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TRACON Pharmaceuticals Presents Positive Clinical Data from TRC105 and TRC102 Studies at American Society of Clinical Oncology (ASCO) 2017 Annual Meeting

On June 5, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported positive clinical results from multiple studies with TRC105 and TRC102 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Annual Meeting in Chicago, IL (Press release, Tracon Pharmaceuticals, JUN 5, 2017, View Source [SID1234519432]).

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Observed Correlation of Biomarker Status with Activity of TRC105 with Votrient (pazopanib) in Advanced Soft Tissue Sarcoma

In this Phase 1b trial, patients who had greater than a 10% reduction in tumor volume following treatment with TRC105 and Votrient were significantly more likely to have lower baseline levels of soluble intracellular adhesion molecule-1 (ICAM-1) (p=0.018) and thrombospondin-2 (p=0.041). These biomarkers will be assessed separately as part of the completed 63 patient Phase 2 trial of TRC105 and Votrient in soft tissue sarcoma and in the ongoing randomized Phase 3 TAPPAS trial of TRC105 and Votrient in patients with angiosarcoma.

Observed Correlation of Biomarker Status with Activity of TRC105 with Inlyta (axitinib) in Advanced Renal Cell Carcinoma

In this Phase 1b trial, patients with a partial response by RECIST 1.1 following treatment with TRC105 and Inlyta were more likely to have lower levels of soluble osteopontin (p=0.026) and higher levels of soluble transforming growth factor-β receptor III (p=0.0028). These biomarkers will also be assessed as part of the ongoing randomized Phase 2 TRAXAR study of TRC105 and Inlyta in patients with renal cell carcinoma.

Data from a Phase 1/2 Trial of TRC102 with Temodar (temozolomide) in Patients with Solid Tumors

The National Cancer Institute (NCI) reported data from a trial of TRC102 in combination with Temodar in patients with refractory solid tumors. Based on partial responses in patients with KRAS-positive colorectal cancer, ovarian cancer and non-small cell lung cancer, the NCI decided to enroll expansion cohorts in each of these tumor types at the recommended Phase 2 oral dose of TRC102 of 150 mg/m2. The authors concluded that the combination of Temodar and TRC102 is active, and DNA damage response markers (Rad51, ϒ-H2AX and/or pNbs1) were induced in 4 of 5 paired colon biopsies, indicating DNA damage following treatment.

All posters are available on TRACON’s website at: www.traconpharma.com/publications.php

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in one Phase 3 and multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumors in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC102

TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

Seattle Genetics and Astellas Announce Updated Enfortumab Vedotin Phase 1 Data in Metastatic Urothelial Cancer at 2017 ASCO Annual Meeting

On June 5, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas reported updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 52nd Annual Meeting in Chicago (Press release, Seattle Genetics, JUN 5, 2017, View Source [SID1234519431]). Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.

"Patients with metastatic urothelial cancer typically have a five-year survival rate of just five percent and are in urgent need of new treatment options. Despite recent clinical advances, up to 80 percent of patients fail to respond to checkpoint inhibitors, or CPIs, and there are no approved therapeutic options for use after CPI failure," said Daniel P. Petrylak, M.D., Ph.D., Yale Cancer Center and presenter of the phase 1 data at ASCO (Free ASCO Whitepaper). "The objective response rates observed in our phase 1 analysis of enfortumab vedotin show the potential benefit of this agent for patients with metastatic urothelial cancer, particularly those who have failed CPI therapy. Enfortumab vedotin was generally well-tolerated, and the most common adverse events were nausea, itching, fatigue and diarrhea."

"Our updated enfortumab vedotin monotherapy phase 1 data at ASCO (Free ASCO Whitepaper) continue to show encouraging antitumor activity and a well-tolerated safety profile in patients with heavily pretreated metastatic urothelial cancer. We plan to initiate this year a pivotal phase 2 study in the CPI-pretreated setting with the intent of pursuing accelerated approval from the FDA," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "Enfortumab vedotin is our first late-stage clinical program for solid tumors, and these data demonstrate the potential for antibody-drug conjugates to provide therapeutic benefit across a wide array of cancers."

"We are encouraged by the data we’ve seen so far in the enfortumab vedotin clinical trials," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "We’re pleased to be moving forward the enfortumab vedotin development program in support of patients who may benefit from this new potential treatment option."

The following updated results from the ongoing phase 1 study evaluating enfortumab vedotin as a monotherapy for mUC were presented by Dr. Petrylak on Monday, June 5:

A Phase I Study of Enfortumab Vedotin (ASG-22CE; ASG-22ME): Updated Analysis of Patients with Metastatic Urothelial Cancer (Abstract #106, oral presentation on Monday, June 5 at 9:45 a.m. CT)

The ongoing trial is evaluating the safety and anti-tumor activity of enfortumab vedotin at escalating doses of 0.5 to 1.25 milligrams per kilogram (mg/kg) weekly for three of every four week cycles. Data were reported from 81 patients diagnosed with mUC and a median age of 67 years. Of these patients, 37 (46 percent) were previously treated with CPIs and 77 (95 percent) had undergone treatment with a platinum-based chemotherapy. Ninety-seven percent of patient screening samples showed Nectin-4 expression, the majority of which were at a high level. All response rates include confirmed and unconfirmed responses, as assessed by the investigator. The recommended phase 2 dose (RP2D) has been established at 1.25 mg/kg. Key findings include:

Of the 71 patients evaluated for response, 29 patients (41 percent) had an objective response, including three (four percent) complete responses and 26 (37 percent) partial responses. Disease control was achieved in 51 patients (72 percent), defined as the sum of patients achieving complete responses, partial responses or stable disease. The preliminary estimate of median duration of response for all patients was 24 weeks.
In 30 patients treated at the RP2D level, 16 patients (53 percent) had an objective response, including one (three percent) complete response and 15 (50 percent) partial responses. Disease control was achieved for 22 patients (73 percent).
Of the 32 patients previously treated with CPIs and evaluated for response, 14 patients (44 percent) had an objective response, including one complete response (three percent) and 13 (41 percent) partial responses. At the RP2D, eight out of 17 CPI-treated patients (47 percent) achieved a partial response, and disease control occurred in 13 patients (77 percent).
Of the 19 patients with liver metastases, nine (47 percent) had an objective response, including one (five percent) complete response and eight (42 percent) partial responses. Disease control was achieved for 13 patients (68 percent).
The most common treatment-related adverse events of any grade occurring in 10 percent or more of patients were nausea (36 percent), pruritus (31 percent), fatigue (30 percent) and diarrhea (28 percent). The most common Grade 3 or 4 adverse events occurring in five percent or more of patients, regardless of attribution, were urinary tract infections, hypophosphatemia, hyponatremia and anemia.
These results support further development of enfortumab vedotin as monotherapy and in combination with other therapies for patients with mUC. Enrollment is ongoing at the RP2D in patients with mUC who have been previously treated with CPIs.
More information about this clinical trial (NCT02091999), including enrolling centers, is available by visiting www.clinicaltrials.gov.

About Urothelial Cancer

Urothelial cancer is most commonly found in the bladder (90 percent). According to the American Cancer Society, approximately 79,000 people in the U.S. will be diagnosed with bladder cancer during 2017 and almost 17,000 will die from the disease. Outcomes are poor for patients diagnosed with metastatic disease, with a five-year survival rate of five percent.

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary, industry-leading linker technology. Enfortumab vedotin is the first and only agent to target Nectin-4, a cell adhesion molecule identified as an ADC target by Agensys (an affiliate of Astellas), which is expressed on many solid tumors.

Nectin-4 is highly expressed in urothelial cancers, particularly in bladder cancer. Preclinical data demonstrate that enfortumab vedotin binds to Nectin-4 on cancer cells and releases the cell-killing agent into these target cells upon internalization.

BeiGene Presents Initial Phase 1 Data on Anti-PD-1 Antibody BGB-A317 Combined with PARP Inhibitor BGB-290 at the 2017 American Society for Clinical Oncology Annual Meeting

On June 5, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported initial data from the dose escalation portion of the Phase 1 trial of anti-PD-1 antibody BGB-A317 in combination with PARP inhibitor BGB-290 in patients with advanced solid tumors at the 2017 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, BeiGene, JUN 5, 2017, View Source [SID1234519430]). The data are being presented in a poster session and are scheduled to be further reviewed during a poster discussion session. The preliminary data suggest that the combination of BGB-A317 and BGB-290 is generally well-tolerated and shows anti-tumor activity in multiple solid tumors.

"Based on the preliminary Phase 1 data, the combination of BGB-A317 and BGB-290 appears feasible and leads to tumor regression in a variety of malignancies. The observed activity was not restricted to patients with a known germline BRCA mutation," commented Michael Friedlander, MRCP, FRACP, PhD, Prince of Wales Hospital, Australia and coordinating principal investigator of the study.

"The evaluation of this combination is supported by published literature demonstrating that damage to DNA can induce an immune response. We believe that this is the largest body of clinical data published to date on the combination of a PD-1 antibody and a PARP inhibitor, and it is also the first published dataset from our internal combination trials. We look forward to further exploring the combination’s clinical activity and tolerability in multiple dose expansion cohorts of patients with specific tumor types," commented Amy Peterson, MD, Chief Medical Officer, Immuno-oncology at BeiGene.

Trial Design

The multicenter, open-label Phase 1/1b study is evaluating the combined use of BGB-A317 and BGB-290. The dose escalation phase is designed to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose, evaluate the pharmacokinetics (PK) of the drug combination, and assess the immunogenicity of BGB-A317. The dose expansion phase is designed to further evaluate the tolerability and activity of the combination in patients with advanced solid tumors likely to harbor DNA damage repair deficiencies or who may be susceptible to treatment either with a PARP inhibitor or with PD-1 blockade.

Summary of Preliminary Results

At the data cut-off of March 31, 2017, 43 patients were enrolled in the dose-escalation portion of the trial. Cohorts of six to 12 patients each received treatments at five planned dose levels (DLs). BGB-A317 was administered at 2 mg/kg every three weeks (Q3W) with BGB-290 at 20, 40, or 60 mg twice daily (BID) in DLs 1, 2, and 3, respectively. BGB-A317 was also administered at a fixed dose of 200 mg Q3W with BGB-290 at 40 or 60 mg BID in DLs 4 and 5, respectively. Duration of treatment was greater than 200 days for 10 patients, and a total of seven patients remained on treatment as of the data cut-off.

The safety analysis suggested that the combination of BGB-A317 and BGB-290 was generally well-tolerated in patients with advanced solid tumors. Dose-limiting toxicities occurred in three patients; these included one patient with grade 2 nausea at DL4, one patient with grade 2 nausea and grade 2 vomiting at DL5, and one patient with grade 4 autoimmune hepatitis at DL5. DL4 was determined to be the MTD. Grade 3 or 4 adverse events (AEs) assessed by the investigator to be related to BGB-A317 and reported in more than one patient included autoimmune hepatitis / hepatitis (12%) and elevated alanine aminotransferase (ALT) (5%). Grade 3 or 4 AEs assessed by the investigator to be related to BGB-290 and reported in more than one patient included anemia (14%), as well as elevated ALT, elevated aspartate aminotransferase (AST), fatigue, and nausea (5% each). Suspected immune-related AEs (irAEs) of any grade regardless of causality occurred in 17 patients (40%); those reported in at least two patients included elevated ALT/AST or gamma-glutamyltransferase (GGT), autoimmune hepatitis, diarrhea, hypothyroidism, and hyperthyroidism. Grade 3-4 liver-related events regardless of causality were reported in eight patients, including five patients with hepatitis and three patients with ALT and/or AST elevations. Together, liver-related AEs of any grade regardless of causality were observed in 12 patients; all events were reversible with or without corticosteroid treatment. Treatment with both agents was discontinued by 33 patients for reasons including disease progression (26 patients), AEs (seven patients), and / or consent withdrawal (two patients). There were no fatal adverse events.

Co-administration of BGB-A317 with BGB-290 did not have a significant impact on the pharmacokinetic profile of either compound. In 29 patients with ovarian or fallopian tube cancer, best responses included one confirmed complete response (CR), two confirmed partial responses (PRs), five unconfirmed partial responses (PRs), and seven cases of stable disease (SD). In two patients with breast cancer, best responses included one confirmed PR. In three patients with pancreatic cancer, best responses included one unconfirmed PR and two cases of SD. The one patient with uterine cancer had a best response of an unconfirmed PR. SD was observed in one of three patients with prostate cancer and the one patient with bile duct cancer. Additional tumor types enrolled in the study include bladder, cervical, lung, and peripheral nerve sheath cancer, with one patient each.

The trial will further evaluate the combination’s activity in expansion cohorts of patients with ovarian, triple-negative breast, castration-resistant prostate, small cell lung, gastric / gastro-esophageal junction, urothelial, and pancreatic cancers.

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, as the ability to bind to Fc gamma receptors has been 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 investigational inhibitor of PARP1 and PARP2 that has been engineered to facilitate unique properties such as brain penetration and PARP–DNA complex trapping for improved cytotoxicity via cell‑cycle arrest and apoptosis. 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.

LION BIOTECHNOLOGIES ANNOUNCES UPDATED DATA AT 2017 AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) ANNUAL MEETING FROM ONGOING LN-144 PHASE 2 CLINICAL TRIAL

On June 5, 2017 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported a poster presentation of additional data from 16 patients enrolled in the first cohort of its ongoing Phase 2 study of LN-144 for the treatment of metastatic melanoma at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Lion Biotechnologies, JUN 5, 2017, View Source [SID1234519429]).

"The data presented today demonstrate that we can manufacture TIL at our central GMP facilities and treat a patient population with a high unmet need at multiple clinical sites," said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Lion Biotechnologies. "These initial data show clinically-meaningful outcomes, as assessed both by ORR and DCR, in a heavily pre-treated patient group, all of which had received prior anti-PD-1 and over 80% with prior anti-CTLA-4 checkpoint inhibitors."

This Phase 2, multicenter, three-cohort study is designed to assess the safety and efficacy of LN-144 for treatment of patients with metastatic melanoma. Cohorts one and two will now enroll up to 30 patients each and cohort three is a re-treatment cohort for a second LN-144 infusion in up to ten patients. The first two cohorts are evaluating two different manufacturing processes for LN-144. Patients in cohort one are receiving fresh, non-cryopreserved TIL and cohort two patients are receiving product manufactured through a more streamlined and rapid three-week procedure yielding a cryopreserved product.

In the poster presentation entitled, "Efficacy of Single Administration of Tumor Infiltrating Lymphocytes (TIL) in Heavily Pre-treated Metastatic Melanoma Patients Following Checkpoint Therapy," Amod Sarnaik, MD, a surgical oncologist in the Department of Cutaneous Oncology at Moffitt Cancer Center and a member of the Immunology Program provided updated data from 16 patients in cohort one who were infused as of April 24, 2017. These advanced metastatic melanoma patients were a median age of 55 and were highly refractory to multiple prior lines of therapy with significant tumor burden at baseline. All had prior anti-PD-1 therapy, 88 percent had anti-CTLA4 therapy and 64 percent had received three or more prior therapies. The results show:

Of the evaluable patients, a 29 percent objective response rate was reported including one complete response (CR) continuing beyond 15 months post-administration of a single TIL treatment
77 percent of patients had reduction in target tumor size
Mean time to first response of 1.6 months, with the CR developing at 6 months
Responses were observed in patients with tumors carrying wild type or BRAF mutations
The protocol allows for administration of up to 6 doses of IL-2. The median number of IL-2 administrations was six.
Additionally, the protocol for this study was amended to both increase the sample size for the study as well as further define the patient population to patients with unresectable or metastatic melanoma who have progressed after immune checkpoint inhibition therapy (e.g., anti-PD-1), and if BRAF mutation-positive, after BRAF targeted therapy.

New Phase 2 Patient Data Presented at ASCO Strengthen the Evidence for Anti-Tumor Activity of VB-111 in Recurrent GBM

On June 5, 2017 VBL Therapeutics (Nasdaq:VBLT), reported the presentation of new data demonstrating that treatment with VB-111 (ofranergene obadenovec) induced durable tumor regression and attenuation of tumor growth in patients with recurrent glioblastoma (rGBM) (Press release, VBL Therapeutics, JUN 5, 2017, View Source [SID1234519427]). Data from the company’s prior Phase 2 study in rGBM, will be presented today at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place in Chicago. They will be presented by Andrew Brenner, MD, PhD, the principal investigator of the Phase 2 study and associate professor in medicine, neurology and neurosurgery at the Cancer Therapy and Research Center (CTRC), University of Texas Health Science Center San Antonio.

VBL’s Phase 2 multi-center study for VB-111 was designed to determine the safety, tolerability and efficacy of VB-111 in patients with rGBM. A total of 46 patients were enrolled in two sequential cohorts. In the first cohort, patients were treated with VB-111 as monotherapy for a median of only one dose and, upon disease progression, switched to Avastin (bevacizumab) alone as standard of care (Limited Exposure cohort). This cohort behaved like an Avastin historical control with a median Overall Survival (mOS) of 8 months.

In the second cohort, patients continued to receive treatment with VB-111 after progression, in combination with Avastin as the standard of care (Treatment Through Progression cohort). This cohort received in median 4 doses of VB-111, about 8 months of treatment.

VBL previously reported that the study met the primary endpoint of statistically-significant increase in median overall survival, with 59 weeks in patients treated continuously with VB-111, compared to 32 weeks in patients with only one dose (in median) of VB-111 (p=0.048), both groups having received Avastin upon progression after a short course of VB-111. 12-Month overall survival was 57% in the VB-111 continuous exposure cohort, compared with only 24% in historical pooled Avastin trials (p=0.03), consistent with data indicating that Avastin monotherapy does not improve OS in rGBM patients.

To further understand the why treatment with VB-111 was associated with prolonged survival, VBL analyzed the tumor growth kinetics in all rGBM patients who participated in the VB-111 Phase 2 trial. These new data demonstrate that tumor growth kinetics was significantly attenuated upon longer treatment with VB-111.

Whereas brief exposure to VB-111 was associated with tumor progression in most patients, longer exposure to VB-111 (median= 4, mean=4.7 doses) led to attenuation of tumor growth kinetics (median % increase (MPI) per 30 days: 0.6 vs 14.1, p=0.0032). Furthermore, tumor regression was more frequent upon longer exposure to VB-111; only 16% of patients with limited exposure to VB-111 had tumors shrink below baseline dimensions during the first 100 days, compared to 61% of patients who continued to receive VB-111 through progression (p=0.002; McNemar’s test). Except for longer treatment with VB-111 leading to favorable OS, there was no evidence for difference between the two cohorts in any of the criteria tested, including patient characteristics, initial tumor growth kinetics, and Avastin treatment of both groups.

Overall, VBL’s Phase 2 data point to a favorable anti-tumor effect of VB-111 in rGBM, in terms of both regression rate and overall survival following treatment through progression, compared to both brief exposure to VB-111 with subsequent Avastin monotherapy and to historical data of Avastin monotherapy. Notably, responses were seen even with VB-111 monotherapy, including a patient who remains in complete remission after over 3 years.

"The new analysis supports the benefit of continuous exposure to VB-111 in combination with Avastin, on both inhibition of tumor growth and survival in rGBM patients," said Dr. Andrew Brenner, CTRC, University of Texas Health Science Center San Antonio, principal investigator in the VB-111 Phase 2 study.

Yael Cohen, MD, Vice President of Clinical Development at VBL Therapeutics, said, "We are encouraged by these Phase 2 results in rGBM, which also are consistent with the findings from our trials of VB-111 in ovarian cancer and thyroid cancer. The current data support the design of our ongoing Phase 3 GLOBE study in rGBM."

VBL’s pivotal Phase 3 GLOBE study in rGBM, comparing VB-111 in combination with Avastin to Avastin alone, is currently being conducted in the US, Canada and Israel. Enrollment in the study, 256 patients in total, was completed in December 2016, five months ahead of schedule. The study is proceeding under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA), with full endorsement by the Canadian Brain Tumor Consortium (CBTC). The company expects an interim analysis of the GLOBE trial to occur in the third quarter of 2017, with top-line results from the full dataset expected in early 2018.

The new Phase 2 data will be presented in a poster session at ASCO (Free ASCO Whitepaper) today at 1:15 PM – 4:45 PM CDT, Hall A, poster board # 297. The poster will be also available on the company’s website, at ir.vblrx.com.

About Ofranergene Obadenovec (VB-111)
Ofranergene obadenovec is a unique biologic agent that uses a dual mechanism to target solid tumors. Based on a non-integrating, non-replicating, Adeno 5 vector, ofranergene obadenovec utilizes VBL’s proprietary Vascular Targeting System (VTS) to target the tumor vasculature for cancer therapy. Unlike anti-VEGF or TKIs, ofranergene obadenovec does not aim to block a specific pro-angiogenic pathway; instead, it uses an angiogenesis-specific sensor (VBL’s PPE-1-3x proprietary promoter) to specifically induce cell death in angiogenic endothelial cells in the tumor milieu. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor and shows activity even after failure of prior treatment with other anti-angiogenics. Moreover, ofranergene obadenovec induces specific anti-tumor immune response, which is accompanied by recruitment of CD8 T-cells and apoptosis of tumor cells.

Ofranergene obadenovec completed a Phase 2 study in rGBM, which showed a statistically significant improvement in overall survival in patients treated with ofranergene obadenovec through progression, compared to either patients treated with ofranergene obadenovec followed by bevacizumab alone, or to historical bevacizumab data. In a Phase 2 trial for recurrent platinum-resistant ovarian cancer, ofranergene obadenovec demonstrated a statistically significant increase in overall survival and 60% durable response rate (as measured by reduction in CA-125), approximately twice the historical response with bevacizumab plus chemotherapy in ovarian cancer. In a Phase 2 study in recurrent, iodine-resistant differentiated thyroid cancer, ofranergene obadenovec met the primary endpoint demonstrating disease stabilization with a positive safety profile, along with a dose-response and evidence of an overall survival benefit. Ofranergene obadenovec has received Fast Track Designation for recurrent glioblastoma in the U.S. and orphan drug status for glioblastoma in both the U.S. and EU.