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Second Quarter 2022

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NeoPhore Enters Three Year Research Collaboration with World Leading Oncologist’s Lab at Major US Cancer Center

On July 28, 2022 NeoPhore Limited, a small molecule neoantigen immuno-oncology company, reported that it has entered a three-year research collaboration agreement with Memorial Sloan Kettering Cancer Center (MSK) in New York, USA (Press release, NeoPhore, JUL 28, 2022, View Source [SID1234617111]). The objective of the collaboration is to determine the potential of NeoPhore’s proprietary DNA mismatch repair inhibitor (MMRi) compounds to enhance tumour immunogenicity and induce tumour immunity.

Building on seminal discoveries and ongoing research of its scientific founders and collaborators, NeoPhore is building a pipeline targeting novel proteins across the DNA mismatch repair (‘MMR’) pathway. The Company’s first-in-class MMR modulators alter the genotype of tumour cells to elicit increased tumour mutational burden, together with higher neoantigen presentation and tumour immunogenicity, which aim to reawaken the anti-tumour immune response and leverage sensitivity to immune checkpoint blockade.

Dr. Matthew Baker, Chief Executive Officer of NeoPhore, stated: "Collaborating with such prominent leaders in the field of applied cancer genetics is a great privilege. NeoPhore’s therapeutic concept aims to induce neoantigen creation and cancer immunity using small-molecule inhibitors of mismatch repair, particularly in combination with other immunotherapy approaches. We look forward to the outcome of this collaboration which will ultimately advance our goal to develop next-generation immuno-oncology therapeutics."

Immunic, Inc. to Announce Financial Results for the Second Quarter Ended June 30, 2022 and Provide Corporate Update

On July 28, 2022 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported that the company will release its financial results for the second quarter ended June 30, 2022, including a corporate update, on Thursday, August 4, 2022, before the opening of the U.S. financial markets (Press release, Immunic, JUL 28, 2022, View Source [SID1234617110]). A webcast will follow at 8:00 am ET.

To participate in the webcast, please register in advance at: View Source or on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations.

Nilogen Oncosystems Announces Opening of Clinical Trial Using Ex Vivo Tumoroids to Predict Immunotherapy Response in Non-Small Cell Lung Cancer (TUMORIN)

On July 28, 2022 Nilogen Oncosystems reported that its clinical observational study TUMORIN (NCT05332925) has commenced enrolment (Press release, Nilogen Oncosystems, JUL 28, 2022, View Source [SID1234617109]). Patients with advanced/metastatic NSCLC who are receiving immune checkpoint inhibitors in the standard of care clinical setting will be enrolled in the study . Nilogen will evaluate 3D-EXplore results with patient outcome data using advanced AI and machine learning algorithms to discover novel biomarker signatures as predictors of patient response and understand the fundamental mechanisms of action for each therapeutic to advance personalised treatment for patients based on the functional response of their cancer.

3D-EXplore is a fresh human tumor ex vivo explant platform which retains the immune compartment and full tumor microenvironment capturing the heterogeneity of the tumor while preserving its immune compartment, which are key to understanding the true response of tumor tissue to oncology therapeutics, allowing drug developers and clinicians to understand drug performance in human tissue, providing an informed approach to clinical development and patient response. This uniquely positions the platform to provide drug developers with answers to mechanistic questions about their immuno-oncology drug candidates and prioritize the most promising candidates for advancement into clinical trials, as well as enabling the discovery of complex biomarker signatures and supporting patient selection and co-clinical studies. For clinicians, the opportunity to select the most beneficial treatment regimen for patients based on functional response rather than surrogate markers will enable truly personalized cancer immunotherapy.

Nilogen Oncosystems Announces Clinical Trial Using Ex Vivo Tumoroids to Predict Immunotherapy Response in NSCLC

"Nilogen’s unique 3D-EXplore explant platform is already in use worldwide by Pharma and Biotech companies large and small to support translational and clinical studies, especially in immuno-oncology and with modalities like Bispecific antibodies, Cell Therapies, ADCs, ADCC, and Oncolytic Virus," said Soner Altiok, Chief Scientific Officer at Nilogen Oncsystems. "We are pleased to begin our observational clinical study to demonstrate the power of 3D-EXplore to predict patient response based on functional response data, with the aim to ultimately provide clinicians and patients with the ability to select the best therapy based on the real response of their cancer to therapies rather than surrogate markers."

3D-EXplore’s unique ability is to resolve tumor tissue heterogeneity and quantitatively and directly measure penetration, proliferation, tumor cell killing and phenotypic changes in the immune compartment and tumor microenvironment in fresh tumor tissue using advanced flow cytometry and high-content confocal microscopy. These complex datasets can be deconvoluted to deliver biomarker signatures and powerful treatment response predictions which can be correlated to clinical outcomes for a more effective and efficient cancer drug development approach. Our CLIA certified facilities enable us to work with patient samples to directly support clinical trials and patient treatment.

CytoImmune Therapeutics and City of Hope Announce First Patient Dosed in a Phase 1 Trial Evaluating a Novel Off-the-Shelf Engineered Natural Killer Cellular Therapy for the Treatment of Non-Small Cell Lung Cancer

On July 28, 2022 CytoImmune Therapeutics, a clinical-stage immuno-oncology company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, and City of Hope, one of the largest cancer research and treatment organizations in the United States reported that the first patient has been dosed in a Phase 1 clinical trial evaluating CYTO-102, a novel cellular therapy consisting of PD-L1-positive tumor-reactive TRACK-NKTM cells (Press release, CytoImmune Therapeutics, JUL 28, 2022, View Source [SID1234617108]). The trial is assessing CYTO-102 as a monotherapy and in combination with atezolizumab in patients with relapsed/refractory non-small cell lung cancer (NSCLC).

This innovative therapy is generated by genetically modifying NK cells to secrete high levels of soluble IL-15, an immune-signaling molecule crucial for optimal antitumor responses with the patient’s own immune system. The engineered NK cells are primed with cytokines IL-12 and IL-18 along with other signals during manufacturing to induce PD-L1 expression. The PD-L1-positive TRACK-NKTM cells are naturally directed to the tumor microenvironment where they are designed to kill the cancer cells as well as to coordinate the adaptive or T cell response by the patient’s own immune system.

"We are thrilled to initiate patient dosing with CYTO-102, in partnership with City of Hope, which marks our transition into a clinical-stage company and brings us an important step closer to understanding the potential our tumor-reactive NK cell-based therapies may have for treating patients with cancer," said Christina Coughlin, M.D., Ph.D., chief executive officer of CytoImmune. "We’ve engineered CYTO-102 to be an off-the-shelf cell therapy that can directly kill cancer cells, broadly stimulate the body’s own endogenous immune system, and enhance tumor killing through generation of a highly effective immune response ultimately leading to improved patient outcomes. We look forward to advancing this trial in an effort to bring the next generation of cellular therapies to patients in need."

"City of Hope is committed to making a difference in the lives of patients with cancer with a goal of transforming the future of cancer care," said Michael Caligiuri, M.D., president of City of Hope National Medical Center, Deana and Steve Campbell Physician-in-Chief Distinguished Chair and CytoImmune’s scientific founder. "NSCLC continues to be a challenging cancer to treat and despite advancements, too many patients are left without durable and effective options. We are pleased to advance this novel cellular therapy together with CytoImmune, which could offer patients with NSCLC a promising new treatment option."

The Phase 1, dose escalation clinical trial will evaluate the safety and tolerability, as well as key biologic endpoints of CYTO-102, including NK cell persistence and trafficking, tumor microenvironment changes and endogenous T and NK cell recruitment by CYTO-102, as both a monotherapy and in combination with atezolizumab, a PD-L1 inhibitor. The trial will enroll approximately 21 patients with relapsed or difficult-to-treat NSCLC. Details regarding the study can be found here.