On May 23, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31-June 4, 2024 in Chicago, IL (Press release, Bio-Path Holdings, MAY 23, 2024, View Source [SID1234643776]).

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!

Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, will present interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). The data show prexigebersen continues to be well-tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy.

"We are honored that our abstract was selected by the ASCO (Free ASCO Whitepaper) Scientific Program Committee and Leadership for a prestigious oral presentation as part of a Rapid Oral Abstract Session. ASCO (Free ASCO Whitepaper) is the ideal setting to present these encouraging data, as it is the world’s largest clinical cancer research meeting with more than 30,000 oncology professionals in attendance," said Peter Nielsen, Chief Executive Officer of Bio-Path. "It is important to showcase these important data and expand awareness of prexigebersen within the field as it may encourage greater participation in this and our other prexigebersen studies."

Details for the oral presentation are as follows:

Title: Interim Safety and Efficacy of BP1001 in a Phase II Acute Myeloid Leukemia
Study Date and Time: Saturday, June 1, 2024 at 8:00 AM CT
Location: McCormick Place
Abstract Number: 6511

On May 23, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA)’s Medical Devices Advisory Committee has strongly recommended FDA approval of the company’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease (Press release, Guardant Health, MAY 23, 2024, View Source [SID1234643674]).

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!

The recommendation signals the advisory committee panel’s consensus on Shield’s safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks. The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions. The FDA is expected to decide whether to approve Shield later this year.

"The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk," said AmirAli Talasaz, co-CEO of Guardant Health. "Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths."

The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication. They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S.2 yet has a 91% five-year survival rate when caught at stage I (localized).3 Despite this, one out of three eligible Americans – 50 million people – are not being screened for CRC.4 Current primary non-invasive screening options include stool-based tests which have proven efficacy in detecting CRC; however, studies have consistently found that barriers such as handling stool and challenges performing the test impact adherence.5,6,7,8 Shield offers patients a choice that can be completed with a simple blood draw during a routine office visit.

"Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,"9 said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. "Clinical evidence and CRC screening guidelines acknowledge the value of offering choice to individuals at average risk for CRC and highlight the role of patient preference in test selection and CRC screening completion."

The panel’s recommendation is based on Guardant’s premarket approval (PMA) application for Shield, including the results of the pivotal ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study, published in the March 2024 issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of existing stool-based tests used as primary CRC screening options, in which overall sensitivity ranges from 67% to 92%.10

For more information about Shield for CRC screening, visit BloodBasedScreening.com.

About the Shield test

The Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. Shield is intended for colorectal cancer screening in individuals at average risk of the disease, age 45 years or older. Patients with an "Abnormal Signal Detected" may have colorectal cancer or advanced adenomas and should be referred for colonoscopy evaluation. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. The test is performed at Guardant Health, Inc.

On May 23, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that the company, along with its collaborators, will present new data at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4, 2024 (Press release, Natera, MAY 23, 2024, View Source [SID1234643668]).

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!

The presentations feature data across a variety of indications, including breast cancer, colorectal cancer (CRC), lung cancer, melanoma, esophageal cancer, and urothelial cancer, with one oral presentation and 12 poster presentations on Signatera, Natera’s personalized and tumor-informed molecular residual disease test, as well as one poster with data on Empower, Natera’s test for hereditary cancer.

Minetta Liu, MD, chief medical officer of oncology at Natera, said, "We look forward to sharing new data across cancer types, reflecting Natera’s deep clinical pipeline in MRD with results from randomized trials as well as real-world studies. This includes promising new findings from the CIRCULATE-Japan GALAXY study demonstrating the prognostic and predictive utility of Signatera and actionable biomarkers in colorectal cancer."

GALAXY is part of the CIRCULATE-Japan trial platform, which also includes ALTAIR, a first-of-its-kind, "treat on molecular recurrence" study evaluating the utility of Signatera in CRC. Natera expects to announce topline results for this phase III randomized trial in August 2024.

Below is the full list of presentations featuring Signatera and Empower at ASCO (Free ASCO Whitepaper):

Poster Presentation | Abstract # 3609 | Presenter: Yoshiaki Nakamura, MD, PhD | CRC
Prognostic and predictive value of ctDNA-based MRD and actionable biomarkers in patients with resectable CRC: CIRCULATE-Japan GALAXY
Oral Presentation | Abstract # LBA507 | Presenter: Sherene Loi, MD, PhD | Breast Cancer
Prognostic utility of ctDNA dynamics in the monarchE trial of adjuvant abemaciclib plus endocrine therapy (ET) in HR+, HER2-, node-positive, high-risk early breast cancer (EBC)
Poster Presentation | Abstract # 3586 | Presenter: Eric Lander, MD | CRC
Genomic alterations in early-onset versus average-onset stage IV CRC
Poster Presentation | Abstract # 5034 | Presenter: Rebecca Hassoun, MD | Testicular Cancer
Longitudinal Evaluation of ctDNA as a Prognostic Biomarker to Detect Minimal Residual Disease (MRD) in Testicular Cancer
Poster Presentation | Abstract # 4587 | Presenter: Adanma Ayanambakkam, MD | Urothelial Cancer
Longitudinal analysis of ctDNA in localised and metastatic urothelial cancer
Poster Presentation | Abstract # 4028 | Presenter: Aziz Zaanan, MD | Esophageal Cancer
Longitudinal ctDNA analysis during treatment (Tx) of locally advanced resectable (LAR) gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ADENOCA): the PLAGAST prospective biomarker study
Poster Presentation | Abstract # 9564 | Presenter: Michael LaPelusa, MD | Melanoma
Association between ctDNA and Recurrence-Free Survival (RFS) in Patients (pts) with Resected Stage III Melanoma – an Exploratory Analysis of SWOG S1404
Poster Presentation | Abstract # 6056 | Presenter: Glenn Hanna, MD | Head and Neck Squamous Cell Carcinoma
Personalized ctDNA for monitoring disease status in HPV-negative head and neck squamous cell carcinoma
Poster Presentation | Abstract # TPS8659 | Presenter: Yasushi Goto, MD, PhD | Lung Cancer
Randomized phase III study comparing suspension or continuation of PD- 1 Pathway Blockade for patients with advanced non-small-cell lung cancer (SAVE study: JCOG1701)
Poster Presentation | Abstract # 569 | Presenter: Mridula George, MD | Breast Cancer
Predicting response to neoadjuvant therapy (NAT) in patients (pts) with early-stage breast cancer (BC) using ctDNA testing
Poster Presentation | Abstract # 549 | Presenter: Marla Lipsyc-Sharf, MD | Breast Cancer
Impact of ctDNA surveillance on clinical care for patients with stage I-III breast cancer: Findings from a multi-institutional study.
Poster Presentation | Abstract # 518 | Presenter: Yoichi Naito, MD | Breast Cancer
ctDNA monitoring for breast cancer at high risk of recurrence: Interim analysis of JCOG1204A1
Poster Presentation | Abstract # 10596 | Presenter: Sarah Lee, MD | Pan-Cancer (Empower)
A targeted panel of actionable high risk hereditary cancer predisposition genes can identify patients with pathogenic/likely pathogenic variants (PVs) irrespective of meeting established NCCN testing criteria
About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers.

On May 23, 2024 Indapta Therapeutics, Inc., a privately held biotechnology company developing differentiated cell therapies for the treatment of cancer and autoimmune diseases, reported that CEO Mark Frohlich, MD, will be giving a plenary talk today titled, "g-NK cells for the treatment of cancer and autoimmune disease" at the New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (Press release, Indapta Therapeutics, MAY 23, 2024, View Source [SID1234643667]).

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!

In his talk, Dr. Frohlich will summarize the differentiated mechanisms of target cell killing for Indapta’s lead clinical program, IDP-023, a g-NK cell therapy product. These mechanisms include highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells. Indapta is currently applying g-NK cells to hematologic cancers in an ongoing Phase 1 trial enrolling patients with non-Hodgkin’s lymphoma, multiple myeloma and acute myelogenous leukemia.

Dr. Frohlich will also describe Indapta’s expanded focus on autoimmune disease, including its plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration for a clinical trial of IDP-023 in multiple sclerosis.

"Based on published evidence that endogenous g-NK cells are not only protective against the development of multiple sclerosis, but also slow the progression of the disease, we plan on filing an IND in mid-2024 to initiate a clinical trial of g-NK cells for this indication," said Dr. Frohlich. "In addition to being able to achieve B cell depletion by combining with a B cell directed monoclonal antibody, g-NK cells have additional mechanisms not shared by conventional NK cells or CAR-T cells, namely their ability to kill HLA-E expressing autoreactive T and B cells as well as address the Epstein Barr Virus reservoir that may contribute to the disease pathogenesis."

Indapta’s Differentiated g-NK Cell Therapy

Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as "g minus" NK cells, or "g-NK" cells. G‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability.

Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, View Source)

On May 23, 2024 Abdera Therapeutics Inc., a biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable, precision radiopharmaceuticals for cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for ABD-147, the first delta-like ligand 3 (DLL3) targeting radiopharmaceutical for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) (Press release, Abdera Therapeutics, MAY 23, 2024, View Source [SID1234643666]). Abdera plans to initiate a Phase 1 clinical trial in the second half of 2024.

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!

ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing DLL3. DLL3 is a protein found on the surface of neuroendocrine tumors, but rarely expressed on the surface of normal cells or tissues.

"ABD-147 represents a potential best-in-class treatment for SCLC and other aggressive neuroendocrine tumors," said Philippe Bishop, M.D., chief medical officer. "Leveraging our ROVEr platform, we custom-engineered ABD-147 with optimized pharmacokinetic properties and tumor penetration to destroy tumor cells while limiting radiation toxicity to the body. We are hopeful this highly potent next generation radiotherapeutic will provide a potential breakthrough addressing a critical medical need for the treatment of SCLC and other high-grade neuroendocrine cancers. We look forward to initiating a Phase 1 clinical trial of ABD-147 later this year."

The Phase 1, first-in-human, open-label clinical study aims to evaluate the safety and preliminary efficacy of 225Ac-ABD-147 in patients with SCLC or LCNEC who previously received platinum-based therapy. The study will determine the recommended dose regimen for future development.

"FDA clearance of our first IND marks a major milestone for Abdera as we transition into a clinical-stage radiopharmaceutical company," said Lori Lyons-Williams, president and chief executive officer. "We believe our ROVEr platform uniquely enables a new wave of innovation in targeted radiotherapeutics, with ABD-147 representing the first in a robust pipeline of custom-engineered programs we are advancing to the clinic."

About Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

The global incidence for SCLC and LCNEC has been reported to represent approximately 325,000 patients and is expected to increase 4% annually through 2029. In the U.S., the incidence has been reported to be approximately 35,000 new cases annually. Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers. These cancers have the most aggressive clinical course of any type of pulmonary tumor and often metastasize to other parts of the body, including the brain, liver and bone. Without treatment, the median survival from diagnosis has been reported to be only two to four months. With treatment, the overall survival at five years is 5% to 10% for SCLC, and 15% to 25% for LCNEC. SCLC and LCNEC generally carry a poor prognosis and new treatment options are urgently needed.

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

About the ROVEr Platform

Abdera’s Radio Optimized Vector Engineering (ROVEr) platform enables the company to custom-engineer targeted radiopharmaceuticals with tunable pharmacokinetic (PK) properties to achieve high tumor uptake while minimizing renal exposure and mitigating other systemic radiotoxicities such as myelosuppression. Abdera can optimize the delivery and therapeutic index of potent radioisotopes capable of emitting powerful alpha or beta particles to selectively destroy tumor cells while sparing healthy cells, providing patients with potentially transformative new cancer treatments.

Abdera’s approach offers the ability to design radiotherapeutics against virtually any cancer target expressed on the cell surface. Coupled with a highly potent mechanism of cell killing, the ROVEr platform is uniquely poised to exploit both high- and low-expressing targets to selectively deliver therapeutic levels of radioisotope to cancer cells.