On May 26, 2020 EORTC reported that Although there are effective treatments for advanced gastrointestinal tumours (GISTs) most patients with this rare disease will eventually become resistant to them (Press release, EORTC, MAY 26, 2020, View Source [SID1234558458]). Finding a drug that will help those patients where treatment has failed is therefore a priority. Now, for the first time, EORTC researchers have identified that the oral agent cabozantinib has clinically relevant anti-tumour activity in patients whose disease was progressing despite treatment with two other anticancer drugs. The research is published in The European Journal of Cancer.

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"Based on very promising findings from my laboratory in self-made, patient-derived mouse models of GIST, we designed a multicentre European clinical trial using cabozantinib in patients who had come resistant to imatinib (Glivec) and sunitinib (Sutent)," said Professor Patrick Schöffski, Head of the Department of General Medical Oncology, University Hospitals Leuven, and of Laboratory for Experimental Oncology, KU Leuven, Leuven Cancer Institute, Leuven, Belgium, who led the investigation for the EORTC Soft Tissue and Bone Sarcoma Group.

"The excellent results of this Phase 2 trial are fully in line with our preclinical data in self-made mouse models of human GIST and confirm once again the predictive character of mouse xenograft work. The working hypothesis that cabozantinib is active in advanced GIST was confirmed, as the trial met its primary endpoint, without any new safety signal detected."

GIST is a rare tumour that occurs most commonly in the stomach or small intestine, and the most common sarcoma in the gastrointestinal tract. The tumours grow from specialised cells found in the gastrointestinal tract called interstitial cells of Cajal (ICCs). GISTs are usually found in adults aged between 40 and 70, but can also occur at younger ages, and even in children.

In the seven-country, academic, investigator-initiated clinical study, 50 patients started treatment with cabozantinib between February 2017 and August 2018. Among the first 41 who were evaluable, 24 had no worsening of disease (‘progression-free’) at week 12. At the end of the trial, the disease had been controlled in 41 of the patients, whereas in eight the disease had progressed despite treatment with cabozantinib, and one was not evaluable – an impressive disease control rate of 82%, particularly when considering the fact that patients had already failed two other established anticancer agents.

Now that clinically relevant anti-tumour activity of cabozantinib has been demonstrated in patients with advanced GIST in whom other treatments had failed, the researchers suggest that the drug should become available for such patients outside clinical trials. "The oral agent was active in all genetically-defined subsets of patients in this trial. The impressive findings of this study should be followed by a more definitive, randomised, blinded Phase 3 trial comparing cabozantinib with placebo or another available agent," says Prof Schöffski.

Reference

1Activity and safety of the multi-target tyrosine kinase inhibitor cabozantinib in patients with metastatic gastrointestinal stromal tumour after treatment with imatinib and sunitinib: European Organisation for Research and Treatment of Cancer phase II trial 1317 ‘CaboGIST’".

P. Schoffski; O. Mir; B. Kasper; Z. Papai; J-Y Blay; A. Italiano; C. Benson; K. Kopeckova; N. Ali; P. Dileo; A. LeCesne; F. Menge; S.Cousin; E.Wardelmann; A. Wozniak; S. Marreaud; S. Litiere; F. Zaffaroni; A. Nzokirantevye; I. Van den Bempt; H. Gelderblom. European Journal of Cancer, Volume 134, July 2020, Pages 62-74,View Source

On May 26, 2020 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that it has commenced a global offering of $500 million (approximately €458.3 million) of ordinary shares, which may be represented by American Depository Shares ("ADSs") (Press release, argenx, MAY 26, 2020, View Source [SID1234558457]).

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The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are expected to close simultaneously.

In addition, argenx intends to grant the underwriters of the offering a 30-day option to purchase additional ordinary shares (which may be represented by ADSs) in an aggregate amount of up to 15% of the total number of ordinary shares (including represented by ADSs) proposed to be sold in the offering, on the same terms and conditions.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX." and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX.".

J.P. Morgan, Cowen and BofA Securities are acting as joint bookrunning managers for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities being offered in the United States will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities being offered in the United States may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected].

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made following pricing of the offering. A prospectus for the listing of the ordinary shares on Euronext Brussels consisting of a universal registration document dated 31 March 2020, an amendment to the aforementioned universal registration document, a securities note and a summary (together, the "Listing Prospectus") will be filed with the Dutch regulator (Stichting Autoriteit Financiële Markten) (the "AFM") for approval and passporting to Belgium in accordance with article 25 of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (as amended, the "Prospectus Regulation"). Upon approval, the Listing Prospectus together with a Dutch translation of the summary will be made available on the website of argenx (www.argenx.com) and copies may be obtained for free from argenx upon request at [email protected] or by telephone at (32) 9 310 34 19.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On May 26, 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 5,142,859 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, MAY 26, 2020, View Source [SID1234558456]). 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 5,142,859 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 May 28, 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 $9.0 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.

On May 26, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CLR 131 in lymphoplasmacytic lymphoma (LPL)/Waldenstrom’s macroglobulinemia (WM) in patients having received two prior treatment regimens or more (Press release, Cellectar Biosciences, MAY 26, 2020, View Source [SID1234558455]). CLR 131 is the company’s small-molecule, cancer-targeting radiotherapeutic Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. It is currently being evaluated in Cellectar’s ongoing Phase 2 CLOVER-1 clinical study in patients with relapsed or refractory multiple myeloma and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia.

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"LPL/WM patients that do not respond optimally or are intolerant of ibrutinib, currently have limited treatment options and poor survival rates. Fast Track Designation for LPL/WM further supports our clinical development strategy to quickly and efficiently provide these patients with an effective therapeutic alternative," said James Caruso, president and CEO of Cellectar. "All four LPL/WM patients treated in our CLOVER-1 Phase 2 study to date achieved a 100% overall response rate and a 25% complete response rate. This strong response rate may represent an important improvement in the treatment of relapsed/refractory LPL/WM as no approved or late-stage development treatments for relapsed or refractory patients have reported complete responses."

Cellectar announced that it had received Orphan Drug Designation (ODD) for CLR 131 in LPL earlier this year. In addition to the variety of benefits derived from the ODD, the company will also receive increased engagement and assistance from the FDA in support of the regulatory approval pathway for LPL/WM.

Fast Track Designation

Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the Fast Track Designation provision is to help facilitate development and expedite the review and potential approval of drugs to treat serious and life-threatening conditions. Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program. These can include meetings to discuss study design, data required to support approval, or other aspects of the clinical program. Additionally, products that have been granted Fast Track Designation may be eligible for priority review of a New Drug Application (NDA) Real Time Oncology Review (RTOR) by the FDA which allows the FDA to begin review of the data within weeks of concluding the pivotal study.

About LPL/WM

Waldenstrom’s macroglobulinemia (WM) is a lymphoma, or cancer of the lymphatic system. The disease occurs in a type of white blood cell called a B-lymphocyte or B-cell, which normally matures into a plasma cell whose job is to manufacture immunoglobulins (antibodies) to help the body fight infection. In WM, there is a malignant change to the B-cell in the late stages of maturing, and it continues to proliferate into a clone of identical cells, primarily in the bone marrow but also in the lymph nodes and other tissues and organs of the lymphatic system. These clonal cells over-produce an antibody of a specific class called IgM.

WM cells have characteristics of both B-lymphocytes and plasma cells, and they are called lymphoplasmacytic cells. For that reason, WM is classified as a type of non-Hodgkin’s lymphoma called lymphoplasmacytic lymphoma (LPL). About 95% of LPL cases are WM; the remaining 5% do not secrete IgM and consequently are not classified as WM. WM is a very rare and incurable disease.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphoma. The company recently completed a Phase 1 dose-escalation clinical study in r/r multiple myeloma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large b-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently, the European Commission granted an ODD for r/r multiple myeloma.

On May 26, 2020 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease, reported that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of an aggregate of 2,084,850 shares of its common stock, at a purchase price of $2.0625 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Caladrius Biosciences, MAY 26, 2020, View Source [SID1234558454]). Caladrius has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 1,042,425 shares of common stock. The closing of the offering is expected to occur on or about May 28, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive lead placement agent for the offering.
The warrants have an exercise price equal to $2.0625 per share, are exercisable immediately upon issuance and will expire five and one-half years from the issuance date.

The gross proceeds from the offering are expected to be approximately $4.3 million. The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes, including the advancement of its CD34+ technology-based clinical programs.

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. 333-226319), including an accompanying prospectus previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on August 2, 2018. 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.

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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.