Termination of Phase I, open-label, dose finding study (NCT02641002) of CC-90002 in subjects with acute myeloid leukemia and high-risk myelodsplastic syndrome

A Phase I, open-label, dose finding study (NCT02641002) of CC-90002 in subjects with acute myeloid leukemia and high-risk myelodsplastic syndrome has been terminated due to that preliminary monotherapy data in relapsed/refractory AML and high-risk MDS did not offer a sufficiently encouraging profile for further dose escalation/expansion (Clinical trial, ClinicalTrials.gov, OCT 4, 2018, View Source;B=13&C=merged#StudyPageTop [SID1234531854]).

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However another Phase I, open-label, dose finding study (NCT02367196) of CC-90002 in subjects with advanced solid and hematologic cancers is still active and confirmed by Celgene October 16, 2018 (Clinicaltrials.gov, OCT 16, 2018, View Source).

Celyad Announces Exclusive Agreement for
Horizon Discovery’s shRNA Platform to Develop Next-Generation Allogeneic CAR-T Therapies

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."

Alexion to Report Third Quarter 2018 Results on Wednesday, October 24, 2018

On October 4, 2018 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the third quarter ended September 30, 2018 before the US financial markets open on October 24, 2018 (Press release, Alexion, OCT 4, 2018, View Source [SID1234529852]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast at 8:00 a.m. Eastern Time (ET).

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To participate in this conference call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 5947065 shortly before 8:00 a.m. ET. The audio webcast can be accessed on the Investor page of View Source and an archived version will be available for a limited time following the presentation.

FDA Grants Coordination Pharmaceuticals IND Approval for CPI-100, a Novel Antitumor Nanomedicine

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."

Immutep Announces Presentations at Society for Immunotherapy of Cancer (SITC) 2018 Annual Meeting

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.