On July 12, 2021 ENTEROME SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, reported that the first patient was dosed in a Phase 1/2 clinical trial (‘SIDNEY’) with EO2463, its second OncoMimicsTM vaccine for the treatment of indolent non-Hodgkin lymphomas (iNHL) (Press release, Enterome, JUL 12, 2021, View Source;utm_medium=rss&utm_campaign=enterome-announces-first-patient-dosed-in-a-phase-1-2-trial-with-second-oncomimicstm-vaccine-eo2463-in-non-hodgkin-lymphoma [SID1234584776]). Initial clinical data from the trial are expected in 2022.

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EO2463 is an innovative, off-the-shelf microbiome-peptide based cancer vaccine that combines four microbiome-peptides of B lymphocyte-specific lineage markers. EO2463 is designed to trigger the immune system into recognizing B cells as bacterial (i.e. non-self) and eliciting a targeted cell-killing response. The clinical rationale behind targeting these specific lineage cell markers is to induce the full depletion of malignant B lymphocytes that cause NHL.

The SIDNEY trial (EONHL1-20; NCT04669171) is a multicenter, open-label, Phase 1/2 study assessing the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination with standard-of-care lenalidomide and/or rituximab in patients with follicular and marginal zone lymphoma. A total of 60 patients are expected to be enrolled in Europe and the US.

This is the third clinical trial investigating OncoMimicsTM cancer vaccine candidates in solid and liquid malignancies to be launched by Enterome in the last 12 months.

Professor Pier Luigi Zinzani, MD, PhD, from the University of Bologna (Italy), is SIDNEY’s Global Coordinating Investigator. Prof. Zinzani is a renowned hematologist with extensive clinical research and drug development experience in the field of NHL, Hodgkin’s disease and chronic lymphocytic leukemia.

Prof. Zinzani, said: "Targeting B-cell specific antigens with a therapeutic non-self, off-the-shelf, vaccine is a very interesting approach to treating NHL. We are excited to begin clinical studies to investigate whether EO2463 can impact not only relapsed disease in combination with established standard-of-care options, but also very early stages of iNHL when used as monotherapy. We look forward to seeing the immunological and clinical impact of the vaccine and providing updates on the progress of this study."

Dr. Jan Fagerberg, Chief Medical Officer of Enterome, said: "EO2463 is Enterome’s second microbiome-peptide based cancer vaccine generated from our unique drug discovery platform. This clinical trial is another significant step in our strategy to deliver proof of concept data for our OncoMimicsTM vaccines, which we believe can target both solid and liquid malignancies. We are delighted to initiate this trial and believe that the data we expect to generate from clinical trials with EO2401 and EO2463 will position Enterome as a clear leader of next-generation cancer vaccines."

On July 12, 2021 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported the enrollment of its first patients in the CRC-PREVENT pivotal trial. The clinical study seeks to evaluate the safety and efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals, a group with no known co-morbidities associated with cancer risk and therefore more challenging to diagnose (Press release, Geneoscopy, JUL 12, 2021, View Source [SID1234584793]). The company’s innovative diagnostic was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in January of 2020.

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"We are pleased to initiate this important study and validate the use of Geneoscopy’s RNA-FIT assay as a valuable noninvasive tool to help prevent cancer through routine colorectal cancer screening," commented Dr. Erica Barnell, Geneoscopy’s co-founder and Chief Scientific Officer. "The ultimate goal of colorectal screening is cancer prevention, but this requires diagnostic screening options with the sensitivity to identify clinically relevant pre-cancerous lesions, including advanced adenomas. The RNA-FIT assay aims to deliver the necessary sensitivity and specificity in a simple, at-home collection kit."

The prospective, single-arm study will enroll more than 12,000 patients across all 48 contiguous United States. Patients will submit samples via the mail and subsequently undergo optical colonoscopy examination. All significant lesions discovered during colonoscopy will be biopsied or removed and sent for histopathology. A comparative analysis will be conducted to determine sensitivities and specificities, as applicable, for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies without findings.

"When it comes to detecting advanced adenomas, noninvasive tests are not currently hitting a 50% threshold. Until now, only colonoscopy can detect advanced adenomas reliably," commented Dr. David Lieberman, Professor of Medicine, Division of Gastroenterology and Hepatology at the Oregon Health Sciences University School of Medicine. "A noninvasive, at-home option that successfully detects these pre-cancerous lesions would represent an important, positive step in early detection for colorectal cancer prevention."

Geneoscopy’s initial clinical study demonstrated high sensitivity of its multifactor RNA-FIT assay compared with colonoscopy findings, demonstrating 95% sensitivity for colorectal cancer, 62% sensitivity for advanced adenomas, and 25% sensitivity for other non-advanced adenomas with an 85% specificity for no findings on a colonoscopy. The promising data was previously presented by Dr. Barnell, at the Association for Molecular Pathology (AMP) 2020 Annual Meeting and the peer-reviewed article recently published in Clinical and Translational Gastroenterology.

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer related death in the United States.1 Disease progression begins with polyps that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, most newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the US, yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, resulting in low patient compliance. Currently available noninvasive screening methods lack sufficient levels of sensitivity to effectively and reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70% of CRC cases.

To learn more about the CRC-PREVENT clinical trial and join in the fight to help prevent colorectal cancer, visit View Source

1Colorectal Cancer Fact Sheet, American Cancer Society, 2021.

On July 12, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor (Press release, Halozyme, JUL 12, 2021, View Source [SID1234584777]). The approval marks Janssen’s sixth indication for DARZALEX FASPRO in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were recently published in The Lancet Oncology.

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"We are delighted that Janssen received this FDA approval for DARZALEX FASPRO, making it the first and only FDA-approved subcutaneous anti-CD38 monoclonal antibody therapy available in this combination," said Helen Torley, president and chief executive officer at Halozyme. "This introduces a new delivery option for multiple myeloma patients in the U.S. being treated with this regimen."

DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

This FDA approval for DARZALEX FASPRO in combination with Pd for patients with multiple myeloma after first or subsequent relapse is supported by data from the Phase 3 APOLLO study, which met its primary endpoint of improved progression-free survival (PFS). For more information related the Phase 3 APOLLO study findings, please view Janssen’s press release.

On July 12, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to produce major improvements in treatment outcomes, and The University of Texas MD Anderson Cancer Center reported the launch of a multi-year strategic research collaboration to investigate and evaluate HMBD-002, Hummingbird’s VISTA antagonist antibody (Press release, Hummingbird Bioscience, JUL 12, 2021, View Source [SID1234584795]).

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Under the agreement, MD Anderson and Hummingbird will collaborate on the design and execution of clinical and translational research studies to better understand how HMBD-002 modulates the anti-tumor immune response, both as a monotherapy and in combination with other checkpoint inhibitors. Working with MD Anderson’s immunotherapy platform and its experts in comprehensive immunoprofiling, the teams will seek to identify biomarkers that may be used to predict clinical outcomes and adverse events.

"We are excited to be collaborating with MD Anderson to advance the clinical research of our novel immunotherapies," said Jerome Boyd-Kirkup, Ph.D., co-founder and CSO of Hummingbird Bioscience. "These studies will strengthen our understanding of VISTA and other emerging immuno-oncology targets and help us ensure that novel treatment strategies for challenging cancers get to patients as quickly as possible."

VISTA, an immune checkpoint protein, is an emerging immunotherapy target for cancer that suppresses the anti-tumor immune response. Studies indicate increased levels of VISTA are associated with the emergence of resistance to current cancer immunotherapies. HMBD-002 is designed to inhibit VISTA, removing the suppression of the immune system and allowing it to mount an anti-tumor response.

"Targeting VISTA is an exciting area of immunotherapy research with the potential to have an impact on a variety of cancer types," said Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology at MD Anderson. "This collaboration aligns our expertise in studying the anti-tumor immune response with Hummingbird’s novel therapeutic pipeline. We look forward to working with Hummingbird to advance immunotherapies that we hope will improve care for our patients."

Sharma and James Allison, Ph.D., regental chair of Immunology, are co-leaders of MD Anderson’s immunotherapy platform and will oversee the collaboration. Jordi Rodon, M.D., Ph.D., associate professor of Investigational Cancer Therapeutics and Genomic Medicine, will lead the clinical study of HMBD-002 at MD Anderson.

Disclosures

Drs. Sharma and Allison receive compensation as consultants to Hummingbird, and Dr. Sharma holds equity in the company. These financial relationships have been disclosed to MD Anderson in accordance with its COI Policy.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that was predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical models have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs progression-free survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor.

Hummingbird’s first-in-class anti-VISTA therapeutic antibody advanced to clinical trials with a US$13.1 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

On July 12, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the appointment of Octávio Costa, MD, as Chief Medical Officer (Press release, Monopar Therapeutics, JUL 12, 2021, View Source [SID1234584778]). In this role, Dr. Costa will oversee global clinical development and regulatory affairs, and will provide strategic direction for Monopar’s pipeline.

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Dr. Costa joins Monopar with over 30 years of experience overseeing clinical development, clinical operations, development strategy and global medical affairs. He has extensive Phase 1 through 4 clinical development expertise as well as regulatory experience. Dr. Costa’s previous roles include positions of increasing responsibility in clinical development at Merck, Celgene, Novartis and most recently as Chief Medical Officer at Rafael Pharmaceuticals. He has played an important role in the development and life-cycle management of significant products, including the blockbuster product REVLIMID (lenalidomide). Dr. Costa earned his Doctor of Medicine from The Medical College of Sorocaba, São Paulo.

"We are excited to welcome Octávio, especially as our lead program enters late-stage clinical studies," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "Octávio’s track record of navigating all stages of clinical development will aid Monopar in executing our growing clinical development pipeline."

"I am thrilled to be joining this accomplished management team, as Monopar’s Chief Medical Officer," said Dr. Costa. "My industry knowledge and expertise in moving cancer therapies through all stages of clinical testing is well suited to help accelerate Monopar’s pipeline of innovative mid- and late-stage clinical programs and early drug development candidates."