On April 21, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that preliminary data from a Phase Ib combination study of its PD-1 antibody BGB-A317 and its PARP inhibitor BGB-290 in patients with advanced solid tumors will be presented in a poster discussion session at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, BeiGene, APR 21, 2017, View Source [SID1234518659]). The ASCO (Free ASCO Whitepaper) Annual Meeting will take place June 2–6, 2017 in Chicago, Illinois. Details of the presentation are provided below. Schedule your 30 min Free 1stOncology Demo! Abstract #3013
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Title: A Phase 1b Study of the Anti-PD-1 Monoclonal Antibody BGB-A317 (A317) in Combination with the PARP Inhibitor BGB-290 (290) in Advanced Solid Tumors.
Presenter: Michael Friedlander, MD, PhD
Poster Discussion Session: Developmental Therapeutics – Immunotherapy
Date: June 5, 2017
Time: 4:45–6:00 PM CT
Location: Hall D1, McCormick Place
Poster Board: #108
About BGB-A317
BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
About BGB-290
BGB-290 is a potent and highly selective inhibitor of PARP1 and PARP2. BGB-290 is being developed as a monotherapy and in combination with other therapies for the treatment of several cancers including ovarian cancer, prostate cancer, breast cancer, glioblastoma multiforme, small cell lung cancer, and gastric cancer.
Author: [email protected]
Atara Bio Announces Collaboration with Merck to Evaluate KEYTRUDA® (pembrolizumab) in Combination with ATA129 in Nasopharyngeal Carcinoma (NPC)
On April 21, 2017 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases, reported that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada), to evaluate Atara Bio’s allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTL), or ATA129, in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum resistant or recurrent EBV-associated NPC (Press release, Atara Biotherapeutics, APR 21, 2017, View Source [SID1234518658]). The Phase 1/2 trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination and is planned for initiation in 2018. Schedule your 30 min Free 1stOncology Demo! Atara Bio’s ATA129 is an investigational therapy in which a healthy donor’s T-cells are stimulated to recognize EBV antigens, or viral proteins, expressed in the cells of certain liquid and solid tumors. ATA129 has previously been evaluated as a single agent in Phase 1 and 2 trials that enrolled patients with a variety of EBV-positive malignancies including 14 patients with chemotherapy refractory, metastatic NPC. In these trials, evidence of radiographic response was observed and EBV-CTLs were also shown to expand after administration without concomitant lymphodepleting chemotherapy. Recent studies suggest that EBV upregulates the transcription of PD-L1 in EBV-associated solid tumors such as NPC and gastric cancer, suggesting the potential for synergy in combination with anti-PD-1 therapies, such as KEYTRUDA.
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KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
"Both ATA129 and KEYTRUDA have shown evidence of objective radiographic responses in NPC, and there is a strong biologic rationale to combine these therapies as their complementary mechanisms of action may enhance the anti-tumor activity," said Chris Haqq, M.D., Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Atara Bio.
The collaboration agreement is between Atara Biotherapeutics, Inc. and Merck Sharp & Dohme B.V. Under the agreement, the trial will be sponsored by Atara Bio. Additional details of the collaboration were not disclosed.
About ATA129
EBV is associated with a wide range of hematologic malignancies and solid tumors, as well as certain autoimmune conditions such as multiple sclerosis. T-cells are a critical component of the body’s immune system and can be harnessed to counteract viral infections and some cancers. By focusing the T-cells on specific proteins involved in the cancers and infections, the power of the immune system can be employed to combat these diseases. Atara Bio’s ATA129 utilizes a technology in which T-cells are collected from the blood of third-party donors and then exposed to EBV antigens. The resulting activated T-cells are then expanded, characterized, and stored for future therapeutic use in an appropriate partially human leukocyte antigen, or HLA, matched patient, providing an allogeneic, cellular therapeutic option for patients. In the context of EBV infection, ATA129 finds the cells expressing EBV and kills them. ATA129 is currently being studied in ongoing Phase 2 clinical trials in patients with EBV-associated cancers, including EBV-associated post-transplant lymphoproliferative disorders (EBV-PTLD) and NPC. ATA129 is also available to eligible patients with EBV-positive tumors through an ongoing multicenter expanded access protocol trial. Atara Bio is planning to initiate two Phase 3 trials of ATA129 in patients with rituximab-refractory EBV-PTLD following either hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
NewLink Genetics Announces Presentation of Two Abstracts at ASCO
On April 21, 2017 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, reported that two abstracts will be presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, NewLink Genetics, APR 21, 2017, View Source [SID1234518649]). Schedule your 30 min Free 1stOncology Demo! Abstract 105 – A Phase 1b dose-escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors, to be presented by our partner on Sunday, June 4, 2017, 10:45 a.m. – 12:15 p.m. ET.
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Abstract 3066 – A Phase 2 randomized, double-blind study of sipuleucel-T followed by IDO pathway inhibitor, indoximod, or placebo in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), to be presented on Monday, June 5, 2017, 9:00 a.m. – 12:30 p.m. ET.
The complete text of the abstracts will be posted online at 5:00 p.m. ET on Wednesday, May 17.
Xenetic Biosciences’ PolyXen™ Platform Technology Accepted for Poster Presentation at the 13th Annual Protein Engineering Summit (PEGS) Boston
On April 20, 2017 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that an abstract highlighting the Company’s proprietary drug development platform technology, PolyXen, which is designed to improve the half-life and other pharmacological properties of biologic drugs, has been accepted for a scientific poster presentation at the 13th Annual PEGS Boston conference to be held May 1-5th, 2017 in Boston, MA (Press release, Xenetic Biosciences, APR 20, 2017, View Source [SID1234537801]).
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The poster presentation details are as follows:
Title: "Polysialylation – A Platform Technology for Enhancing Therapeutic Proteins and Its Clinical Application"
Authors: He Meng, Curtis Lockshin, Sanjay Jain, Dmitry Genkin, Umesh Shaligram, Joseph Martinez, David B Hill, Camille Ehre, Henry Hoppe IV
Date: May 1-2, 2017
Location: Poster Session A
The poster will be accessible following the conference on the Publications page of the Company’s website, www.xeneticbio.com.
Polaris Provides Early Evidence of Response to Arginine Depletion by ADI‑PEG 20 in Argininosuccinate Synthetase Deficient Thoracic Tumors
On April 20, 2017 Polaris Group reported that its lead therapeutic ADI‑PEG 20 (pegylated arginine deiminase) in combination with pemetrexed and cisplatin (ADIPemCis) demonstrated a good safety profile and a strong efficacy signal in argininosuccinate synthetase (ASS1) deficient malignant pleural mesothelioma (MPM) and non-small cell lung carcinoma (NSCLC), as reported in the Journal of Clinical Oncology (Press release, Polaris Pharmaceuticals, APR 20, 2017, View Source [SID1234526286]). In the first nine patients (5 MPM, 4 NSCLC) enrolled in the dose escalation cohorts of this biomarker-directed phase 1 study, partial response was seen in 7 patients (4 MPM, 3 NSCLC). The study was led by Dr. Peter Szlosarek of Barts Cancer Center, Queen Mary University of London, and involved multiple sites in the United Kingdom.
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The main goal of this phase 1 study is to determine the recommended phase 2 dose, safety and tolerability of ADIPemCis in patients with ASS1-deficient MPM and NSCLC. The nine enrolled patients were treated with fixed-dose pemetrexed and cisplatin (PemCis), the standard first-line chemotherapy for MPM and NSCLC, in combination with increasing doses of ADI‑PEG 20. The treatment appeared to be safe and well tolerated. Notably, three out of four MPM patients with a partial response had non-epithelioid tumor histology, which carries an unfavorable prognosis and historically responded poorly to chemotherapy.
"Based on the encouraging efficacy signal from these preliminary results, we have initiated a randomized, double blind, phase 2/3 trial comparing ADIPemCis with PemCis in patients with non-epithelioid MPM," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "With ADIPemCis, we hope to bring an effective treatment to this subset of MPM patients, who have a dire need for medical intervention."
About ADI‑PEG 20
ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.