On May 1, 2017 AstraZeneca and its global biologics research and development arm, MedImmune, reported that the US Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi (durvalumab) (Press release, AstraZeneca, MAY 1, 2017, View Source [SID1234518771]). Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. Imfinzi is approved under the FDA’s accelerated approval pathway, based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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Pascal Soriot, Chief Executive Officer of AstraZeneca, said: "We are excited to offer Imfinzi as a breakthrough therapy for patients with locally-advanced or metastatic bladder cancer. Imfinzi is the cornerstone of our extensive Immuno-Oncology programme, in development across many tumour types, as monotherapy and in combination. This first approval for Imfinzi is an important milestone in our return to growth and brings us another step closer to our goal of redefining the way cancer is treated."

Imfinzi is also under investigation in the Phase III DANUBE trial as 1st- line treatment in urothelial carcinoma as monotherapy and in combination with tremelimumab.

Nicholas J. Vogelzang, MD, FACP, FASCO, Clinical Professor at the University of Nevada School of Medicine; SWOG GU Vice Chair; US Oncology Research GU Chair; Comprehensive Cancer Centers of Nevada, said: "The usual course of treatment for patients with advanced bladder cancer begins with a standard platinum-containing chemotherapy. Patients who have disease progression during or following chemotherapy are left with few other treatment options. The approval of Imfinzi to treat this population of select patients signifies hope for those who are currently suffering, or may find themselves with limited options in the future."

The recommended dose of Imfinzi is 10 mg/kg body weight administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.

The accelerated FDA approval of Imfinzi, a human monoclonal antibody that blocks PD-L1, is based on data from Study 1108. This Phase I/II trial evaluated the safety and efficacy of Imfinzi in patients with locally-advanced or metastatic urothelial carcinoma of the bladder. Patients had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting.

In the trial, Imfinzi demonstrated rapid and durable responses, with an objective response rate (ORR) of 17.0% (95% confidence interval [CI]: 11.9; 23.3) in all evaluable patients, regardless of PD-L1 status, and 26.3% (95% CI: 17.8; 36.4) in patients with PD-L1 high-expressing tumours (as determined by the VENTANA PD-L1 (SP263) Assay, Ventana Medical Systems Inc., a member of the Roche Group). PD-L1 high was defined as ≥25% of tumour cells (TC) or tumour-infiltrating immune cells (IC) expressing membrane PD-L1 if ICs involved >1% of the tumour area, or TC≥25% or IC=100% if ICs involved ≤1% of the tumour area. Additionally, approximately 14.3% of all evaluable patients achieved partial response and 2.7% achieved complete response. Of patients who had received only neoadjuvant or adjuvant therapy prior to trial entry, 24% (n=9) responded. Based on a secondary endpoint in this single-arm trial, median time to response was six weeks. Among the total 31 responding patients, 14 patients (45%) had ongoing responses of six months or longer and five patients (16%) had ongoing responses of 12 months or longer.

Efficacy results for Study 1 (bladder cancer cohort of Study 1108


All Patients
(N=182)
PD-L1
High
(N=95)
PD-L1 Low/Negative (N=73)
PD-L1 Not Evaluable (N=14)
Objective Response Rate (ORR) by BICR*, n (%)
(95% confidence interval [CI])
31 (17.0%)
(11.9; 23.3)
25 (26.3%)
(17.8; 36.4)
3 (4.1%)
(0.9; 11.5)
3 (21.4%)
(4.7; 50.8)
Complete Response (CR)
5
3
1
1
Partial Response (PR)
26
22
2
2
Median Duration of Response (DoR), months (range)
Not reached
(0.9+; 19.9+)
Not reached
(0.9+; 19.9+)
12.3
(1.9+; 12.3)
Not reached
(2.3+; 2.6+)
*BICR=Blinded Independent Central Review
+ Denotes a censored value

Patients should be monitored for immune-mediated adverse reactions including pneumonitis, hepatitis, colitis, endocrinopathies (including adrenal insufficiency, hypophysitis, or Type 1 diabetes mellitus), nephritis, rash, thrombocytopenic purpura, infection, infusion-related reactions, or embryo-fetal toxicity. Serious adverse reactions occurred in 46% of patients. The most frequent serious adverse reactions (>2%) were acute kidney injury (4.9%), urinary tract infection (4.4%), musculoskeletal pain (4.4%), liver injury (3.3%), general physical health deterioration (3.3%), sepsis, abdominal pain, and pyrexia/tumour associated fever (2.7% each). Eight patients (4.4%) who were treated with Imfinzi experienced Grade 5 adverse events of cardiorespiratory arrest, general physical health deterioration, sepsis, ileus, pneumonitis, or immune-mediated hepatitis. Three additional patients were experiencing infection and disease progression at the time of death. Imfinzi was discontinued for adverse reactions in 3.3% of patients.

Clinical trials have demonstrated that patients with PD-L1 high-expressing tumours have a higher likelihood of response through blockade of the PD-1/PD-L1 pathway. PD-L1 expression testing may be a useful tool to help guide physicians in their treatment decisions, but it is not required for use of Imfinzi.

About Imfinzi (durvalumab)

Imfinzi (durvalumab, previously known as MEDI4736) is a human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80.

Durvalumab is also being tested in the 1st-line treatment of patients with unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, as part of the DANUBE Phase III trial, which had the last patient commenced dosing during the first quarter of 2017 (global trial, excluding China). Additional clinical trials are ongoing to investigate durvalumab as monotherapy or in combination in multiple solid tumours and blood cancers.

About bladder cancer

Urothelial bladder cancers arise from the epithelium of the bladder and are the ninth most common form of cancer worldwide. It is estimated that in 2016, about 430,000 people were diagnosed with bladder cancer around the world and 165,000 did not survive. Metastatic bladder cancer remains an area of unmet medical need in particular; among patients treated with standard-of-care chemotherapy, the five-year survival rate is below 15%.

The tumour microenvironment of urothelial carcinoma (UC) significantly impairs lymphocyte function, helping the cancer to evade immune detection by exploiting inhibitory checkpoint pathways, such as PD-L1/PD-1. PD-L1 is widely expressed in tumour and immune cells in UC patients and helps tumours to evade detection from the immune system through binding to the PD-1 receptor on cytotoxic T lymphocytes.

On May 1, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported company highlights and financial results for the first quarter ended March 31, 2017 (Press release, Ignyta, MAY 1, 2017, View Source [SID1234518768]). The company is issuing this press release in lieu of conducting a conference call.

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"We are excited by the continued advancement of our pipeline of precision medicine therapies for the benefit of patients with cancer, including the progress of STARTRK-2, the registration-enabling Phase 2 clinical trial of our lead product candidate, entrectinib, our novel, investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1, or ALK fusions," said Jonathan Lim, M.D., Chairman and CEO of Ignyta.

Company Highlights

Updated Progress Towards Entrectinib Dual TRK and ROS1 NDA Submissions

In April 2016, we announced a comprehensive program update on entrectinib and the STARTRK-2 trial. As of that update:

Entrectinib program is more than 85% enrolled to goal for the primary efficacy analysis to potentially support a TRK tissue agnostic NDA submission
More than 50 patients with ROS1 fusion-positive NSCLC were enrolled; interim data from 32 of these patients as assessed by investigator demonstrated 75% (24 of 32) confirmed RECIST ORR and 17.2 months DOR
Entrectinib demonstrated a confirmed RECIST ORR of 64% (7 of 11) in ROS1 NSCLC patients with CNS metastases
The program is tracking towards dual NDA submissions in TRK and ROS1 in 2018 if supported by clinical data, with anticipated US commercial launch in both indications in 2019.

Multiple Entrectinib Peer-Reviewed Publications

In March 2017, a case report on the successful treatment with entrectinib of a clinical trial patient with a primary brain tumor harboring an NTRK1 fusion was published in the peer-reviewed journal, Precision Oncology. The genomic analysis study, led by researchers at Massachusetts General Hospital, reported three NTRK fusions out of 26 tumors evaluated, and reported that in a patient with a BCAN-NTRK1 fusion, clinical trial treatment with entrectinib resulted in a 60 percent regression in tumor size and a resolution of clinical symptoms that was maintained for 11 months on treatment.

In February 2017, updated results from two Phase 1 trials of entrectinib were published in the peer-reviewed journal, Cancer Discovery. We believe this is the largest published safety experience of any TRK inhibitor in clinical development. Highlights of that publication included:

Findings that entrectinib continues to be well tolerated
As of September 2016 data cutoff, RECIST responses were noted in 3 of 3 patients with TRK-positive extracranial solid tumors, with the longest ongoing TRK responder on therapy for 17 months; and RECIST responses in 12 of 14 patients with ROS1-positive solid tumors, with the longest ongoing ROS1 responder on therapy for 32 months
RECIST responses were noted in 63% of patients (5 out of 8) with TRK, ROS1, or ALK fusions, and primary or metastatic disease involving the brain
Amendment of Lilly Agreement

In March 2017, the company announced that it was exploring strategic options for taladegib – an orally bioavailable small molecule hedgehog/smoothened inhibitor – and had entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the taladegib oncology program.

First Quarter 2017 Financial Results

For the first quarter of 2017, net loss was $40.2 million, or $0.96 per share, compared with $25.5 million, or $0.79 per share, for the first quarter of 2016. The vast majority of the increase was due to $12.8 million ($9.8 million of which was non-cash) recorded in 2017 in connection with the amendment of the Lilly license. This amount represents the remaining $12.0 million of timing-based milestones owed over the subsequent three calendar years, discounted back to today’s cash value, and booked as a largely non-cash expense.

Ignyta did not record any revenue for the first quarter of 2017, or for the first quarter of 2016.

Research and development expenses for the first quarter of 2017 were $34.0 million, compared with $19.8 million for the first quarter of 2016. This increase was due to the $12.8 million charge recorded in 2017 in connection with the Lilly license amendment and increased facilities costs of $1.2 million due to the expansion of our leased facilities space. We also incurred additional stock compensation costs of $0.2 million due to the increase in the number of outstanding stock options.

General and administrative expenses were $5.6 million for first quarter of 2017, compared with $5.2 million for first quarter of 2016. The increase in general and administrative expenses was primarily attributable to an increase in our facilities costs.

At March 31, 2017, the company had cash, cash equivalents and available-for-sale securities totaling $108.0 million and current and long-term debt of $32.0 million. At December 31, 2016, the company had cash, cash equivalents and available-for-sale securities totaling $133.0 million and current and long-term debt of $32.0 million. Excluding a $3.0 million milestone payment related to the Lilly license, cash burn in the quarter was $22.0 million.

On May 1, 2017 ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company focused on new immunotherapies, reported its financial results for the first quarter ended March 31, 2017, and provided an update on the company’s recent activities (Filing, Q1, Ziopharm, 2017, MAY 1, 2017, View Source [SID1234518767]).

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"ZIOPHARM is making significant advances, including progress towards finalizing a registration path for Ad-RTS-hIL-12 + veledimex for recurrent glioblastoma and furthering development in our point-of-care approach with T-cell CAR-based therapies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM Oncology. "ZIOPHARM is assessing several paths for the pivotal trial, including a single-arm study of Ad-RTS-hIL-12 + veledimex compared to historical controls. With a commercialization path in view, we are evaluating partnership opportunities for Ad-RTS-hIL-12 + veledimex to understand the breadth of options available to ZIOPHARM for bringing this important therapeutic candidate to patients."

"The IL-12 data from the brain cancer trial firmly establishes that the RheoSwitch Therapeutic System works as a switch in humans," added Dr. Cooper. "By combining the most clinically advanced non-viral gene integration platform, Sleeping Beauty, and transcriptional switch system, RheoSwitch, we will use our point-of-care approach to significantly shorten the time to manufacture T cells and to tailor the expression of introduced genes after infusion using veledimex. This will address two major issues with CAR-based therapies, namely the cost of therapy and control of T cells to reduce toxicity."

Recent Updates
Ad-RTS-hIL-12 + veledimex
Ad-RTS-hIL-12 + veledimex is ZIOPHARM’s gene therapy candidate for the controlled expression of interleukin-12 (IL-12), a critical protein for stimulating an anti-cancer immune response, using a RheoSwitch Therapeutic System (RTS) inducible gene-delivery system, or switch, that enables controlled in vivo expression of therapeutic proteins. ZIOPHARM is currently conducting a multi-center Phase 1 study of Ad-RTS-hIL-12 + orally administered veledimex in patients with recurrent or progressive glioblastoma multiforme (GBM), an aggressive form of brain cancer.
ZIOPHARM will be presenting updated results from its Phase 1, multicenter, dose-escalation study of Ad-RTS-hIL-12 + veledimex in patients with recurrent or progressive glioblastoma at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5, 2017.

"Our initial discussions with regulators have been encouraging, and we look forward to moving Ad-RTS-hIL-12 + veledimex into a pivotal study as quickly as possible this year. Details of the pivotal Phase 3 trial will be made available following completion of discussions with regulators and clinical advisors," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "We continue to see encouraging outcomes in our Phase 1, multi-center study of Ad-RTS-hIL-12 + veledimex in patients with recurrent high-grade gliomas and plan to share updated results from this study at ASCO (Free ASCO Whitepaper)."

The Company also expects to initiate Phase 1 studies of Ad-RTS-hIL-12 + veledimex in pediatric brain cancer, as well as in combination with an anti-PD-1 checkpoint inhibitor in adult glioblastoma, as planned, in the first half of 2017.

Adoptive Cell Therapies
ZIOPHARM is developing chimeric antigen receptor (CAR) T cell (CAR+ T), T-cell receptor (TCR) T cell (TCR+ T), and natural killer (NK) adoptive cell-based therapies. These programs are being advanced in collaboration with Intrexon Corporation, MD Anderson Cancer Center, the National Cancer Institute and Merck Serono, the biopharmaceutical business of Merck KGaA (CAR+ T only).
Announced Advancement of Next-Generation Non-Viral CAR+ T Platform Empowered by Membrane-Bound IL-15 Under RTS Gene Switch Control. In April 2017, ZIOPHARM and its partners, Intrexon and Merck KGaA, Darmstadt, Germany, announced the advancement of a unique approach to develop therapeutic candidates for two CAR+ T targets expressed on a wide range of tumor types, including hematologic malignancies and solid tumors. The distinctive methodology centers on the proprietary RTS platform to regulate production of membrane-bound interleukin-15 (mbIL15) co-expressed with CARs and Sleeping Beauty, a non-viral genetic modification system to genetically modify clinical-grade T cells. The companies expect to advance this innovative approach towards the clinic in 2018.

The IL-15 cytokine is increasingly recognized as a key driver of therapeutic effect in CAR+ T therapy, including in a recent Journal of Clinical Oncology publication which correlated lymphoma remissions in patients whose IL-15 levels were elevated after lymphodepleting chemotherapy. Through the RTS gene switch, the expression of mbIL15 can be regulated to help CARs target cancers in a controlled manner, thus providing a new paradigm in T-cell therapy.
Announced Advances in Point-of-Care Approach for Rapidly Producing CAR-Expressing T Cells Utilizing the Sleeping Beauty System. In January 2017, ZIOPHARM announced improved production times utilizing its non-viral platform to engineer T cells in an ongoing Phase 1 study of second-generation Sleeping Beauty-modified CD19-specific CAR+ T cells. ZIOPHARM continues to refine its Sleeping Beauty system to further reduce time to manufacture genetically modified T cells. Preclinical studies of third-generation Sleeping Beauty-modified CAR+ T cells co-expressing mbIL15 demonstrated reduced time to administration (less than two days) through elimination of the need for in vitro T-cell activation and propagation. Plans to progress this point-of-care approach with infusion of CAR+ T cells in less than two days are underway. The combination of Sleeping Beauty and RTS-mbIL15, has the potential to solve the dual problems of cost and toxicities as genetically modified T cells can be rapidly produced for preclinical testing, and the RTS is a clinically validated switch, which may be used with veledimex to control T-cell persistence via conditional expression of mbIL15. The Company expects to advance towards a Phase 1 study evaluating the point-of-care in 2017.

Announced Cooperative Research and Development Agreement (CRADA) With the National Cancer Institute Utilizing Sleeping Beauty System to Generate T Cells Targeting Neoantigens. In January 2017, ZIOPHARM and its partner, Intrexon, announced the signing of a CRADA with the National Cancer Institute (NCI) for the development of adoptive cell transfer-based immunotherapies genetically modified using the Sleeping Beauty system to express TCRs targeting neoantigens for the treatment of solid tumors. Research conducted under the CRADA will be at the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research. The Company anticipates that this program will advance to Phase 1 during the second half of 2017.
Anticipated and Achieved 2017 Milestones

• Intra-tumoral IL-12 RheoSwitch programs:

• Updated clinical data from Phase 1 of Ad-RTS-hIL-12 + veledimex for recurrent GBM to be presented at ASCO (Free ASCO Whitepaper)

• Initiate pivotal clinical trial for recurrent GBM

• Initiate combination study of Ad-RTS-hIL-12 + veledimex with iCPI (anti-PD-1) for recurrent GBM during the first half

• Initiate Phase 1 study in the treatment of brain tumors in children during the first half

• CAR+ T programs:

• Continue CD19-specific CAR+ T second-generation clinical study, enrolling patients under shortened manufacturing

• Advance CD19 third-generation mbIL15 towards a Phase 1 clinical study evaluating point-of-care

• Initiate a CD33-specific CAR+ T clinical study in adults and children for relapsed or refractory acute myeloid leukemia

• Advance CAR+ T-cell preclinical studies for at least one hematological malignancy under a shortened manufacturing process towards point-of-care

• TCR programs

• Execute CRADA with NCI utilizing Sleeping Beauty to generate T cells targeting neoantigens for treatment of patients with solid tumor malignancies

• Advance development of process for delivering personalized gene-modified T-cell products against neoantigens

• NK cell programs

• Initiate a Phase 1 study of off-the-shelf (OTS) NK cells for elderly patients with acute myeloid leukemia not eligible for standard intensive chemotherapy

• GvHD (graft-versus-host disease) programs

• Advance preclinical studies

First-Quarter 2017 Financial Results

• Net loss applicable to the common shareholders for the first quarter of 2017 was $19.7 million, or $(0.15) per share, compared to a net loss of $12.0 million, or $(0.09) per share, for the first quarter of 2016. The increase in net loss for the three months ended March 31, 2017 is primarily due to decreased collaboration revenue of $0.4 million, an increase in operating expenses of $1.5 million, an increase in the charge for the change in derivative liabilities of $1.6 million and income attributable to preferred shareholders of $4.2 million.

• Research and development expenses were $12.0 million for the first quarter of 2017, compared to $10.2 million for the first quarter of 2016. The increase in research and development expenses for the three months ended March 31, 2017 is primarily due to our gene therapy and cell therapy programs, along with increased headcount.

• General and administrative expenses were $3.6 million for the first quarter of 2017, compared to $3.8 million for the first quarter of 2016. The decrease in general and administrative expenses is primarily due to decreased employee-related expenses.

• The Company ended the quarter with cash and cash equivalents of approximately $66.4 million, which the Company believes will be sufficient to fund its currently planned activities through the fourth quarter of 2017, including initiating a pivotal trial for Ad-RTS-hIL-12 + veledimex.

On May 1, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the Company will withdraw its European Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older (Press release, Sunesis, MAY 1, 2017, View Source [SID1234518766]). The decision follows recent interactions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), during which the Company learned that the committee was likely to formally adopt a negative opinion in its evaluation of the application.

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"We are disappointed to not achieve approval for vosaroxin’s MAA given its reported efficacy in a patient population with such poor outcomes. Although we did not receive a definitive CHMP opinion, we believed that a positive opinion was unlikely," said Daniel Swisher, President and Chief Executive Officer of Sunesis. "Following our appearances before the committee’s Scientific Advisory Group Oncology Division and CHMP, we carefully considered feedback from our rapporteurs and input from retained regulatory experts to make our decision to notify EMA to withdraw vosaroxin’s MAA as our assessment concluded it was unlikely we could achieve a majority vote of CHMP members at this time or upon an immediate re-examination for our proposed indication based on VALOR data from a sub-group of a single pivotal trial that had missed reaching full statistical significance in its primary analysis."

Mr. Swisher added: "In light of this, we are significantly reducing our investment in the AML program and shifting an increasing portion of resources to our kinase inhibitor pipeline, including lead asset SNS-062, our non-covalent reversible BTK-inhibitor, which will begin dosing this quarter in a Phase 1b/2 trial in cancer patients with B-cell malignancies. We expect to continue to advance the development of vosaroxin through a modest investment in investigator-sponsored group trials, and will carefully assess business development alternatives to support the conduct of another pivotal trial to achieve future regulatory approval of vosaroxin. We expect that our current cash resources are sufficient to fund the company beyond Q1 2018."

About SNS-062
SNS-062 is a novel, second-generation BTK inhibitor, a class of kinase inhibitors that selectively inhibits the enzyme Bruton’s tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. Unlike other drugs in its class, SNS-062 has a distinct kinase selectivity profile and binds non-covalently to the BTK enzyme. This alternate binding site potentially provides an opportunity to address the leading resistance mechanism, a mutation in the enzyme’s binding site required for covalent binding. In preclinical studies, SNS-062 demonstrated potent activity against Cys-481S mutated B-cell malignancies, and has been studied in healthy subjects in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the drug’s safety, pharmacokinetics, and pharmacodynamics. With the reported successful study outcome, SNS-062 is proceeding to a Phase 1B/2 study in patients with B-cell malignancies.

About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed/refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

On May 1, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes, reported one oral and one poster presentation at the 14th International Symposium on Myelodysplastic Syndromes taking place May 3-6, 2017 at the Palacios de Congresos de Valencia in Valencia, Spain (Press release, Onconova, MAY 1, 2017, View Source [SID1234518754]). These presentations will be made by the Company’s collaborators from the Mount Sinai School of Medicine and the Cleveland Clinic.

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Abstract Details:

Poster Presentation:
Date: May 4th through May 6th
Time: 8:00 am
Location: Poster Presentation Section
Presenter: Dr. Aziz Nazha – Cleveland Clinic, Cleveland, Ohio

A Validation of a Post-Hypomethylating Agent Failure (HMAF) Prognostic Model in Myelodysplastic Syndromes (MDS) Patients Treated with Rigosertib versus Best Supportive Care (BSC) in a Randomized Controlled Phase III trial

Oral Presentation:
Date: Saturday May 6th
Time: 8:30 am-10 am
Location: Auditorium 1
Presenter: Dr. Shyamala Navada – Mount Sinai School of Medicine, NYC

Combination of Oral Rigosertib and Injectable Azacitidine In Patients with Myelodysplastic Syndromes (MDS)

Additional details and content from these presentations will be available on the Company’s website on the day of the presentations.