Foundation Medicine Establishes Immuno-Oncology Companion Diagnostics Collaboration with Merck

On May 24, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported a collaboration with Merck, known as MSD outside the United States and Canada, to develop companion diagnostic tests for use with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability (MSI) high or mismatch repair deficient solid tumors (Press release, Foundation Medicine, MAY 24, 2018, View Source [SID1234526886]). The companion diagnostic tests will leverage FoundationOne CDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating multiple companion diagnostics. The companies will collaborate on the development of a pan-cancer companion diagnostic to measure MSI. In addition, they plan to develop companion diagnostics for tumor mutational burden (TMB), as well as additional potential novel biomarkers of response.

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"By collaborating, Merck and Foundation Medicine can continue to push the frontier on innovation in immuno-oncology and personalized cancer care, making a positive difference in the lives of individuals with cancer," said Melanie Nallicheri, chief business officer and head, biopharma for Foundation Medicine. "The addition of MSI and TMB companion diagnostics to FoundationOne CDx re-affirms the validity and clinical utility of these critical immuno-oncology biomarkers, can simplify diagnostic testing through the use of one test that provides physicians with necessary information to both rule-in and rule-out potential treatment options based on each patient’s genomic and biomarker status, and can help accelerate patient access to personalized healthcare."

"Rapidly evolving knowledge of cancer biology and immuno-oncology continues to improve understanding of how to deploy our medicines to identify those patients most likely to respond effectively," said Dr. Eric Rubin senior vice president oncology clinical development, Merck Research Laboratories. "We look forward to working with Foundation Medicine on this companion diagnostics strategy."

FoundationOne CDx, an FDA-approved CGP assay for all solid tumors, assesses genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment options. FoundationOne CDx is also FDA-approved as a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, 12 of which are approved as first line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as MSI and TMB, that can help inform the use of other targeted oncology therapies, including immunotherapies and relevant clinical trial information. In all of these ways, FoundationOne CDx is available to biopharma companies as an FDA-approved platform for clinical research and as a CGP platform for biopharma companies seeking to develop companion diagnostics for their precision therapeutics.

FoundationOne CDx is available to order online at www.foundationmedicine.com/genomic-testing/order, or visit View Source to sign up for an account.

Merus Announces First Patient Dosed in Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors

On May 24, 2018 Merus N.V. (Nasdaq:MRUS), a clinicalstage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics), reported that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA158 in patients with solid tumors with an initial focus on metastatic colorectal cancer (Press release, Merus, MAY 24, 2018, View Source [SID1234532108]). The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States.

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MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G proteincoupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). MCLA-158 was identified from a large library of bispecific antibodies targeting molecules belonging to the Wnt and receptor tyrosine kinase signaling pathways as part of work performed by the suppresSTEM consortium, a project that was funded by the European Union. Functional evaluation of patient-derived colorectal tumors, including those harboring RAS and/or PI3K mutations, demonstrated that MCLA-158 was more effective at inhibiting tumor growth and promoting apoptosis than an approved targeted therapy comparator for metastatic colorectal cancer, cetuximab. In preclinical studies, Merus also observed that the growth inhibitory activity of MCLA-158 was greater for colon tumors compared to normal colon tissue, consistent with its good safety profile in non-human primates.

"The commencement of our Phase 1 clinical trial of MCLA-158 is an important milestone for the advancement of our pipeline of bispecific antibodies obtained from our Biclonics technology platform," said Ton Logtenberg, Ph.D., Chief Executive Officer. "We believe MCLA-158 has the potential to address features that limit currently approved colorectal cancer-targeted therapies, including issues with offtarget toxicity and inability to target tumor stem cells, and thus, potentially treat a broader population of patients more effectively."

The Phase 1, open-label, multicenter clinical trial of MCLA-158 consists of two parts, a dose escalation and a dose expansion. The dose escalation part is intended to determine the appropriate dose of MCLA158. The dose expansion part will evaluate the safety and tolerability of the defined dose of MCLA-158 in patients with solid tumors. The dose escalation and expansion parts of the trial will also examine the preliminary antitumor activity of single-agent MCLA-158.

Cotinga Pharmaceuticals Announces FDA Clearance of Significant Protocol Changes for COTI-2 Clinical Program

On May 24, 2018 Cotinga Pharmaceuticals Inc. (TSX-V:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported the clearance of a protocol amendment for its ongoing clinical trial of COTI-2 (Press release, Cotinga, MAY 24, 2018, https://globenewswire.com/news-release/2018/05/24/1511485/0/en/Cotinga-Pharmaceuticals-Announces-FDA-Clearance-of-Significant-Protocol-Changes-for-COTI-2-Clinical-Program.html [SID1234533153]). The multi-part protocol amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers. The Company will initially evaluate COTI-2 combined with standard of care cisplatin in up to 30 patients with any of ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma.

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"Following extensive work with our academic collaborators and the FDA, we are pleased to expand the ongoing clinical trial of our lead asset, COTI-2, to evaluate its potential as a combination therapy in various cancers with severe unmet medical need," said Alison Silva, President and Chief Executive Officer. "We have already begun to roll-out the initial part of the protocol amendment for our sites at MD Anderson Cancer Center and Northwestern University, and we will continue to work closely with investigators to ensure the process runs smoothly. We look forward to announcing the first patient dosed with combination therapy and providing updates as we continue to advance the clinical development of COTI-2."

Phase 1b/2a Trial of COTI-2
The ongoing trial of COTI-2 will now focus on evaluating COTI-2 as a combination therapy for the potential treatment of a wide spectrum of cancers. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating monotherapy with COTI-2 was generally safe and well-tolerated. Monotherapy with COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

The current protocol amendment being implemented by the Company in May 2018 expands the ongoing trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers.

This protocol amendment evaluates COTI-2 combined with standard of care cisplatin in up to 30 patients with any of the following malignancies: ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma. Patients in this dose finding study will be given a 60 mg/m2 IV dose of cisplatin every three weeks in combination with an oral dose of COTI-2 five days per week. Up to five COTI-2 dose levels will be evaluated ranging from 0.5 mg/kg to 3.5 mg/kg and patient assessments will occur every eight weeks. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacokinetics and various signals of efficacy. Additional details on the protocol amendment are available on clinicaltrials.gov.

McKesson Reports Fiscal 2018 Fourth-Quarter and Full-Year Results

On May 24, 2018 McKesson Corporation (NYSE:MCK) reported that revenues for the fourth quarter ended March 31, 2018, were $51.6 billion, up 6% compared to $48.7 billion a year ago (Press release, McKesson, MAY 24, 2018, View Source [SID1234526887]). On a constant currency basis, revenues increased 4% over the prior year. For the fiscal year, McKesson had revenues of $208.4 billion, up 5% compared to $198.5 billion a year ago. On a constant currency basis, revenues increased 4% over the prior year.

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On the basis of U.S. generally accepted accounting principles ("GAAP"), fourth-quarter loss per diluted share from continuing operations was $(5.58), compared to earnings per diluted share of $16.79 a year ago. Full-year GAAP earnings per diluted share from continuing operations was $0.30, compared to $23.28 a year ago. Fourth-quarter GAAP loss per diluted share and full-year GAAP earnings per share included after-tax net charges totaling $1.9 billion and $2.6 billion, respectively, or $9.07 and $12.32 per diluted share, respectively, driven primarily by non-cash goodwill and long-lived asset impairment charges in the company’s European and Canadian retail businesses, partially offset by benefits related to the Tax Cuts and Jobs Act of 2017.

Prior year fourth-quarter and full-year GAAP earnings per diluted share included an after-tax net gain of $3.0 billion, or $14.10 per diluted share and $13.53 per diluted share, respectively, related to the creation of the Change Healthcare joint venture.

Fourth-quarter Adjusted Earnings per diluted share was $3.49, up 2% compared to $3.41 a year ago. Full-year Adjusted Earnings per diluted share was $12.62, up 1% compared to $12.54 for the prior year, which includes the $0.31 per diluted share contribution to create a non-profit foundation.

For the full year, McKesson generated cash from operations of $4.3 billion and ended the year with cash and cash equivalents of $2.7 billion. During the year, McKesson repaid approximately $765 million in net long-term debt, paid $2.9 billion for acquisitions, repurchased approximately $1.7 billion of its common stock, invested $580 million internally and paid $262 million in dividends."

"While we realized significant charges in the fourth quarter reflecting challenging market conditions in Europe and Canada, I’m pleased with the Fiscal 2018 performance across our other businesses. And the strength of our balance sheet and cash flow enabled us to make internal investments and acquisitions that will drive growth," said John H. Hammergren, chairman and chief executive officer. "This strong financial position, combined with actions we are taking in relation to our recently announced multi-year strategic growth initiative, ensures McKesson’s ongoing focus on delivering shareholder value.

"We also returned capital to shareholders through share repurchases and a quarterly dividend. And yesterday, our Board of Directors approved an additional share repurchase authorization of $4 billion, as we believe that the company’s shares are an attractive investment opportunity and repurchasing stock is an important part of our diversified capital allocation strategy," continued Hammergren.

Segment Results

Distribution Solutions revenues were $51.6 billion for the quarter, up 7% on a reported basis and 5% on a constant currency basis. For the full year, Distribution Solutions revenues were $208.1 billion, up 6% on a reported basis and 5% on a constant currency basis, compared to the prior year.

North America pharmaceutical distribution and services revenues of $42.7 billion for the quarter were up 5% on both a reported basis and constant currency basis. For the full year, North America pharmaceutical distribution and services revenues were $174.2 billion, up 6% on both a reported and constant currency basis, compared to the prior year. Revenue growth for the quarter and the full year was driven primarily by market growth and acquisitions, partially offset by branded to generic conversions.

International pharmaceutical distribution and services revenues were $7.2 billion for the quarter, up 19% on a reported basis and 4% on a constant currency basis, driven by acquisitions and market growth, which were the same factors that drove full year revenues of $27.3 billion, up 10% on a reported basis and up 5% on a constant currency basis, compared to the prior year.

Medical-Surgical distribution and services revenues were $1.7 billion for the quarter, up 9%, driven primarily by market growth, including the impact of a stronger flu season. For the full year, Medical-Surgical distribution and services revenues were $6.6 billion, up 6% compared to the prior year.

Fourth-quarter Distribution Solutions GAAP operating loss was $(689) million and GAAP operating margin was (1.33)%. On a constant currency basis, fourth-quarter adjusted operating profit was $1.1 billion, up 8% from the prior year on a reported basis and 7% on a constant currency basis. Adjusted operating margin for the Distribution Solutions segment was 2.26% on a constant currency basis. Adjusted operating margin excluding noncontrolling interests for the Distribution Solutions segment was 2.17% on a constant currency basis.

For the full year, Distribution Solutions GAAP operating profit was $1.2 billion and GAAP operating margin was 0.59%. On a constant currency basis, full-year adjusted operating profit was $4.1 billion, up 8% from the prior year on a reported basis and 7% on a constant currency basis. Adjusted operating margin for the Distribution Solutions segment was 1.96% on a constant currency basis. Adjusted operating margin excluding noncontrolling interests for the Distribution Solutions segment was 1.87% on a constant currency basis.

Fourth-quarter Technology Solutions GAAP operating profit was $23 million. Fourth-quarter adjusted operating profit was $72 million, driven by the company’s proportionate share of the income from McKesson’s equity investment in Change Healthcare.

Full-year Technology Solutions GAAP operating loss was $(23) million. Full-year adjusted operating profit was $304 million, primarily driven by the company’s proportionate share of the income from McKesson’s equity investment in Change Healthcare.

Fiscal Year 2018 Reconciliation of GAAP Results to Adjusted Earnings

Adjusted Earnings per diluted share of $12.62 for the fiscal year ending March 31, 2018, excludes the following GAAP items:

Amortization of acquisition-related intangibles of $2.60 per diluted share;
Acquisition-related expenses and adjustments of $1.20 per diluted share;
Last-In-First-Out ("LIFO") inventory-related credits of 31 cents per diluted share;
Restructuring charges of $2.82 per diluted share, including non-cash long-lived asset impairment charges; and
Other adjustment net charges of $6.01 per diluted share, primarily including non-cash goodwill asset impairment charges, partially offset by benefits related to the Tax Cuts and Jobs Act of 2017.
Revised Segment Financial Reporting Effective Fiscal Year 2019

Following the retirement of the president of Distribution Solutions in January 2018 and an evaluation of the company’s management and operating structure, McKesson has revised its reportable segments commencing in the first quarter of Fiscal 2019. McKesson’s new reportable segments are:

U.S. Pharmaceutical and Specialty Solutions, which includes the U.S. Pharmaceutical and McKesson Specialty Health businesses;
European Pharmaceutical Solutions; and
Medical-Surgical Solutions.
All remaining operating segments and business activities that are not significant enough to require reportable segment disclosure will be included in Other. Other primarily includes McKesson Canada, McKesson Prescription Technology Solutions (MRxTS) and the company’s equity method investment in Change Healthcare.

Please refer to a second 8-K filed today with the Securities and Exchange Commission for historical supplemental information for the fiscal years ending March 31, 2018; March 31, 2017; and March 31, 2016 reflecting historical results by revised reportable segment.

Fiscal Year 2019 Outlook

McKesson expects Adjusted Earnings per diluted share of $13.00 to $13.80 for the fiscal year ending March 31, 2019.

"Our Fiscal 2019 outlook represents mid- to high-single digit percentage growth year over year, reflecting a more stable market environment and effective capital allocation, while including the previously outlined headwinds in our European and Rexall businesses," Hammergren concluded.

McKesson has ceased providing forward-looking guidance on a GAAP basis as the company is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, as items are inherently uncertain and depend on various factors, many of which are beyond the company’s control.

Key Assumptions for Fiscal 2019

The Fiscal 2019 outlook is based on the following key assumptions and is also subject to the Risk Factors outlined below:

McKesson to deliver mid-single digit percent revenue growth and down slightly to up mid-single digit percent adjusted income from operations growth in Fiscal 2019.
U.S. Pharmaceutical and Specialty Solutions to deliver low- to mid-single digit percent revenue growth and flat to down mid-single digit percent adjusted operating profit growth in Fiscal 2019.
European Pharmaceutical Solutions to deliver flat to mid-single digit percent revenue and adjusted operating profit growth in Fiscal 2019.
Medical-Surgical Solutions is expected to deliver low-double digit percent revenue growth and mid- to high-single digit percent adjusted operating profit growth in Fiscal 2019.
Other is expected to deliver low-single digit percent revenue growth and adjusted operating profit to be flat in Fiscal 2019, which includes a gross headwind of between $100 million and $120 million related to the generic pricing initiative the Canadian provincial governments enacted April 1, 2018, as well as the impact of an increase in minimum wage in multiple provinces.
Adjusted equity earnings from the company’s investment in Change Healthcare are expected to grow in the low- to mid-single digit percent in Fiscal 2019.
Expect low-double digit percent decline in corporate expenses compared to Fiscal 2018.
Interest expense is expected to decline year over year.
The guidance range assumes a full-year adjusted tax rate of approximately 21% to 23%, which may vary from quarter to quarter.
Income attributable to noncontrolling interests is expected to decline year over year.
The company’s ownership position in McKesson Europe is assumed to be approximately 77% for Fiscal 2019.
Foreign currency exchange rate movements are assumed to have a net favorable impact of up to 10 cents per diluted share year over year.
Commencing in Fiscal 2019, the company will provide free cash flow guidance. Free cash flow is expected to be approximately $3.0 billion, which is net of expected property acquisitions and capitalized software expenditures of between $600 million and $800 million.
Weighted average diluted shares used in the calculation of earnings per share are expected to be approximately 200 million for the year.
Adjusted Earnings

McKesson separately reports financial results on the basis of Adjusted Earnings. Adjusted Earnings is a non-GAAP financial measure defined as GAAP income from continuing operations, excluding amortization of acquisition-related intangible assets, acquisition-related expenses and adjustments, LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring charges, and other adjustments. A reconciliation of McKesson’s GAAP financial results to Adjusted Earnings is provided in Schedules 2, 3 and 4 of the financial statement tables included with this release.

The company will not provide forward-looking guidance on a GAAP basis prospectively as McKesson is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

Constant Currency

McKesson also presents its financial results on a constant currency basis. The company conducts business worldwide in local currencies, including the Euro, British pound and Canadian dollar. As a result, the comparability of the financial results reported in U.S. dollars can be affected by changes in foreign currency exchange rates. Constant currency information is presented to provide a framework for assessing how the company’s business performed excluding the effect of foreign currency exchange rate fluctuations. The supplemental constant currency information of the company’s GAAP financial results and Adjusted Earnings (Non-GAAP) is provided in Schedule 3 of the financial statement tables included with this release.

Non-GAAP Measures

McKesson also provides adjusted operating profit margin excluding noncontrolling interests. The company has arrangements involving third-party noncontrolling interests. As a result, pre-tax results are affected by the portion of pre-tax earnings attributable to noncontrolling interests. Adjusted operating profit margin excluding noncontrolling interests information is presented to provide a framework for assessing how the company’s business performed excluding the effect of pre-tax earnings that is not attributable to McKesson. The supplemental adjusted operating profit margin excluding noncontrolling interests information of the company’s GAAP financial results and Adjusted Earnings (Non-GAAP) is provided in Schedule 3 of the financial statement tables included with this release.

McKesson also provides a free cash flow estimate on a forward-looking basis. Free cash flow is defined as net cash provided by operating activities less property acquisitions and capitalized software expenditures, as outlined in the company’s condensed consolidated statements of cash flows.

Risk Factors

Except for historical information contained in this press release, matters discussed may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. These statements may be identified by their use of forward-looking terminology such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "plans", "estimates" or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. It is not possible to predict or identify all such risks and uncertainties; however, the most significant of these risks and uncertainties are described in the company’s Form 10-K, Form 10-Q and Form 8-K reports filed with the Securities and Exchange Commission and include, but are not limited to: changes in the U.S. healthcare industry and regulatory environment; managing foreign expansion, including the related operating, economic, political and regulatory risks; changes in the Canadian healthcare industry and regulatory environment; exposure to European economic conditions, including recent austerity measures taken by certain European governments; changes in the European regulatory environment with respect to privacy and data protection regulations; fluctuations in foreign currency exchange rates; the company’s ability to successfully identify, consummate, finance and integrate acquisitions; the performance of the company’s investment in Change Healthcare; the company’s ability to manage and complete divestitures; material adverse resolution of pending legal proceedings; competition and industry consolidation; substantial defaults in payment or a material reduction in purchases by, or the loss of, a large customer or group purchasing organization; the loss of government contracts as a result of compliance or funding challenges; public health issues in the U.S. or abroad; cyberattack, natural disaster, or malfunction of sophisticated internal computer systems to perform as designed; the adequacy of insurance to cover property loss or liability claims; the company’s proprietary products and services may not be adequately protected, and its products and solutions may be found to infringe on the rights of others; system errors or failure of our technology products or services to conform to specifications; disaster or other event causing interruption of customer access to data residing in our service centers; changes in circumstances that could impair our goodwill or intangible assets; new or revised tax legislation or challenges to our tax positions; general economic conditions, including changes in the financial markets that may affect the availability and cost of credit to the company, its customers or suppliers; changes in accounting principles generally accepted in the United States of America; withdrawal from participation in multiemployer pension plans or if such plans are reported to have underfunded liabilities; inability to realize the expected benefits from the company’s restructuring and business process initiatives; difficulties with outsourcing and similar third party relationships; risks associated with the company’s retail expansion; and the company’s inability to keep existing retail store locations or open new retail locations in desirable places. The reader should not place undue reliance on forward-looking statements, which speak only as of the date they are first made. Except to the extent required by law, the company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

Conference Call Details

The company has scheduled a conference call for today, Thursday, May 24th, at 8:00 AM ET. The dial-in number for individuals wishing to participate on the call is 323-701-0225. Craig Mercer, senior vice president, Investor Relations, is the leader of the call, and the password to join the call is ‘McKesson’. A telephonic replay of this conference call will be available for five calendar days. The dial-in number for individuals wishing to listen to the replay is 719-457-0820 and the pass code is 3609926. An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Shareholders are encouraged to review the company’s filings with the Securities and Exchange Commission.

VBL Therapeutics to Present at Upcoming Conferences in June

On May 24, 2018 VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that the Company will present an update on the OVAL Phase 3 trial of VB-111 in platinum-resistant ovarian cancer at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting, to be held June 1-5 in Chicago, Illinois (Press release, VBL Therapeutics, MAY 24, 2018, View Source [SID1234526889]). In addition the Company will present data on its novel MOSPD2 program at the 2018 BIO International Convention, to be held June 4-7, 2018 in Boston.

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2018 ASCO (Free ASCO Whitepaper) Annual Meeting – Presentation Details

Title: Clinical trial in progress: A study of VB-111 combined with paclitaxel vs. paclitaxel for treatment of recurrent platinum-resistant ovarian cancer (OVAL, VB-111-701/GOG-3018).
Abstract: TPS5609
Session Title: Gynecologic Cancer
Date: June 4, 2018
Time: 1:15 PM-4:45 PM CDT
Location: Hall A
Poster Board: #331b
Presenter: Dr. Richard T. Penson, M.D.,MRCP, associate professor of Medicine, Harvard Medical School, clinical director of Medical Gynecologic Oncology, Massachusetts General Hospital
2018 BIO International Convention – Presentation Details

Date: Tuesday, June 5, 2018
Time: 2:45 pm EDT
Presentation Room: Theater 1
Location: Boston Convention & Exhibition Center
Webcast: Bio International Webcast Link
About VB-111 (ofranergene obadenovec)
VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead oncology product currently being studied in a Phase 3 trial for ovarian cancer. VB-111 has received an Orphan Designation for the treatment of ovarian cancer by the European Medicines Agency (EMA). At the 2016 ASCO (Free ASCO Whitepaper), the Company presented data in platinum-resistant ovarian cancer, demonstrating a meaningful and significant increase in overall survival with VB-111 given in combination with chemotherapy (810 days vs. 172 days, p=0.042), along with a 60% durable CA-125 response rate—approximately two times the historical response observed with bevacizumab (Avastin) plus chemotherapy in ovarian cancer. The OVAL study is conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation, Inc., a leading organization for research excellence in the field of gynecologic malignancies.

About MOSPD2
MOSPD2 is a novel tumor-related target identified by VBL that may be used as a marker for selective targeting of several types of tumors. Research conducted by VBL has shown that MOSPD2 is a novel membrane protein found on tumor cells that is present when they start invading tissues or creating metastatic lesions. The Company believes that targeting of MOSPD2 may have several therapeutic applications, including inhibition of tumor cell metastases and targeting of MOSPD2-positive tumor cells. There are also potential applications in the inhibition of monocyte migration in chronic inflammatory conditions. VBL is developing the VB-600 series of pipeline candidates towards these applications.