On May 17, 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 financial results for the first quarter ended March 31, 2018 and provided a corporate update (Press release, VBL Therapeutics, MAY 17, 2018, View Source [SID1234526744]).

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"We continue to advance the OVAL trial, our Phase 3 potential registration trial in platinum-resistant ovarian cancer, in collaboration with the GOG Foundation," said Yael Cohen M.D., VP Clinical Development of VBL Therapeutic. "We are in the process of amending the protocol to include an interim analysis for evidence of an early efficacy signal with a potential readout from this analysis in the fourth quarter of 2019."

"We are also advancing our MOSPD2 program for oncology and inflammatory indications and, at the recent American Academy of Cancer Research (AACR) (Free AACR Whitepaper) meeting, presented new proof-of-concept on the use of a bispecific antibody to kill MOSPD2-expressing cancer cells," said Dror Harats M.D., Chief Executive Officer of VBL Therapeutics. "VBL is well capitalized, with approximately $50 million in cash, which will enable us to continue the development of VB-111 and our deep pipeline through 2020.’

First Quarter and Recent Corporate Highlights:

Continued to treat patients in the ongoing Phase 3 OVAL trial, studying VB-111 in platinum-resistant ovarian cancer. The OVAL study has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the U.S. and Israel.

— The Company is modifying the OVAL protocol to incorporate an efficacy interim readout, which is expected to occur in the fourth quarter of 2019.

The Company is conducting an in-depth analysis of the GLOBE study, including analysis of patient subgroups, in order to better understand the outcome of the study, the major difference between the Phase II and the GLOBE trial and the potential activity of VB-111 in rGBM.

Presented late breaking research on the Company’s MOSPD2 oncology program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 annual meeting.

— The data provide proof-of-concept on the use of a bispecific antibody to kill MOSPD2-expressing cancer cells, with potential applicability to solid tumors and myeloid malignancies.

— The MOSPD2 program was also featured in a presentation at the 17th MIXiii-BIOMED 2018 Conference and Exhibition, May 15-17 in Tel Aviv, Israel.

— VBL is developing its VB-600 series of antibodies targeting MOSPD2 for oncology and inflammatory applications.

Awarded 8.9 million New Israeli Shekels (approximately US$2.5 million) non-dilutive grant by the Israel Innovation Authority (IIA).

— The funds will support the development of VB-111 as well as the Company’s Vascular Targeting System (VTS) platform for therapeutic gene therapy.

Appointed two senior pharmaceutical executives, Susan Kelley, M.D., and David Hastings, to its Board of Directors.
First Quarter Ended March 31, 2018 Financial Results:

Revenues: In 2017 the Company entered into an exclusive license agreement with NanoCarrier Co., Ltd. and received an up-front and a milestone payment of $17.0 million in aggregate, of which $0.2 million was recognized as of March 2018.

Cash Position: Cash, cash equivalents and short-term bank deposits at March 31, 2018, were $49.9 million. Working capital at March 31 was $44.3 million. The Company expects that the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements through 2020.

R&D Expenses: Research and development expenses for the quarter ended March 31, 2018, were approximately $5.8 million, compared to approximately $4.1 million in the comparable period in 2017. R&D expenses are shown net of IIA grants.

G&A Expenses: General and administrative expenses for the quarter ended March 31, 2018 were $1.4 million, compared to $1.1 million for the comparable period in 2017.

Comprehensive Loss: The Company reported a comprehensive loss for first quarter ended March 31, 2018 of $7.2 million, or ($0.24) per share, compared to a net loss of $5.0 million, or ($0.19) per share in first quarter ended March 31, 2017.
Conference Call:

On May 17, 2018 Boston Biomedical, Inc., an industry leader in the development of novel cancer therapeutics, reported that it will feature several studies evaluating investigational compounds napabucasin and DSP-7888 at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago from June 1-5 (Press release, Boston Biomedical, MAY 17, 2018, View Source [SID1234526762]).

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Napabucasin is currently being investigated in phase 3 studies – CanStem303C for metastatic colorectal cancer (NCT02753127) and CanStem111P for metastatic pancreatic cancer (NCT02993731). Included in the napabucasin studies that will be presented at ASCO (Free ASCO Whitepaper) are data from a phase 1b/2 trial in patients with metastatic pancreatic cancer (Poster, Bekaii-Saab, 6/3, 8 a.m. – 11:30 a.m.). Boston Biomedical, Inc. will also present detailed findings from the phase 3 BRIGHTER trial evaluating the efficacy and safety of napabucasin plus paclitaxel for pretreated advanced gastric and gastroesophageal junction adenocarcinoma (Poster discussion, Shah, 6/3, 4:45 p.m. – 6 p.m.). Last year, the Company announced that the study was unblinded early after the Data and Safety Monitoring Board (DSMB) determined that the study was unlikely to reach its primary endpoint. No safety concerns were identified by the DSMB. Separately, data with napabucasin in advanced thymoma and thymic carcinoma, rare tumor types, is available as an online publication.

DSP-7888 is being evaluated in several early and mid-stage studies across multiple tumor types. The Company will present the study design of a phase 2 study of DSP-7888 in combination with bevacizumab for recurrent or progressive glioblastoma, WIZARD201G (Poster, de Groot, 6/2, 1:15 p.m. – 4:45 p.m.), which recently began enrolling patients (NCT03149003).

"As our pipeline and clinical development program continues to evolve, we are looking forward to sharing our learnings with the scientific community at the ASCO (Free ASCO Whitepaper) annual meeting," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc.

Abstracts to be presented by Boston Biomedical, Inc. include the following:

Abstract Title Details Authors
A randomized, multicenter phase 2 study of DSP-7888 dosing emulsion in combination with bevacizumab (Bev) versus Bev alone in patients with recurrent or progressive glioblastoma

Abstract #TPS2071
June 2, 1:15-4:45 PM

Poster presentation

Hall A

John Frederick de Groot, University of Texas MD Anderson Cancer Center
The BRIGHTER trial: A phase 3 randomized double-blind study of napabucasin (NAPA) plus paclitaxel (PTX) versus placebo (PBO) plus PTX in patients (pts) with pretreated advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma

Abstract #4010
June 3, 8:00-11:00 AM

Poster presentation

Hall A

June 3, 4:45 – 6:00 PM

Poster Discussion Session

Hall D2

Manish A. Shah,
Weill Cornell University, New York

Phase 1b/2 trial of cancer stemness inhibitor napabucasin (NAPA) + nab-paclitaxel (nPTX) and gemcitabine (Gem) in metastatic pancreatic adenocarcinoma (mPDAC)

Abstract #4110
June 3, 8:00-11:00 AM

Poster presentation

Hall A

Tanios S. Bekaii-Saab, Mayo Clinic Cancer Center
A phase 1b study of napabucasin (NAPA) + weekly paclitaxel (PTX) in patients (pts) with advanced thymoma and thymic carcinoma

Abstract #e20578
Online publication only

Maitri Kalra, Indiana University

About Napabucasin

Napabucasin is an orally-administered investigational agent that affects multiple oncogenic cellular pathways, including inhibition of the STAT3 pathway, which has been implicated in viability of cancer cells and cancer cells with stemness phenotypes.

Napabucasin is currently being investigated in CanStem303C, a phase 3 study for metastatic colorectal cancer (NCT02753127) and CanStem111P, a phase 3 study for metastatic pancreatic cancer (NCT02993731). It is also being investigated in earlier phases in multiple solid and hematologic malignancies. In 2016, the U.S. Food and Drug Administration granted Orphan Drug Designation for napabucasin in pancreatic cancer.

About DSP-7888 (ombipepimut-S*)

DSP-7888 is an investigational cancer peptide vaccine containing peptides that induce WT1-specific cytotoxic T lymphocytes (WT1-CTL) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that by adding helper T cell inducing peptides, improved outcomes may be achieved compared to a killer peptide treatment regimen alone.

DSP-7888 is currently being investigated in three Wizard201G monotherapy studies: a phase 1/2 study in myelodysplastic syndrome (MDS) (NCT02436252), a phase 1/2 study in pediatric patients with relapsed or refractory high grade gliomas (NCT02750891) and a phase 1 study in advanced malignancies (NCT02498665). DSP-7888 is currently being investigated in combination with bevacizumab in a phase 2 study in patients with recurrent or progressive glioblastoma (NCT03149003) and in a phase 1 study in combination with nivolumab or atezolizumab in patients with advanced solid tumors (NCT03311334). In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for DSP-7888 in MDS and brain cancer. More information on DSP-7888 and ongoing clinical studies can be found at www.BostonBiomedical.com.

On May 17, 2018 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported that new clinical data on the oncolytic virus Pexa-Vec will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from 1 to 5 June in Chicago (Press release, Transgene, MAY 17, 2018, View Source [SID1234526728]).

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These results were obtained from a clinical ("neoadjuvant") study that evaluated the biological effects of pre-operative intravenous (IV) administration of Pexa-Vec in patients with locally advanced or metastatic cancers, prior to planned surgical resection. University of Leeds (United Kingdom) is the sponsor of this trial that was supported by Transgene.

Poster title: Single intravenous preoperative administration of the oncolytic virus Pexa-Vec to prime anti-tumor immunity

Session Title: Developmental therapeutics – Immunotherapy
Poster and abstract number: 3092
Date, time, location: June 4, 8:00 AM-11:30 AM, Hall A
Presenter: Dr. Alan Anthoney, University of Leeds
The abstract is now available on the ASCO (Free ASCO Whitepaper) website (View Source).

Notes to editors

About Pexa-Vec
Pexa-Vec (JX594) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: selectively destroy cancer cells through the direct lysis (breakdown) of cancer cells through viral replication, reduce the blood supply to tumors through vascular disruption, and stimulate the body’s immune response against cancer cells.
Pexa-Vec is currently being evaluated in a Phase 3 trial in hepatocellular carcinoma (HCC, liver cancer) in combination with sorafenib (current standard of care). Other trials evaluating the oncolytic virus in solid tumors are underway and expected to readout in 2018, including a Phase 2 trial in combination with nivolumab (HCC).
Transgene has exclusive rights to develop and commercialize Pexa-Vec for the treatment of solid tumors in Europe. Its partner SillaJen, Inc. is focused on developing Pexa-Vec for the North American market and has also granted exclusive development and commercial rights to Pexa-Vec in Hong Kong and The People’s Republic of China to Lee’s Pharmaceutical.

On May 17, 2018 Cue Biopharma, Inc.’s provided its Corporate Overview (Presentation, Cue Biopharma, MAY 17, 2018, View Source [SID1234526763]).

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On May 17, 2018 TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company developing oncology therapies with a focus on addressing current drug resistance, reported that the Phase 1 data from the ongoing TRIDENT-1 Study of Ropotrectinib (TPX-0005) has been accepted for poster presentation and discussion on June 4 at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, TP Therapeutics, MAY 17, 2018, View Source [SID1234526781]).

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TP Therapeutics Announces Phase 1 Data of Ropotrectinib (TPX-0005) to be Presented at the Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting

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The presentation is entitled "A phase 1 study of the next-generation ALK/ROS1/TRK inhibitor Ropotrectinib (TPX-0005) in patients with advanced ALK/ROS1/NTRK+ cancers (TRIDENT-1)".

The schedule for the poster display and discussion is as follows:

Poster Discussion
Time: 6/4/2018, 3:00 PM-4:15 PM

Title: A phase 1 study of the next-generation ALK/ROS1/TRK inhibitor Ropotrectinib (TPX-0005) in patients with advanced ALK/ROS1/NTRK+ cancers (TRIDENT-1)
Abstract Number: 2513
Session Title: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Location: S406
Discussant: Valentina Boni, MD, PhD, START Madrid CIOCC Hospital Universitario Sanchinarro

Poster Display Information: Monday, June 4, 2018, 8:00-11:30 am
Location: Hall A
Lead author: Alexander Drilon, MD, Memorial Sloan Kettering Cancer Center

About Ropotrectinib (TPX-0005)

Ropotrectinib (TPX-0005) is a potent and orally bioavailable investigational small molecule kinase inhibitor for ALK, ROS1, and TRK family. The clinical benefits of targeting ALK, ROS1, or TRK fusion kinase have been demonstrated with multiple kinase inhibitors already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), in addition to crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. The successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. TPX-0005 is a potent kinase inhibitor against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple line treatments. Ropotrectinib may provide new opportunities in the clinic to inhibit the abnormal signaling of ALK, ROS1, or TRK family in solid malignancies, and overcome resistance seen in refractory patients. TPX-0005 is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1, NCT03093116). For additional information about ropotrectinib trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can also contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email [email protected].