On June 1, 2020 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported Ayala management will present at two upcoming investor conferences (Press release, Ayala Pharmaceuticals, JUN 1, 2020, View Source [SID1234563987]):

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Jefferies Virtual Global Healthcare Conference: Wednesday, June 3, 2020 at 10:30 am ET.
Raymond James 2020 Human Healthcare Innovation Conference: Thursday, June 18, 2020 at 8:20 am ET.
A live webcast of each presentation may be accessed by visiting the Investors and News section of Ayala’s website at www.ir.ayalapharma.com. An archived replay of each webcast will be available on the website for 90 days following the presentations.

On June 1, 2020 VBL Therapeutics (Nasdaq: VBLT), reported the presentation of the positive outcome of pre-planned interim analysis results from the OVAL Phase 3 pivotal clinical trial in platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 virtual annual meeting (Press release, VBL Therapeutics, JUN 1, 2020, View Source [SID1234558783]).

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The analysis compared the CA-125 objective response rate (ORR) according to GCIG criteria in the treatment and control arms among the first 60 evaluable patients. The CA-125 ORR in those patients was 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate was 69%.

The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in the prior Phase 2 study, which enrolled a similar patient population and showed overall survival benefit. In the previously reported Phase 2 study of VB-111 in platinum resistant ovarian cancer, 58% of the patients treated with VB-111 and paclitaxel demonstrated a CA-125 response. Those patients with a CA-125 response demonstrated a median overall survival of 808 days, versus 351 days for those patients without a CA-125 response.

"The OVAL interim data are very encouraging as they demonstrate the potential benefit of VB-111 over standard-of-care in a randomized-controlled setting," said Tami Rachmilewitz, M.D., Vice President Clinical Development of VBL Therapeutics. "With over 25% of the patients already enrolled in the study, we look forward to further advancing the OVAL study by expansion to Europe and Japan later this year."

For VBL’s presentation at ASCO (Free ASCO Whitepaper) see: Link

About the OVAL (VB-111-701/GOG-3018) study (NCT03398655)
OVAL is an international Phase 3 randomized, double-blind, placebo-controlled potential registration clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.

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 June 1, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported it will provide a corporate overview at BIO Digital being held virtually June 8-12, 2020 (Press release, Aeglea BioTherapeutics, JUN 1, 2020, View Source [SID1234560724]).

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Presentation Details

Date: June 8-12, 2020
Presenter: Anthony G. Quinn, M.B. Ch.B., Ph.D., Aeglea’s president and chief executive officer
Location: View Source

The presentation will be available for download on the Presentations & Events section of the Company’s website and also will be available on-demand to registered participants of BIO Digital at View Source/sessions/620997.

On June 1, 2020 BERG, a clinical-stage biotech company that uses Artificial Intelligence (AI) to research diseases and develop innovative treatments, reported results from a Phase 1 clinical study of its investigational drug, BPM 31510 (novel ubidecarenone formulation) in glioblastoma (GBM) (Press release, Berg, JUN 1, 2020, View Source [SID1234560741]). The study, presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), highlights safety, tolerability and the impact of BPM 31510-IV influence on metabolism in patients, supporting planned Phase 2 clinical development.

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"At BERG, we understand the toll cancer takes not only on a patient, but also their loved ones, and we want to lead in the battle to fight the disease," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "BPM 31510 is a unique therapeutic modality targeting cell metabolism that is consistent with our proprietary Interrogative Biology platform. We are excited at the opportunities the findings will have in refining clinical development among multiple cancer indications, especially in brain cancers."

GBM is a destructive type of brain cancer often acknowledged for its steep morbidity and mortality rates. There are few effective treatment options available in the marketplace, thus substantiating the urgent need for novel therapeutic approaches to improve outcomes for this disease. BPM 31510 is a unique therapeutic modality which specifically targets cell metabolism and shifts the cancer’s glycolytic dependency toward mitochondrial oxidative phosphorylation. When applied, it induces oxidative stress and causes cell death, specifically of cancer cells. BPM 31510 serves as particularly relevant indication for GBM’s glycolytic dependency.

The study was led by Seema Nagpal, M.D. Clinical Associated Professor of Neurology & Neurological Sciences, and Lawrence Recht, M.D., Professor of Neurology & Neurological Sciences, both of Stanford University School of Medicine, with other Stanford Medicine researchers and in collaboration with BERG.

Details of the BERG presentation:
This Poster is available to registered 2020 ASCO (Free ASCO Whitepaper) Virtual Scientific Program attendees and can be viewed at:
View Source

In its commitment to serve patients afflicted with cancer, BERG has collaborated on other projects with leading institutions, like MD Anderson Cancer Institute (clinical trials) and Harvard/BIDMC (Project Survival), among others.

On June 1, 2020 Cleveland BioLabs, Inc. (NASDAQ:CBLI), reported that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of an aggregate of 1,515,878 shares of its common stock, at a purchase price of $2.0945 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Cleveland BioLabs, JUN 1, 2020, View Source [SID1234560792]). Cleveland BioLabs has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 757,939 shares of common stock. The closing of the offering is expected to occur on or about June 3, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price equal to $2.033 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

The gross proceeds from the offering are expected to be approximately $3.175 million. The Company currently intends to use the net proceeds from the offering for general corporate purposes.

The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-238578), including an accompanying prospectus previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on May 29, 2020. The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.