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 Veru Inc. (NASDAQ: VERU), a urology and oncology biopharmaceutical company, reported the publication of data from preclinical studies of VERU-111, a novel oral alpha and beta tubulin inhibitor, showing potent activity in a highly resistant model of human prostate cancer (Press release, Veru, MAY 17, 2018, View Source [SID1234529113]). An abstract of the data was published as part of the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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Oral VERU-111 was evaluated in the 22Rv1 prostate cancer model, which represents a highly resistant and aggressive form of the disease possessing androgen receptor splice variants that are commonly found in prostate cancer resistant to hormonal approaches like abiraterone and enzalutamide. In the same model, docetaxel administered by injection did not have significant effect on tumor growth. Animals receiving docetaxel lost weight on the study, a surrogate for toxicity, whereas those on VERU-111 either maintained or gained weight while receiving the drug.

"The findings in this clinically relevant model of prostate cancer provide us with additional support and enthusiasm for evaluating VERU-111 in a Phase 1/2 clinical trial, which is scheduled to commence later this year. This is an animal model in which few drugs have been shown to be active. In addition, VERU 111 may be effective against other tumor types known to be sensitive to taxanes that are already FDA approved," said Mario Eisenberger, MD, the Dale Hughes Professor of Oncology at The Johns Hopkins University.

"Oral VERU-111 has shown positive and encouraging signs to become an important therapeutic option for a particularly challenging form of prostate cancer. We are studying VERU-111 in multiple other cancers, the data of which is also being published at ASCO (Free ASCO Whitepaper) this year. We have begun performing the required toxicity studies and our IND submission and first clinical studies are planned for later this year," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.

About VERU-111
VERU-111 is a novel oral therapy targeting alpha and beta tubulin for the treatment of metastatic prostate, breast, endometrial, ovarian, and other cancers. In 2017, there were approximately 161,000 new cases of prostate cancer in the U.S. and about 25% of these men will die from the disease. In the U.S., 5% of men with prostate cancer will have metastatic cancer and up to 30% of men with high-risk, localized prostate cancer will develop metastatic cancer following initial therapy. The median survival of patients with metastatic prostate cancer ranges from 3.2 to 4.5 years. For these men, the 1st line therapy is androgen deprivation therapy, or medical castration. Although most will initially respond, nearly all these patients will progress to metastatic castration resistant prostate and have a poor prognosis with an average survival of 1.5 years. New 2nd line hormonal agents, like XTANDI (enzalutamide) and ZYTIGA (abiraterone/prednisone) have resulted in an additional four to five months of average survival, but nearly all men on these agents will develop progressive metastatic prostate cancer.

Drugs like VERU-111 that target tubulin, the subunits of microtubules, have been shown to be the most effective targeted cytotoxic chemotherapy for the treatment of metastatic prostate cancer. Microtubules are critical for cancer cell replication to stimulate genes for cancer cell proliferation. Docetaxel and cabazitaxel are examples of FDA-approved chemotherapy drugs that are given intravenously (IV) that target tubulin to treat metastatic prostate cancer. Although effective, the challenges for this class of chemotherapy drugs, also known as taxanes, include that they must be given intravenously (IV) and that the cancer cells develop resistance to taxanes. There are also serious safety concerns with IV taxanes which include serious hypersensitivity reactions, myelosuppression and neurotoxicity such as peripheral neuropathy and muscle weakness.

Unlike taxanes which bind to just the beta subunit of tubulin, VERU-111 binds strongly to both the alpha and beta subunits of tubulin. VERU-111 has: high oral bioavailability; less resistance as it does not interact with multiple drug resistance proteins so it cannot be pumped out of the cancer cell; minimal drug to drug interactions and high activity against many tumor types including: prostate cancer resistant to drugs like enzalutamide, AR-V7 positive and taxanes, as well as triple negative breast cancer, ovarian cancer, pancreatic cancer, lung cancer, and melanoma. In preclinical studies, VERU-111 appears to have less toxicity and less suppression of white blood cells compared to taxanes and other chemotherapy agents.

Production of the VERU-111 active pharmaceutical ingredient and preclinical safety toxicology studies required for an IND are expected to be completed in 2018. We anticipate filing an IND in 2018 and Phase 1/2 studies are planned for late 2018. Phase 1 studies of VERU-111 are planned in men who have metastatic prostate cancer that has progressed while taking androgen deprivation therapy and abiraterone or enzalutamide as well as in patients with metastatic breast, endometrial, and ovarian cancers. In the U.S., there is a $5 billion annual market for 2nd line hormone therapies for prostate cancer and a $4.8 billion annual market for IV-given taxanes and vinca alkaloids chemotherapies (docetaxel $1 billion and cabazitaxel $500 million in prostate cancer) per Decision Resources Group and Allied Market Research. Second line hormonal therapies like enzalutamide and abiraterone/prednisone have almost complete cross-resistance and should not be used in sequence for the treatment of metastatic prostate cancer. VERU-111 could be substituted for IV given docetaxel and cabazitaxel antitubulin chemotherapies. VERU-111 could also be developed as an oral dosing alternative to chemotherapies for the treatment of metastatic breast, endometrial and ovarian cancers as these tumors that responded to IV taxane chemotherapies.

On May 16, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that the complete safety and efficacy results of the Phase 1 study of its lead proprietary oncology drug, MP0250, will be presented at the Annual Meeting 2018 of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Molecular Partners, MAY 16, 2018, View Source [SID1234526673]).

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MP0250 is a multi-DARPin candidate targeting simultaneously VEGF and HGF, two prominent escape pathways, and has the potential to reverse resistance that has built to standard of care cancer therapies. MP0250 is currently evaluated in a Phase 2 study in combination with bortezomib and dexamethasone in patients with relapsed refractory multiple myeloma. An additional Phase 1b/2 study will evaluate MP0250 in combination with osimertinib in patients with EGFR-mutated NSCLC (Non-small cell lung cancer).

The data to be presented at ASCO (Free ASCO Whitepaper) include the complete safety and efficacy results and pharmacokinetics data from the First-in Human Phase 1 study of MP0250 in advanced solid tumor patients.

"We are very pleased with the Phase 1 data of MP0250," commented Andreas Harstrick, Chief Medical Officer of Molecular Partners. "MP0250 was well tolerated and about half of the patients stayed on treatment for three months or longer, with the longest treatment duration beyond one year. We are looking forward to additional results from our Phase 2 combination studies."

The MP0250 data will be presented in the following sessions:

Monday, June 4, 2018, 8.00 am ET, Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics / Abstract 2520 (Poster Board: #346):
First-in-class phase I study evaluating MP0250, a VEGF and HGF neutralizing DARPin molecule, in patients with advanced solid tumors (Azaro et al.)
Monday, June 4, 2018, 3:00 pm – 4:15 pm ET, room S406:
Discussion of the abstract at the Poster Discussion Session
Full details on the Molecular Partners’ session at ASCO (Free ASCO Whitepaper) 2018 as well as all presentations can be found here. Following its presentation at the ASCO (Free ASCO Whitepaper), the poster will also be available one the Molecular Partners website.

*DARPin is a registered trademark owned by Molecular Partners AG.

Financial Calendar
August 30, 2018 – Publication of 2018 Half-year Results
November 01, 2018 – Q3 2018 Management Statement
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.
With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.
Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and in Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On May 16, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that a wide selection of abstracts highlighting the Company’s diverse oncology portfolio across a broad range of cancers have been accepted for oral and poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 1-5 in Chicago (Press release, Astellas Pharma US, MAY 16, 2018, View Source [SID1234526696]). Highlights of the data and studies being presented include findings for: men with non-metastatic Castration-Resistant Prostate Cancer (CRPC) taking enzalutamide* and androgen deprivation therapy; patients with locally advanced or metastatic urothelial cancer taking enfortumab vedotin**, an investigational antibody-drug conjugate (ADC); and patients taking gilteritinib in Phase 3 trial in FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML).

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Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

"The Astellas abstracts accepted for presentation at this year’s ASCO (Free ASCO Whitepaper) meeting demonstrate the depth and breadth of our growing leadership in oncology across a broad range of cancers," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "These data demonstrate the strength and progress of our oncology pipeline driven by investment in R&D and collaborative partnerships."

The following will be presented during an oral presentation:

Title: (Abstract 4504) Updated Results from the enfortumab vedotin Phase 1 (EV-101) Study in Patients with Metastatic Urothelial Cancer (mUC)

Presenter: Jonathan E. Rosenberg, MD

Session Date/Time: June 3, 9:12 AM – 9:24 AM CDT
Oral Abstract Session: Genitourinary (Nonprostate) Cancer
Location: Arie Crown Theater
Additionally, the following data will be shared during poster presentations:

Title: (Abstract TPS4590) EV-201 Study: A Single-Arm, Open-Label, Multicenter Study of enfortumab vedotin for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer who previously Received Immune Checkpoint Inhibitor Therapy

Presenter: Jonathan E. Rosenberg, MD

Session Date/Time: June 2, 8:00 AM – 11:30 AM CDT
Poster Session: Genitourinary (Nonprostate) Cancer
Location: Hall A
Title: (Abstract 5010) Health-Related Quality of Life (HRQoL) Deterioration and Pain Progression in Men with Non-Metastatic Castration-Resistant Prostate Cancer (M0-CRPC): Results from the PROSPER study

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: June 2, 1:15 PM – 4:45 PM CDT
Poster Session: Genitourinary (Prostate) Cancer
Location: Hall A
Poster Discussion Session on June 2, 2018, 4:45 PM – 6:00 PM CDT, at S406
Title: (Abstract 5043) Association Between Health-Related Quality of Life (HRQoL) and clinical outcomes in non-metastatic castration-resistant prostate cancer (M0 CRPC): Results from the PROSPER study

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: June 2,1:15 PM – 4:45 PM CDT
Poster Session: Genitourinary (Prostate) Cancer
Location: Hall A
Title: (Abstract TPS7075) A Phase 3, Trial of Gilteritinib, as Maintenance Therapy after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with FLT3-ITD + AML

Presenter: Mark J. Levis, MD, PhD

Session Date/Time: June 4, 8:00 AM – 11:30 AM CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Location: Hall A
*Enzalutamide is developed through a collaboration between Pfizer and Astellas and commercialized under the brand name XTANDI.
**Enfortumab vedotin is developed through a collaboration between Seattle Genetics and Astellas