On February 6, 2019 Pathios Therapeutics ("Pathios"), an innovative biotech company focused on the development of first in class therapies for autoimmune diseases and immuno-oncology and Sygnature Discovery ("Sygnature"), reported a strategic partnership to accelerate Pathios’ drug discovery and development programmes (Press release, Pathios Therapeutics, FEB 6, 2019, View Source [SID1234650160]).

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As part of the agreement, Pathios and Sygnature will collaborate on an integrated drug discovery programme against a novel G Protein-Coupled Receptor (GPCR) target. Specifically, Sygnature are providing their industry leading expertise in GPCR bioscience and medicinal chemistry to expand Pathios’ current hit-to-lead programme. Sygnature are also deploying their computational chemistry, library design and synthesis and medium throughput screening capability to broaden Pathios’ hit finding. As part of this agreement, Sygnature will receive equity in addition to fees.

Pathios Therapeutics brings together cutting-edge European science and a leading drug discovery and development team to modulate the activity of GPR65, a pH sensing GPCR. This drug target is characteristic of certain T helper 17 (Th17) cell populations which have been shown to contribute significantly to the pathology of autoimmune conditions, such as ankylosing spondylitis and psoriatic arthritis. In addition, recently published studies have demonstrated GPR65 drives tumour associated macrophages (TAM) to adopt a phenotype that supports cancer immune evasion.

Tom McCarthy, Executive Chairman and Co-founder of Pathios Therapeutics Limited, commented: "We founded Pathios to build on emerging science that demonstrated GPR65 sits at the nexus of autoimmune disease and immuno-oncology as this receptor links pathology caused by a low pH environment. The ultimate aim is to block the pathological process that GPR65 initiates without interfering with the physiological role of this receptor. In addition to developing potent and selective drugs to modulate GPR65, we are continuing to broaden the understanding of the fundamental biological processes that link to GPR65’s effects in Th17 cells, TAMs and other cell types. Our team has worked closely with Sygnature in the past and know they have the deep experience, expertise and state-of-the-art drug discovery and development infrastructure to drive our programme forward. I’m delighted on this rare occasion Sygnature also chose to invest in Pathios and expand our GPR65 drug discovery efforts while we explore Series A funding opportunities".

Simon Hirst, CEO of Sygnature, added: "We are extremely pleased to take this exceptional opportunity to partner with, and invest in Pathios on their drug discovery projects. Based on our diligence activities, we are excited about the potential for GPR65 modulation to be central to new treatments for autoimmune disease and a critical mechanism of action in next generation immunooncology drugs targeting the tumour micro-environment. We are excited to have the opportunity to work with Tom and the rest of Pathios’ tremendously talented team again and contribute to the potential positive impact their therapeutics will have on patients’ lives".

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 6, 2019 Cofactor Genomics, pioneers in the field of Predictive Immune Modeling, reported a $100,000 grant program to reward innovations with the Cofactor ImmunoPrismTM Assay (Press release, Cofactor Genomics, FEB 6, 2019, View Source [SID1234533097]). The program was unveiled at the 2019 Immuno-Oncology 360° Conference in New York.

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In December 2018, Cofactor made available the use of its proprietary database of Health Expression Models (HEMs). The Health Expression Models leveraged in the ImmunoPrism Assay enable quantification of immune cells and subtypes in solid tumor tissue, shown to be important in predicting response to immunotherapies. Built using machine-learning, these models have been demonstrated to provide measurable improvements to sensitivity and specificity over single-gene approaches currently used by the field. Access to Cofactor’s database of Health Expression Models has empowered translational and clinical scientists, along with drug development companies to utilize multidimensional biomarkers in their cancer research and clinical trials. Early adopters of Cofactor’s Predictive Immune Modeling technologies include the Fred Hutchinson Cancer Research Center, National Cancer Institute, and Genocea Biosciences.

"We are sitting on the 10 year anniversary of RNA-seq with shelves stuffed full of samples and data, created by cell profiling and analysis, yet we still can’t answer the fundamental question of predicting which immunotherapy will work with a specific patient or certain type of cancer," said Jarret Glasscock, Cofactor CEO and founder. "The new Predictive Immune Modeling Grant is designed to inspire the science, research, and clinical communities to take a different approach to producing highly predictive multidimensional biomarkers to ultimately solve this massive problem."

Cofactor Genomics will be showcasing its Predictive Immune Modeling technology during the Immuno-Oncology 360 conference with a talk in the "Transactional Science & Emerging Biomarkers" track and the panel on "Next Generation Biomarker and Companion Diagnostics for Predicting Response."

Applications for the Grant Program will be accepted through April 15, 2019 and more details may be found here: View Source