On February 6, 2019 Kleo Pharmaceuticals Inc., a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics, reported that its Chief Executive Officer Douglas J. Manion, M.D., FRCP(C), will present at the BIO CEO & Investor Conference to be held February 11-12, 2019, at the Marriott Marquis in New York’s Time Square (Press release, Kleo Pharmaceuticals, FEB 6, 2019, View Source [SID1234533111]).

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Dr. Manion will present an overview of Kleo’s development strategy for its pipeline of small molecule and synthetic peptide compounds that function similar to highly complex biologics, while offering multiple potential advantages. The overview will also outline Kleo’s key value drivers including the three proprietary technology platforms that drive in-house drug development and partnership opportunities, the multiple in-house and collaborative channels through which it is building its immuno-oncology pipeline, and its discovery collaboration with PeptiDream.

Kleo is well-funded to achieve multiple preclinical and early clinical milestones following the November 2018 closing of an oversubscribed $21 million Series B financing to advance its first clinical candidates through IND-enabling studies and into the clinic in 2020.

Details of Kleo’s presentation are as follows:

Event: 2019 BIO CEO & Investor Conference
Date: Monday, February 11, 2019
Time: 3:30 p.m. (Eastern Time)
Location: New York Marriott Marquis, Herald/Soho Room

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 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 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 5, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic disease, and cancer, reported it has entered into a research and license agreement with Genentech, a member of the Roche Group, to develop and commercialize novel IL-15 cytokine therapeutics, including XmAb24306. XmAb24306 is an IL-15/IL-15Rα cytokine complex engineered with Xencor’s bispecific Fc domain and Xtend Fc technology and is Xencor’s most advanced preclinical cytokine program (Press release, Xencor, FEB 5, 2019, View Source [SID1234533064]).

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"This partnership with Genentech accelerates our immuno-oncology work by enabling the exploration of novel XmAb24306 combinations with Genentech’s leading oncology portfolio and our growing internal pipeline of bispecific antibodies," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "A wide-ranging combination strategy will be critical to realize the potential of IL-15 bispecific cytokines such as XmAb24306, so we plan to explore our cytokines with a broad spectrum of leading commercial-stage and investigational cancer therapies."

"We believe cytokine therapy will play an important role in the treatment of a wide range of diseases, including cancer," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This collaboration with Xencor will further enhance our understanding of a critical immune activation pathway and may present a potential new way to use the immune system to target cancer."

IL-15 is a highly active cytokine, or immune signaling protein, that when pre-complexed with IL-15 receptor alpha (IL-15Rα) will bind to IL-15Rβγ and stimulate the expansion and activation of natural killer (NK) cells and cytotoxic T cells, but with reduced regulatory T cell activation compared to IL-2. Xencor’s IL-15 bispecific cytokine platform provides a more druggable version of IL-15 with potentially superior tolerability, slower receptor-mediated clearance and a prolonged half-life, and is intended for development with a wide range of combination agents due to its proposed mechanism of activating tumor-killing immune cells.

Under the terms of the agreement, the companies will co-develop XmAb24306 and other potential IL-15 programs, in which the companies will share development costs and profits. Genentech will commercialize medicines worldwide, and Xencor has the option to co-promote in the United States. Additionally, the companies will engage in a two-year research program to discover new IL-15 drug candidates, including ones targeted to specific immune cell populations. Genentech will pay Xencor $120 million upfront, and Xencor will be eligible to receive up to $160 million in development milestones for the XmAb24306 program and up to $180 million in development milestones for each new IL-15 drug candidate.

The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and closing is expected to occur in the first half of 2019