On April 30, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported dosing of the first patient in a clinical trial to evaluate the administration of ROLONTISon the same day as chemotherapy (Press release, Spectrum Pharmaceuticals, APR 30, 2020, View Source [SID1234556821]). The trial will evaluate the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy in patients with early stage breast cancer. ROLONTISis an investigational drug not approved by the U.S. Food and Drug Administration (FDA) and the BLA is currently under active review by the agency for the treatment of chemotherapy induced neutropenia with a PDUFA date of October 24, 2020.

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"This study exemplifies our commitment to unlocking the full potential of ROLONTIS, the first novel biologic positioned to enter the G-CSF market since 2001. A same day dosing option would be a unique and meaningful addition to the G-CSF category," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We will continue to follow the science and explore ways to add value to patients and health care providers. The initiation of this study, despite the pandemic, highlights investigator’s interest and our team’s dedication."

"This clinical trial will provide information on the pharmacodynamic effects of ROLONTIS given the same day as chemotherapy and it could provide a scientific basis to re-examine the way neutropenia is managed in patients who receive myelosuppressive chemotherapy," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "Same day dosing could possibly enhance compliance, lead to better patient outcomes and minimize patient’s burden in terms of simplified logistical issues associated with the administration of currently available growth factors that specify next day dosing following chemotherapy."

About the ROLONTIS Same Day Dosing Clinical Trial

This clinical trial will compare the effect of ROLONTISon the duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following docetaxel and cyclophosphamide. Approximately 45 patients will be enrolled in this Phase 1, open label, trial with 1:1:1 randomization to three dosing time schedule arms. Each treatment cycle will be 21 days and a total of four cycles will be evaluated. On day 1 of cycle 1, patients will receive chemotherapy followed by administration of ROLONTIS at 30 minutes, 3 hours or 5 hours. During cycles 2 – 4, patients will receive ROLONTIS 24 hours after chemotherapy. The primary endpoint is duration of Grade 4 neutropenia in cycle 1. A number of secondary endpoints in cycle 1 will be evaluated including incidence of neutropenia, time to recovery of severe neutropenia, incidence of grade 3 febrile neutropenia, pharmacokinetics, and number of patients with adverse events as a measure of safety. Additional information about this clinical trial can be found at www.clinicaltrials.gov using the identifier NCT04187898.

On April 30, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its first quarter 2020 financial results on Thursday, May 7, after the close of the U.S. financial markets (Press release, Syndax, APR 30, 2020, View Source [SID1234556820]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, May 7, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 5579109
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On April 30, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the pricing of an underwritten public offering of 5,555,556 shares of its common stock at a price to the public of $18.00 per share (Press release, Syndax, APR 30, 2020, View Source [SID1234556819]). The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $100 million. The offering is expected to close on May 4, 2020, subject to customary closing conditions. Additionally, Syndax granted the underwriters a 30-day option to purchase up to 833,333 additional shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock in the offering will be sold by Syndax.

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Citigroup and Cowen are acting as joint book-running managers for the offering. Barclays is also acting as joint bookrunning manager. BTIG is acting as lead manager, and Baird is acting as co-manager.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

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.

On April 30, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that important new preclinical data on the mechanism of action for its late-stage clinical candidate, uproleselan, are published in the April 27, 2020, issue of Nature Communications (Press release, GlycoMimetics, APR 30, 2020, View Source [SID1234556811]). The paper outlines how uproleselan, an investigational, first-in-class, targeted inhibitor of E-selectin, can reduce chemoresistance in acute myeloid leukemia (AML) through the key mechanism of targeted E-selectin inhibition.1

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"This paper offers compelling data on the mechanism of action of uproleselan," said John Magnani, Ph.D., GlycoMimetics Senior Vice President and Chief Scientific Officer. "AML cells that bind E-selectin become chemoresistant in protective niches in the bone marrow, eventually causing relapsed disease. This data demonstrates that, as a potent antagonist of E-selectin, uproleselan breaks this chemoresistance."

Barbier et.al. explain in the manuscript how AML blasts release inflammatory cytokines that further enhance the expression of E-selectin. AML blasts that strongly express the E-selectin ligand (sialyl Lex), in particular, are 12 times more likely to survive chemotherapy, and this is a major cause of relapsed disease. By selectively inhibiting E-selectin, uproleselan disrupts this pro-survival pathway and prolongs survival when paired with chemotherapy in an animal model of AML.

The journal article can be accessed here.

1 Barbier et.al. Nature Communications (April 27) doi.org/10.1038/s41467-020-15817-5

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

On April 30, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that important new preclinical data on the mechanism of action for its late-stage clinical candidate, uproleselan, are published in the April 27, 2020, issue of Nature Communications (Press release, GlycoMimetics, APR 30, 2020, View Source [SID1234556810]). The paper outlines how uproleselan, an investigational, first-in-class, targeted inhibitor of E-selectin, can reduce chemoresistance in acute myeloid leukemia (AML) through the key mechanism of targeted E-selectin inhibition.1

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"This paper offers compelling data on the mechanism of action of uproleselan," said John Magnani, Ph.D., GlycoMimetics Senior Vice President and Chief Scientific Officer. "AML cells that bind E-selectin become chemoresistant in protective niches in the bone marrow, eventually causing relapsed disease. This data demonstrates that, as a potent antagonist of E-selectin, uproleselan breaks this chemoresistance."

Barbier et.al. explain in the manuscript how AML blasts release inflammatory cytokines that further enhance the expression of E-selectin. AML blasts that strongly express the E-selectin ligand (sialyl Lex), in particular, are 12 times more likely to survive chemotherapy, and this is a major cause of relapsed disease. By selectively inhibiting E-selectin, uproleselan disrupts this pro-survival pathway and prolongs survival when paired with chemotherapy in an animal model of AML.

The journal article can be accessed here.

1 Barbier et.al. Nature Communications (April 27) doi.org/10.1038/s41467-020-15817-5

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.