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]).

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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.

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.

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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.

On January 24, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that its partners Bruce Power and Isogen (a partnership between Kinectrics and Framatome) have completed the installation of a groundbreaking Isotope Production System (IPS), becoming the first power reactor in the world with the installed capability to produce Lutetium-177 (Lu-177), a medical isotope used in the treatment of various cancers, such as neuroendocrine tumors and prostate cancer (Press release, ITM Isotopen Technologien Munchen, JAN 24, 2022, View Source [SID1234606741]). This system will also have the ability to produce other isotopes for medical uses over the long term.

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"This installation of the IPS is an exciting milestone on our journey to becoming the first power reactor in the world to provide a scalable, game-changing solution in the supply of life-saving medical isotopes for the global medical community," said James Scongack, Bruce Power’s Chief Development Officer and Executive Vice President, Operational Services. "Our medical Isotope Program and the IPS installation are a result of years of innovation and development in partnership with Isogen (a Framatome and Kinectrics company), Saugeen Ojibway Nation, and ITM; and will provide large-scale capacity to help produce medical isotopes, which will be used across the world in new treatments to fight cancer."

With the new system installed, activities will now shift to planned commissioning along with preparation activities for commercial production that will follow once these activities and regulatory submissions are successfully completed.

"Ontario is leading the way in the production and supply of medical isotopes around the world," said Hon. Todd Smith, Ontario’s Minister of Energy. "I’m proud of the innovative work being done by Bruce Power and its partners in the supply chain, including Framatome and Kinectrics. Their efforts are helping to further cement our position as an international isotope superpower, while providing critical medical tools to help meet the needs of patients battling cancer."

Lu-177 offers doctors an alternative to traditional chemotherapy by deploying a "seek-and-destroy" dose to target cancer cells while limiting damage to surrounding healthy tissues and organs.

The IPS was developed and manufactured by Isogen, a joint venture between Framatome and Kinectrics, that is focused on developing innovative isotope production technologies.

"The installation and successful transfer of the first target marks a major accomplishment and successful implementation of Framatome Healthcare technology; the first Isotope Production System (IPS) in a power reactor for commercial production of therapeutic medical isotopes," said Curtis Van Cleve, President and CEO of Framatome Canada Ltd. "We applaud the dedication and efforts of our partners, at Bruce Power, Saugeen Ojibway Nation, Kinectrics, ITM and our team, and the support of their families that allowed them to see this installation through."

"The installation of the IPS is the result of countless hours of support from many people at Bruce Power, Framatome, Kinectrics, Saugeen Ojibway Nation and our suppliers. The entire team demonstrated tremendous dedication, especially during the pandemic." said David Harris, CEO of Kinectrics. "This was a critical step to enable the production of Lutetium-177 for our partner, ITM, and to fortifying a strong, reliable, and large-scale global supply chain of life-saving isotopes, that both physicians and patients can depend on."

With its new IPS system, Bruce Power will conduct the irradiation of Ytterbium-176 (176Yb) as a first step in the production of no-carrier-added Lutetium-177 (n.c.a. 177Lu). Processing of the irradiated Ytterbium-176 for the production of n.c.a. Lutetium-177 as well as the global supply of n.c.a. 177Lu will be handled by ITM.

"The successful installation of this production site builds an important milestone in our partnership with Bruce Power and Isogen to scale-up the production of high-quality medical radioisotopes," said Steffen Schuster, CEO at ITM. "We look forward to the upcoming launch of the IPS system and are proud to contribute with our unique manufacturing methodology to yield high-quality n.c.a. 177Lu and to make it accessible for cancer patients worldwide."

The installation of the IPS is a significant step in the landmark isotope project, which is a partnership that began more than three years ago with over 400 dedicated professionals working on various stages of the project.

In November 2021, Bill Walker, MPP of Bruce-Grey-Owen Sound, introduced a Private Member’s motion – which passed with all party support – to assert Ontario’s leadership role in the production and supply of medical isotopes as a strategic priority for the province. Today’s announcement exemplifies that Ontario continues to be at the forefront of medical isotope technology.

"I want to congratulate Bruce Power, Framatome and Kinectrics on this important accomplishment," said MPP Walker. "Ontario has long been looked to as a leader in the medical isotope space, and these partners are playing an important role in the global supply chain to provide patients around the world with life-saving cancer treatments and diagnostic tools."

Bruce Power will market the new isotope supply in an historic collaboration partnership with Saugeen Ojibway Nation (SON). The partnership project with SON, named "Gamzook’aamin Aakoziwin," includes an equity stake for SON and a revenue-sharing program that directly benefits the SON.

"From the initial concept in 2019 to production expected in 2022, our Gamzook’aamin Aakoziwin project is on track to meet an ambitious timeline to have isotope supply ready to meet the increasing demand from doctors and cancer patients around the world," said Chief Lester Anoquot, Chippewas of Saugeen First Nation. "Saugeen Ojibway Nation is proud of the part we have played and will continue to play in this project."

"Short-lived medical isotopes are essential tools for doctors and researchers in the fight against cancer, and this project will provide a much-needed source of these isotopes for patients close to home, in our communities, and around the world," added Chief Veronica Smith, Chippewas of Nawash Unceded First Nation.

"Thanks to the investments being made into the Bruce Power site today we can look to the future and realize a vital role in providing life-saving medical isotopes to the world, while also supplying clean, reliable and low-cost electricity to Ontario, growing the economy and fostering innovation for decades to come," said Hon. Lisa Thompson, Minister of Agriculture, Food and Rural Affairs, and MPP for Huron-Bruce.

On January 24, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported that it will present data highlighting its portfolio of skin cancer tests at Maui Derm for Dermatologists 2022, being held Jan. 24-28, 2022, in Maui, Hawaii (Press release, Castle Biosciences, JAN 24, 2022, View Source [SID1234606739]).

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Presentation details are as follows:

Title: Integrating the 31-gene expression profile and clinicopathologic data to determine the risk of sentinel lymph node positivity and recurrence-free survival in cutaneous melanoma
Title: Appropriate utilization of the prognostic 40-gene expression profile (40-GEP) test for cutaneous squamous cell carcinoma (cSCC) demonstrated by clinical reports and physician evaluation of real-world cases
Title: Evidence review of the prognostic 40-gene expression profile test for cutaneous squamous cell carcinoma
Title: A comprehensive diagnostic offering workflow increases the rate of actionable results of the 23- and 35-gene expression profile tests for use as ancillary diagnostic tools for difficult-to-diagnose melanocytic lesions
All posters will be available for viewing digitally at the poster viewing station in the Haleakala Foyer, on monitors throughout the conference and through the conference app and virtual conference platform.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through Sept. 30, 2021, DecisionDx-Melanoma has been ordered 84,195 times for use in patients with cutaneous melanoma.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

On January 24, 2022 SeqOne Genomics, provider of next genomic analysis solutions for personalized medicine reported a Series A funding round of €20M (Press release, SeqOne, JAN 24, 2022, View Source [SID1234606738]).

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The round, led by Omnes, Merieux Equity Partners, together with the Software Club and existing investors, Elaia and IRDI Capital Investissement, will enable SeqOne Genomics to accelerate its international sales and the development of new collaborative genomic analysis tools to facilitate communications between different disciplines in the medical team, in order to improve patient outcomes in cancer and hereditary disease.

The company will intensify investments in the development of its genomic-aware data lake to improve the use of big data and machine learning approaches in genomic analysis with the aim of better addressing the fast-evolving needs of molecular biology labs that provide genomic analysis in clinical routine environments, as well as to biopharma companies developing new therapies.

SeqOne’s cloud-based solution manages the entire genomic analysis process from raw data to final report presented to clinicians. The solution’s end-to-end approach affords better analytic performance, high levels of traceability and improved operational efficiency and has already been adopted by a score of hospitals and central labs and biopharmas as well as spawning partnerships with leading manufacturers of genomics analysis hardware and reagents.

Nicolas Philippe, Ph.D., Co-founder and CEO of SeqOne Genomics stated "We are extremely happy to have closed this round with leading investors who bring extensive experience in deep-tech, healthcare and biotherapy and who share our vision of building SeqOne into a global leader in personalized medicine. The funding will give us the resources we need to enhance and commercialize our solution to make genomic analysis more accessible and affordable so that each patient can benefit from personalized medicine recommandations."

"The genomics analysis market is experiencing exponential growth driven by the needs of personalized medicine. With the rapid expansion in the available genomic-linked treatments, the complexity of treatment interactions, and the staggering volume of biological and medical data to be factored into each medical decision, biologists and doctors must have access to reliable and actionable analyses in real-time," stated Fabien Collangettes, Director at Omnes. "We were particularly impressed by SeqOne’s innovative technological approach that enables improved accuracy of genomic test while reducing turnaround time and cost, thus delivering a key competitive advantage in this fast-growing market."

With the closing of this round, SeqOne’s board of directors will be: Sacha Loiseau, Ph.D. independent board member and Chairman of the Board, Fabien Collangettes, Director at Omnes, Yoann Bonnamour, Investment Manager at Merieux Equity Partners, Marc Rougier, Partner at Elaia, Nicolas Philippe, co-founder and CEO of SeqOne Genomics and Jean-Marc Holder, Co-founder and Chief Strategy and Innovation officer of SeqOne Genomics.

This new funding round brings the total amount raised by SeqOne Genomics since its founding in 2017 to €23M.

The company currently employs over 40 staff, primarily experts in genomic medicine, data science, bioinformatics, software development and regulatory compliance / quality assurance. It plans to double its staff within the year to execute its ambitious plans.