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The Canadian Intellectual Property Office intends to grant RhoVac’s patent application for RV001 (onilcamotide) cancer vaccine

On January 24, 2022 RhoVac AB ("RhoVac") reported that the Canadian Intellectual Property Office ("CIPO") has issued a "Notice of Allowance", which means that it intends to grant RhoVac’s patent application for RV001 (onilcamotide) cancer vaccine (Press release, RhoVac, JAN 24, 2022, View Source [SID1234606747]). The company has previously been granted patents relating to onilcamotide in USA, Europe and Japan. The Canadian patent will provide RhoVac’s onilcamotide vaccine with broad protection in a key market and significantly strengthens the company’s patent portfolio.

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The Canadian Intellectual Property Office ("CIPO") has communicated its intention to grant RhoVac’s Patent Application No. 2,710,061. The patent covers RhoVac’s onilcamotide cancer vaccine, possible variants of the vaccine and the use of such vaccines in the treatment or prevention of metastatic cancer where RhoC is expressed. Once the issue fee is paid by RhoVac and necessary formalities have been completed by CIPO, the patent will be granted. The patent term will then extend to December 2028, potentially longer if an application for a Certificate of Supplementary Protection is filed and granted in Canada.

Patents from this first patent family have previously been granted in USA, Europe and Japan for treatment with onilcamotide of metastatic cancer expressing the RhoC protein. The Canadian patent, when granted, will complement these granted patents and another pending US application in this family

CEO Anders Månsson comments:"This patent provides very important protection for our cancer vaccine in Canada, which is an important territory for innovative therapies such as onilcamotide. This patent, when granted, will give product protection for our vaccine, along with additional protection for its use in the treatment and prevention of metastatic cancer [where RhoC is expressed], and in combination therapies".

Illumina collaborates with National Cancer Center Japan to address a leading cause of death in Asia

On January 24, 2022 Illumina, Inc. (NASDAQ: ILMN) and the National Cancer Center Japan reported an international joint research project that will use Illumina’s high-throughput DNA sequencing to analyse the blood-based genomic profile and clinical information of patients living with Nasopharyngeal Carcinoma (Press release, Illumina, JAN 24, 2022, View Source [SID1234606746]). The study will be known as a part of the Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing (A-TRAIN).

We are immensely proud to contribute to this international collaboration and prospective study. Through our joint efforts, we will fuel initiatives that improve health outcomes for people living with nasopharynx cancer and progress the development of personalized treatment, especially those in the Asian community where this carcinoma is most prevalent.
One of the main research areas of the project is nasopharyngeal carcinoma, a rare tumor of the head and neck which originates in the nasopharynx and has a higher incidence rate in Asian countries. More than 80 percent of new cases occur in Asia, with Southeast Asian countries accounting for 67 percent of the global burden of all cancer. Nasopharyngeal cancer ranked ninth among incident cancers and eighth among cancer deaths in Southeast Asia.

"We are immensely proud to contribute to this international collaboration and prospective study," said Gretchen Weightman, Head of Global Commercial Strategy and General Manager of Asia Pacific and Japan at Illumina. "Through our joint efforts, we will fuel initiatives that improve health outcomes for people living with nasopharynx cancer and progress the development of personalized treatment, especially those in the Asian community where this carcinoma is most prevalent."

"As nasopharyngeal carcinoma occurs more frequently in Asia and is more difficult to treat, there is a strong need to develop new treatments," said Dr. Kan Yonemori, Principal Investigator at A-TRAIN. "A comprehensive genome profiling panel is a powerful tool to help solve this problem by using blood for genetic analysis. We are grateful for Illumina’s support in enabling this important research in numerous Asian countries."

The A-TRAIN study led by the National Cancer Center Hospital Japan is an international joint research project in a number of Asian countries to develop novel treatments based on genomic abnormalities for cancers that are common in Asia. The overall project includes research involving patients with cervical cancer, ovarian cancer, ovarian clear cell carcinoma, nasopharyngeal carcinoma, endometrial cancer and breast cancer, the database will be constructed and analysed by examining genomic abnormalities comprehensively by liquid biopsy, together with clinical information such as treatment details and prognosis.

The study will be conducted as part of an international collaborative study under the Asian clinical TriaLs network for cAncerS (ATLAS) project, which aims to accelerate the implementation of clinical research and to develop personalized treatments. In this study, genomic analysis of blood samples of up to 96 patients with nasopharynx cancer will be analyzed using Illumina’s TruSight Oncology 500 ctDNA.

Over the next year, the resulting data will be used by the Japan-led initiative to establish a platform for international collaborative trials with Malaysia, Thailand, the Philippines, Indonesia and Vietnam, which are actively promoting cancer treatment development in the Asian region.

About TruSight Oncology 500
TSO 500 is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500. To learn more about TSO 500, click here.

NCCN Announces Funding for Lung and Thyroid Cancer Quality Projects, in Collaboration with Lilly

On January 24, 2022 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported new funding for quality projects to improve patient care and outcomes in lung and thyroid cancers (Press release, NCCN, JAN 24, 2022, View Source [SID1234606745]). Funding will be provided through support from Eli Lilly and Company (Lilly).

"The overall goal of this project is to develop innovative healthcare provider and systems performance and quality improvement initiatives to enhance patient care and outcomes in non-small cell lung cancer and thyroid cancer" said Crystal S. Denlinger, MD, FACP, Senior Vice President, Chief Scientific Officer, NCCN. "Congratulations to all of these inspiring investigators. We are eager to learn their findings and hope they can be expanded to other practices as well."

The selected projects are:

Waddah Arafat, MD, UT Southwestern Simmons Comprehensive Cancer Center
Harnessing an Electronic Health Record (EHR) Genomics Module to Guide Clinical Decisions for Non-Small Cell Lung Cancer (NSCLC) Care
Grace K. Dy, MD, Roswell Park Comprehensive Cancer Center
Multidisciplinary Workflow Optimization to Overcome Challenges in Biomarker Testing and to Expedite Biomarker-Based Treatment Decisions for Patients with NSCLC
Cristina P. Rodriguez, MD and Perrin E. Romine, MD, MSc, University of Washington School of Medicine/Seattle Cancer Care Alliance
Streamlining Molecular Profiling of Thyroid Malignancies in an Academic Tertiary Referral Oncology Center and its Community Satellite Clinics
John Strickler, MD, Duke Cancer Institute
Expansion of the Duke Molecular Tumor Board to Community Oncology Sites Across the Southeast to Support Adoption of Comprehensive Genomic Profiling and Biomarker Driven Therapy Selection for Lung and Thyroid Cancer Patients
"Lilly is committed to supporting initiatives that increase the appropriate use of comprehensive biomarker testing in metastatic non-small cell lung cancer and thyroid cancer," said Anthony N. Sireci, MD, MSc, Vice President, Clinical Biomarkers and Diagnostics Development Loxo Oncology at Lilly. "We are proud to collaborate with NCCN on the selected projects to explore how the proposed innovations can ultimately improve patient care and outcomes."

Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert oncologists from NCCN Member Institutions. It is known that predictive biomarker testing on tumor-derived tissue or circulating tumor DNA (ctDNA) plays an important role in the treatment decision-making process for both metastatic non-small cell lung cancer as well as metastatic thyroid cancers. The goal of this project is to provide funding to study projects that, ultimately, are aimed at helping healthcare professionals deliver the optimal guideline-adherent treatment to each patient at the appropriate time. The selected projects are set to be completed within two years. The total amount of grants awarded for this research is approximately $1.2 million.

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website, an informed consent database, and points to consider on the best practices for biorepositories, registries, and databases. For more information, visit NCCN.org/orp.

ImmVira’s New-Generation Vector Poised to Enable CAR-T Treatment for Solid Tumors

On January 24, 2022 Demonstrating innovation leadership on a global level, ImmVira reported that, its custom-designed new-generation oncolytic herpes simplex virus ("oHSV") vector enabling CAR-T treatment for solid tumors has started pilot-scale manufacturing and Pharmacological and toxicological studies for IND filing in both the U.S. and China (Press release, Immvira, JAN 24, 2022, View Source [SID1234606744]).

Solid tumor has long been a challenge for CAR-T. Major obstacles include solid tumor heterogeneity, lack of tumor associated antigens as CAR-T targets, complicated tumor microenvironment ("TME"), inadequacy of T-cell homing to the tumor site, T-cell immunosuppression and exhaustion and etc. While most efforts continue to focus on further modification of CAR-T cells, including locating highly-specific targets, receptor modification, recognition of multiple antigens, modulating CAR-T viability through other drugs, incorporation of external "weapons" to overcome immunosuppression and etc. ImmVira takes a new approach, leveraging viral vectors that can modify the tumor into targets to achieve a more direct and safe effect. The first three products of MVR-T7 series are MVR-T7011 with the combination of CD19 and BCMA, MVR-T7012 with the combination of CD19 and Trop-2, and MVR-T7013 with the combination of CD19 and HER-2. With MVR-T7, extracellular domains of aforementioned biomarkers can be continuously and precisely expressed on the cell membranes of solid tumors after customized oHSV entering into tumor site, providing targets for CAR-T treatment. At the same time, MVR-T7 series also carry chemokine CCL5, PD-1 antibody and IL-12 genes to further enhance the killing effects on tumor cells.

The design principle of MVR-T7 series is to use oHSV as vector to safely deliver biomarkers that have demonstrated success in CAR-T treatment of hematologic malignancies and make these biomarkers viable in solid tumors. Specifically engineered to allow biomarkers to be precisely expressed on target tumor cell membranes with a long and continuous time window, CAR-T therapy can be enabled on solid tumors without any further modification on the CAR-T cells targeting blood cancer. In addition, oncolysis caused by oHSV turn dense solid tumor tissues soft and loose, allowing CAR-T penetration into solid tumor stroma. More importantly, incorporation of CCL5 carried by the product enhances T-cell infiltration in solid tumors. CCL5 attracts and activates T-cells, and also promote macrophages and dendritic cells to secret CXCL9 thus further promoting circulating T-cell infiltration. Besides tumor modification, exogenous therapeutic genes including PD-1 antibody and IL-12 can induce prompt IFN-γ secretion to create 3-in-1 anti-tumor effects. The elegant design is a breakthrough to achieve maximum treatment benefit for CAR-T therapy on solid tumors.

As CAR-T enabler, MVR-T7 series made optimal modification of viral vector, combinations of biomarkers, chemokines and promoters based on scientific and treatment target specific design, in accordance with scientific foresight and clinical application. Completing rigorous in-vitro and in-vivo experiments, these three products did not compromise proliferation and viability of CAR-T and showed significant anti-tumor activities used in combination with CAR-T. Currently, ImmVira has independently completed in-house pilot-scale manufacturing for MVR-T7011, the first product of MVR-T7 series, and comprehensively launched extensive research for the purpose of IND application with strategic partners. In recent years, several CAR-T products have been approved as treatment, this breakthrough to treat solid tumors will open a significant market opportunity for CAR-T therapy.

ImmVira’s unique approach to modify the tumor environment paves way for a large range of current and emerging cancer therapies to become more effective. In addition to CAR-T, MVR-T7 series is designed to enhance treatment outcome when in combination with CAR-NK, ADC and BiTE. ImmVira will continue to adhere to a science-driven, original innovations and patient-focused philosophy, to continue research and development of new viral vectors drugs. Meanwhile, non-viral vector anti-tumor pipelines research, such as engineering exosomes for targeted drug delivery are underway with innovations in specific delivery scenarios or safety parameters to reignite the hope for patients around the world.

Preclinical Data on NT-I7 Published in Clinical Cancer Research

On January 24, 2022 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported the publication of preclinical data evaluating the company’s lead asset NT-I7 (efineptakin alfa), a novel T cell amplifier, in mouse models of glioblastoma (GBM) (Press release, NeoImmuneTech, JAN 24, 2022, View Source [SID1234606742]). The data come from a publication titled "Long-acting recombinant human interleukin-7, NT-I7, increases cytotoxic CD8 T cells and enhances survival in mouse glioma models," in the Clinical Cancer Research journal. The paper was published in collaboration with lead author Dr. Jian Li Campian, M.D., Ph.D., of the Mayo Clinic and Principal Investigator of this study, along with additional authors from NeoImmuneTech. These data show that NT-I7, in combination with radiation therapy, significantly prolonged survival in two glioma models dependent on the NT-I7-driven increase of CD8 T cells.

This study utilized a murine model of glioblastoma, in which one dose of NT-I7 significantly boosted lymphocyte levels in the blood, lymphoid organs and tumor and enhanced the anti-tumor response in animal. When NT-I7 was combined with radiation therapy, this translated to a significant improvement in mouse survival; the addition of temozolomide (TMZ) offered no additional survival improvement.

"The standard of care for glioblastoma patients is radiation and TMZ, a treatment regimen which causes severe prolonged lymphopenia that is associated with lower patient survival," said Dr. Campian. "NT-I7 demonstrated the ability to correct this treatment-related lymphopenia in our study, and this potential is extremely promising in the pursuit to improve outcomes for patients with glioblastoma."

In addition, data showed that NT-I7 promoted an inflamed tumor microenvironment by significantly increasing the CD8 to Treg ratio, and enhanced the anti-tumor response by increasing the infiltration of IFNγ-expressing T cells in the tumor. While chemoradiation caused a notable decrease in the number of CD4 and CD8 T cells in the lymph nodes, the addition of NT-I7 not only restored these numbers but in some cases surpassed the levels seen in untreated controls.

NT-I7 is currently under evaluation for the treatment of glioblastoma in an ongoing Phase 1/2 trial (NCT03687957).

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.