On February 6, 2019 Advaxis, Inc. (NASDAQ:ADXS), (the Company) a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the presentation of the progression of its Lm platform from discovery to clinical application, and the unique opportunity the platform affords Advaxis in its pursuit of innovative new cancer therapeutics (Press release, Advaxis, FEB 6, 2019, View Source [SID1234533096]).

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The presentation is being made today by Robert G. Petit, Ph.D., the Company’s Chief Scientific Officer and Executive Vice President and Andres A. Gutierrez, M.D., Ph.D., the Company’s Chief Medical Officer and Executive Vice President, during a plenary session at the Immuno-Oncology 360° Conference at the Crowne Plaza Times Square in New York City. The session begins at 4:00 p.m. ET and the Company’s presentation begins at 4:55 p.m. ET.

Drs. Petit and Gutierrez will provide an overview of the Company’s proprietary Lm platform, including the following features that have been observed:

Ability to generate CD8+ T cells rapidly and against large percentage of peptides/neoantigens targets;
Excellent priming without adding adjuvant, systemic pro-inflammatory immune "macroenvironment";
Antigen spreading demonstrated in clinical trials including our neoantigen-directed drug constructs;
No neutralizing antibodies allowing for repeat boosting;
Efficacy signals include single agent complete responses in late stage cancer and improved survival; and
Manageable safety profile – nearly 500 patients treated to date, mostly grade 1 or grade 2 treatment related adverse events.
Drs. Petit and Gutierrez will also present an overview of the Company’s neoantigen-directed therapy programs, ADXS-NEO (customized, personalized neoantigens) and ADXS-HOT (off-the-shelf, hotspot or shared neoantigens and other antigens). The presentation will be available on the Company’s website, www.advaxis.com.

"We are looking forward to presenting an overview of our proprietary Lm platform which, over the last several years, has accumulated a large amount of data supporting immune response, clinical activity and safety in the treatment of multiple cancers. Leveraging the knowledge gained from our single-antigen targeting constructs, we have further optimized our Lm vector in the development of our multiple-antigen targeting constructs. Our discussion today will provide insight into immunological activity that we’ve observed in our ADXS-NEO clinical trial," said Dr. Petit. He concluded, "These preliminary data suggest our approach may be among the best-in-class for CD8+ T cell response which we believe is important for successful clinical outcomes."

"We have a broad pipeline of drug candidates being evaluated for multiple cancer types at various stages of development. We anticipate our first drug construct from our ADXS-HOT program, ADXS-503 for non-small cell lung cancer, to enter the clinic later this quarter." said Dr. Gutierrez. He added, "We believe that our neoantigen-directed drug candidates will likely be used in combination with checkpoint inhibitors and have the potential to significantly impact the cancer treatment paradigm." He concluded, "The preliminary clinical data from our ADXS-NEO Phase 1 study demonstrate broad and rapid anti-tumor immunity. We are looking forward to providing clinical data read-outs from several studies throughout 2019."

ADXS-NEO, the Company’s personalized neoantigen program, is in an ongoing Phase 1 dose-escalation study to treat a variety of cancers. ADXS-HOT is the Company’s off-the-shelf program and consists of several different drug constructs that target hotspot or shared neoantigens, and other antigens. We expect the first drug construct from this program, ADXS-503, or HOT-Lung, will enter the clinic this quarter.

On February 6, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for FT516, the Company’s off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel CD16 Fc receptor (Press release, Fate Therapeutics, FEB 6, 2019, View Source [SID1234533095]). FT516 is the first-ever cell therapy derived from a genetically engineered pluripotent stem cell cleared for clinical testing in the world, and is the Company’s second off-the-shelf, iPSC-derived NK cell product candidate cleared for clinical investigation by the FDA within the past two months. The Company intends to initiate clinical testing of FT516 in patients with certain relapsed/refractory hematologic malignancies, including acute myelogenous leukemia (AML) as a monotherapy, non-Hodgkin’s lymphoma (NHL) in combination with rituximab, and multiple myeloma (MM) in combination with elotuzumab.

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"This allowance by the FDA of our FT516 IND application is a watershed event in the clinical development of engineered cell therapies. Our industry-leading iPSC product platform enables the manufacture of engineered cell products that can be extensively characterized, cryopreserved and delivered ‘on demand’ to reach more patients," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "FT516 is a first-of-kind cell product in that it originates from a single genetically engineered pluripotent stem cell, which serves as a clonal master cell line that can be repeatedly used to mass-produce large quantities of homogeneous cell product in a cost-effective manner. This innovative approach uniquely supports a new treatment paradigm with engineered cell therapies, where multiple doses of cell product are readily available for administration with the goal of driving deeper and more durable responses. We look forward to treating patients with multiple doses of FT516, including in combination with FDA-approved monoclonal antibody therapy, across multiple treatment cycles in this first clinical study."

CD16 is naturally expressed on NK cells and mediates antibody-dependent cellular cytotoxicity (ADCC), a potent immune mechanism through which NK cells can recognize, bind and kill antibody-coated cancer cells. ADCC is an underlying mechanism associated with the clinical efficacy of many monoclonal antibodies that are approved for the treatment of various cancers, including hematologic malignancies and solid tumors. The expression of CD16 on NK cells can undergo considerable down-regulation in cancer patients, which significantly inhibits the immune system’s anti-tumor response. FT516 incorporates a novel CD16 Fc receptor, which has been modified to prevent its down-regulation and to augment its binding to tumor-targeting antibodies, for enhanced ADCC.

The initial clinical study of FT516 is intended to assess the safety and tolerability of three weekly doses for the treatment of certain relapsed/refractory hematologic malignancies. The study includes three independent, dose-escalating treatment arms: monotherapy for AML; combination with rituximab for NHL; and combination with elotuzumab, plus pomalidomide and dexamethasone, for MM. All subjects will receive low-dose conditioning chemotherapy consisting of cyclophosphamide and fludarabine (Cy/Flu) and cytokine support with IL-2. Subjects are eligible to receive a second treatment cycle following an initial 28-day safety assessment.

FT516 is the second off-the-shelf, iPSC-derived NK cell product candidate cleared for clinical investigation by the FDA from the Company’s proprietary iPSC product platform. In November 2018, the FDA cleared the Company’s IND application for FT500, an off-the-shelf, iPSC-derived NK cell product candidate for use in combination with checkpoint blockade therapy for the treatment of solid tumors.

On February 6, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that management will present at the Guggenheim Healthcare Talks Idea Forum | Oncology Day on Thursday, February 14, 2019 (Press release, Seattle Genetics, FEB 6, 2019, View Source [SID1234533094]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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On February 6, 2019 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that its Chief Financial Officer, Anthony H. Kim, will present a corporate overview at the upcoming 2019 BIO CEO & Investor Conference on Monday, February 11, 2019 (Press release, Marker Therapeutics, FEB 6, 2019, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=Marker+Therapeutics+to+Present+at+the+2019+BIO+CEO+%26+Investor+Conference [SID1234533093]).

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Presentation Details

Date: Monday, February 11, 2019
Time: 3:45 p.m. EST
Location: New York Marriott Marquis Hotel

On February 6, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the enrollment of the first patient in the investigator-sponsored Phase II study EMERGE (ClinicalTrials.gov identifier: NCT03812796), conducted by Prof. David Cunningham from The Royal Marsden NHS Foundation Trust (London, UK) (Press release, 4SC, FEB 6, 2019, View Source [SID1234533092]).

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The multi-center, single-arm, open-label study examines domatinostat plus checkpoint inhibitor avelumab in up to 75 patients with advanced gastrointestinal cancer – precisely microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer. The study is intended to establish the safety of combining domatinostat with avelumab as well as to generate proof-of-concept clinical data in this patient population.

Jason Loveridge, Ph.D., CEO of 4SC: "Enrolling the first patient in the EMERGE study is a significant milestone for 4SC. We thank Prof. Cunningham and his team as well as the involved clinical centers for their enthusiasm in conducting this important study.

We are convinced that the combination of domatinostat with checkpoint inhibitors is the best route to most rapidly progress domatinostat towards market approval. In parallel to the EMERGE study, we are evaluating domatinostat in combination with another checkpoint inhibitor (pembrolizumab) in melanoma patients in the SENSITIZE study.

We will continue to execute on our clinical development plan, which is intended to lead to the initiation of a potentially pivotal trial in 2019."