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CB-1158 Phase I Data Accepted for an Oral Presentation at the ASCO Annual Meeting

On April 20, 2017 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that clinical data for its drug candidate CB-1158, an orally bioavailable arginase inhibitor, will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from June 2 to June 6, 2017 in Chicago, Illinois (Press release, Calithera Biosciences, APR 20, 2017, View Source [SID1234518643]). Clinical results to be presented include monotherapy data from Calithera’s Phase I trial in solid tumors. CB-1158 is being developed in collaboration with Incyte Corporation.

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CX-1158-101: A first-in-human phase 1 study of CB-1158, a small molecule inhibitor of arginase, as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor in patients with solid tumors.
Abstract #3005
Presenter: Kyriakos Papadopoulos MD, South Texas Accelerated Research Therapeutics
Date: June 5, 2017
Session: 1:15 p.m. – 4:15 p.m. CT, Developmental Therapeutics-Immunology, Hall D1

AVEO Announces Presentations at the 2017 ASCO Annual Meeting

On April 20, 2017 AVEO Oncology (NASDAQ:AVEO) reported that poster presentations for three clinical studies will be presented at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 2-6, 2017 (Press release, AVEO, APR 20, 2017, View Source [SID1234518642]).

Among these is a Trials in Progress presentation highlighting the ongoing Phase 3, randomized, controlled, multi-center, open-label TIVO-3 study comparing tivozanib, the Company’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, to sorafenib in subjects with refractory advanced renal cell carcinoma. The remaining two presentations will highlight ficlatuzumab, the Company’s potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities, in two investigator-sponsored studies, one in head and neck squamous cell carcinoma and the other in acute myeloid leukemia.

Tivozanib is partnered for oncologic indications with EUSA Pharma under an exclusive license agreement covering territories outside of North America and Asia, including Europe, South America and South Africa. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab.

Details for the poster presentations at ASCO (Free ASCO Whitepaper) 2017:

Title: Tivo-3: A phase 3, randomized, controlled, multi-center, open-label study to compare
tivozanib hydrochloride to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC)

Presenter: Brian I. Rini, MD, FACP, Professor of Medicine, Lerner College of Medicine,
Leader, GU Program, Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute

Abstract Number: TPS4600

Session: Genitourinary (Nonprostate) Cancer

Date and Time: Sunday, June 4, 2017, 8:00-11:30 AM CT

Title: Phase I study of the anti-HGF monoclonal antibody (mAb), ficlatuzumab, and cetuximab
in cetuximab-resistant, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)

Presenter: Julie E. Bauman, MD, MPH, Chief, Division of Hematology and Oncology,
Associate Director, Translational Research, University of Arizona Cancer Center

Abstract Number: 6038

Session: Head and Neck Cancer

Date and Time: Monday, June 5, 2017, 1:15-4:45 PM CT

Title: CyFi: A phase I study exploring the role of cMET pathway inhibition with
ficlatuzumab (Fi) combined with high-dose cytarabine (Cy) in patients with
high risk relapsed or refractory acute myeloid leukemia (AML)

Presenter: Charalambos (Babis) Andreadis, MD, Hematologic Malignancies and
Blood and Marrow Transplantation Program, University of California, San Francisco

Abstract Number: 7040

Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: Monday, June 5, 2017, 8:00-11:30 AM CT

Phase 1/2 Clinical Trial of Agenus’ anti-PD-1 Antibody Begins

On April 20, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported that the first patient has been dosed in a Phase 1/2 clinical trial of its anti-PD-1 antibody, AGEN2034.

The open-label, dose-escalation portion of the trial is designed to evaluate the safety and pharmacological activity of AGEN2034 in patients with advanced solid tumors. Part 2 of the trial is planned to evaluate the recommended dose of AGEN2034 in patients with second line cervical cancer. Preliminary safety and efficacy data are expected to be available within the next 9-12 months.

"The entry of our PD-1 antagonist into the clinic is key to our strategy to pursue combination therapies," said Garo H. Armen, Ph.D. Chairman and CEO of Agenus. "PD-1 is a clinically validated target, and to combine it with our CTLA-4 directed antibody is the backbone of Agenus’ combination strategy. We also intend to pursue combinations of PD-1 and CTLA-4 antibodies with our novel portfolio of other checkpoint antibodies as well as our neoantigen cancer vaccines."

AGEN2034 is an antagonist antibody targeting programmed death 1, or PD-1. PD-1 is an inhibitory receptor expressed on activated T cells. When this receptor interacts with PD-L1 or PD-L2 molecules expressed on cancer cells, the T cells’ ability to kill cancer cells is neutralized. Therefore, blocking PD-1 with AGEN2034 may allow T cells to recognize and kill tumor cells.

"Immune checkpoint antibodies targeting PD-1/PD-L1 and CTLA-4 have become the mainstay of I-O combinations," said Jean-Marie Cuillerot, M.D., Chief Medical Officer of Agenus. "Co-targeting the PD-1/PD-L1 axis in combination with CTLA-4 has shown a near doubling of clinical efficacy in certain indications. We believe our strategy in pursuing virally-induced cancers presents a rapid path to BLA for our PD-1 and CTLA-4 antagonists. In addition, combination approaches involving our vaccines offer a unique opportunity for differentiation in patients who are unresponsive to checkpoint directed monotherapies."

Additional information about the trial can be found here.

AGEN2034 was originally developed under a Collaborative Research and Development Agreement between Ludwig Cancer Research, 4-Antibody AG and Recepta Biopharma S.A.

Nektar Therapeutics to Host Analyst & Investor Event at 2017 ASCO Annual Meeting

On April 20, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported that it will host an analyst and investor event with clinical investigators on Saturday, June 3, 2017 at 6:00 pm CDT in Chicago, IL during the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting. The event will include a presentation and discussion of updated clinical data for the company’s CD122-biased agonist, NKTR-214.

Data from two studies of NKTR-214 will be reviewed at the event, including the Phase 1 dose-escalation study of NKTR-214 in combination with nivolumab in patients with melanoma, renal cell carcinoma and non-small cell lung cancer (PIVOT-02); and the Phase 1 study of monotherapy NKTR-214 in patients with advanced solid tumors (EXCEL).

Presenters will include Dr. Adi Diab, Assistant Professor, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, Dr. Nizar Tannir, Professor, Genitourinary Medical Oncology at the University of Texas MD Anderson Cancer Center and Dr. Michael Hurwitz, Assistant Professor of Medicine (Medical Oncology) at Yale Cancer Center.

NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 targets CD122 specific receptors found on the surface of these cancer-fighting immune cells in order to stimulate their proliferation. In preclinical studies, treatment with NKTR-214 resulted in a rapid expansion of these cells and mobilization into the tumor micro-environment.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

Investors and analysts are invited to listen to a live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.

For those interested in attending this event in person, please contact [email protected]. Please RSVP in advance as seating is limited.

Mateon Announces Initiation of Investigator-Sponsored Phase 1 Study of CA4P in Combination with Everolimus in Neuroendocrine Tumors

On April 20, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that the Markey Cancer Center at the University of Kentucky has enrolled the first patient into a new phase 1 study of CA4P in combination with everolimus for the treatment of neuroendocrine tumors (Press release, Mateon Therapeutics, APR 20, 2017, View Source [SID1234518638]).

"The combination of CA4P and everolimus has the potential to decrease the ability of tumor cells to recover between CA4P treatment cycles," stated Lowell B. Anthony, M.D., Professor of Medicine and Chief, Division of Medical Oncology, Markey Cancer Center, University of Kentucky. "This is the first trial testing this hypothesis in neuroendocrine tumors – with CA4P disrupting the existing tumor blood supply and everolimus preventing a new tumor blood supply from re-forming. Our findings from this trial should lead to a larger clinical study once we have identified the optimal dose and schedule for the combination of these two agents."

Study MCC-2016-088 is designed to demonstrate whether the addition of CA4P to everolimus may improve tumor control without additional toxicity. Everolimus has been approved by the U.S. Food and Drug Administration for the treatment of advanced pancreatic neuroendocrine tumors and progressive gastrointestinal neuroendocrine tumors, among other indications, and is marketed by Novartis under the tradename AFINITOR. Mateon has previously demonstrated initial evidence of efficacy for CA4P in patients with neuroendocrine tumors when CA4P was provided as a single agent.

Study MCC-2016-088 is being sponsored, funded, and conducted by the Markey Cancer Center, with Mateon providing the investigational drug. The study is designed as a single center, open label, phase 1 clinical trial for patients with grade 1-3 gastroenteropancreatic neuroendocrine tumors. In the first part of the study, up to 15 patients will be treated with everolimus in combination with two different dosing regimens of CA4P to establish appropriate CA4P dosing levels and evaluate the safety of the drug combination. The second part of the study is designed to enroll 15 additional patients for assessment of additional safety and efficacy data. Patients enrolled in MCC-2016-088 will be treated with CA4P and everolimus for 12 weeks.

For further information about the clinical trial, please visit www.clinicaltrials.gov, Study NCT03014297.

Mateon has received orphan drug designation for CA4P for the treatment of neuroendocrine tumors from both the U.S. Food and Drug Administration and from the European Medicines Agency.