On July 28, 2022 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported that the company will release its financial results for the second quarter ended June 30, 2022, including a corporate update, on Thursday, August 4, 2022, before the opening of the U.S. financial markets (Press release, Immunic, JUL 28, 2022, View Source [SID1234617110]). A webcast will follow at 8:00 am ET.

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To participate in the webcast, please register in advance at: View Source or on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations.

On July 28, 2022 Nilogen Oncosystems reported that its clinical observational study TUMORIN (NCT05332925) has commenced enrolment (Press release, Nilogen Oncosystems, JUL 28, 2022, View Source [SID1234617109]). Patients with advanced/metastatic NSCLC who are receiving immune checkpoint inhibitors in the standard of care clinical setting will be enrolled in the study . Nilogen will evaluate 3D-EXplore results with patient outcome data using advanced AI and machine learning algorithms to discover novel biomarker signatures as predictors of patient response and understand the fundamental mechanisms of action for each therapeutic to advance personalised treatment for patients based on the functional response of their cancer.

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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

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3D-EXplore is a fresh human tumor ex vivo explant platform which retains the immune compartment and full tumor microenvironment capturing the heterogeneity of the tumor while preserving its immune compartment, which are key to understanding the true response of tumor tissue to oncology therapeutics, allowing drug developers and clinicians to understand drug performance in human tissue, providing an informed approach to clinical development and patient response. This uniquely positions the platform to provide drug developers with answers to mechanistic questions about their immuno-oncology drug candidates and prioritize the most promising candidates for advancement into clinical trials, as well as enabling the discovery of complex biomarker signatures and supporting patient selection and co-clinical studies. For clinicians, the opportunity to select the most beneficial treatment regimen for patients based on functional response rather than surrogate markers will enable truly personalized cancer immunotherapy.

Nilogen Oncosystems Announces Clinical Trial Using Ex Vivo Tumoroids to Predict Immunotherapy Response in NSCLC

"Nilogen’s unique 3D-EXplore explant platform is already in use worldwide by Pharma and Biotech companies large and small to support translational and clinical studies, especially in immuno-oncology and with modalities like Bispecific antibodies, Cell Therapies, ADCs, ADCC, and Oncolytic Virus," said Soner Altiok, Chief Scientific Officer at Nilogen Oncsystems. "We are pleased to begin our observational clinical study to demonstrate the power of 3D-EXplore to predict patient response based on functional response data, with the aim to ultimately provide clinicians and patients with the ability to select the best therapy based on the real response of their cancer to therapies rather than surrogate markers."

3D-EXplore’s unique ability is to resolve tumor tissue heterogeneity and quantitatively and directly measure penetration, proliferation, tumor cell killing and phenotypic changes in the immune compartment and tumor microenvironment in fresh tumor tissue using advanced flow cytometry and high-content confocal microscopy. These complex datasets can be deconvoluted to deliver biomarker signatures and powerful treatment response predictions which can be correlated to clinical outcomes for a more effective and efficient cancer drug development approach. Our CLIA certified facilities enable us to work with patient samples to directly support clinical trials and patient treatment.

On July 28, 2022 CytoImmune Therapeutics, a clinical-stage immuno-oncology company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, and City of Hope, one of the largest cancer research and treatment organizations in the United States reported that the first patient has been dosed in a Phase 1 clinical trial evaluating CYTO-102, a novel cellular therapy consisting of PD-L1-positive tumor-reactive TRACK-NKTM cells (Press release, CytoImmune Therapeutics, JUL 28, 2022, View Source [SID1234617108]). The trial is assessing CYTO-102 as a monotherapy and in combination with atezolizumab in patients with relapsed/refractory non-small cell lung cancer (NSCLC).

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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

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This innovative therapy is generated by genetically modifying NK cells to secrete high levels of soluble IL-15, an immune-signaling molecule crucial for optimal antitumor responses with the patient’s own immune system. The engineered NK cells are primed with cytokines IL-12 and IL-18 along with other signals during manufacturing to induce PD-L1 expression. The PD-L1-positive TRACK-NKTM cells are naturally directed to the tumor microenvironment where they are designed to kill the cancer cells as well as to coordinate the adaptive or T cell response by the patient’s own immune system.

"We are thrilled to initiate patient dosing with CYTO-102, in partnership with City of Hope, which marks our transition into a clinical-stage company and brings us an important step closer to understanding the potential our tumor-reactive NK cell-based therapies may have for treating patients with cancer," said Christina Coughlin, M.D., Ph.D., chief executive officer of CytoImmune. "We’ve engineered CYTO-102 to be an off-the-shelf cell therapy that can directly kill cancer cells, broadly stimulate the body’s own endogenous immune system, and enhance tumor killing through generation of a highly effective immune response ultimately leading to improved patient outcomes. We look forward to advancing this trial in an effort to bring the next generation of cellular therapies to patients in need."

"City of Hope is committed to making a difference in the lives of patients with cancer with a goal of transforming the future of cancer care," said Michael Caligiuri, M.D., president of City of Hope National Medical Center, Deana and Steve Campbell Physician-in-Chief Distinguished Chair and CytoImmune’s scientific founder. "NSCLC continues to be a challenging cancer to treat and despite advancements, too many patients are left without durable and effective options. We are pleased to advance this novel cellular therapy together with CytoImmune, which could offer patients with NSCLC a promising new treatment option."

The Phase 1, dose escalation clinical trial will evaluate the safety and tolerability, as well as key biologic endpoints of CYTO-102, including NK cell persistence and trafficking, tumor microenvironment changes and endogenous T and NK cell recruitment by CYTO-102, as both a monotherapy and in combination with atezolizumab, a PD-L1 inhibitor. The trial will enroll approximately 21 patients with relapsed or difficult-to-treat NSCLC. Details regarding the study can be found here.

On July 28, 2022 Novartis and the University of California, Berkeley reported that they have extended their research-based collaboration to develop new technologies for the discovery of next-generation therapeutics, following its successes over the last five years (Press release, Novartis, JUL 28, 2022, View Source [SID1234617107]). The combined research team is pursuing a vast number of disease targets in cancer and other illnesses that have eluded traditional small-molecule compounds and drug discovery strategies.

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"One of the biggest challenges facing drug discovery is that the majority of proteins are currently still considered ‘undruggable,’" said covalent chemoproteomics expert Daniel Nomura, Director of the Institute and Professor of Chemistry, Molecular and Cell Biology in the Molecular Therapeutics Division, and Nutritional Sciences and Toxicology at UC Berkeley. "Most proteins do not possess well-defined binding pockets or ‘ligandable hotspots’ that can be pharmacologically and functionally targeted for therapeutic benefit. Tackling these undruggable proteins requires the development of innovative technologies for ligand discovery and the discovery of novel therapeutic modalities to functionally manipulate these intractable proteins for therapeutic benefit."

This research collaboration allows UC Berkeley scientists to work with their scientific peers at Novartis Institutes for BioMedical Research (NIBR) to find new cures for debilitating illnesses. The second phase of the research collaboration is the Novartis-Berkeley Translational Chemical Biology Institute, and is based at UC Berkeley. The Berkeley team includes Professors Nomura, F. Dean Toste, Thomas Maimone, Ziyang Zhang, and James Olzmann. The science and strategy underpinning the research collaboration aim to harness covalency, coupled with chemoproteomics technology, to enable the discovery of small-molecule compounds that could ultimately form the basis of proximity-based therapeutics.

"I am thrilled to be able to help build off the momentum gained during the past five years and equally excited to synergize with new colleagues," said Maimone, Associate Professor of Chemistry at UC Berkeley. "With expanded scientific expertise, increasingly sophisticated chemistries, and new envisioned therapeutic modalities, the next several years will be exhilarating."

The inaugural research collaboration, the Novartis-Berkeley Center for Chemistry and Proteomics Technologies, led to multiple groundbreaking discoveries, including the development of several novel recruiters of E3 ubiquitin ligases that can be exploited in the degradation of disease causing proteins; the development of new chemistry that can be used to enhance the scope of covalent chemoproteomic technologies; and the creation of a new therapeutic platform called Deubiquitinase Targeting Chimeras (DUBTACs) for stabilizing the levels of proteins that are aberrantly degraded. This work has led to several publications and patents and facilitated the training of emerging scientists. The DUBTAC platform is also the basis of a spinout company, Vicinitas Therapeutics, focused on developing DUBTACs into a unique, potential, proximity-based therapeutic modality for cancer, genetic disorders, and other indications.

"We joined forces with Berkeley five years ago because we knew that many compelling targets in disease biology remain beyond reach – and that no one team or discipline could tackle the toughest among them alone," said Jay Bradner, President of NIBR. "Today, we recommit to working shoulder-to-shoulder to make these so-called ‘undruggable’ targets druggable."

Moving forward, the alliance will continue to develop new chemistries and chemical technologies for targeting undruggable proteins, expand upon emerging therapeutic modalities such as targeted protein degradation (TPD) that exploit the cell’s natural protein disposal system to destroy disease-causing proteins, and develop new therapeutic modalities that enable access into larger swaths of the undruggable protein landscape.

On July 28 Vicinitas Therapeutics, a biotechnology company advancing a proprietary targeted protein stabilization platform to develop novel therapeutics in cancer and genetic disorders, reported that launched with $65 million in Series A financing (Press release, Vicinitas Therapeutics, JUL 28, 2022, View Source [SID1234617106]). The financing was co-led by a16z and Deerfield Management, with participation from Droia Ventures, GV, The Mark Foundation for Cancer Research and the Berkeley Catalyst Fund. Vicinitas Therapeutics is a spin-out company that resulted from the Deubiquitinase Targeting Chimera (DUBTAC) platform, which was developed through an academic-industry research collaboration between the Novartis Institutes for BioMedical Research and researchers at the University of California, Berkeley.

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Many diseases, including cancer and monogenic diseases, are often caused by specific proteins that are abnormally degraded and lost from the cell. In cancer, protective tumor suppressors are aberrantly destroyed, allowing cancer cells to circumvent cell death, thus promoting unobstructed cell proliferation. In monogenic disorders, mutations in certain genes cause the resulting protein to become unstable and degraded, which leads to abnormally low levels of the particular protein and the disease pathology. To date, many aberrantly degraded proteins have been considered "undruggable" or intractable to drug discovery efforts, and patients with these diseases would greatly benefit from a therapeutic that stabilizes and restores the levels of these proteins, allowing normal function to be restored.

The DUBTAC platform was developed to therapeutically target these degraded proteins by removing ubiquitin chains (tags on proteins that signal the cell to degrade and eliminate the protein using the cell’s protein disposal system) from specific proteins to stop their degradation and stabilize their levels for therapeutic benefit. DUBTACs, developed through an academic-industry research collaboration between Professor Daniel Nomura, his research group at UC Berkeley and scientists at the Novartis Institutes for BioMedical Research, are bifunctional small molecules consisting of a protein-targeting ligand connected via a linker to a deubiquitinase (DUB) recruiter. In a unique application of induced-proximity biology, DUBTACs bring a DUB into the vicinity of a ubiquitin-tagged protein to remove the ubiquitin chain and subsequently prevent degradation of the target protein.

In a hallmark study published in Nature Chemical Biology, Dr. Nomura, the Nomura Lab and Novartis colleagues discovered covalent allosteric recruiters against OTUB1, a known DUB. They showed that this covalent OTUB1 recruiter could be linked to various protein-targeting ligands to stabilize the levels of aberrantly degraded proteins, including the mutated chloride channel CFTR that causes cystic fibrosis and the tumor suppressor WEE1 kinase in cancer cells.

Vicinitas Therapeutics has exclusively licensed the DUBTAC platform from both UC Berkeley and Novartis and aims to become the leading company in targeted protein stabilization by developing next-generation disease therapies against an entire class of previously inaccessible aberrantly degraded proteins. The company is initially focused on developing therapies in cancer and monogenic diseases.

"We are excited about the potential of the DUBTAC platform to develop novel therapies against therapeutic targets that were previously deemed undruggable and will respond to protein stabilization," said Daniel K. Nomura, Ph.D., founder of Vicinitas Therapeutics and Professor of Chemical Biology in the Departments of Chemistry, Molecular and Cell Biology, and Nutritional Sciences and Toxicology at UC Berkeley.

"The concept of chemically induced proximity – using multispecific molecules to bring two targets physically together – has yielded notable successes in the field of protein degradation," said Jorge Conde, General Partner at a16z. "Vicinitas is leveraging its proprietary DUBTAC platform to pioneer the emerging space of targeted protein stabilization. This approach has the potential to access highly valued yet currently undruggable proteins and create differentiated therapies that will impact patient lives."

Leadership Team and Formation of Scientific Advisory Board

The Vicinitas Therapeutics team is comprised of scientific leaders from academia and industry who have demonstrated years of commitment and success in the field, and who remain dedicated to advancing science and technology and delivering highly impactful drugs.

Vicinitas Therapeutics’ leadership team includes:

Daniel K. Nomura, Ph.D., Founder and Professor of Chemical Biology in the Departments of Chemistry, Molecular and Cell Biology and the Molecular Therapeutics Division, and Nutritional Sciences and Toxicology, UC Berkeley; Investigator at the Innovative Genomics Institute
Daniel Marquess, D.Phil, Chief Scientific Officer
Joe Budman, Ph.D., Vice President of Biology
Vicinitas Therapeutics’ board of directors includes:

Jorge Conde, General Partner, a16z
Cameron Wheeler, Ph.D., Partner, Deerfield Management
George Golumbeski, Ph.D., Partner, Droia Ventures
Daniel K. Nomura, Ph.D., Founder and Professor of Chemical Biology in the Departments of Chemistry, Molecular and Cell Biology and the Molecular Therapeutics Division, and Nutritional Sciences and Toxicology, UC Berkeley; Investigator at the Innovative Genomics Institute
Vicinitas has also established a scientific advisory board, including:

Daniel K. Nomura, Ph.D., Founder and Professor of Chemical Biology in the Departments of Chemistry, Molecular and Cell Biology and the Molecular Therapeutics Division, and Nutritional Sciences and Toxicology, UC Berkeley; Investigator at the Innovative Genomics Institute
Michael Rape, Ph.D., Professor, Department of Molecular and Cell Biology, UC Berkeley; Investigator of the Howard Hughes Medical Institute
Thomas Maimone, Ph.D., Associate Professor in the Department of Chemistry, UC Berkeley
James Olzmann, Ph.D., Associate Professor, Departments of Molecular and Cell Biology and Nutritional Sciences and Toxicology, UC Berkeley; Investigator of the Chan Zuckerberg Biohub
Kevan Shokat, Ph.D., Professor, Department of Cellular and Molecular Pharmacology, UCSF; Investigator of the Howard Hughes Medical Institute
F. Dean Toste, Ph.D., Gerald E. K. Branch Distinguished Professor of Chemistry, UC Berkeley
Angela Koehler, Ph.D., Associate Professor, Biological Engineering, MIT, Associate Director, Koch Institute for Integrative Cancer Research at MIT
"Vicinitas Therapeutics has emerged as a pioneer of targeted protein stabilization, and we’re excited to be a part of the Series A funding," said Cameron Wheeler, Ph.D., Partner at Deerfield Management. "As a therapeutic modality, stabilization has the power to elicit substantial changes to disease biology with relatively minor alterations to target proteins, and we are optimistic about the potential of the DUBTAC platform across oncology, rare and chronic diseases."