AXIM® Biotechnologies Begins Pre-Clinical Pharmacokinetic Animal Drug Studies on its Cancer Drug Compound SPX-1009

On June 1, 2020 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological research, reported that its subsidiary Sapphire Biotech, Inc. ("Sapphire") has started pre-clinical animal drug studies on its new compound, SPX-1009 (Press release, AXIM Biotechnologies, JUN 1, 2020, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-begins-pre-clinical-pharmacokinetic-animal-drug-studies-on-its-cancer-drug-compound-spx-1009 [SID1234560718]).

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"We look forward to the next step in the race to finding a cure for cancer," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "After very positive in vitro studies, this pharmacokinetic animal study will tell us whether we have a potential drug candidate for humans. Because it is an analog of a drug that has already completed animal studies, we expect positive results."

Quiescin Sulfhydryl Oxidase 1 (QSOX1), an enzyme that is over-expressed by tumor cells in numerous cancers, has been shown to be involved in cancer invasion and metastasis. Earlier this year, Sapphire acquired exclusive license rights to a small molecule, SBI-183. SBI-183 has been proven to inhibit the enzymatic activity of QSOX1 and suppress tumor cell invasion in vitro and metastasis of MDA-MB-231 breast tumor cells in vivo. SBI-183 also suppressed human xenograft primary kidney tumor growth by 86 percent compared to controls.

Sapphire scientists have generated and tested over 90 analogs of SBI-183 and discovered that one analog, SPX-1009, was tenfold more potent than SBI-183 in suppressing tumor invasion and metastasis in vitro. Further testing revealed that SPX-1009 suppressed invasion of breast, kidney and pancreas tumor cells in 2D and 3D invasion assays at tenfold lower concentrations than the parent compound SBI-183.

Oral and intravenous therapy (IV) formulations of SPX-1009 are being tested in pharmacokinetic animal studies to determine the optimal route of treatment.

"We are hopeful that SPX-1009 will block metastasis in patients which, after all, is what causes death in the vast majority of cancer patients," said Catalina Valencia, Chief Executive Officer of Sapphire Biotech.

ARCA BIOPHARMA ANNOUNCES $9.4 MILLION REGISTERED DIRECT OFFERING

On June 1, 2020 ARCA biopharma, Inc. (Nasdaq: ABIO) a late stage biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported that it has entered into a definitive securities purchase agreement with certain institutional and accredited investors to purchase, in a registered direct offering, 348,000 shares of ARCA’s common stock, at a purchase price of $9.00 per share, and pre-funded warrants to purchase 694,222 shares of common stock at a purchase price of $8.999 per warrant (Press release, Arca biopharma, JUN 1, 2020, View Source [SID1234560717]). The gross proceeds to ARCA, before deducting placement agent fees and other offering expenses, are expected to be approximately $9.4 million. Subject to customary closing conditions, the transaction is expected to close on Wednesday, June 3, 2020.

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JonesTrading Institutional Services LLC is acting as the exclusive placement agent for the offering.

ARCA anticipates that the net proceeds from this offering will be used to initiate its clinical trial of AB201 and for working capital and general corporate purposes.

The shares of common stock are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-238067), which was declared effective by the Securities and Exchange Commission (SEC) on May 20, 2020. A prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may be obtained, when available, from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing [email protected], or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

BioLineRx Announces $4.39 Million Registered Direct Offering

On June 1, 2020 BioLineRx Ltd. (Nasdaq: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported that it has entered into definitive agreements with several healthcare-focused, institutional and accredited investors for the purchase and sale of 2,510,286 of the Company’s American Depositary Shares (ADSs), at a purchase price of $1.75 per ADS, in a registered direct offering (Press release, BioLineRx, JUN 1, 2020, View Source [SID1234558793]). BioLineRx has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 2,510,286 ADSs. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The offering is expected to close on or about June 3, 2020, subject to 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 will have an exercise price of $2.25 per ADS and will be exercisable at any time upon issuance and will expire two and one-half years from the date of issuance.

The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants issued in the concurrent private placement), before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, are expected to be $4.39 million. BioLineRx intends to use the net proceeds for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.

The ADSs (but not the warrants or the ADSs underlying the warrants) are being offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222332) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on December 28, 2017 and declared effective by the SEC on January 19, 2018. The offering of the ADSs will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the ADSs being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or 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 ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs 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.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

RedHill Biopharma to Present at BIO Digital

On June 1, 2020 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that Mr. Adi Frish, RedHill’s Senior Vice President Business Development and Licensing, will present a corporate overview at BIO Digital, taking place June 8-12, 2020 (Press release, RedHill Biopharma, JUN 1, 2020, View Source [SID1234558792]).

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The presentation will be available during the conference on-demand via View Source, as well as on the Company’s website, View Source for 30 days.

DelMar Pharmaceuticals to Present Updates of Two Phase 2 Clinical Trials of VAL-083 at the 2020 American Association for Cancer Research Virtual Annual Meeting II

On June 1, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that two posters updating results from the company’s two Phase 2 clinical trials of VAL-083 will be presented at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II to be held June 22-24, 2020 (Press release, DelMar Pharmaceuticals, JUN 1, 2020, View Source [SID1234558791]).

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Details regarding the posters to be presented in the Phase 2 Trials in Progress session are as follows:

Title: "Phase 2 trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma"
Lead Author: Dr. Zhong-Ping Chen, Sun Yat-sen University Cancer Center
Poster Number: CT273
Summary: This poster will include data from the company’s ongoing Phase 2 trial of VAL-083 being conducted at Sun Yat-sen University Cancer Center as a first line therapy, and includes updates on enrollment, safety and efficacy.

Title: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the recurrent or adjuvant setting"
Lead Author: Dr. Barbara O’Brien, M.D. Anderson Cancer Center
Poster Number: CT272
Summary: This poster will include data from the company’s ongoing Phase 2 trial of VAL-083 being conducted at M.D. Anderson Cancer Center as a treatment in the recurrent and adjuvant settings, and includes updates on enrollment, safety and efficacy.

Additional posters relevant to VAL-083 to be available from the conference include:

Session: Mechanisms of DNA Damaging Therapeutics
Title: "Dianhydrogalactitol (VAL-083) synergizes with topoisomerase inhibitors to overcome homologous recombination repair activity in glioblastoma and prostate cancer cells"
Poster Number: 1369

Session: DNA-reactive Agents and Other
Title: "Dianhydrogalactitol (VAL-083) exhibits strong efficacy in GBM tumors with different (epi)genetic background and treatment history"
Poster Number: 5231

All abstracts can be accessed via View Source!/9045.

About VAL-083
VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source