On June 9, 2020 UbiVac, Inc. (www.ubivac.com) reported it has entered into a clinical trial collaboration with Bristol Myers Squibb (NYSE:BMY) to evaluate the safety, tolerability, and preliminary efficacy of UbiVac’s investigational product, DPV-001, a first-in-class cancer vaccine that exploits autophagy, in combination with Bristol Myers Squibb’s anti-OX40 (BMS-986178) combined with sequenced administration of the programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab) (Press release, UbiVac, JUN 9, 2020, View Source [SID1234560946]). The Phase 1b multicenter trial will test the hypothesis that combination immunotherapy with the DPV-001 cancer vaccine and anti-OX40 will augment anticancer immunity in patients with advanced triple negative breast cancer.

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Triple Negative Breast Cancer is negative for estrogen receptors, progesterone receptors and HER2 receptors, and therefore treatment options are limited. This type of breast cancer tends to metastasize frequently, and occur in younger patients (less than 50 years of age) and those with the inherited BRCA1 mutation.

This is the first clinical trial to combine a cancer vaccine (DPV-001), that educates the immune system to destroy cancer cells, with a T cell agonist, Bristol Myers Squibb’s anti-OX40 (BMS-986178), that amplifies immune system activity. Patients also will receive anti-programmed death 1 immune checkpoint therapy, Bristol Myers Squibb’s Opdivo, which takes the brakes off the immune system.

"UbiVac is thrilled to be working with Bristol Myers Squibb, a world leader in immuno-oncology, to research this innovative cancer vaccine therapy, combined with anti-OX40 and checkpoint blockade, and evaluate whether this treatment boosts anticancer immunity in patients with advanced Triple Negative Breast Cancer," said Bernard A. Fox, PhD., President and CEO of UbiVac and the Harder Family Chair for Cancer Research at the Earle A. Chiles Research Institute and Providence Cancer Institute. The trial will be led by David Page, MD, at Providence Portland Medical Center and enroll patients in Portland and at other centers in the U.S. "I am excited to lead this first-in-human trial, which builds on 25 years of immunotherapy research from the Earle A. Chiles Research Institute," said Dr. Page. "We believe that cutting-edge immunotherapy combinations have the potential to induce long-lasting anticancer immunity and translate into clinical responses in patients with triple negative breast cancer."

About UbiVac’s Innovative Cancer Vaccine Technology

The lead biologic, DRibble Platform Vaccine 001, DPV-001, is a dendritic cell-targeted microvesicle containing short-lived proteins that are thought to represent the dominant HLA-presented epitopes on the surface of cancer cells. These microvesicles are packaged with multiple TLR and NOD agonists, together with 15 DAMPs and chaperones. The microvesicle vaccine also contains more than 100 proteins that are overexpressed by the average triple negative breast cancer and as many as 1700 altered peptide ligands that can augment immunity against cancer antigens. Together this formulation drives B cells, CD4 and CD8 T cells as well as innate components of the host’s immune system to mediate anticancer function.

In preclinical models this vaccine can convert tumors that are considered "cold" because they lack immune cells into tumors that are "hot" with cancer killer cells. This is important as many human tumors are thought to be unresponsive to immunotherapy because they lack immune cells capable of recognizing their cancer and are considered to be "cold" tumors. "Based on these data we believe UbiVac’s DRibble platform vaccine technology combined with anti-OX40 will light a fire in the immune system of patients with cold tumors, turning them into hot tumors that will be more responsive to checkpoint blockade," Hong-Ming Hu, PhD, CSO at UbiVac, said.

On June 9, 2020 Biotechnology company Lycia Therapeutics, Inc. reported exited stealth mode with a $50 million commitment from founding investor Versant Ventures (Press release, Versant Ventures, JUN 9, 2020, View Source [SID1234560945]). Proceeds are being used to develop lysosomal targeting chimeras, or LYTACs, as therapeutics for a broad set of currently intractable cell surface targets.

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Interest in the field of protein degradation continues to grow, as classical approaches to developing small molecule and biologic therapeutics have proven to be ineffective on many disease-relevant targets. This is especially the case for extracellular and secreted proteins that have inaccessible active sites, complex and challenging molecular structures, and other limiting factors.

"Our understanding of the biological pathways and targets relevant to certain diseases has far outreached our ability to develop effective therapeutic modalities," said Lycia CEO Aetna Wun Trombley, Ph.D. "LYTACs offer the promise of targeting a wider array of proteins on the cell surface or in the extracellular compartment. Many of these have been linked to cancer, autoimmune and other serious diseases."

Targeting extracellular proteins with LYTACs

Versant established Lycia in 2019 within the firm’s San Diego-based Inception labs in collaboration with academic founder Carolyn Bertozzi, Ph.D., professor of chemistry and HHMI investigator at Stanford University. The initial aim was to develop and validate a drug discovery platform.

The LYTACs platform leverages decades of work in the field of lysosomal biology. In a 2019 publication, Dr. Bertozzi’s team at Stanford demonstrated that a cation-independent receptor called CI-M6PR could be exploited to capture and drag extracellular proteins into cells, trafficking them to the lysosome for destruction.

In addition to CI-M6PR, Lycia has now extended this approach and leveraged other tissue-specific internalizing receptor systems to further expand the technology’s therapeutic potential.

"Our understanding of multiple receptor systems including M6PR offered Lycia the opportunity to take the protein degradation field in a new direction," said Dr. Bertozzi. "I look forward to working closely with the team to advance the science and explore the broader applications to developing effective therapeutics for intractable cancers and many other challenging diseases."

Relevance to numerous diseases and modalities

With the Inception team, Lycia has been able to validate, optimize and expand this approach. Confirmatory studies have shown targeted degradation of cell surface proteins such as EGFR, PD-L1, as well as secreted proteins like ApoE4. Collectively these results suggest that LYTACs can potentially serve as effective therapeutics for a wide range of difficult-to-treat conditions. Further work continues to target other membrane proteins, including receptor tyrosine kinases, and pathogenic immune complexes in circulation.

Moreover, the platform has the potential to extend the reach of other modalities including gene therapy, which cannot be chronically dosed due to the production of autoantibodies. The platform can be exploited to develop a LYTAC binder able to capture and drag the autoantibodies into a lysosomal trafficking pathway.

Advisors and operating plans

The Lycia team will work alongside experienced entrepreneurs and leading scientists who have made important contributions in the field and bring relevant experience to the company.

Carolyn Bertozzi, Ph.D., who chairs Lycia’s Scientific Advisory Board, is the Anne T. and Robert M. Bass Professor of Chemistry and Professor of Chemical & Systems Biology and Radiology at Stanford University, and an Investigator of the Howard Hughes Medical Institute. Dr. Bertozzi’s research interests span the disciplines of chemistry and biology with an emphasis on studies of cell surface glycosylation pertinent to disease states. She is an elected member of the Institute of Medicine, National Academy of Sciences, and American Academy of Arts and Sciences. She has been awarded the Lemelson-MIT Prize, the Heinrich Wieland Prize, and a MacArthur Foundation Fellowship, among many others.

Randy Schekman, Ph.D., is an investigator of the Howard Hughes Medical Institute and a Professor of Cell and Developmental Biology in the Department of Molecular and Cell Biology at the University of California at Berkeley. He was awarded the Nobel Prize in Physiology or Medicine in 2013.

Mark M. Davis, Ph.D. is the Director of the Stanford Institute for Immunology, Transplantation and Infection (ITI), a Professor of Microbiology and Immunology and a Howard Hughes Medical Institute Investigator at Stanford University. He received a B.A. from Johns Hopkins University and a Ph.D. from the California Institute of Technology. Dr. Davis is well known for identifying many of the T-cell receptor genes, which are responsible for the ability of these cells to recognize a diverse repertoire of antigens. His current research focuses on obtaining a systems level understanding of the human immune system.

Brian Druker, M.D., is Professor of Medicine and Director of the OHSU Knight Cancer Institute and the JELD-WEN Chair of Leukemia Research. His research focuses on activated tyrosine kinases with an emphasis on their role in cancer. His work resulted in Gleevec, the first drug to target the molecular defect of a cancer while leaving healthy cells unharmed. He has been recognized with numerous awards, including the Warren Alpert Prize from Harvard Medical School, the Lasker-DeBakey Award for Clinical Medical Research, the Japan Prize in Healthcare and Medical Technology, and most recently, the 2018 Tang Prize in Biopharmaceutical Science.

Alanna Schepartz, Ph.D., is the T.Z. and Irmgard Chu Distinguished Chair in Chemistry and Professor of Molecular and Cell Biology at the University of California at Berkeley. Her research spans the fields of chemical and synthetic biology. A primary focus is to uncover the chemistry that drives complex cellular processes and apply this knowledge to design or discover molecules – large and small – that possess unique or useful properties.

Monther Abu-Remaileh, Ph.D., is Assistant Professor of Chemical Engineering at Stanford University. His lab is focused on identifying novel pathways that enable cellular and organismal adaptation to metabolic stress and changes in environmental conditions, as well as how these pathways go awry in human diseases such as cancer, neurodegeneration and metabolic syndrome, in order to engineer new therapeutic modalities.

Laurent Fischer, M.D., who is an independent member of Lycia’s Board of Directors, was senior vice president and head of the liver therapeutic area at Allergan. Before that, he was CEO of Tobira Therapeutics, which Allergan acquired in 2016 for $1.7 billion. Dr. Fischer has held numerous CEO roles at biotechnology companies, as well as senior leadership positions at large pharmaceutical companies. He has been involved in the launch of multiple drugs.

Lycia will be headquartered in the San Francisco Bay Area and will continue collaborating with the San Diego-based Inception team during the startup phase. With this financing, the company plans to build out its foundational LYTAC platform, develop an internal pipeline, and will also consider discovery-stage partnerships to fully exploit the potential of this novel approach.

"The team at Lycia has begun to translate recent insights on the utility of targeted lysosomal trafficking into a new class of therapeutics," said Clare Ozawa, Ph.D., Versant managing director and a Lycia board member. "With this financing, we hope to build on this progress and to generate a broad pipeline of development candidates."

On June 9, 2020 IncellDx, Inc., a global leader in single-cell diagnostics, reported approval by the Costa Rican Ministry of Health of its Next Generation HPV/cervical cancer assay, OncoTect 3Dx (Press release, IncellDx, JUN 9, 2020, View Source [SID1234560944]). This novel assay is the only test to simultaneously detect and quantify 3 molecular markers of cervical cancer—overexpression of oncogenes (E6, E7 mRNA), proliferation, and aneuploidy. Using high throughput flow cytometry, 96 cervical cytology samples can be tested and resulted in less than 4 hours, without having to examine slides.

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"We are thrilled to have received approval for the HPV OncoTect 3Dx assay, thanks to the perseverance of our team and our international collaboration with IncellDx," said Dr. Rodrigo Mora, Ph.D., Professor of Medical Virology, Faculty of Microbiology, University of Costa Rica. "We are so looking forward to start offering this test to women in Costa Rica who are currently at risk of over-treatment. Now, we will finally be able to distinguish and separate HPV infection from HPV disease to contribute to the health of our women and reduce the psychological burden associated with HPV."

Nearly 1.9 million women are at risk of cervical cancer in Costa Rica, and it is the 3rd most common female cancer in the country. Human Papillomavirus (HPV) infection has been directly linked to the development of cervical intraepithelial lesions and increased risk for cervical cancer. The HPV OncoTect 3Dx assay aids in the determination of which patients need to be further evaluated for the presence of high-grade cervical intraepithelial neoplasia.

Dr. Bruce Patterson, chief executive officer of IncellDx, added, "We appreciate the hard work done by Dr. Mora and his team in validating this assay for staging of cervical cancer using the only test in the world that combines three molecular biomarkers in a single assay in intact cells from a liquid-based cytology specimen. This assay is the next step after determining infection with a high-risk HPV genotype to determine the biological behavior of high-risk HPV infections when the overwhelming majority of these infections will not progress to cervical cancer."

On June 9, 2020 C2i Genomics ("C2i"), a company dedicated to improving cancer patient lives and outcomes with a breakthrough tumor pattern recognition approach for liquid biopsy, reported that it has raised $12 million in its Series A financing (Press release, C2i Genomics, JUN 9, 2020, View Source [SID1234560943]). The financing was led by Casdin Capital and joined by additional new investors including NFX Capital, The Mark Foundation for Cancer Research and other investors. Proceeds from the financing will be used to fund the development and clinical validation of C2i Genomics’ personalized, real-time solution for monitoring recurrence and treatment response for various types of solid cancers.

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"This Series A funding will allow us to take the next major step in our growth and advance our core technology into pilot and pivotal validation studies in several oncology indications," said Asaf Zviran, C2i Genomics’ co-founder, chief executive officer and chief scientific officer. "We believe that the improvement in sensitivity we’ve achieved will allow physicians to quantitatively monitor their patient treatment response and detect treatment failure or disease recurrence months and even years before they would do otherwise. We have built C2i on a solid scientific and technological foundation and are excited to work with our investors and other partners toward the deployment of our cloud-based platform for disease management. The great support of our clinical collaborators from the US, Europe and Asia highlights the global need that underlines our mission to support effective therapy decisions for millions of cancer patients around the world."

C2i Genomics’ innovative solution is based on research performed at the New York Genome Center (NYGC) and Weill Cornell Medicine (WCM) by Dr. Zviran, along with Dr. Dan Landau, core faculty member at the NYGC and assistant professor of Medicine at WCM, who serves as scientific co-founder and member of C2i’s scientific advisory board. C2i then welcomed Dr. Boris Oklander as chief technology officer, and Ezra Sofer as its general manager and chief financial officer, both of whom bring extensive executive leadership and management expertise and experience from their previous roles in the healthcare industry. The technology has been validated through longitudinal clinical cohorts in collaboration with cancer centers in New York and Boston and was recently published in Nature Medicine. This proof-of-concept research was supported by a 2017 grant from The Mark Foundation for Cancer Research.

"The C2i technology allows for the company to develop a bio-platform approach that works across cancer types and allows effective guidance of diverse treatment modalities from surgery and chemotherapy to immunotherapy and targeted therapies." said James Currier, managing partner of NFX Capital. "Such a data-based treatment management platform will produce a network effect, which will increase the value of C2i’s data and services over time. We predict that this is a unique opportunity to build a sector defining company."

Existing liquid biopsy methods focus on detecting specific mutations in targeted panels. Panel-based methods can have limited sensitivity and show only mutation-specific response which do not typically represent the full complexity of the cancer’s response due to tumor heterogeneity. C2i’s liquid biopsy analysis platform can detect and quantify very small amounts of residual disease in the patient’s blood by utilizing a personalized tumor "fingerprint" representing thousands of mutations for each individual patient. This novel genome-wide signature detection, coupled with proprietary mathematical inference models and machine learning techniques, provides ultra-sensitive quantification of the amount of circulating tumor DNA in the patient’s blood, accurately capturing the aggregate response of the heterogenic tumor.

Ultra-sensitive treatment monitoring holds promise to improve patient outcome while reducing the overall cost burden on the health system. Through effective monitoring, C2i technology also offers the opportunity to accelerate clinical trials, aiming to bring lifesaving treatments to the clinic.

"Genomic tools are bringing enormous benefit to the cancer patient treatment through more powerful and precise care and therapeutic development," said Eli Casdin, managing partner of Casdin Capital. "The C2i approach breaks through sensitivity limitations of current approaches by exploiting the team’s unique capabilities at the intersection of genomic and data sciences. The Series A financing catalyzes progress towards making an impact by supporting clinical development partnerships and collaborations with the biopharma industry."

On June 9, 2020 Promega Corporation reported CE marking for the OncoMate MSI Dx Analysis System (OncoMate MSI) as a new in vitro diagnostic (IVD) medical device in Europe (Press release, Promega, JUN 9, 2020, View Source [SID1234560942]). OncoMate MSI is a PCR-based, validated gold standard for determining microsatellite instability (MSI) status in solid tumors.1,2,3 It offers analytical sensitivity and unsurpassed specificity with a short turn-around time.4,5

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"European guidelines recommend MSI testing to assess deficient mismatch repair function of solid tumors for a spectrum of cancers, including colorectal cancer and endometrial cancer, in order to reduce morbidity and mortality," said Richard Hamelin, Ph.D., Research Director (Ret) at Inserm. "Data show that OncoMate MSI provides clinicians a valuable DNA-based MSI reading that is complementary to a standard MMR immunohistochemistry panel and can be used as an independent biomarker to predict response with immuno-oncology therapies."

Loss of mismatch repair (MMR) protein function results in tumor cells with DNA MSI.6 MSI testing is an important first step in the molecular characterization related to loss of MMR function, including Lynch Syndrome-related cancers.7,8 A study led by Hamelin shows accumulating evidence suggesting that MSI-High status identifies a subset of colorectal cancers with distinctive biological and clinical properties, emphasizing the importance of simple, accurate markers for detection.9 Using a pentaplex PCR system allows for accurate evaluation of tumor MSI status of DNA with high sensitivity and specificity.9

OncoMate MSI uses the most sensitive panel of markers for MSI status detection, as included in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines. Screening cancer patients with these reliable markers can provide pathologists, oncologists, and patients with information that characterizes tumors to help guide care and treatment decisions.10

"Promega MSI technology demonstrates our commitment to developing precise and reliable tools for life scientists around the world," said Heather Tomlinson, Director of Clinical Diagnostics at Promega Corporation. "With the CE marking of OncoMate MSI, Promega aims to make MSI testing more broadly accessible to laboratories within Europe and to aid clinicians in making vital decisions in cancer patient care and treatment."

Promega MSI technology is one of the leading standard tests for MSI status detection in research laboratories and achieved innovation status and priority review by the National Medical Products Administration (NMPA) in China. It has been used extensively in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications. Promega continues to advance the promise of MSI technology globally and intends to seek regulatory clearance for OncoMate MSI in the United States and China.

To learn more about OncoMate MSI Dx Analysis System, visit: www.promega.com/OncoMateCEIVD

About OncoMate MSI Dx Analysis System

OncoMateTM MSI Dx Analysis System encompasses a complete workflow for MSI determination from DNA extraction to data analysis, offering an easy to use and standardized system. It includes the same validated and endorsed loci as the Promega Research Use Only MSI Analysis System Version 1.2 with the new advantages of a shorter turn-around time and GoTaq MDx DNA polymerase. OncoMate MSI is a fluorescent, multiplex PCR-based test to detect DNA sequence length changes in microsatellite regions of tumor cell DNA relative to the same regions from the patient’s normal cells thereby indicating microsatellite instability. OncoMate MSI targets seven microsatellite markers: five mononucleotide-repeat markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) and two pentanucleotide-repeat markers (Penta C and Penta D). These mononucleotide-repeat markers are analyzed to determine MSI status and were selected for high sensitivity and specificity to alterations in repeat lengths in samples containing mismatch repair defects. MSI is a form of genomic instability caused by insertion or deletion of additional bases into DNA microsatellites, regions of repeating bases distributed throughout the human genome. During DNA replication, failure of the mismatch repair system to correct these errors causes MSI.