On May 23, 2019 VBL Therapeutics (Nasdaq: VBLT), reported the upcoming presentation of final results from the Phase 2 study of VB-111 in ovarian cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, to be held May 31 – June 4, 2019 in Chicago, Illinois (Press release, VBL Therapeutics, MAY 23, 2019, View Source [SID1234536552]). An additional presentation at ASCO (Free ASCO Whitepaper) will focus on analysis of VB-111 MRI data from Phase 2 and Phase 3 studies in recurrent GBM and the potential of VB-111 in this indication. VBL will also give a company presentation at the 2019 BIO International Convention, to be held June 3-6, 2019 in Philadelphia.

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2019 ASCO (Free ASCO Whitepaper) Annual Meeting – Presentation Details

1. Title: Ofranergene obadenovec (VB-111) in platinum resistant ovarian cancer
Abstract: 5542
Session Type: Poster Session
Session Title: Gynecologic Cancer
Date: June 1, 2019
Time: 1:15 PM – 4:15 PM CDT
Location: Hall A
Poster Board: #365
Presenter: Richard T. Penson, MD, MRCP, Massachusetts General Hospital

2. Title: Quantitative radiographic analysis of phase II and III trials in recurrent glioblastoma treated with VB-111 with or without bevacizumab or bevacizumab monotherapy.
Abstract: 2018
Session Type: Poster Session
Session: Central Nervous System Tumors
Date: June 2, 2019
Time: 8:00 AM – 11:00 AM CDT
Location: Hall A
Poster Board: #207
Presenter: Benjamin M. Ellingson, PhD, MS. University of California Los Angeles

3. Title: Quantitative radiographic analysis of phase II and III trials in recurrent glioblastoma treated with VB-111 with or without bevacizumab or bevacizumab monotherapy.
Abstract: 2018
Session Type: Poster Discussion Session
Session: Central Nervous System Tumors
Date: June 2, 2019
Time: 4:30 PM – 6:00 PM CDT
Location: S404
Poster Board: #207
Presenter: Benjamin M. Ellingson, PhD, MS. University of California Los Angeles

2019 BIO International Convention – Presentation Details

Date: June 4, 2019
Time: 3:30 pm EDT
Presentation Room: Theater 2
Location: Philadelphia Convention Center
Webcast: 2019 BIO International Convention Webcast

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 the OVAL potential-registration Phase 3 pivotal trial for ovarian cancer (ClinicalTrials.gov Identifier: NCT03398655). VB-111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970). VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.

On May 23, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2019 (Press release, Nordic Nanovector, MAY 23, 2019, View Source [SID1234553450]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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Eduardo Bravo, CEO, commented:

"As we advance the clinical development programmes with Betalutin, including PARADIGME, we are also beginning to initiate some of the other pre-commercialisation activities, such as manufacturing, that are crucial to ensure that we can submit our regulatory filing in a timely and efficient manner. The recent fundraising is key to this and we expect to intensify these activities as we get closer to the initial data read-out from PARADIGME."

Q1’19 Highlights

Approximately NOK 225 million (USD 26.4m) (gross) raised in a private placement and subsequent repair offering to support manufacturing and other activities in preparation for the commercialisation of Betalutin.
Pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) progressing with 74 (of 80-85) sites in 23 countries open for enrolment, as of 22 May 2019.
Jan H. Egberts, M.D. elected new Chairman of the Board of Directors.
Dr Mark Wright appointed as Head of Manufacturing to lead production of Betalutin for clinical trials and future commercialisation, and of CD37-targeting candidates emerging from the company’s pipeline.

Events after Q1’19

Phase 1b Archer-1 trial of Betalutin plus rituximab (RTX) in patients with relapsed/refractory 2L FL advanced into second safety cohort.
Phase 1 LYMRIT 37-05 trial of Betalutin in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) advanced to the final dosing cohort – preliminary results from the dose-escalation expected in 2H 2019.
Promising preclinical results from R&D collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours were presented at the 11th International Symposium on Targeted-Alpha-Therapy.
Fredrik Haavind appointed Head of Legal and Compliance bringing significant experience in domestic and international corporate law.
Financial Highlights Q1’19

(Figures in brackets = same period 2018 unless otherwise stated)

Revenues for the first quarter amounted to NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the first quarter were NOK 90.0 million (NOK 82.3 million).
Comprehensive loss for the first quarter amounted to NOK 91.6 million (loss of NOK 90.7 million).
Cash and cash equivalents amounted to NOK 538.5 million as at 31 March 2019 (NOK 440.1 million as 31 December 2018).
Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with a once-only administration of Betalutin in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in the first half of 2020.

Nordic Nanovector intends to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies and antibody drug conjugates across NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2019 from 7:00am CEST the same day.

On May 23, 2019 Allergan plc (NYSE: AGN) reported that Chief Commercial Officer William Meury will participate in a fireside chat at the Jefferies 2019 Healthcare Conference in New York, NY (Clinical trial, Allergan, MAY 23, 2019, View Source [SID1234536554]). The presentation will begin at 2:00 p.m. Eastern Time on Thursday, June 6, 2019.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: View Source;

An archived version will be available following the live presentation and can be accessed at the same location for 90 days.

On May 23, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic"), a clinical stage US-China oncology drug development company (XYN), reported that long-term follow up data of exceptional responders to abexinostat/pazopanib will be presented by Dr. Rahul Aggarwal, a lead investigator at the University of California, San Francisco ("UCSF") (Press release, Xynomic Pharmaceuticals, MAY 23, 2019, http://xynomicpharma.com/en/xynomic-pharma-to-present-long-term-follow-up-data-showing-abexinostat-combined-with-pazopanib-has-durable-responses-in-patients-with-pre-treated-kidney-cancer/ [SID1234536538]). Dr. Aggarwal will present the information at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, IL on June 1, 2019 in a presentation titled "Exceptional Responders to Abexinostat ("ABX") Plus Pazopanib ("PAZ") in Pre-Treated Renal Cell Carcinoma ("RCC") and Other Solid Tumors: Long-Term Follow Up of a Phase 1b Study" (Abstract No: 3022).

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The initial results from the Phase 1b study of Xynomic’s potent pan-HDAC inhibitor ABX plus PAZ demonstrated acceptable toxicity profile and encouraging anti-tumor activity (Aggarwal et al. Journal of Clinical Oncology, 2017). In this trial, 51 patients (including 22 RCC patients) were enrolled between June 2012 and October 2015. Among them, 10 patients (20%) had experienced disease progression on prior PAZ; 30 patients (59%) had received prior vascular endothelial growth factor ("VEGF") targeted therapy.

The ASCO (Free ASCO Whitepaper) presentation long-term follow up data of exceptional responders and additional correlative analyses associated with clinical outcomes. In particular, as of February 2019, among the 10 patients who had experienced disease progression on prior PAZ treatment, 5 patients achieved durable partial response ("PR") lasting for more than 2 years, and 1 patient who was previously a PAZ-refractory patient with RCC, remained on treatment with ongoing PR, for more than 6 years. In addition, higher peripheral blood HDAC2 expression was associated with prolonged progression-free survival (median PFS 5.9 vs. 3.5 months, log-rank p=0.02). Induction of histone acetylation on ABX lead-in treatment was associated with subsequent time to progression (p=0.002). On-treatment plasma VEGF levels were inversely correlated with PBMC histone acetylation (p=0.02). The new data demonstrate that (1) marketed durable responses with ABX + PAZ are achievable, including in patients with PAZ- and VEGF-refractory RCC and other solid tumor malignancies, and (2) host factors including HDAC expression and acetylation status may identify those patients most likely to benefit from this combination therapy.

A global, randomized pivotal Phase 3 trial is underway of ABX + PAZ as a first- or second-line therapy in patients with locally advanced or metastatic RCC (RENAVIV; NCT03592472). The U.S. Food and Drug Administration has granted Fast Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of RCC.

On May 23, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company, taking a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, reported that Trovagene and Nektar have entered into a research collaboration to explore the combination of Trovagene’s PLK1 inhibitor, onvansertib, and Nektar’s topoisomerase I inhibitor, ONZEALD, for the treatment of metastatic colorectal cancer (mCRC) (Press release, Trovagene, MAY 23, 2019, View Source [SID1234536555]). Under the collaboration, the two companies will evaluate the antitumor activity and tolerability of the combination of onvansertib and ONZEALD in two (HT29 – BRAF mutant and HCT-116 – KRAS mutant) preclinical tumor models of colorectal cancer.

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ONZEALD is the first long-acting topoisomerase I-inhibitor (Topo I) designed to enhance the anti-cancer effects of topo I-inhibition while minimizing its toxicities. In a wide range of human xenograft tumors, including two colorectal models (HT29 and DLD-1), ONZEALD has shown superior antitumor activity, compared with irinotecan.1 ONZEALD is currently being evaluated in a Phase 3 study in patients with breast cancer who have stable brain metastases.

Onvansertib, an oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, has shown strong antitumor activity in preclinical models of colorectal cancers, and demonstrated significant and durable synergistic antitumor activity in combination with irinotecan, and was greater than either drug alone. Trovagene has three active clinical trials: a Phase 1b/2 study in relapsed or refractory Acute Myeloid Leukemia (AML), a Phase 2 study in metastatic Castration-Resistant Prostate Cancer (mCRPC) and a Phase 1b/2 study in mCRC.

"We look forward to collaborating with Trovagene to explore a combination therapy with our respective drug candidates, ONZEALD and onvansertib, in tumor models of colorectal cancer," said Jonathan Zalevsky, PhD, Chief Scientific Officer of Nektar Therapeutics. "Importantly, this research collaboration will allow us to evaluate the efficacy of the combination in preclinical models, and potentially identify a promising treatment regimen that we would consider advancing into clinical studies."

"Our research partnership with Nektar is a key milestone achievement in the advancement of our onvansertib clinical development program," said Mark Erlander, PhD, Chief Scientific Officer of Trovagene. "We believe that the clinical data generated to date for ONZEALD, will potentially lead to an optimal treatment option, when combined with onvansertib, for patients with mCRC. Working together with Nektar will enable us to very quickly assess the potential value of the onvansertib/ONZEALD combination and our collective goal of developing an innovative and targeted treatment regimen that may have application in other cancer types beyond CRC."

About Onvansertib

Onvansertib is a first-in-class, 3rd generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple cancers, including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform, only (not PLK2 or PLK3), is orally administered, has a 24-hour drug half-life with only mild to moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK1 inhibitor, onvansertib, with other compounds has the potential to improve clinical efficacy in Acute Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate Cancer (mCRPC), Non-Hodgkin Lymphoma (NHL), Colorectal Cancer, Triple Negative Breast Cancer (TNBC), as well as other types of cancer.

About ONZEALD

ONZEALD (etirinotecan pegol) is the first long-acting topoisomerase I-inhibitor (Topo I) designed to enhance the anti-cancer effects of topo I-inhibition while minimizing its toxicities. Nektar Therapeutics invented ONZEALD using their unique chemistry platform and is currently developing it for the treatment of advanced breast cancer patients with a history of brain metastases. In preclinical models, ONZEALD achieved a 300-fold increase in tumor concentration as compared to a first-generation topo I-inhibitor.2 Because ONZEALD is a large molecule, it is believed to penetrate the leaky vasculature within the tumor environment more readily than normal vasculature, concentrating and trapping ONZEALD in the tumor tissue.