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Asana BioSciences Announces Acceptance of Its Third IND Application in Oncology

Asana BioSciences, LLC, an oncology-focused, clinical stage biopharmaceutical company, reported that the FDA has accepted the IND application for ASN003, a selective RAF/PI3K inhibitor (Press release, Asana BioSciences, OCT 4, 2016, View Source [SID:SID1234515590]).

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"We are extremely pleased with the execution of our strategy to work on clinically validated targets and develop drugs that are clearly differentiated from the competition," said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. Using a unique, virtual and efficient operating model, Asana is focused on the development of ‘best-in-class’ drugs that are expected to offer significant benefit over the existing standards of care and address unmet medical needs. "To the best of our knowledge, ASN003 is the only molecule in development that selectively targets both RAF and PI3 kinase pathways. This program represents Asana’s 3rd successful IND in oncology in less than two years, and several other lead molecules from our pipeline are positioned to enter clinical development in the near future," stated Dr. Gupta.

The Phase I, open-label, dose-finding and cohort expansion study will evaluate safety and tolerability of ASN003 as well as preliminary efficacy in patients with advanced solid tumors with RAF or PI3K pathway alterations. The RAS-RAF-MEK and PI3K pathways are two major signaling pathways involved in abnormal cell growth and are frequently mutated in melanoma and other cancers, such as colon and lung cancer. Dual targeting of RAF and PI3K pathways with ASN003 has the potential to overcome and/or delay acquired resistance to selective RAF inhibitors and may thus result in improved activity against cancers driven by both pathways.

Asana’s other lead candidates, ASN001 and ASN002, are in Phase I/II clinical development. ASN001, a novel and highly selective CYP17 inhibitor that does not require prednisone co-administration, targets metastatic castration resistant prostate cancer. ASN002 is a novel oral inhibitor of spleen tyrosine kinase (SYK) and Janus kinase (JAK), which is currently in Phase I/II studies in patients with non-Hodgkin’s lymphoma and solid tumors. Evaluation of ASN002 in autoimmune disease indications is also being planned. Both these programs are approaching the end of dose-finding phase of the trials, and Asana expects to announce initial safety and efficacy results early next year. ASN004 is an antibody drug conjugate (ADC) targeting 5T4-oncofetal antigen that selectively and efficiently delivers a cytotoxic agent into tumor cells, resulting in potent, selective anti-proliferative activity and complete tumor regression in multiple tumor models including breast, lung and colon. ASN007 is a novel ERK inhibitor that shows potent activity against multiple KRAS mutant driven tumor models. These programs will enter clinical development in 2H 2017.

IncellDx’s Quantitative Immuno-Oncology Assay OncoTect iO Published in New Study

On October 4, 2016 IncellDx, Inc., a single cell, precision medicine company, reported that the international peer-reviewed medical journal Cancer Immunology, Immunotherapy has published a manuscript entitled: "Quantification of PD-L1 and PD-1 expression on tumor and immune cells in non-small cell lung cancer (NSCLC) using non-enzymatic tissue dissociation and flow cytometry (Press release, IncellDx, OCT 4, 2016, View Source [SID:SID1234515589])." Dr. Bruce Patterson, MD, Founder and CEO explained that this is a novel, single cell approach to quantifying the expression of PD-L1 and PD-1 expression on tumor and immune cells in non-small cell lung cancer (NSCLC) tumor samples. The methodology has been validated on both fine needle aspiration (FNA) and tumor biopsies. The samples are non-enzymatically homogenized into single cell suspensions using IncellDx’s IncellPREP kit yielding a single-cell sample before a formalin-fixed paraffin embedded (FFPE) block is made.

As Dr. Patterson explained, "We believe this objective quantitation of PD-L1 expression in tumor and immune cells in NSCLC will allow for better prediction of patient response to the new PD-1 immunotherapies within a work flow that is suited well for primary indications where the initial diagnosis may be made using several approaches to sampling the tumor. Further, the assay and sample preparation are automated allowing for same day turn around."

The PD-L1 and PD-1 assay is the first release of IncellDx, Inc.’s newest family of single cell, multi-parametric molecular products called OncoTect iO for immuno-oncology in a multitude of tissue types. The paper is now available online at View Source

Altor BioScience Corporation and NantKwest Inc. Announce Co-Development Agreement to Advance Innovative Natural Killer Cell Combination Immunotherapies for the Treatment of Cancer

On October 4, 2016 Altor BioScience Corporation (Altor), a leading developer of novel cytokine-based immunotherapeutics for cancer and infectious diseases and NantKwest Inc. (Nasdaq: NK), a clinical-stage immunotherapy company focused on harnessing the unique power of off-the-shelf Natural Killer (NK) cells to treat cancer, infectious diseases and inflammatory disorders reported the establishment of a co-development agreement focused on Altor’s lead candidates developed from its proprietary technology platforms, based on cytokines Interleukin-15 (IL-15) and Interleukin-2 (IL-2), that are currently in several Phase 1/2 clinical trials for hematologic and solid tumors (Press release, NantKwest, OCT 4, 2016, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2209112 [SID1234515586]).

Under the terms of the agreement, Altor and NantKwest will exclusively collaborate on the development of therapeutic applications combining Altor’s proprietary IL-15 superagonist (ALT-803) and its single-chain T cell receptor/IL-2 fusion protein (ALT-801) products with NantKwest’s proprietary NK cell therapy platforms for oncology indications. Financial terms of this co-development are not disclosed.

Hing C. Wong, Ph.D., Altor’s founder and CEO stated, "This partnership is a significant strategic collaboration for Altor and NantKwest. We believe there are significant opportunities to develop groundbreaking NK cell-based therapies using ALT-803 and ALT-801 in concert with NantKwest’s proprietary NK cell therapy and guided by a comprehensive genomic and proteomic molecular analysis using GPS cancer in the war against cancer. As Altor’s immunotherapeutic platform can play a key role in activating NK and T cells, we are enthusiastic to explore the synergy of this collaboration and rapidly advance clinical evaluation of these combination therapies in patients with cancer. Cell-based therapy combinations with Altor’s proprietary immunotherapeutics are an important component of our corporate strategy and we are excited to participate in the Cancer Moonshot 2020 program and the QUILT trials."

Patrick Soon-Shiong, M.D., FRCS (C), FACS, NantKwest’s CEO, commented, "Cell based therapies and comprehensive genomic, transcriptomic and proteomic analysis of the tumor tissue represents the future of precision immuno-oncology and the opportunity to bring the potential of 21st century medicine to patients today. As an off-the-shelf therapy, NantKwest’s proprietary, natural killer cell therapy offers a simple, easy-to-use therapy that we believe can become the standard of care for a broad range of cancer types. Recognizing the importance of omics guided (www.gpscancer.com) combination therapy to further improve therapeutic effectiveness and patient outcomes, the Cancer MoonShot 2020 program (www.cancermoonshot2020.org) was launched in January 2016 to bring together a wide range of novel therapeutic agents that can be utilized in novel, synergistic combinations. Altor’s ALT-803 and ALT-801 are two such therapeutic agents that offer the potential to be used in combination with NantKwest’s natural killer cell therapies to further improve therapeutic effectiveness and patient outcomes."

Five Prime Therapeutics Advances into Phase 1b Portion of Trial Evaluating the Immunotherapy Combination of Cabiralizumab (FPA008) and OPDIVO (nivolumab) in Multiple Tumor Types

On October 4, 2016 Five Prime Therapeutics, Inc. (Nasdaq:FPRX) a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it has initiated the Phase 1b portion of the clinical trial evaluating the immunotherapy combination of cabiralizumab (FPA008), Five Prime’s investigational monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R), with OPDIVO (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, in multiple tumor types (Press release, Five Prime Therapeutics, OCT 4, 2016, View Source [SID:SID1234515585]).

"We are very pleased to progress to the Phase 1b portion of this trial evaluating cabiralizumab in combination with nivolumab as a treatment for patients with multiple types of tumors, many of whom currently have no effective treatment options," said Robert Sikorski, M.D., Ph.D., Chief Medical Officer, at Five Prime. "Our goal is to develop new therapeutics that unleash the immune system’s natural anti-cancer activity. Based on the science, we believe that targeting both the CSF1R and PD-1 pathways has the potential to produce a synergistic treatment effect."

Five Prime initiated the Phase 1a/1b trial, which is expected to enroll approximately 280 patients, in September 2015. During Phase 1a, Five Prime evaluated the safety, pharmacokinetics and biomarkers of escalating doses of cabiralizumab as a monotherapy, as well as in combination with the approved 3 mg/kg dose of nivolumab.

Five Prime will continue to run the Phase 1b portion of the trial and will evaluate the safety, tolerability and preliminary efficacy of the selected dose of cabiralizumab in combination with nivolumab for the treatment of advanced solid tumors, including but not limited to non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer.

About Cabiralizumab (FPA008)
Cabiralizumab is an investigational antibody that inhibits the CSF-1 receptor and has been shown in preclinical models to block the activation and survival of monocytes and macrophages. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. Cabiralizumab is currently in a Phase 2 clinical trial in pigmented villonodular synovitis (PVNS) and a Phase 1 clinical trial in oncology indications. Cabiralizumab is being developed under an exclusive worldwide license and collaboration agreement entered into with BMS in October 2015.

EXCLUSIVE LICENSING AGREEMENT FOR IN-HOUSE DEVELOPED MONOCLONAL ANTIBODY FARLETUZUMAB IN LATIN AMERICA CONCLUDED WITH EUROFARMA LABORATÓRIOS S.A.

On October 4, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its research subsidiary Morphotek, Inc. (Headquarters: Pennsylvania, United States, President and CEO: Nicholas Nicolaides, "Morphotek") has signed an exclusive licensing agreement with Eurofarma Laboratórios S.A. (Headquarters: São Paulo, Brazil, President: Maurizio Billi, "Eurofarma") to develop and commercialize the monoclonal antibody farletuzumab (development code: MORAb-003) as a potential anticancer agent in Latin America (Press release, Eisai, OCT 4, 2016, View Source [SID:SID1234515584]).

Under the terms of the agreement, Morphotek will receive from Eurofarma an upfront payment as well as scheduled development and sales milestone payments. Additionally, Morphotek will receive royalties from commercial sales of farletuzumab in Latin America. Morphotek will supply Eurofarma with clinical and commercial materials while Eurofarma has the option to assume responsibility for filling and packaging farletuzumab vials. Morphotek retains all rights to develop and commercialize farletuzumab in regions outside of Latin America.

Discovered by Morphotek, farletuzumab is an investigational, humanized, monoclonal antibody that binds to folate receptor alpha (FRA), which is reported to be highly expressed on ovarian and several other epithelial cancer cells, but mostly absent from normal tissue. Farletuzumab is currently being studied in a randomized, placebo-controlled, double-blind Phase II clinical study in first-relapsed, platinum-sensitive ovarian cancer patients with low levels of the CA-125 tumor antigen, a biomarker for ovarian cancer. The study is designed to investigate the efficacy and safety of farletuzumab in combination with standard chemotherapy.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Through this collaboration, Eisai hopes to accelerate development and maximize the value of farletuzumab as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.