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).

On October 3, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, recognizing it as one of the most promising private biotechnology companies in the industry (Press release, FLX Bio, OCT 3, 2018, View Source [SID1234529772]).

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"We are honored to be selected as a Fierce 15 company, which we feel highlights the incredibly hard work by our team and our unique approach to targeting the immune system," said Brian Wong, M.D., Ph.D., Chief Executive Officer of FLX Bio. "We believe that our big-data and cutting-edge drug discovery capabilities permit selective control of key immuno-modulatory cells such as regulatory T cells to effectively treat cancers and other immune disorders."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. Every year FierceBiotech evaluates hundreds of private companies from around the world for inclusion on its annual Fierce 15 list. Selection is based on a variety of factors including the strength of a company’s technology, partnerships, venture backers, and competitive market position.

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.