On April 21, 2017 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that an abstract describing results from its global Phase 3 clinical trial evaluating aldoxorubicin versus investigators’ choice in patients with relapsed and refractory soft tissue sarcomas (STS) has been selected for an oral presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2017 in Chicago (Press release, CytRx, APR 21, 2017, View Source [SID1234518660]).

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In addition, updated data from the Company’s ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna in patients with first-line soft tissue sarcomas has also been selected for a poster presentation.

"We look forward to presenting the more detailed and updated global Phase 3 results to the medical community at ASCO (Free ASCO Whitepaper) this year," said Daniel Levitt, M.D., Ph.D., Chief Operating Officer and Chief Medical Officer of CytRx. "The Phase 3 trial and the combination trial of aldoxorubicin with ifosfamide continue to build on our prior studies showing the utility of aldoxorubicin as a treatment for patients with STS. These trials, together with our other clinical and pre-clinical studies of aldoxorubicin, will support our planned New Drug Application submission."

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

Oral Presentation

Title: Phase III study of aldoxorubicin vs investigators’ choice as treatment for relapsed/refractory soft tissue sarcomas
Presenter: Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, and Principal Investigator
Abstract #: 11000
Session Title: Oral Abstract Session: Sarcoma
Location: S100bc
Date and Time: Friday, June 2, 2017; 3:00pm-6:00pm CT

Poster Presentation

Title: Administration of aldoxorubicin and 14 days continuous infusion of ifosfamide/Mesna in metastatic or locally advanced sarcomas.
Presenter: Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center
Abstract #: 11051
Session Title: Poster Session: Sarcoma
Location: Hall A
Poster board#: 374
Date and Time: Sunday, June 4, 2017; 8:00am-11:30am CT

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue. It can arise anywhere in the body at any age. STS remains a high unmet medical need because of the difficulty in treating the more than 50 types of this aggressive cancer. According to the American Cancer Society, in 2016 more than 12,300 new cases were diagnosed in the U.S. and approximately 5,000 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream. Protein-hungry tumors concentrate albumin, which facilitates the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. Typically, doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 6,500 mg/m2 of doxorubicin equivalents. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line STS.

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.

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Abstract #3013

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.

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.

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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.

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).

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]).

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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.
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.