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Ultimovacs Publishes Positive Long-term UV1 Data from Phase I Malignant Melanoma Combination Study in Frontiers in Immunology

On May 11, 2021 Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, reported the publication in Frontiers in Immunology of its positive long-term Overall Survival (OS) data from the Phase I trial evaluating the Company’s universal cancer vaccine, UV1, in combination with checkpoint inhibitor ipilimumab in patients with metastatic malignant melanoma (Press release, Ultimovacs, MAY 11, 2021, View Source [SID1234579716]). As published in the journal, in addition to the achievement of the primary endpoints of safety and tolerability, 50% of the patients were still alive at the data cut-off, supporting the combination of the Company’s proprietary UV1 vaccine with ipilimumab, a CTLA-4 checkpoint inhibitor and standard-of-care treatment, in this late-stage patient population.

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"Publishing our clinical trial data in such a prestigious peer-reviewed publication adds validation for UV1 as a promising therapeutic option for cancer patients. As we continue to evaluate UV1 in various combinations and indications, it is valuable to gain increased international recognition from the clinical community for this study," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "Historical data on the use of ipilimumab as monotherapy in malignant melanoma have shown a 5-year survival rate below 20%, therefore the results published today reinforce UV1’s potential in this indication."

The data published in Frontiers in Immunology covers 4.8 years of follow-up on the total of 12 metastatic malignant melanoma patients that were enrolled in the Phase I trial. As reported in the journal, the OS was 50% at 4.8 years, which was confirmed by the results of 5 years of follow-up announced by the Company in December 2020.

Building on these promising Phase I results, Ultimovacs is currently enrolling INITIUM, its Phase II clinical trial evaluating UV1 in combination with ipilimumab and nivolumab in patients with metastatic malignant melanoma. The company expects to announce data on the trial’s primary endpoint in 2H2022. In addition, Ultimovacs has an ongoing and fully-enrolled Phase I trial evaluating UV1 in combination with pembrolizumab, a PD-1 checkpoint inhibitor, as a first line treatment in metastatic malignant melanoma patients.

The publication in Frontiers in Immunology can be found under doi: 10.3389/fimmu.2021.663865.

About UV1

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as an "off-the-shelf" therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs

As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials: INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. The DOVACC study is sponsored by the Nordic Society of Gynaecological Oncology. In total, 184 patients with high-grade ovarian cancer will be enrolled to evaluate UV1 in combination with durvalumab and olaparib, both provided by AstraZeneca. FOCUS is an investigator-sponsored, randomized clinical trial enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, and will evaluate the impact of adding UV1 to this regimen. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2H2022 and for the DOVACC and FOCUS studies in 2023.

Accelerated Biosciences’ Immune-Privileged Human Trophoblast Stem Cells (hTSCs) Offer Breakthrough Opportunities in Cancer-Targeting Therapeutics and Regenerative Medicine Treatments

On May 11, 2021 Accelerated Biosciences, a regenerative medicine innovator, reported that new data that further demonstrates statistically significant cytolysis with induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells programmed from its ethically sourced human trophoblast stem cells (hTSCs) (Press release, Accelerated Biosciences, MAY 11, 2021, View Source [SID1234579715]). Pluristyx, a Seattle-based firm supporting drug development, regenerative medicine, and cell and gene therapies, further confirmed Accelerated Biosciences’ hTSC line offers before-unrealized opportunities in cell-specific therapeutics. Along with this recent data on successful iPSC differentiation, Accelerated Biosciences has already demonstrated efficient differentiation of its pluripotent stem cells with remarkable doubling times and growth characteristics to programmed NK, cartilage, bone, fat, neuron, pancreas, liver, and secretome cells.

"This new data validates our findings," explains Yuta Lee, President and Founder of Accelerated Biosciences. "We know the properties of our trophoblast stem cells have been long-sought by the medical science community because of the potential to speed and amplify the development of life-saving therapeutics; they’re immune privileged, chromosomally stable (not tumorigenic), pathogen free, pluripotent, easy to scale and manufacturer, and of special interest, they are ethically sourced from the chorionic villi (pre-placental tissue) of non-viable and often life-threatening tubal ectopic pregnancies." Mr. Lee’s father, Professor Jau-Nan Lee, MB, MD, PhD, an obstetrics and gynecologic physician and researcher in Taiwan, first isolated hTSC in 2003. Mr. Lee created Accelerated Biosciences to elevate the visibility of this pluripotent human trophoblast stem cell platform to those engaged in developing allogeneic cell therapeutics and has been instrumental in the filing and prosecution of intellectual property to protect the company’s hTSC platform – to date holding 34 patents.

Benjamin Fryer, PhD, Co-founder and CEO of Pluristyx, worked closely with Accelerated Biosciences to prepare much of its key hTSC data. Dr. Fryer, a trophoblast expert who was previously a research scientist at Janssen Research & Development of Johnson & Johnson, now serves on Accelerated Biosciences’ Scientific Advisory Board. "Initially I was skeptical these cells were what they said they were. If we hadn’t grown and characterized them in our lab, I might have remained skeptical. These are indeed trophoblast stem cells," explained Dr. Fryer. "The potential of these cells is enormous. One of the industry’s largest challenges is that it’s almost impossible to scale primary cells. These cells are scalable. With these cells you can make the amount required for millions of patients and they’re sourced compliant to regulatory requirements. We’ve made IPS cells (induced pluripotent stem cells) and NK (natural killer) cells from them, which is the next wave of cells for cell therapies. For therapeutic developers, because these cells are not sourced from a person or viable embryo, these cells deliver the trifecta of legal, ethical, and IP advantages."

"As the biotechnology industry works toward developing therapies that target only diseased cells without harming healthy cells and tissues, cell-based therapies draw increasing interest," explains industry expert, Martina Molsbergen, CEO of C14 Consulting, who has partnered with Accelerated Biosciences in a business development role. "With all the promise that cell therapies hold, the biotechnology industry also remains concerned that the therapeutics are derived in a socially and ethically responsible manner. Accelerated Biosciences has discovered and is now offering what scientists see as the holy grail of stem cell sources."

Prominent biosciences experts have been drawn to Accelerated Biosciences’ cell breakthrough. Protein chemist and molecular biologist Igor Fisch, PhD, former President and CEO of Selexis, Geneva, Switzerland, recognizes the impact that Accelerated Biosciences’ hTSCs will have on human health: "Not only are these cells ‘politically correct’, but they can also differentiate. Because they are sourced from pre-placenta material, they’re immune privileged, which means that are not seen as foreign by the human body. With these cells, we can create a cell bank – a single source for a wide range of patients."

Peter Hudson, FTSE, BSc Hons, PhD, Chief Scientist and a senior advisor to Avipep P/L in Melbourne, Australia, and an adjunct professor at the University of Queensland, led a large oncology consortium to complete the first Phase 1 clinical trial of a novel engineered antibody targeting prostate and ovarian cancer. Hudson’s interest in Accelerated Biosciences’ hTSCs has evolved into a role on its Scientific Advisory Board. "Trophoblast stem cells are likely to be the next wave of cancer-targeting therapeutics," explains Dr. Hudson. "The ability to ethically source trophoblast stem cells and program them to target only diseased, cancerous cells is very powerful technology."

Why are scientists so interested in stem cell-based therapies?

The human body constantly produces specialized cells from its own stem cells (undifferentiated cells) to renew and repair itself. Current therapies harness this power in autologous cell therapies in which the patient’s own cells are removed, differentiated into disease-fighting cells, and reinserted.

What makes the human trophoblast stem cell so important to medical science?

The human trophoblast stem cell (hTSC) comes from placental tissue and has special properties that make it extremely desirable to therapeutic developers. The hTSC is such an early stem cell that it has much more capacity for growth than a stem cell taken from an adult, for example. This means that one cell can become millions. The hTSC also carries with it the same immune-privilege that a growing embryo has inside its mother: it’s not seen as foreign although it’s genetically different than its mother. Unlike other foreign materials, the hTSC is not rejected by the human body, which means that it can be used with many different patients (allogeneic cell therapy). With these benefits, the scientific community holds a high regard for hTSCs, but it also faces socio-ethical concerns about how those stem cells are typically sourced.

Accelerated Biosciences sidesteps hTSC sourcing concerns in a profoundly elegant way. Dr. Jau-Nan Lee, an OB-GYN in Taiwan, found inspiration in what was considered medical waste. When surgical intervention was necessary to remove an ectopic pregnancy that would otherwise risk the woman’s life, the non-viable embryo and pre-placental tissue lodged in the fallopian tube was removed, sent to pathology, and discarded. Gaining permission from institutional colleagues and sampling the pre-placental tissue, Dr. Lee isolated hTSC that offered all the benefits of hTSC – pluripotency, immune privilege, and scalability – without pathogens and without ethical compromises.

Molecular Targeting Technologies, Inc. and University of Antwerp Begin First-in-Human Study of TDURA Diagnostic for Early Detection of Response to Colon Cancer Therapy

On May 11, 2021 Molecular Targeting Technologies, Inc. (MTTI) and University of Antwerp reported the approval of a Clinical Trial Application by the European Federal Agency for Medicines and Health Products (FAMHP) (equivalent to a US IND) (Press release, Molecular Targeting Technologies, MAY 11, 2021, View Source [SID1234579714]). The clinical study will evaluate the safety, dosimetry and treatment response of TDURA (99mTc-Duramycin), in patients with advanced colorectal cancer (CRC)* .

Colorectal cancer is the third most commonly diagnosed malignancy in the world and the second leading cause of cancer death in the United States. While a range of novel active agents has improved the prognosis of patients with colorectal cancer, 50% of advanced colorectal cancer patients die from metastatic disease.

Monitoring treatment efficacy early, within days, can significantly improve patient outcomes. Current diagnostic techniques can take weeks to months to gauge tumor killing drug efficacy. In some cases, treatment may only be effective in 40% of patients, leading to rapidly advancing cancer and higher costs while regrouping to change therapies.

Duramycin, a naturally occurring peptide that binds to phosphatidylethanolamine (PE), has been radiolabeled and used for early imaging of tumor death in animal models.

Professor Sigrid Stroobants, MD, Chair of Nuclear Medicine, U of Antwerp commented "Objective and accurate evaluation of tumor response to therapy is one of the biggest challenges in oncology. Early assessment of therapeutic ineffectiveness can avoid treatment related toxicity and could lead to improved survival through earlier treatment intensification, stopping the ineffective therapy, or starting second-line therapy."

Chris Pak, MTTI President & CEO said, "The most commonly used methods to evaluate the effectiveness of a treatment are morphological and volumetric which cannot see the effects of therapy early. If TDURA optimizes patient treatment, the benefits to the patients and savings to health care systems will be substantial."

Lucence Launches US Validation Study for LiquidHALLMARK® Liquid Biopsy Test for Biomarker Detection in Lung Cancer

On May 11, 2021 Precision oncology company Lucence is currently conducting the first US validation study of its technology, reported that examining the use of the company’s amplicon-based LiquidHALLMARK liquid biopsy assay versus tissue biopsy in detecting guideline-recommended biomarkers in lung cancer (Press release, Lucence, MAY 11, 2021, View Source [SID1234579713]).

LIQUIK, Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients With Advanced Non-Small Cell Lung Cancer, aims to better understand the concordance of LiquidHALLMARK with conventional tissue-based profiling. The prospective study will enroll 200 treatment-naive newly diagnosed metastatic non-squamous non-small cell lung cancer (NSCLC) patients. LIQUIK will compare LiquidHALLMARK with tissue next-generation sequencing (NGS) for mutation profile results in NSCLC patients who have at least one of nine clinically relevant genes— EGFR, ALK, RET, ROS1, NTRK fusions, MET, BRAF, ERBB2 and KRAS—detected by tissue biopsy. LIQUIK has enrolled its first patient and will continue enrollment across 7 study sites nationwide.

"The launch of our first prospective multicenter study in the United States brings us one step closer to advancing precision cancer care for the benefit of patients everywhere," said Dr. Min-Han Tan, founding CEO of Lucence. "Building evidence to support the clinical utility and sensitivity of our test will enable us to make LiquidHALLMARK’s high resolution, target-rich insights more widely available to patients across the country."

Liquid biopsy holds promise for a range of applications across cancer including non-invasive screening, biomarker detection, treatment monitoring, and testing for minimal residual disease. For non-small cell lung cancer, liquid biopsy is a NCCN guideline-recommended option for testing in cases where a tissue biopsy is not medically feasible or when there is insufficient material for molecular analysis.

LiquidHALLMARK is a comprehensive, amplicon-based NGS assay for ultrasensitive biomarker detection. Powered by AmpliMark, a proprietary sequencing technology, LiquidHALLMARK examines plasma circulating tumor DNA mutations in 80 genes, including fusions in 10 genes. LiquidHALLMARK provides >99% sensitivity at a detection limit of 0.1% variant allele frequency, and targets single nucleotide variants (including cis-trans), insertions and deletions, copy number variations, microsatellite instability, fusions, and viruses. LiquidHALLMARK targets have been identified in 15 cancers.

AmpliMark is the foundational technology in Lucence’s liquid biopsy tests. AmpliMark uses a unique molecular barcode and error-correction technology designed to improve liquid biopsy test sensitivity for single nucleotide variants and fusion genes.

Late last year Lucence’s Palo Alto laboratory received certification from the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. LiquidHALLMARK is currently available to US oncologists as a laboratory developed test.

BostonGene Announces Cancer Research Collaboration with the Abramson Cancer Center of the University of Pennsylvania

On May 11, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a Master Clinical Research Collaboration Agreement with the Abramson Cancer Center (ACC) of the University of Pennsylvania to support multiple research projects at the cancer center (Press release, BostonGene, MAY 11, 2021, View Source [SID1234579712]).

The first research project to arise from this collaboration aims to support clinical research focusing on personalized cancer vaccines, a new approach of active immunotherapy which utilizes the patient’s own immune system to identify tumor specific neoantigens. BostonGene’s advanced computational algorithms will identify cancer specific neoantigens and profile the immune activation status of the tumor by performing advanced multi-omics analysis, including the interpretation and visualization of cancer patient’s genomic, transcriptomic and imaging datasets. The analysis includes the identification of targetable molecular alterations, evaluation of gene expression and gene signatures, characterization of cellular components in the tumor microenvironment, estimation of tumor heterogeneity, prediction of neoantigens and tumor clonality.

"BostonGene’s strategy is to revolutionize medicine in the quest to identify better, personalized treatment options with successful outcomes," said Andrew Feinberg, President and CEO at BostonGene. "We are pleased to support the Abramson Cancer Center by providing sophisticated analytics and integration of scientific and clinical knowledge in an effort to improve the standard of care and redefine the treatment selection approach for cancer patients."

The ACC, a global leader in basic, translational, clinical, and biomedical research for the advancement of cancer care, is a matrix cancer center embedded within the University of Pennsylvania and the University of Pennsylvania Health System. The ACC, a National Cancer Institute-Designated Comprehensive Cancer Center, is comprised of cancer specialists committed to offering cancer patients the newest and most innovative therapeutic advances.

"We look forward to using BostonGene’s technology to help in our work to better understand the mechanisms of cancer neoantigen recognition and to the discovery of new immunotherapy treatment options," said Gerald Linette, MD, PhD, a professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania and Clinical Director of the Parker Institute for Cancer Immunotherapy at Penn. "We are excited about this collaboration, and with our combined expertise have an opportunity to make a profound impact on how cancer patients are treated in the future."