On January 24, 2020 Ervaxx, a biotechnology company pioneering the use of Dark Antigens to develop T-cell receptor (TCR)-based immunotherapies and off-the-shelf cancer vaccines, reported that it has entered a licensing and research collaboration with a leading T-cell immunology group at Cardiff University (Cardiff, UK) (Press release, Ervaxx, JAN 24, 2020, View Source [SID1234553525]).

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The new collaboration will support a multi-year research program with Prof. Andrew Sewell’s T-cell modulation group at Cardiff University focusing on the discovery and characterization of T-cells and TCRs reactive to cancer-specific antigens and ligands, including Ervaxx’ proprietary Dark Antigens. Ervaxx will fund the program.

The collaboration will also advance exciting new research published earlier this week by the Cardiff University team in Nature Immunology1, where they identified a T cell clone that recognized and killed multiple different types of human cancer, while remaining inert to non-cancerous cells. The T cell clone targets MR1, an MHC class 1-related protein, via an unidentified cancer-specific ligand. These exciting findings, validated in a preclinical model, open the prospect of immunotherapies with broad utility across patients with diverse cancers. This approach into previously unexplored cell surface epitopes complements and extends Ervaxx’s exploration of novel cancer-specific antigens.

Under the agreement, Ervaxx gains an exclusive license to relevant Cardiff University patents claiming T cells and TCRs reactive to cancer-specific antigens. The Company has the right to advance resulting candidate T-cell/TCR-based immunotherapeutics and cancer vaccines through development and commercialization. Cardiff University is eligible to receive milestone payments on any candidates that advance from the discovery collaboration into clinical development and royalty payments on sales of any products that reach the market.

"Ervaxx’s Dark Antigens, which are derived from the 98% of the genome that does not encode known proteins, constitute a promising and yet untapped source of targets for immunotherapies. This collaboration will use our world-class expertise in T-cell biology to identify T cells and TCRs reactive to those targets and pave the way for a new wave of treatments in cancer, and potentially other areas. This includes our most recent discovery, published in Nature Immunology, of a T-cell clone that targets MR1 to recognize and kill cancer cells, irrespective of cancer or human leukocyte antigen (HLA) type, offering opportunities for pan-cancer, pan-population cancer immunotherapies."

Prof. Andrew Sewell, Head of the T-cell modulation group, Cardiff University
"We are excited to announce this collaboration with Prof. Sewell’s world-class research group. We have great hope that through the combination of this expertise with our Dark Antigens and application of our EDAPT platform, we will be able to identify further targets to expand our portfolio of TCR-based therapies and cancer vaccines. We are also thrilled to contribute to the development of the group’s exciting new MR1 research, which shows early but enormous potential for the treatment of cancers. This partnership, which follows those with the University of Oxford, University of Cambridge and Johns Hopkins University School of Medicine, reinforces our ambition to collaborate with leading academic institutions and be at the cutting edge of the T-cell immunology field to drive the development of novel off-the-shelf cancer therapies .

On January 24, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMvigor010 study evaluating Tecentriq (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC) (Press release, Hoffmann-La Roche, JAN 24, 2020, View Source [SID1234553544]). Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.

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"Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers."

The goal in treating MIUC early is to reduce the risk of the disease recurring or spreading to other parts of the body. More treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within 2 years of surgery.1

In addition to ongoing Phase III studies in early and advanced bladder cancer, Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMvigor010 study
IMvigor010 is a global Phase III, open-label, randomised, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared to observation in 809 people with MIUC, who are at high risk for recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomisation to invasive urothelial cancer recurrence or death.

About bladder cancer and muscle-invasive urothelial cancer
In 2018, there were over half a million new cases of bladder cancer diagnosed globally, with approximately 200,000 deaths from the disease.2 Urothelial cancer is the most common type of bladder cancer, accounting for about 90–95% of all cases.3 MIUC is a type of urothelial cancer that has spread into the muscle of the bladder, ureter or renal pelvis.4 Approximately 25% of new cases of bladder cancer are diagnosed with muscle-invasive disease,5 which is associated with a poorer prognosis than non-MIUC.4

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

On January 24, 2020 University Hospitals Seidman Cancer Center reported that it treated its first patient in a new clinical trial to validate the groundbreaking effects of the poliovirus on glioblastoma (GBM), a deadly Grade IV cancer of the brain (Press release, University Hospitals, JAN 24, 2020, View Source [SID1234553527]).

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UH is the only Midwest site participating in this clinical trial, which was initiated at Duke Cancer Institute in Durham, NC. The original study, which ran from 2012-2017, was published in New England Journal of Medicine in July 2018 as well as highlighted on "60 Minutes" in 2015 and again in 2018. The study found that survival rates were significantly higher in glioblastoma patients who received an intratumoral infusion of a modified viral chimera combining the polio and rhinoviruses (PVSRIPO immunotherapy) compared to patients receiving standard treatment at the same institution.

"We are proud that University Hospitals was selected as one of a handful of top brain tumor centers such as the Massachusetts General Hospital and UCSF to participated in this Phase II clinical trial based on our expertise in immunotherapy and reputation for treating brain tumors," said Andrew E. Sloan, MD, FAANS, FACS, Director of the Brain Tumor and Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at UH Seidman Cancer Center and the UH Neurological Institute. "We want to offer this treatment opportunity to patients with recurrent glioblastomas who want to pursue groundbreaking alternatives that may improve their chances of survival from the most challenging of brain cancers."

The 59-year-old man first enrolled in this trial suffered from glioblastoma that recurred after initial surgery and treatment. Following a biopsy to verify the progression of the brain tumor, Dr. Sloan placed a catheter into the tumor and the modified attenuated poliovirus was convected through the catheter into the tumor the next morning. Through this process, known as convection enhanced delivery (CED) and performed in the NeuroIntensive Care Unit at UH Cleveland Medical Center, the poliovirus attacks the tumor creating an anti-tumor immune response. The patient went home the next day.

"This trial uses a polio virus modified to specifically target a receptor (CD155) found only on tumor cells," Dr. Sloan said. "While it only kills a small number of tumor cells directly, the virus and the immune response it exerts exposes these tumor cells, which have been hiding from the immune system and creates a significant anti-tumor immune response that takes over and kills the rest of the tumor that the virus has not destroyed. Unlike the native polio virus, the modified virus does not attack neurons."

Traditionally, survival from a GBM is less than a year, and patients typically live less than six months after recurrence. The survival rate among those receiving PVSRIPO immunotherapy was 21 percent at 24 and 36 months, much higher than the 4 percent survival rate among historical controls treated at Duke, according to the article published in the New England Journal of Medicine on July 12, 2018.

Researchers at Duke first discovered that the poliovirus delivered directly into intracranial tumors was able to trigger a positive immune reaction, which led to a longer survival rate from the notoriously difficult-to-treat cancer. In Phase I of the clinical trial, doctors determined the correct dose of the virus to administer while mitigating side effects. In Phase II, researchers will compare outcomes in patients.

"The body has an amazing immunological memory," Dr. Sloan said. "If you’ve received the polio vaccine as a child, your immune system remembers that polio is a bad thing. The injection of the polio virus jump-starts the immune response, which in turn attacks the cancer."

On January 24, 2020 Bionetix, a biotech company developing novel oncology drugs; ProQinase, an oncology-focused contract research organization (CRO) recently acquired by Reaction Biology Corporation (Malvern/PA, USA); and MercachemSyncom, a chemistry CRO specializing in medicinal chemistry and comprehensive medicinal chemistry (CMC), reported they have signed a joint multiyear integrated drug-discovery project, starting from target identification (TI) up to clinical candidate selection on an undisclosed target aimed at acute myeloid leukemia (AML) (Press release, Mercachem, JAN 24, 2020, View Source [SID1234553571]). The goal of the three-party team is to advance the project to the clinical phase by 2023. The total investment sum is "significant, of multimillion Euros", but details are not being disclosed.

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"We are excited to start this new project with MercachemSyncom and ProQinase," said Dr. DooYoung Jung, CEO of Bionetix. "They have proven their quality in another project of ours, which is currently in the early development phase. When this new opportunity came up, our decision was quick and easy. We are convinced that the team will advance this program very efficiently."

Dr. Frank Leemhuis, Managing Director of MercachemSyncom, commented: "Our skilled and experienced team has a proven track record in medicinal chemistry and CMC and built valuable research assets, as the result of a consistent innovation strategy. This research project is an opportunity to build on these qualities, with the goal of serving and creating value for our client. ProQinase is ourtrusted biology partner, through years of collaboration. Together with Bionetix, we look forward to making essential contributions to this oncology program."

"We are very grateful for our long-lasting partnership with MercachemSyncom, which enables us to deliver combined top-class scientific expertise to Bionetix," said Dr. Sebastian Dempe, Chief Executive Officer of ProQinase. "This new opportunity of a multiyear collaboration, utilizing our entire breadth of oncology preclinical services, aims to develop a high-value asset for our mutual client. Working together on solid but flexible research plans, combined with efficiency, allow for short lead times and robust datageneration processes, which are key to the success of such integrated drug-discovery projects. With MercachemSyncom, we will make sure that our promises to Bionetix are met."

On January 24, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that it will host a key opinion leader symposium on the role of survivin in cancer biology and DPX-Survivac’s potential as a targeted immunotherapeutic agent across a range of tumor types (Press release, IMV, JAN 24, 2020, View Source [SID1234553529]). The event will be held on Thursday, February 27, 2020 from 8:30 – 10:00 a.m. ET in New York, NY.

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The event will feature presentations by key opinion leaders, including:

Sally P. Wheatley, Ph.D., Assistant Professor, School of Life Sciences, University of Nottingham;

Jeannine Villella, D.O., FACOG, FACS, Chair of Gynecologic Oncology, Department of Obstetrics and Gynecology, Lenox Hill Hospital and NYU Winthrop Hospital; and

Oliver Dorigo, M.D, Ph.D., Associate Professor of Obstetrics and Gynecology, Stanford University Medical Center, Stanford University Medical Center.

Additionally, IMV management will provide a corporate update, including an overview of recent data from ongoing studies of DPX-Survivac, which is currently being evaluated in three Phase 2 studies in advanced ovarian cancer, relapsed/refractory diffuse large B-cell lymphoma and a basket of solid tumor indications. Topline results are expected from all three studies in 1H20.

A live webcast of the event will be available under "Events, Webcasts and Presentations" in the Investors section of IMV’s website and will be available for replay approximately two hours following the live event.