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BioLineRx Announces Receipt of FDA Biological Product Designation for Novel Cancer Immunotherapy Candidate AGI-134

On November 20, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that the U.S. Food and Drug Administration (FDA) has granted the Biological Product Designation for AGI-134, the Company’s novel immunotherapy compound (Press release, BioLineRx, NOV 20, 2018, View Source;p=RssLanding&cat=news&id=2377772 [SID1234531480]). This designation provides the Company with eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA. This regulatory market exclusivity adds an incremental layer of protection in addition to that afforded by existing patents granted in the United States and Europe, and pending in other countries, covering the use of AGI-134 for the treatment of solid cancer tumors. These patents are valid until May 2035, with a possible term extension of up to five additional years.

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"We are extremely pleased to receive the FDA’s Biological Product Designation for AGI-134, our second lead oncology asset. This classification as a biological product is very significant, since it provides us with additional valuable exclusivity and confirms the FDA’s acceptance of AGI-134’s main mechanism of action as a vaccine," said Philip Serlin, Chief Executive Officer of BioLineRx. "Pre-clinical studies have demonstrated that treatment with AGI-134 leads to complete regression of primary tumors, prevents growth of untreated distal secondary tumors, and triggers a vaccine effect that may prevent the development of future metastases. Furthermore, in prior studies, the combination of AGI-134 with an anti-PD-1 immune checkpoint inhibitor demonstrated a synergistic effect in protection from secondary tumor growth. We recently initiated a Phase 1/2a study of this promising product in solid tumors, as both monotherapy and in combination with checkpoint inhibitors, and we anticipate initial top-line results from this important study by the end of 2020."

About AGI-134

AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intratumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

Ipsen and 3BP announce First Patient Dosed in Phase I/II study for first-in-class radionuclide (IPN01087)

On November 20, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) and 3BP reported the first patient has been dosed in a Phase I/II study for the first-in-class radionuclide 177Lu-IPN01087 (formerly known as 3BP-227) (Press release, Ipsen, NOV 20, 2018, View Source [SID1234531478]). IPN01087 is a compound that targets cancer cells in patients with advanced solid tumors which express the Neurotensin Receptor Subtype 1 (NTSR1).

The key objective of the Phase I dose-escalation trial (EUDRACT Number 2017-001263-20) is to evaluate the safety and activity, as well as to identify the optimum systemically-administered dose of radiation to treat patients with any of the following solid tumors expressing NTSR1: pancreatic ductal adenocarcinoma, colorectal cancer, gastric cancer, gastrointestinal stromal tumors, Ewing sarcoma and squamous cell carcinoma of the head and neck.

Alexandre Lebeaut, Executive Vice President, R&D and Chief Scientific Officer, Ipsen, said: "Ipsen is committed to bringing to cancer patients innovative systemic radiation therapy with targeted radiopharmaceuticals. We are pleased to report progress of the development of IPN01087 in this Phase I/II study. Our targeted theranostic approach – which we are advancing in partnership with 3B Pharmaceuticals- provides a novel and exciting potential therapeutic solution for unmet medical needs across a number of solid tumours."

"This is a great milestone for IPN01087 and for 3B Pharmaceuticals," said Dr. Ulrich Reineke, Managing Director of 3BP. "We are pleased that the compound is in clinical trials and we remain passionate about systemic radiation therapy and its potential to improve patients’ lives."

VBL Therapeutics Announces Third Quarter 2018 Financial Results

On November 20, 2018 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, VBL Therapeutics, NOV 20, 2018, View Source [SID1234531467]).

"We continue the development of our novel anticancer drug VB-111, as we enroll and treat patients in the ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer while exploring the opportunity to develop it in other indications," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We are excited about the potential of our MOSPD2-targeting platform and are advancing two parallel programs exploring MOSPD2 as a therapeutic target in both oncology and inflammatory disease."

"VBL is well capitalized with more than $53 million in cash and equivalents at September 30, 2018. We believe this will be sufficient to support our Phase 3 clinical trial for VB-111 for ovarian cancer, and advance our pipeline, including the VB-600 platform targeting MOSPD2, for at least the next three years," concluded Dr. Harats.

Third Quarter and Recent Corporate Highlights:

Continued to treat patients in the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer.
° OVAL is evaluating VB-111 in combination with chemotherapy, without any change from the regimen which demonstrated overall survival (OS) benefit in the Phase 2 study for ovarian cancer.
° An efficacy interim readout is expected to occur in the fourth quarter of 2019.
° Data on the immune mechanism of VB-111 in platinum resistant ovarian cancer will be presented in March 2019 at the 50th Annual Meeting conference of the Society of Gynecologic Oncology (SGO) in Hawaii.
Presented new analysis from the Phase 3 GLOBE study of VB-111 in patients with recurrent glioblastoma at the 2018 Society for Neuro-Oncology (SNO) annual meeting.
VBL is developing two independent platforms of proprietary monoclonal antibodies targeting MOSPD2; one for inflammatory indications using classical antibodies, and a second, separate platform for oncology indications, based on bi-specific antibodies.
Presented new data on the Company’s MOSPD2 oncology program:
° In July 2018, a paper published in the International Journal of Cancer featured VBL data showing that MOSPD2 can play a major role in breast cancer cell migration and metastasis, and that targeting MOSPD2 may be a viable therapeutic strategy to prevent the spreading of breast cancer cells.
° Previously, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 annual meeting, the Company presented a late-breaking study demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding to MOSPD2.
Presented new data on the Company’s MOSPD2 inflammatory disease program:
° At the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), VBL presented data demonstrating that MOSPD2 is essential for the disease development and progression in the experimental autoimmune encephalomyelitis (EAE) model for multiple sclerosis. VBL’s proprietary monoclonal antibodies were successfully used both to prevent development, as well as to treat EAE once symptoms had appeared.
Published positive new data on Lecinoxoid drug candidates for the treatment of renal fibrosis in Basic and Clinical Pharmacology and Toxicology.
° The paper published in Basic and Clinical Pharmacology and Toxicology describes the role of the Company’s lecinoxoid drug candidates, VB-201 and VB-703, in slowing the decline of kidney function in renal fibrosis.
° Recently granted US patent provides patent protection for lecinoxoids treatment of liver and renal fibrosis until at least November 2035 and supports potential partnering opportunities.
Continued to strengthen the Company’s intellectual property portfolio – European Patent Office issued Patent No. 2908865, extending exclusive protection for VB-111 until October 2033, before any further potential extension. Similar VB-111 composition-of-matter patents have also been granted in the US, Japan, China and additional countries.
Strengthened the Board of Directors with the appointment of Dr. Shmuel ("Muli") Ben Zvi, a well-known pharmaceutical executive in Israel and former senior manager at Teva Pharmaceuticals Industries Ltd.
Third quarter Ended September 30, 2018 Financial Results:

Revenues: Revenues related to the Company’s collaboration in Japan amounted to $0.1 million in the third quarter ended September 30, 2018.
Cash Position: Cash, cash equivalents and short-term bank deposits at September 30, 2018, were $53.7 million and working capital was $50.1 million. The Company estimates that, based on current projections, the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements for more than 3 years and is expected to be sufficient to support the Company’s Phase 3 clinical trial for VB-111 for ovarian cancer, and to advance its pipeline, including the VB-600 platform targeting MOSPD2 during this period.
R&D Expenses: Research and development expenses for the quarter ended September 30, 2018, were approximately $4.1 million, compared to approximately $4.8 million in the comparable period in 2017.
G&A Expenses: General and administrative expenses for the quarter ended September 30, 2018 were $1.4 million, compared to $1.7 million for the comparable period in 2017.
Comprehensive Loss: The Company reported a comprehensive loss for third quarter ended September 30, 2018 of $5.4 million, or ($0.15) per share, compared to a net loss of $6.5 million, or ($0.24) per share in third quarter ended September 30, 2017.
For further details on VBL’s financials, including the results for the nine month period ended September 30 2018, refer to Form 6-K filed with the S.E.C.

Conference Call:
Tuesday, November 20th @ 8:30am Eastern Time
US Domestic: 888-204-4368
International: 323-994-2082
Conference ID: 4933637
Webcast: View Source

Bexion Pharmaceuticals, Inc. Presents Clinical Data at 2018 SNO Annual Meeting

On November 19, 2018 Bexion Pharmaceuticals, Inc., a clinical – stage biopharmaceutical company focused on rare brain and solid tumors, reported that a clinical oral report followed by poster review and a second case study poster were presented at the Society of Neuro – Oncology (SNO) Annual Meeting held November 16 – 18 in New Orleans, LA (Press release, Bexion, NOV 19, 2018, View Source [SID1234531577]). The SNO Annual Meeting brings together more than 2600 research ers and clinicians in the field of neuro – oncology.

Bexion’s representation:
High – Grade Glioma O utcomes in the Phase 1 BXQ – 350 Trial of Cancer – Selective SapC – DOPS Nanovesicles

Vinay Puduvalli, MD, Professor and Director, Division of Neuro – Oncology, The Ohio State University Comprehensive Cancer Center gave an oral presentation on November 16 th discussing the safety outcomes of High Grade Glioma (HHG) patients from a Phase 1a BXQ – 350 trial (NCT02859857). This was followed by a traditional poster viewing.

Initial Experience in Ependymoma with Investigational Cancer – Targeting BXQ – 350 SapC – DOPS Nanovesicles: A Rare Tumor Case Study

During a poster presentation on Saturday November 17 th , John Villano MD, Director, Clinical Neuro – Oncology Research Program, Markey Cancer Center and Professor of Medicine, University of Kentucky HealthCare discussed the safety profile in a rare tumor type resulting from a Phase 1a BXQ – 350 trial (NCT02859857).

"Bexion was honored to participate in the SNO Annual meeting. We are exc ited to have presented new BXQ – 350 data from our Phase 1 program by our Principal Investigators ," stated Dr. Ray Takigiku, Founder and CEO of Bexion.

About BXQ – 350
BXQ – 350 is a unique formulation of a synthetically produced, human lysosomal protein, Saposin C (sphingolipid activator protein, or SapC), and the phospholipid dioleoylphosphatidylserine (DOPS).

Guardant Health Reports Third Quarter 2018 Financial Results

On November 19, 2018 Guardant Health, Inc. (Nasdaq:GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the third quarter ended September 30, 2018 (Press release, Guardant Health, NOV 19, 2018, View Source [SID1234531532]).

Recent Highlights

Revenues of $21.7 million for the third quarter of 2018, representing a 95% increase over the third quarter of 2017

Reported 7,027 tests to clinical customers and 2,505 tests to biopharmaceutical customers in the third quarter, representing increases of 14% and 67% respectively, over the third quarter 2017

Lung cancer study published in JAMA Oncology demonstrated Guardant360 outperformed tissue biopsy alone in identification of targetable mutations

Awarded Medicare coverage for the Guardant360 assay in non-small cell lung cancer through a local coverage determination from Palmetto GBA, a Medicare Administrative Contractor; successfully received first payment

Completed initial public offering, raising approximately $249.5 million of net proceeds, after underwriting fees and other expenses
"Our third quarter accomplishments reflect the ongoing strength of our business," said Helmy Eltoukhy, PhD, Chief Executive Officer. "We are continuing to build proof points for a blood-first paradigm ahead of traditional tissue genotyping, as demonstrated by the study from the University of Pennsylvania which was recently published in JAMA Oncology."
"In addition, we are pleased with the successful completion of our IPO," continued Dr. Eltoukhy. "We are grateful for the support of our investors who participated in the offering, and we are focused on the creation of long-term shareholder value through unprecedented access to cancer’s molecular information throughout all stages of the disease."
Third Quarter 2018 Financial Results
Revenue was $21.7 million in the three months ended September 30, 2018, a 95% increase from $11.1 million in the three months ended September 30, 2017. Precision oncology revenue increased 78% driven by higher testing volume and increases in revenue per test. Tests for clinical customers increased 14% (after excluding tests in the third quarter of 2017 from a customer that began processing tests in-house in March 2018 based on a joint development agreement) and tests for biopharmaceutical customers increased 67%.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services, was $11.6 million for the third quarter of 2018, an increase of $9.1 million from $2.5 million in the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 53.7%, as compared to 22.2% in the corresponding prior year period.
Operating expenses were $35.8 million for the third quarter of 2018, as compared to $31.1 million in the corresponding prior year period, an increase of 15%.
Net loss attributable to Guardant Health, Inc. common stockholders was $24.5 million in the third quarter of 2018, as compared to $33.3 million in the corresponding period of the prior year. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.94 in the third quarter of 2018, as compared to $2.76 in the corresponding period of the prior year.
Cash, cash equivalents and marketable securities were $274.3 million as of September 30, 2018. In October 2018, Guardant completed an initial public offering, raising approximately $249.5 million net of underwriting fees and other expenses.
2018 Financial Guidance
Guardant Health expects full year 2018 revenue to be in the range of $82.0 million to $84.0 million.
Webcast and Conference Call Information
Guardant Health will host a conference call to discuss the third quarter 2018 financial results after market close on Monday, November 19, 2018 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone (866) 417-5537 for U.S. callers or (409) 217-8233 for international callers (Conference ID: 9156645). The webcast can be accessed at View Source