV) and Tentarix Biotherapeutics reported a multi-year collaboration focused on the discovery and development of conditionally-active, multi-specific biologic candidates in oncology and immunology (Press release, AbbVie, FEB 22, 2024, View Source [SID1234640401]). The collaboration will integrate AbbVie’s expertise in oncology and immunology with Tentarix’s proprietary Tentacles platform.

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Tentacles are multi-functional, conditionally-active antibody-based biologics that are designed specifically to activate immune cells that can modulate disease pathways, while potentially mitigating safety concerns associated with non-specific targeting of other immune cells.

"Oncology and immunology are two of our key strategic growth areas where we are pursuing novel technologies that aim to deliver transformative therapies, which address unmet patient needs," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "This strategic partnership complements our ongoing efforts in developing novel biologics, potentially to expand our oncology and immunology portfolios with conditionally-active multi-specific molecules."

"We are excited to join forces with AbbVie to help accelerate cutting-edge, conditionally-active therapeutic programs towards clinical applications for patients in need," said Don Santel, interim chief executive officer, Tentarix Biotherapeutics. "This collaboration adds to our portfolio of internal and external pipeline programs and is a strong validation of our approach in understanding and targeting complex immune interactions that drive cancers and inflammatory diseases."

Under the terms of the agreements, Tentarix will receive upfront option payments, totaling $64 million from AbbVie, for the two programs. AbbVie will receive an exclusive option to fully acquire the programs following candidate nomination, for an additional undisclosed payment for each program.

On February 22, 2024 Immunofoco, a company dedicated to developing cell therapy products for solid tumors, reported a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ) (Press release, Immunofoco, FEB 22, 2024, View Source [SID1234640400]).

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EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low. It has been identified as a promising therapeutic target for GI tumors with a wide range of expandable indications. IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ". In August 2023, the product was granted Orphan Drug Designation (ODD) by the U.S. FDA.

The impressive clinical results of IMC001 have been shared at prestigious medical conferences, including being orally presented at the annual meeting of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) in 2022 and updated during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in 2023.

As of January 31, 2024, in the IIT clinical trial for advanced gastric cancer, a safe and effective recommended dose has been identified, with two (2) out of five (5) patients in this dose group achieved partial remission (PR), with an overall response rate (ORR) of 40%. Among them, one PR patient underwent a successful radical surgery for gastric cancer 30 weeks after a single infusion of IMC001 and is still alive 85 weeks after IMC001 treatment. Another PR patient exhibited a 48% reduction in tumor size by week 16.

Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed her congratulations and gratitude to the entire team. She highlighted the significance of Immunofoco’s achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China. Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells. About 90% of the patients with gastrointestinal tumors exhibit EpCAM expression, which satisfies a broader clinical need. With the US/CN approval of this IND application, IMC001 is now poised to undertake further clinical trials and forge international collaborations, positioning itself as a promising new therapeutic option for patients with advanced GI tumors on a global scale.

On February 22, 2024 Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases reported that the international multicenter Phase III clinical study of its non-surgical treatment for cervical HSIL product APL-1702, will be presented for the first time in the form of an oral presentation at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN), to be held on March 13-16 (Press release, Asieris Pharmaceuticals, FEB 22, 2024, View Source [SID1234640398]).

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Oral presentation (Abstract No.6802) Photodynamic therapy with APL-1702 for high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study (YHGT-CEV-1/APRICITY)

This study is a prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. It is led by Academy Member Dr. Jinghe Lang from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and has enrolled 402 participants. The trial met its primary endpoint, together with a robust safety profile. APL-1702 holds the potential to become the world’s first non-surgical product with proven clinical efficacy against cervical HSIL.

EUROGIN is the leading international multidisciplinary Congress on Human Papillomavirus (HPV), aims to translate scientific and evidence-based research into clinical practice, accelerating the reduction of the burden of HPV-related cancers and their mortality.

On February 22, 2024 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following update on the expansion of the clinical trial into Europe (Press release, Greenwich LifeSciences, FEB 22, 2024, https://investor.greenwichlifesciences.com/news-events/press-releases/detail/78/protocol-accepted-by-european-regulators [SID1234640397]).

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The Company’s application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA’s Clinical Trials Information System (CTIS). The Company was informed that the manufacturing, non-clinical, clinical, statistical, and regulatory sections of its application are acceptable and the regulators’ requests for information have been addressed. The regulators have thus approved the clinical trial, marking a major milestone for the Company.

The 5 individual countries in Europe will now make a final determination, and if acceptable, they will allow the first group of approximately 105 sites in Europe to begin initiation and activation. Once an individual site has been activated patients can be screened and enrolled.

CEO Snehal Patel commented, "Our interactions with EMA and the 5 participating countries through the CTIS process provided great insight into EMA’s expectations for a marketing license application in Europe for GLSI-100. We will continue the dialogue with EMA regulators as we operate Flamingo-01 in Europe, which will help us prepare for an EU licensing application in the future in parallel to filing a BLA in the US."

About Flamingo-01 and GLSI-100

Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on Flamingo-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.