On June 26, 2019 CBM BioPharma Inc. ("CBM") reported that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance and Issue Fee Due in CBM’s patent application related to the treatment of pancreatic cancer (Press release, CBM BioPharma, JUN 26, 2019, View Source;trademark-office-allows-patent-claims-for-cbm-biopharma-incs-patent-application-for-pancreatic-cancer-treatment-300875038.html [SID1234537290]).

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CBM has received from the USPTO a Notice of Allowance for patent application 15/115,393. This application is licensed from the University of Texas by CBM. Once the patent issue fee is paid, the new patent will protect one of CBM’s lead drug candidates, Gem-DHA, a novel gemcitabine derivative intended for the treatment of pancreatic cancer. Preliminary data indicates that Gem-DHA is more effective than gemcitabine in mice pancreatic cancer models. This asset is to be sold to Spherix Inc. (NASDAQ: SPEX) as part of the previously announced Asset Purchase Agreement between CBM and Spherix. The transaction is subject to shareholder approval by Spherix shareholders and other customary closing conditions.

Anthony Hayes, Spherix CEO, stated, "I am very excited by the potential of this drug and especially by the data showing that Gem-DHA works better in reducing the growth of pancreatic tumors than the first-line chemotherapy drug gemcitabine. The data indicates that Gem-DHA preferentially concentrates itself in the pancreas relative to other organs, suggesting it may be a promising candidate for further trials in pancreatic cancer. We are constantly working to return value to our shareholders and this news is another data point that establishes the value of the CBM assets."

On June 26, 2019 3P Biopharmaceuticals (3P) and Norwegian biopharmaceutical company Nordic Nanovector have extended their collaboration agreement for the biopharmaceutical development of Betalutin late stage manufacturing for B-cell non-Hodgkin lymphoma (NHL) treatment (Press release, 3P Biopharmaceuticals, JUN 26, 2019, View Source [SID1234537291]).

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The non-Hodgkin lymphoma (NHL) is cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.

3P and Nordic Nanovector started their collaboration in 2013 and successfully advanced Betalutin project through these years.

The current agreement is consolidating the relationship describing how both companies will successfully progress the project up to the regulatory submission of the product including development, clinical supply and late-stage activities, such as process characterization and validation.

"Our partnership with Nordic Nanovector is a great example of how together we can achieve more than planned and succeed in the late stage of Betalutin development," said Dámaso Molero, General Manager at 3P Biopharmaceuticals.

He also added, "this project demonstrates how we can bring together various parties to successfully reach the project goals by using complex technologies in this challenging project."

HH1 (Lilotomab) is a murine IgG1 antibody that targets the human glycoprotein CD37, which is found on the surface of B cells and B cell tumors.

The antibody is a component of Betalutin, a radioimmunoconjugate molecule (RIC) which is being developed for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).

On June 26, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported the pricing of an underwritten public offering of 4,750,000 shares of its common stock, offered at a price of $26.00 per share (Press release, Odonate Therapeutics, JUN 26, 2019, View Source [SID1234537275]). In addition, Odonate has granted the underwriters a 30-day option to purchase up to an additional 712,500 shares of its common stock on the same terms and conditions. All shares of common stock sold in the offering are being sold by Odonate. The offering is expected to close on or about June 28, 2019, subject to customary closing conditions.

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The gross proceeds from the proposed underwritten public offering are expected to be $123.5 million before deducting customary underwriting discounts and offering expenses. Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development and regulatory activities relating to tesetaxel, as well as for working capital and general corporate purposes.

Jefferies and Cowen are acting as joint book-running managers. LifeSci Capital is acting as lead manager for the offering.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-229785), which became effective on February 28, 2019. A final prospectus supplement relating to and describing the terms of the offering will be filed with the Securities and Exchange Commission (SEC). The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering can be made only by means of a prospectus supplement and an accompanying base prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]) or Cowen and Company, LLC (c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717; telephone: 631-274-2806; email: [email protected]).

On June 26, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, is reported the acceptance of two oral presentations and five poster presentations at the International Society of Pediatric Oncology (SIOP) Annual Congress held October 23 through October 26, 2019 in Lyon, France (Press release, Y-mAbs Therapeutics, JUN 26, 2019, View Source [SID1234537276]). The abstracts for oral presentations are publicly available online at View Source

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The abstracts include the following presentation of omburtamab, one of the Company’s lead product candidates, which is currently being evaluated for the treatment of patients with CNS/Leptomeningeal metastasis from neuroblastoma, diffuse intrinsic pontine glioma ("DIPG"), and desmoplastic small round cell tumors ("DSRCT"):

"A curative approach to central nervous system metastatis of neuroblastoma," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (oral presentation)
The abstracts also include the following presentations of naxitamab, the Company’s second lead product candidate, which is currently being evaluated for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma, osteosarcoma and other GD2-positive tumors:

"Naxitamab-based chemoimmunotherapy for resistant high-risk neuroblastoma: Preliminary results of "HITS" pilot/phase II study," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (oral presentation)
"Preliminary tolerability assessment of naxitamab (humanized anti-GD-2 monoclonal antibody) therapy in a phase 2 osteosarcoma trial," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)
"High-dose naxitamab (humanized-3F8) plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for consolidating ≥2nd complete remission of high-risk neuroblastoma," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)
"High-dose naxitamab (humanized-3F8) plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for neuroblastoma: Outpatient treatent low immunogenicity, and major responses in a Phase II trial," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)
"High-dose naxitamab (humanized-3F8) plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for relapsed neuroblastoma resistant to salvage therapy: A Phase II trial," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)
"High-dose naxitamab plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for high-risk neuroblastoma: Efficacy against histologically-evident primary refractory metastases in bone marrow," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)

On June 26, 2019 BridgeBio Pharma, Inc. ("BridgeBio") reported the pricing of its initial public offering of 20,500,000 shares of its common stock at a price to the public of $17.00 per share, above the range of $14.00 to $16.00 (Press release, BridgeBio, JUN 26, 2019, View Source [SID1234576265]). In addition, BridgeBio has granted the underwriters a 30-day option to purchase up to 3,075,000 additional shares of its common stock. The shares are expected to begin trading on the Nasdaq Global Select Market on June 27, 2019, under the ticker symbol "BBIO" and the offering is expected to close on July 1, 2019, subject to customary closing conditions.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, SVB Leerink LLC, KKR Capital Markets LLC, Piper Jaffray & Co., Mizuho Securities USA LLC, BMO Capital Markets Corp. and Raymond James & Associates, Inc. are acting as book-running managers for the offering.

A registration statement relating to the securities being sold in this offering has been filed with and was declared effective by the U.S. Securities and Exchange Commission on June 26, 2019. This offering is being made only by means of a written prospectus. Copies of the final prospectus may be obtained, when available, from the office of J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-866-803-9204 or by emailing [email protected]; Goldman, Sachs & Co., Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526 or by emailing [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: 1-877-547-6340, or by emailing [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, telephone: 1-800-808-7525, ext. 6132, or by emailing [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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.