On October 4, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies, reported an exclusive agreement with Horizon Discovery Group plc (LSE: HZD), for the use of its shRNA technology to generate Celyad’s second non-gene-edited allogeneic platform (Press release, Celyad, OCT 4, 2018, View Source [SID1234530340]).

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Celyad recently announced its first-in-class non-gene edited allogeneic CAR-T candidate, CYAD-101 a non-gene-edited allogeneic NKG2D-based CAR using the TIM (TCR Inhibiting Molecule). As a result of the agreement with Horizon Discovery, Celyad now also has access to a novel shRNA-based platform.

Data from preclinical studies demonstrating the versatility of the shRNA platform in the allogeneic setting, will be presented at the upcoming 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Washington, D.C., November 7th – 11th. These promising preclinical data will pave the way for the next steps in the development of Celyad’s differentiated non-gene edited allogeneic approach to CAR-T cell therapy.

"We are excited to have the opportunity to leverage Horizon’s shRNA platform to further advance our pioneering approach to non-gene edited allogeneic CAR-T cells", said Dr. Christian Homsy, CEO of Celyad. "Celyad is committed to rapidly advancing its allogeneic program based on highly promising preclinical data which will be presented at SITC (Free SITC Whitepaper). These data provide proof of concept for our shRNA based non-gene-edited allogeneic approach. In addition to very promising preclinical data, our allogeneic approach is also strengthened by Celyad’s strong patent estate in the U.S., which broadly covers the use of allogeneic CAR-T using cells that are TCR inhibited or suppressed by any means."

Jon Moore, CSO of Horizon Discovery added: "The high performance shRNA technology licensed by Celyad is the same as that deployed in our range of SMARTvector products and is designed to deliver efficient target knock down with high specificity. Horizon’s collaboration with Celyad is designed to let Celyad find a highly effective solution for its needs. Horizon sees its shRNA technology as a serious rival to gene editing approaches for delivering enhanced performance to therapeutic cell products. We see enormous promise in cell therapies and are committed to develop and supply innovative technologies that allow our partners to bring transformative cell therapies to the clinic and fulfil unmet clinical needs."

On October 3, 2018 Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company focused on nanotechnology-based cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 clinical study of CPI-100 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, OCT 3, 2018, View Source [SID1234532212]).

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CPI-100 is a structurally optimal core-shell nanoparticles based on CPI’s proprietary nanoscale coordination polymer (NCP) platform technology to selectively deliver immunostimulatory chemotherapeutic combinations to tumors, providing a new approach to initiate and stimulate immune-mediated eradication of cancer cells using synergistic nanomedicines. "FDA’s timely acceptance and approval of CPI-100 IND is an important milestone for the company. We are excited about the opportunity to study the first NCP-based product in clinical trials." said Wenbin Lin, Ph.D., founder and chairman of CPI and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We expect this study will generate important insights into the safety of CPI-100 and its preliminary therapeutic efficacy in cancer patients."

On October 3, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that clinical data on the company’s lead product candidate eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting being held November 7-11, 2018, in Washington, D.C (Press release, Immutep, OCT 3, 2018, View Source [SID1234529718]).

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Abstract titles and authors are:

Title: Results from a Phase I dose escalation trial (TACTI-mel) with the soluble LAG-3 protein (IMP321, eftilagimod alpha) together with pembrolizumab in unresectable or metastatic melanoma

Authors: Victoria Atkinson; Frederic Triebel; Christian Mueller; Chrystelle Brignone; Melissa Eastgate; Amitesh Roy; Adnan Khattak; Andrew Haydon

Title: A multicenter, phase II study in patients with first line NSCLC, or recurrent PD-X refractory NSCLC or with recurrent HNSCC receiving Eftilagimod Alpha in combination with Pembrolizumab (TACTI-002)

Authors: Martin Forster; Frederic Triebel; Christian Mueller; Chrystelle Brignone; Tatsiana Skrahina

The exact time of Immutep’s presentation and further details will be available closer to the conference date.

On October 3, 2018 Tomorrow, William Hearl, Ph.D., Chief Executive Officer (CEO) of Immunomic Therapeutics, Inc., will participate in a panel discussion on advanced therapeutics for oncology at the 18th Annual Biotech in Europe Forum. Dr. Hearl will discuss the potential capabilities of Immunomic’s UNiversal Intracellular Targeted Expression (UNITE) investigational technology as a comprehensive platform for precision immuno-oncology and beyond (Press release, Immunomics, OCT 3, 2018, View Source [SID1234529955]). Immunomic’s nucleic acid vaccines have the potential to use the body’s natural biochemistry to develop a broad immune response, including antibody production, cytokine release and critical immunological memory. This approach could put UNITE at the crossroads of immunotherapies in a number of illnesses, including cancer.

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Immunomic’s lysosomal targeting technology is currently being employed in a Phase II clinical trial as a cancer immunotherapy. The company is pursuing research in the early stages of three other specific oncology applications: hepatitis B and hepatocellular carcinoma, Epstein-Barr virus driven cancers, such as nasopharyngeal carcinoma, and human papilloma virus driven cancers.

On October 3, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that axicabtagene ciloleucel (formerly KTE-C19) has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL) and transformed follicular lymphoma (TFL), which are aggressive forms of non-Hodgkin lymphoma (NHL) (Press release, Daiichi Sankyo, OCT 3, 2018, View Source [SID1234530246]).

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"Receiving Orphan Drug designation is an important step in expediting the development of axicabtagene ciloleucel in Japan and underscores the unmet needs of patients with these aggressive forms of relapsed or refractory B-cell lymphomas," said Kouichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "This designation represents the third Orphan Drug designation granted for an investigational therapy in our oncology pipeline, demonstrating our commitment to transforming innovative science into value for patients. We look forward to working closely with the Japan Health Authority to bring this important cell therapy to patients in Japan as soon as possible."

The Japan MHLW Orphan Drug designation system is designed to promote research activities and support the development of orphan drugs for serious, difficult-to-treat diseases that affect fewer than 50,000 patients in Japan, and for which significant unmet medical need exists. An investigational therapy can qualify for Orphan Drug designation if there is no approved alternative treatment option or if there is high efficacy or safety compared to existing treatment options expected. Therapies receiving Orphan Drug designation qualify for several measures intended to support development including, but not limited to, guidance and subsidies for research and development activities, priority consultation for clinical development and priority review of applications.

Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight certain types of B-cell lymphoma. In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite Pharma, Inc., a Gilead company. Based on the results of a Phase 1/2 study (ZUMA-1), axicabtagene ciloleucel has been approved in the U.S. and Europe. A Phase 2 study similar to the ZUMA-1 study is currently being planned in Japan.