On January 27, 2020 On Target Laboratories, Inc., a privately-held biotechnology company developing the use of fluorescent markers to target and illuminate cancer during surgery, reported the results of a multi-institutional Phase 2 clinical trial in which outcomes were improved for 26 percent of patients undergoing pulmonary resection for non-small cell lung cancer (NSCLC) (Press release, Applied BioMath, JAN 27, 2020, View Source [SID1234553595]).

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The results were presented today at the 56th Annual Meeting of the Society of Thoracic Surgeons (STS), held in New Orleans, LA., and were featured in a plenary session as a J. Maxwell Chamberlain Memorial Paper for General Thoracic Surgery, considered to be among the top-rated abstracts at STS.

"Our goal is to provide surgeons with new technology to help them provide a more complete resection to more patients. This gives patients the best chance of improved outcomes after surgery," said Christopher Barys, president and CEO of On Target Laboratories.

Lung cancer is the leading cause of cancer-related deaths in the United States. Pulmonary resection, either a wedge resection, segmentectomy, or lobectomy, is recommended for most patients who have operable stage I-II non-small cell lung cancer. Intraoperative molecular imaging (IMI)—also referred to as fluorescence-guided surgery—may increase the likelihood of a more complete surgical resection, which could translate into increased survival for patients and reduced re-operations or adjuvant treatment for hospitals.

Conducted over 18 months, the study included 92 patients eligible for analysis. There were no drug-related serious adverse events and 24 patients (26 percent) were impacted during pulmonary resection, with eight percent of patients having a change in their stage due to the use of IMI.

The study showed that IMI improved localization of small and peripheral lesions, which can be difficult for surgeons to identify visually or through manual palpitation, and enabled localization of otherwise unlocalizable lesions in 11 patients (12%). Further ten additional cancers were found in seven patients (8%). During the Specimen Check Phase, when the surgeon confirms the nodule is in the specimen and analyzes the margins, surgeons felt all margins were adequate, yet back-table inspection using IMI revealed inadequate margins in eight patients (9%).

"OTL38 is the first technique that is specific to imaging adenocarcinomas of the lung, which is one of the most common types of invasive lung cancer," said Inderpal (Netu) S. Sarkaria, MD, Department of Cardiothoracic Surgery at the University of Pittsburgh Medical Center in Pennsylvania. "Near-infrared imaging with OTL38 may be a powerful tool to help surgeons significantly improve the quality of lung cancer surgery by more clearly identifying tumors and allowing the surgeon to better see and completely remove them—one of the most vital components in the overall care of patients with this disease."

OTL38 is under development in two Phase 3 clinical trials for lung and ovarian cancer indications. Both trials are being conducted under a Special Protocol Agreement with the FDA. OTL38 has also received a Fast Track designation for both the lung and ovarian cancer indications and an orphan designation for ovarian cancer from the FDA.

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories’ fluorescent markers are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. These markers illuminate the cancerous lesions, lighting the way for the resection of malignant tissue and enabling surgeons to see and remove more diseased tissue.

On Target’s first novel compound, OTL38, targets folate receptors commonly found on many cancers, including lung and ovarian cancers. A small single dose of the compound is administered via IV infusion one to 24 hours before surgery, allowing the surgeon to identify malignant tissue during the procedure using the near-infrared camera.

On January 27, 2020 Amgen (NASDAQ:AMGN) reported that it will report its fourth quarter and full year 2019 financial results on Thursday, Jan. 30, 2020, after the close of the U.S. financial markets (Press release, Amgen, JAN 27, 2020, View Source [SID1234553594]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On January 27, 2020 Human Longevity, Inc. (HLI), an innovator in providing data-driven health intelligence and precision health to physicians and patients, reported the publication of a groundbreaking study in the journal Proceedings of the National Academy of Sciences (PNAS) (Press release, Human Longevity, JAN 27, 2020, View Source [SID1234553593]). The study titled, "Precision medicine integrating whole-genome sequencing, comprehensive metabolomics, and advanced imaging," showed that by integrating whole-genome sequencing with advanced imaging and blood metabolites, clinicians identified adults at risk for key health conditions. Data from 1190 self-referred individuals evaluated with HLI’s multi-modal precision health platform, Health Nucleus, show clinically significant findings associated with age-related chronic conditions including cancer, heart disease, diabetes, chronic liver disease, and neurological disorders — leading causes of premature mortality in adults.

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"The goal of precision medicine is to provide a path to assist physicians in achieving disease prevention and implementing accurate treatment strategies," said C. Thomas Caskey, MD, FACP, FACMG, FRSC, chief medical officer for Human Longevity, Inc., lead author of the study, and a member of the National Academy of Sciences. "Our study showed that by employing a holistic and data-driven health assessment for each individual, we are able to achieve early disease detection in adults."

Study highlights include:

Approximately 1 in 6 adult individuals (17.3%) had at least one pathogenic genetic variant, and when integrated with deep phenotyping (imaging, blood test, etc.), 1 in 9 (11.9%) had genotype and phenotype associations, supporting the clinical diagnosis of a genetic disorder.
Additional highly actionable findings in this self-referred cohort, most of which were not previously known, include:
Insulin resistance and/or impaired glucose tolerance (34.2%)
Elevated liver fat (29.2%)
Cardiac structure or function abnormalities such as valvular disorders (16.2%)
Significant calcified coronary artery plaque (calcium score > 100) (11.4%)
Elevated liver iron (9.3%)
Cardiac arrhythmias such as atrial fibrillation (6.1%)
Cardiac conduction disorders (4.8%)
Early stage tumors, most malignant (1.7%)
A lack of phenotype and genotype associations were observed in 5.8% of individuals with pathogenic genetic variants, further suggesting that the identification of pathogenic genetic variant(s) by sequencing alone is not sufficient for a definitive diagnosis, highlighting the importance of a multi-modal assessment.
Genomics and metabolomics associations revealed 5.1% of heterozygous carriers with phenotype manifestations, affecting serum metabolite levels, suggesting that some genetic carriers may not be completely asymptomatic.
"This study shows that the definition of ‘healthy’ may not be what we think it is and depends upon a comprehensive health evaluation," said J. Craig Venter, PhD, founder, Human Longevity, Inc. and a member of the National Academy of Sciences. "The data underscore Human Longevity’s innovative approach to helping clinicians with early detection and personalized treatments, potentially achieving better health outcomes for patients."

"Our traditional approach to the annual health assessment has been very superficial and will need to be replaced by data-driven measures that will be made possible as costs continue to decline for whole-genome sequencing, advanced imaging, especially MRI, and specialized blood analytics," said David Karow, MD, PhD, president and chief innovation officer, Human Longevity, Inc.

ABOUT THE STUDY

The study cohort was composed of 1190 self-referred participants who enrolled at Health Nucleus with a median age of 54 y (range 20 to 89+ y, 33.8% female, 70.6% European). A multidisciplinary team, including cardiologists, radiologists, primary care physicians, clinical geneticists, genetic counselors, and research scientists, integrated deep phenotype data with genome data for each study participant. Participants were enrolled in the study between September 2015 and March 2018.

On January 27, 2020 OncoImmune, Inc. reported that clinical data from its Phase IIa clinical trial of CD24Fc are being presented at the 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Meeting, taking place in Orlando, Florida in February (Press release, ONCOIMMUNE, JAN 27, 2020, View Source [SID1234553592]). The Phase IIa data will be presented by the study’s Principle Investigator, Dr. John Magenau of the University of Michigan’s Department of Medicine, at 11:15 am on February 21. Dr. Pan Zheng, the Chief Medical Officer of OncoImmune, Inc., will present Phase III clinical trial design in a poster session on February 19-20th.

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CD24Fc is OncoImmune’s first-in class fusion protein that selectively represses inflammation induced by tissue injury while preserving innate immune response to pathogens. The Phase IIa study is a randomized, double blind, placebo controlled, multi-center study to investigate adding CD24Fc to standard of care tacrolimus and methotrexate in acute graft-versus host disease (GVHD) prophylaxis for allogeneic hematopoietic stem cell transplantation (HCT) with matched unrelated donors in treatment of leukemia and myelodysplastic syndrome. The trial included three CD24Fc dose cohorts: 240 mg at day -1, 480 mg at day -1, and the multi-dose cohort of 480-240-240 mg at day -1, day 14 and day 28. CD24Fc has received orphan drug designation from both the US FDA and European Medical Agency (EMA) for GVHD prophylaxis.

The presentation, entitled, "Mitigating Damage Response with CD24 Fusion Protein for Prevention of Acute Graft-Versus Host Disease," compares safety and efficacy data of CD24Fc when used in combination with standard of care GVHD prophylaxis compared to placebo and historical controls. The results demonstrate that CD24Fc was safe and well tolerated in the patient population. More importantly, patients receiving CD24Fc performed significantly better than placebo and historical controls in 180 day grade III-IV GVHD-free survival, the planned primary endpoint for the Phase III trial. These data thus provided strong support for the primary endpoint and dosing regimen of the upcoming phase III clinical trial. Moreover, significantly better relapse free survival (RFS) was observed over placebo control and historical controls. Overall survival (OS) was also significantly improved when compared with a matched historical control. Furthermore, a significant, dose-dependent reduction of mucositis was observed.

"We are very excited by the data observed in the Phase IIa clinical trial. In addition, we have completed enrollment of an open label Phase II expansion study where the drug continues to perform very well with clear signs of clinical efficacy," said Dr. Pan Zheng. "HCT is a curative therapy for refractory leukemia patients but hampered by GVHD, leukemia relapse and conditioning toxicity. As suggested by our preliminary data, CD24Fc shows significant promise in all three of these outcomes and would likely be transformative for the HCT field," she continued.

On January 27, 2020 Immunomic Therapeutics, Inc. reported that it will present data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses and inhibits tumor growth when used with its investigational vaccine, ITI-4000, in mice (Press release, Immunomic Therapeutics, JAN 27, 2020, View Source [SID1234553591]). In preclinical studies, ITI-4000, a DNA vaccine targeting EBNA1, demonstrated robust activation of anti-tumor CD4 and CD8 T cells in vivo and promoted tumor infiltration with activated TNFα-producing CD8 T cells. Intratumoral IL-12-producing dendritic cells and iNOS-producing macrophages were also induced by the vaccine. This data will be presented at the SITC (Free SITC Whitepaper)-ASCO Clinical Immuno-Oncology Symposium in Orlando, Florida.

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"ITI-4000 is an innovative and novel approach to an EBV-tumor vaccine," says Rich Ambinder, M.D., Ph.D., Director of the Division of Hematologic Malignancies and Professor of Oncology at Johns Hopkins, Immunomic’s Scientific Advisory Board member, and expert in viral-driven malignancies.

Current treatment strategies for nasopharyngeal carcinoma are limited to radiation and chemotherapy, demonstrating a need for new, targeted therapies. Most nasopharyngeal carcinomas express Epstein-Barr nuclear antigen 1 (EBNA1), a sequence-specific DNA-binding protein involved in maintenance of the episomal virus genome that is required for EBV latency and associated transformation. Targeting EBNA1 allows for an immunotherapeutic approach by exploiting the potential of the immune system to recognize tumor cells through their expression of this viral antigen. We designed a DNA vaccine encoding EBNA1 using the UNITE platform (ITI-4000). The UNITE platform is based in part on lysosomal targeting technology which results in enhanced antigen presentation and a balanced T cell response. We report that the ITI-4000 induced IFNγ- and TNFα-producing effector memory CD4 T and CD8 T cells, with complete rejection of EBNA1-expressing tumors observed in 50% of mice. Mice rejecting tumors were protected from rechallenge with CT26-EBNA1, demonstrating that antigen-specific memory was induced in these animals. These pre-clinical data suggest that ITI-4000 has the potential to be used as an immunotherapeutic agent against EBV-associated cancers.

Poster Session B

Poster Title: The Effect of Lysosomal-associated membrane protein-1-targeting of Epstein–Barr virus nuclear antigen 1 (EBNA1) elicits potent immune responses and inhibits tumor growth in preclinical studies

Date and Time: 02/07/2020, 11:30 AM – 1:00 PM; 02/07/2020, 6:00 PM – 7:00 PM

Abstract ID: #74

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release, and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy, and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.