On April 21, 2020 Blue Earth Diagnostics Ltd, a Bracco company focused on molecular imaging diagnostics, reported expanded access to Axumin (fluciclovine (18F)) in Europe (Press release, Blue Earth Diagnostics, APR 21, 2020, View Source [SID1234556470]). The first commercial delivery of Axumin was made in Slovakia in April 2020. This was possible through the Blue Earth Diagnostics’ distribution partner in Slovakia, MGP, spol. s r. o. Axumin is a PET imaging agent approved in the European Union for use in men with suspected recurrence of prostate cancer. Axumin is commercially available in Belgium, Luxembourg, Italy, France, Norway, the Czech Republic, The Netherlands, Austria and, now, Slovakia, with further European countries set to follow soon.

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Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "We are very pleased that Axumin is now available in Slovakia. Expansion of supply into this new European country demonstrates the productive relationships that we have with our manufacturing and distribution partners, and supports our mission to make Axumin commercially available to clinicians and their patients across Europe."

Karel Zeleny, Chief Executive Officer of MGP commented, "We are proud of our continuing partnership with Blue Earth Diagnostics, and are happy to be able to distribute Axumin to another new market, contributing to the management of patients with prostate cancer recurrence."

On April 21, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported the presentation of the results for Cohort 1 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, APR 21, 2020, View Source [SID1234556452]). The abstract titled "Poziotinib activity and durability of responses in previously treated EGFR exon 20 NSCLC patients – a Phase 2 study" will be part of the Lung Cancer Targeted Therapy session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, to be held April 27-28, 2020. Full details of the presentation are as follows:

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Abstract Title: Poziotinib activity and durability of responses in previously treated EGFR exon 20 NSCLC patients – a Phase 2 study
Authors: Xiuning Le, M.D., Ph.D., et al.
Session: VCTPL08 – Lung Cancer Targeted Therapy
Date and Time: April 27, 2020, 2:05 p.m. – 2:15 p.m. EDT
Abstract Number: CT081
Location: The first edition of the AACR (Free AACR Whitepaper) Virtual Annual Meeting will be available free to everyone. Attendees will be asked to create an account to access the meeting platform which could be found at: View Source

Conference Call and Webcast

Spectrum’s management will host a webcast and conference call at 8:30 a.m. ET / 5:30 a.m. PT on April 28, 2020 to review the data and program strategy. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 5536065. A live webcast of the call will be available from the Investors and Media section of the company’s website at View Source and will be archived there shortly after the live event.

On April 21, 2020 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, for the treatment of patients with various solid tumor malignancies, reported that the company will present data from its first in human study of PEN-866 at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, occurring April 27-28, 2020 (Press release, Tarveda Therapeutics, APR 21, 2020, View Source [SID1234556471]).

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PEN-866 is the initial clinical program from Tarveda’s HSP90 binding miniature drug conjugate platform, which is designed to bind to activated Heat Shock Protein 90 (HSP90) to accumulate and release its potent topoisomerase 1 inhibitor (SN-38) payload in solid tumors.

Details of the poster presentation are as follows:

Title: Characterization of PEN-866, a Heat Shock Protein 90 (HSP90) binding conjugate of SN-38, in patient plasma and tumors from the first in human study
Date: Monday, April 27, 2020
Time: 9:00 AM – 6:00 PM ET
Location: AACR (Free AACR Whitepaper) Virtual Annual Meeting I accessible on the AACR (Free AACR Whitepaper) website at www.aacr.org

On April 21, 2020 VBL Therapeutics (Nasdaq: VBLT) reported that it has been awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS) (approximately $0.9 million) by the Israel Innovation Authority (IIA) (Press release, VBL Therapeutics, APR 21, 2020, View Source [SID1234556453]). The IIA has approved a budget of approximately $1.8 million for the VB-111 project during 2020, with 50% of this amount as an IIA grant. The funds will support the continued development of VBL’s lead product candidate, VB-111, a first-in-class targeted anti-cancer gene-therapy agent. VB-111 is currently being evaluated in a Phase 3 potential registration study (OVAL) for the treatment of platinum-resistant ovarian cancer.

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On March 26, 2020, VBL announced a positive outcome in the first interim analysis in the OVAL study, demonstrating an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm. According to the interim data, the response rate in the treatment arm was 58% or higher. In patients with post-treatment fever, the CA-125 response was 69%. Fever is frequently observed after VB-111 treatment. The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in the successful Phase 2 trial, which enrolled a similar population of patients with platinum-resistant ovarian cancer and showed overall survival benefit.

"We thank the IIA for their continued support and external validation of our VB-111 program, which continues to demonstrate encouraging clinical data in ovarian cancer, as well as in additional solid tumor indications," said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. "Our OVAL Phase 3 study continues to recruit patients and we expect our next interim analysis to occur in the fourth quarter of 2020, as planned."

About VB-111 (ofranergene obadenovec)
VB-111 is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also 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. 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).

On April 21, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education, reported the return of the International Symposium on Ovarian Cancer and Other Gynecologic Malignancies (Press release, Physicians’ Education Resource, APR 21, 2020, View Source [SID1234556472]). The conference will be held May 2 as a live CME-accredited webcast.

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"We are beyond excited to announce the return of our International Symposium on Ovarian Cancer and Other Gynecologic Malignancies conference," said Phil Talamo, president of PER. "To ensure the safety of our faculty and attendees during the global pandemic and support the oncology community in the treatment of their patients with gynecologic malignancies, we made the decision to transition our live meeting in San Diego to a virtual CME-certified webcast."

The meeting will be co-chaired by Robert L. Coleman, M.D., FACOG, FACS, gynecologic oncologist and chief scientific officer of the US Oncology Network; Ursula A. Matulonis, M.D., director and chief of the division of gynecologic oncology and Brock-Wilson Family chair at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School; and Bradley J. Monk, M.D., FACOG, FACS, professor and director of the division of gynecologic oncology at Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center and medical director of gynecological oncology research at the US Oncology Network.

The 11th Annual International Symposium on Ovarian Cancer and Other Gynecologic Malignancies is a one-day educational and scientific webcast that will focus on key topics in the management of ovarian cancer, as well as endometrial, uterine and cervical malignancies. This historic meeting, led by leading experts in the field of gynecologic malignancies, will offer medical, surgical and radiation oncologists the chance to learn, debate and discuss the latest diagnostic, therapeutic and supportive care strategies for patients with gynecologic cancers. Case-based presentations will allow for vibrant discussion of the practical concerns of treating patients in the real world. Promising novel agents undergoing clinical trial evaluation will also be highlighted during the live discussion.

Accredited by the Accreditation Council for Continuing Medical Education and approved by the California Board of Registered Nursing, this live webinar will provide participants the opportunity to earn up to 6.5 AMA PRA Category 1 Credits and 6.5 nursing contact hours.