On July 12, 2021 Vaccibody AS (Euronext Growth (Oslo): VACC), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that it has entered into an exclusive license agreement with Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, to use a broad selection of virus-specific T cell epitopes identified by Adaptive for Vaccibody to design and develop novel SARS-CoV-2 vaccines (Press release, Vaccibody, JUL 12, 2021, View Source [SID1234584775]).

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!

Vaccibody’s development strategy for its second-generation SARS-CoV-2 vaccine is designed to respond to the emerging threats of evolving variants with reduced sensitivity to first generation vaccines that were developed using the 2020 prototype spike protein. The 2-armed strategy aims to develop two candidates for the broad population. First, a vaccine candidate encoding the receptor binding domain (RBD) derived from the South African beta variant of concern. And second, a T cell based vaccine candidate, encoding multiple validated immunodominant, conserved Adaptive-identified T-cell epitopes spanning multiple antigens across the SARS-CoV-2 genome. 2

"To date, SARS-CoV-2 has resulted in the death of over 4 million people globally and we are facing a tremendous threat from emerging variants of concern. We are very excited to have access to Adaptive’s T cell epitopes for our use in developing second-generation SARS-CoV-2 vaccines to specifically address current and future variants of concern. Vaccibody has exclusively licensed validated SARS-CoV-2 T-cell epitopes for use in the design and development of our T-cell vaccine candidates, including the candidate in our previously announced clinical trial" said Agnete B. Fredriksen, Chief Innovation and Strategy Officer of Vaccibody.

Adaptive has mapped the T cell immune response using more than 6,500 samples from patients impacted by COVID-19. Adaptive used its immune medicine platform, leveraging its proprietary antigen mapping and deep sequencing capabilities, to identify naturally processed and presented T-cell epitopes to SARS-CoV-2 antigens. Adaptive’s T-cell epitopes will be used by Vaccibody in its modular vaccine technology platform to target specific SARS-CoV-2 antigens to antigen presenting cells.

Michael Engsig, Chief Executive Officer of Vaccibody continued, "Our aim is to design and develop novel second-generation COVID-19 vaccines using Vaccibody’s unique modular vaccine technology platform and Adaptive’s functionally validated, immunodominant T-cell epitopes."

"The SARS-COV-2 virus’ ability to rapidly mutate can impact the efficacy of many firstgeneration vaccines. Adaptive’s unique ability to read and access the immune system enables us to identify and validate SARS-COV-2 T-cell epitopes from convalescent COVID-19 individuals. We are excited to combine the strength of validated T-cell epitopes, identified using our immune medicine platform, with Vaccibody’s innovative vaccine technology in fighting the pandemic," added Harlan Robins, Chief Scientific Officer and co-founder of Adaptive Biotechnologies.

Mikkel W. Pedersen, Ph.D., Chief Scientific Officer of Vaccibody continued, "We are thrilled to work with Adaptive Biotechnologies to accurately identify immunogenic and conserved T-cell epitopes. Adaptive’s epitopes have enabled us to create a multivalent SARS-CoV-2 T-cell vaccine that may provide more complete viral protection, long-term immunity and viral clearance compared to first generation vaccines. Our T-cell candidate may have both prophylactic and therapeutic potential and may also fit the profile of a universal SARS-CoV-2 vaccine booster for individuals previously vaccinated with Spike based vaccines."

Vaccibody has demonstrated that the SARS-CoV-2 vaccine candidate that incorporates Adaptive’s T-cell epitopes induces a rapid, strong and broad T-cell response after administration of a single dose in a humanized preclinical model.

Under the terms of the license agreement, Adaptive has provided certain selected T-cell epitopesfor exclusive use in Vaccibody’s next-generation SARS-CoV-2 vaccines. Vaccibody will 3 be responsible for further development of the potential T-cell SARS-CoV-2 vaccine candidates. Financial terms of this agreement will not be disclosed.

The phase 1/2 trial is currently in the planning phase. The CTA (Clinical Trial Application) is expected to be submitted in Q3 2021 and initiation is planned for Q4 2021. The clinical trial will be conducted in Norway. Please also referto Vaccibody’s announcement on June 29, 2021 about the clinical trial.

Webcast
Michael Engsig, Chief Executive Officer of Vaccibody, and other members of Vaccibody’s management team will host a webcast on July 12, 2021 at 4 p.m. CET / 10 a.m. EDT. Harlan Robins, Chief Scientific Officer of Adaptive Biotechnologies, will also join them to discuss how Adaptive identified the T cell epitopes that Vaccibody will use in its second generation COVID19 vaccine using its proprietary immune medicine platform. A presentation will be available on Vaccibody’s website, www.vaccibody.com/financial-reports-and-presentations, before the webcast.

On July 12, 2021 Servier, a global independent pharmaceutical Group, and Nymirum, a pioneer in RNA-targeted small molecules, reported that they have entered into a strategic collaboration to identify and develop RNA-modulatory drugs for the treatment of neurological diseases (Press release, Servier, JUL 12, 2021, View Source [SID1234584792]).

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!

Under the collaboration agreement, Nymirum will leverage its proprietary DART Platform (Dynamic Atomic-Resolution RNA Targeting Platform) to discover novel small molecule therapeutics for multiple neurological targets. Servier is responsible for joint preclinical development and has the right to pursue further development on the current targets as well as expand the scope of the collaboration. The collaboration provides Nymirum with an initial payment, followed by future success payments.

"We are excited to pair Nymirum’s expertise in targeting RNA with Servier’s experience in CNS (Central Nervous System) to advance transformative therapies. The ability to resolve and leverage RNA’s dynamic structure opens a new chapter for drug discovery, enabling novel programs across all therapeutic areas," said Joshua Fairbank, Chief Executive Officer and Co-Founder of Nymirum. "Thanks to its expertise in CNS and small molecule therapeutics, Servier is a valuable partner in this collaboration, and together we look forward to accelerating the search for treatments for patients with severe neurological disorders."

"This new collaboration is the opportunity to progress innovative RNA-targeted approaches towards clinical assessment in patients with very limited or absent treatment options," stated Ross Jeggo, Global Head of Neuroscience and Immuno-inflammation Therapeutic Area at Servier. "We are delighted to work in partnership with Nymirum on multiple drug discovery projects, harnessing their platform to deliver RNA-targeting small molecules for neurodegenerative diseases. The therapeutic advantage associated to a small molecule versus other DNA- or RNA-based approaches is truly innovative and very promising for potential treatments for patients suffering from disorders of the central nervous system."

On July 12, 2021 Albany Molecular Research, Inc. (AMRI), a leading global contract research, development and manufacturing organization serving the pharmaceutical and biopharmaceutical industries, reported that it is changing its name to Curia, effective July 12, 2021 (Press release, Curia, JUL 12, 2021, View Source [SID1234644965]). The new name reinforces the company’s strategic positioning as an end-to-end global CDMO, applying its scientific expertise and extensive capabilities from research and development (R&D) through to commercial manufacturing to enable its pharmaceutical and biotechnology customers to advance important new products that improve lives. Along with the name change, the company is introducing a new brand identity including a new website: CuriaGlobal.com.

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 name Curia is derived from a Latin word for purposeful assembly and references Curia’s patient-inspired mission. The company recently celebrated three decades of growth since its founding in Albany, New York. Today, Curia offers a global suite of R&D and commercial manufacturing capabilities, with industry-leading expertise to help its customers accelerate the journey from idea to impact. Curia employs more than 3,000 people in 21 locations around the world, including more than 600 chemists, 70 biologists, 225 senior scientists and approximately 400 quality and regulatory specialists. The company’s ongoing commitment to science that scales is demonstrated by its 564 active patents and its production of more than 20 treatments included on the list of essential medicines from the World Health Organization.

"Our new name reflects the assembled deep expertise of our people, the breadth of our products, services and solutions, and our relentless determination to help customers advance from curiosity to cure," said Curia Chairman and CEO John Ratliff. "Our new brand honors our foundation in research and innovation while creating a platform for our ambitions of life-changing science so we can make ever-growing contributions to improving patients’ lives. Over the past three decades we have broadened and deepened our capabilities to become a leading provider of CDMO solutions. Today marks the beginning of the next chapter in our history."

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.

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!

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.

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 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.