On September 5, 2018 Innate Immunotherapeutics reported that it has elected to change the Company name to Amplia Therapeutics Limited and the Company stock code will change to ATX from IIL (Press release, Innate Immunotherapeutics, SEPT 5, 2018, View Source [SID1234529286]). The change received shareholder approval in a Special Resolution at the Company’s Annual General Meeting held on 30 August in Melbourne.

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The change of name is part of a wider branding refresh of the Company as it focuses on the development of a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an important therapeutic target that is significantly upregulated in highly fibrotic tumours such as pancreatic and ovarian cancer. Drugs targeting FAK have the potential to sensitize the tumour microenvironment to both immuno-oncology drugs and chemotherapies.

Amplia Chairman Dr. Warwick Tong, noted "The Amplia name reflects the therapeutic action of inhibiting FAK to ‘amplify’ the effect of existing immuno-oncology and chemotherapeutic drugs in a number of difficult to treat cancers".

Amplia’s lead drug candidate AMP945 is expected to have a significant clinical advantage over other FAK-targeting molecules because of its high potency and selectivity for FAK. Amplia is also developing AMP886, which is a multi-action inhibitor that, in addition to potent FAK activity, also modulates FLT3 and VEGF, both highly synergistic targets in a number of solid and hematologic cancers. The development of these drug candidates is supported by an international team of worldclass reseachers and clinicians.

On September 5, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the successful injection of the first patient under the amended protocol of the THINK trial, which assesses treatment with CYAD-01 after a non-myeloablative preconditioning chemotherapy regimen of cyclophosphamide and fludarabine in refractory metastatic colorectal cancer (CRC) patients (Press release, Celyad, SEPT 5, 2018, View Source [SID1234529285]).

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"The first dosing of CYAD-01 in the amended THINK trial marks another important step for our company," said Dr. Christian Homsy, CEO of Celyad. "CYAD-01 has shown promising signs of clinical activity as a standalone approach, and we are committed to maximizing the clinical benefit for patients by evaluating CYAD-01 in a range of clinical settings. We aim to evaluate the anti-tumor activity of CYAD-01 not only as a standalone approach, but also with prior preconditioning and standard of care chemotherapy in both hematological malignancies and solid tumors. These additional studies will elucidate the best clinical path forward for a patient population severely in need of new therapeutic options."

The amended THINK is a single arm, open-label, Phase I study designed to evaluate the safety and anti-tumor activity of CYAD-01 only in metastatic CRC patients following the administration of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²). Based on initial data from the trial, a per protocol expansion cohort may be initiated.

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-01 is currently in clinical development through a number of trials for hematological malignancies and solid tumors.

On September 5, 2018 Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company focused on delivering first-in-class biological therapies that have the potential to transform the lives of people with serious diseases, reported that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for US Patent Application No. 13/319597 (Press release, Immunocore, SEP 5, 2018, View Source [SID1234529281]). The allowed claims cover the optimal format for TCR-based T cell redirectors and will provide broad protection for the Company’s novel ImmTAC platform. The grant of this U.S. patent will complete broad patent protection for the ImmTAC platform in the US and adds to equivalent patent protection already obtained in other major territories including Europe and China. ImmTAC molecules are the first T cell redirectors to have demonstrated a durable response and robust overall survival rate in patients with solid tumours.

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Commenting on the announcement, Andrew Hotchkiss, Chief Executive Officer at Immunocore, said: "We are delighted that the USPTO has issued this Notice of Allowance, which will provide protection of our proprietary platform technology in the US until 2030. Together with other granted and pending patents, the Notice of Allowance cements the Company’s position as a leader in soluble TCR-based therapeutics."

Bent Jakobsen, Chief Scientific Officer at Immunocore and co-inventor of the technology, added: "The allowance of this patent application further exemplifies the Company’s world-leading science and innovation in the design of potent TCR-based biologics able to address some of the most difficult-to-treat tumours."

Immunocore’s extensive IP portfolio provides broad protection for the ImmTAC platform and serves to underpin the Company’s expanding pipeline of TCR-based biologics for the treatment of cancer and other serious diseases. The first ImmTAC to reach the clinic, IMCgp100 is in pivotal trials for the treatment of metastatic uveal melanoma, and a second ImmTAC molecule, IMCnyeso has recently commenced clinical testing for the treatment of various solid tumours.

On September 4, 2018 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that its collaborator ProMab Biotechnologies, Inc. ("ProMab") will present at the CAR-TCR Summit 2018 being held from September 4th – 7th, 2018 in Boston, Massachusetts (Press release, Helix BioPharma, SEP 4, 2018, View Source [SID1234530406]).

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Dr. Vita Golubovskaya, Director, R&D, BD of Promab Biotechnologies will present on September 5th at 12:25pm. The title of the presentation is "Novel CAR-T Cells Against Solid and Hematological Cancers". Dr. Golubovskaya’s presentation will include certain preclinical data from the multiple myeloma project currently in collaboration with Helix.

Helix continues to aim for a possible first-in-human CAR-T study in 2019. To achieve this goal, Helix’s wholly-owned Polish subsidiary Helix Immuno-Oncology ("HIO") will be leading the preclinical and clinical development program in Poland prioritizing a possible European clinical submission. Helix and HIO are engaging experts to advise on the program and are currently securing the necessary financial resources to meet the project timelines.

On September 4, 2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported publication of a preclinical study demonstrating that inhalation of a TLR9 agonist can stimulate effective immunity against lung tumors and complement the actions of PD-1 blockade to generate durable, systemic anti-tumor immunity (Press release, Dynavax Technologies, SEP 4, 2018, View Source [SID1234530120]). The paper titled Inhaled TLR9 Agonist Renders Lung Tumors Permissive to PD-1 Blockade by Promoting Optimal CD4+ and CD8+ T cell Interplay, by Dynavax scientists M.Gallotta, H. Assi, E. Degagné, S. Kannan, R.Coffman and C. Guiducci was published in the journal Cancer Research. The study demonstrated that combining an inhaled TLR9 agonist with systemic anti-PD-1 led to long-term survival in two different mouse lung tumor models, mediated by systemic immunity that eradicated tumors both in the lung and in distal organs. The study further delineated the distinctive mechanisms of action of these agents in the lung environment.

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Administration of the TLR9 agonist SD-101 into the lungs of mice with metastatic tumors generated anti-tumor responses that controlled or eliminated tumor growth in the lungs as well as in non-treated organs, including liver. Treatment with SD-101 resulted in ~90% decrease in tumor burden in both the lung and liver. This led to a significant increase in survival time, with a majority of mice surviving beyond 90-100 days. Treatment with SD-101 and anti-PD-1 resulted in a large increase of tumor-reactive T cells, which were required for anti-tumor activity. The durable control of liver metastases shows that local administration of SD-101 to the lung generates an anti-tumor T cell response capable of controlling tumor growth beyond the lung itself.

The TLR9 agonist used in these studies was SD-101, Dynavax’s lead clinical candidate currently being developed as an intratumoral agent in combination with anti-PD-1 therapy in patients with advanced melanoma and head and neck squamous cell carcinoma. Unpublished data demonstrates that another TLR9 agonist, DV281 – optimized for delivery to primary lung tumors and lung metastases – has equivalent activity in these models. These studies provide the preclinical rationale for the Phase 1b dose escalation study of inhaled DV281 currently being conducted by Dynavax in advanced non-small lung cancer patients (NCT03326752). DV281 and SD-101 stimulate potent Type 1 interferon induction along with maturation of dendritic cells into effective antigen-presenting cells. These combined actions lead to the increased numbers of cytotoxic T cells that are critical for the induction of effective systemic anti-tumor immunity.