On February 9, 2021 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported that the CanStem303C study evaluating the efficacy and safety of investigational agent napabucasin when given in combination with FOLFIRI with or without bevacizumab in patients with previously treated metastatic colorectal cancer failed to reach the primary endpoints of overall survival (OS) (Press release, Sumitomo Dainippon Pharma, FEB 9, 2021, View Source [SID1234574821]). Napabucasin in combination with FOLFIRI failed to show significant OS improvement in the general study population and in patients whose tumor was positive for the phosphorylated signal transducer and activator of transcription 3 (pSTAT3) biomarker.

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"Patients with metastatic colorectal cancer have a high unmet medical need, and our hope was to develop a new treatment option for this population. We are disappointed with the results of this Phase 3 trial and would like to express gratitude to the trial participants, investigators and staff for their efforts and contributions to the study," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "SDP Oncology is committed to continuing our pursuit of advancing our pipeline to bring forward innovative treatments for patients with cancer."

The multicenter, open-label, randomized Phase 3 CanStem303C study evaluated the efficacy and safety of napabucasin in approximately 1,250 patients with previously treated metastatic colorectal cancer. Patients were randomized 1:1 in the study. The study had two primary endpoints – overall survival in all randomized patients and overall survival in a subpopulation of patients whose tumor was positive for the pSTAT3 biomarker. Napabucasin at a dose of 240 mg was administered orally, twice daily in combination with FOLFIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab.

The most common adverse events, occurring in patients in the napabucasin combination arm, were consistent with previously published data and included diarrhea, nausea, vomiting and abdominal pain.

Final data and analyses of this study will be published for the oncology community.

About Napabucasin

Napabucasin is an investigational, orally administered reactive oxygen species (ROS) generator that is bioactivated by the intracellular antioxidant NAD(P)H:quinone oxidoreductase 1 (NQO1).1 Napabucasin exerts its antitumor activity by increasing levels of ROS beyond a cytotoxic threshold, causing cancer cell death.1,2

About Colorectal Cancer

Colorectal cancer is the third leading cause of cancer-related deaths in men and in women in the U.S. It is estimated that there will be 149,500 new cases of colorectal cancer and 52,980 deaths from colorectal cancer in the U.S. this year.3 Metastatic colorectal cancer occurs when cancer cells break way from a tumor in the colon or the rectum to other parts of the body through the bloodstream or lymphatic system.4 Approximately 22% of colorectal cancer cases are metastatic at initial diagnosis, and about 70% of patients will eventually develop metastatic relapse. Patients with metastatic colorectal cancer face poor prognosis in general, with a relative 5-year survival rate of 14%, compared to 71% and 90% in those with regional and localized colorectal cancer in the U.S.5

On February 9, 2021 Enveric Biosciences Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 3,007,026 shares of Enveric’s common stock, at a purchase price of $4.27 per share, in a registered direct offering (Press release, Enveric Biosciences, FEB 9, 2021, View Source [SID1234574820]). Enveric has also agreed to issue to the investors unregistered warrants to acquire 1,503,513 shares of Common Stock at $4.90 per share, exercisable immediately and terminating five years after the date of issuance. The closing of the offering is expected to occur on or about February 11, 2021, subject to the satisfaction of customary closing conditions. Following completion of the offering, the Enveric is expected to have 18,336,367 shares of common stock issued and outstanding.

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The gross proceeds to Enveric from this offering are expected to be approximately $12,840,000, before deducting advisory and other offering expenses. Enveric intends to use the net proceeds from this offering for working capital and general corporate purposes.

Palladium Capital Group, LLC acted as a financial advisor to the issuer.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Enveric pursuant to a "shelf" registration statement on Form S-3 (File No. 333-233260) previously filed with the Securities and Exchange Commission (the "SEC") on August 14, 2019, and declared effective by the SEC on November 19, 2019, and an additional registration statement on Form S-3 filed pursuant to Rule 462(b) relating to these securities became automatically effective upon filing. The offering of the securities 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 accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source

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 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. Enveric has agreed to register the shares of common stock issuable upon exercise of the warrants for resale pursuant to a customary registration rights agreement.

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 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.

On February 9, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported that Revitope Oncology is extending its collaboration to develop a systems pharmacology model for Revitope’s dual antigen targeting TwoGATE platform for solid tumor indications (Press release, Applied BioMath, FEB 9, 2021, View Source [SID1234574819]). "Our previous collaborations with Applied BioMath proved extremely valuable as we leveraged their models to identify optimal therapeutic parameters in our development process," said Werner Meier, CSO of Revitope Oncology. "We look forward to extending our prior collaboration with this project to help accelerate our lead pipeline candidate towards the clinic." In this collaboration, Applied BioMath will develop a semi-mechanistic systems pharmacology model to aid in the prediction of a human efficacious dose.

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Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "We are very excited to assist Revitope as they advance their therapeutic," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Systems pharmacology models are increasingly necessary given the complexity of modern therapeutics. We look forward to extending our collaboration with the Revitope Oncology team."

On February 9, 2021 Amgen (NASDAQ:AMGN) reported that Greg Friberg, vice president and global oncology therapeutic area head at Amgen, will participate in a fireside chat as part of the Guggenheim Healthcare Talks 2021 Oncology Day on Friday, Feb. 12 at 12:30 p.m. ET (Press release, Amgen, FEB 9, 2021, View Source [SID1234574818]).

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Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On February 9, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company that applies its Nucleosomics platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose a range of cancers and other diseases, reported that it is commencing an underwritten public offering of its common stock (the "Offering") (Press release, VolitionRX, FEB 9, 2021, View Source [SID1234574817]). All of the shares to be sold in the Offering will be sold by Volition, subject to customary closing conditions. In addition, Volition intends to grant the underwriter for the Offering a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the Offering.

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Cantor Fitzgerald & Co. is acting as the sole book running manager of the Offering.

The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-227248) previously filed by Volition with the Securities and Exchange Commission (the "SEC") on September 26, 2018 and declared effective by the SEC on September 28, 2018. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the Offering will be filed with the SEC.

Before you invest, you should read the registration statement, the preliminary prospectus, the documents that Volition has filed with the SEC that are incorporated by reference into the registration statement, and the other documents Volition has filed with the SEC for more complete information about Volition and the offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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.