On July 22, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that it is further expanding its poziotinib clinical program by adding three new cohorts in its cornerstone poziotinib clinical trial, ZENITH20 (Press release, Spectrum Pharmaceuticals, JUL 22, 2019, View Source [SID1234537648]). The ZENITH20 trial is an open-label, multi-center, global phase 2 trial with sites in the U.S., Canada, and Europe, evaluating the impact of poziotinib treatment on non-small cell lung cancer (NSCLC) patients.

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"With increased use of osimertinib as the treatment of first-line NSCLC patients with classical EGFR mutations, the emergence of osimertinib resistance is a growing occurrence in this setting," said Jeffrey Clarke, MD, Assistant Professor of Medicine at Duke University Hospital/Duke Cancer Institute. "One resistance pattern that is emerging is through the development of an additional EGFR mutation and recent pre-clinical publications suggest that poziotinib may be active against EGFR-dependent resistance mechanisms. Exploring the role of poziotinib as an investigational therapeutic option for those patients who fail first-line osimertinib and for those who have de novo atypical mutations is an exciting development and requires clinical confirmation."

Three new cohorts are currently open to patient enrollment in the ZENITH20 trial. Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains. All three new cohorts are now open to enrollment.

"Strong preclinical evidence led to the development of poziotinib in exon 20 mutations. Similarly guided by elegant science, we are expanding the poziotinib program to evaluate its potential in patients with additional difficult to treat mutations in non-small cell lung cancer," said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. "The emergence of osimertinib resistance and the lack of effective treatments for atypical mutations are growing treatment voids that poziotinib may be uniquely suited to fill."

The ZENITH20 trial now consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) are in previously-treated NSCLC setting and are fully enrolled. Cohort 3 (EGFR) and 4 (HER2) are in the first-line setting and are currently enrolling patients. Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate (ORR). Additional endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and safety. Topline results from cohort 1 are expected in Q4 2019.

"Our poziotinib clinical program is aggressive, proactive and designed to provide us with a full understanding of poziotinib’s potential impact on non-small cell lung cancer," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Thus far, we are pleased with the rapid recruitment and are eagerly awaiting our first topline readout in patients with previously treated EGFR exon 20 insertion mutations in the fourth quarter of this year."

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR (HER1) as well as HER2 and HER4. Importantly this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer.

Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several trials in multiple solid tumors.

On July 22, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that it closed its previously announced $15.0 million underwritten public offering (Press release, Xenetic Biosciences, JUL 22, 2019, View Source [SID1234537647]). In conjunction with the closing of the offering, Xenetic completed its previously announced acquisition of the novel CAR T ("Chimeric Antigen Receptor T Cell") platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, which has demonstrated proof-of-mechanism in B-cell Non-Hodgkin lymphomas. The XCART technology, developed by The Scripps Research Institute ("Scripps") in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, is believed to have the potential to significantly enhance the safety and efficacy of cell therapy for B-cell lymphomas by generating patient- and tumor-specific CAR T cells.

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"We believe that the XCART technology platform has the capability to expand the potential of CAR T cell therapy, an area driving new breakthroughs in the treatment of cancer. We are incredibly pleased to have closed this acquisition and look forward to leveraging this innovative technology to propel Xenetic into its next phase of growth," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "The XCART platform has demonstrated proof-of-mechanism and promising preclinical evidence of target specificity. We believe this acquisition positions us to drive momentum in the innovation and development of new oncology therapeutics where there remains significant unmet need. Our R&D efforts will initially focus on leveraging the XCART platform to develop cell-based therapeutics for the treatment of B-cell Non-Hodgkin lymphomas, an initial global market opportunity estimated to exceed $5 billion per year." [1]

The XCART technology platform was designed by its originators to utilize an established screening technique to identify peptide ligands that bind specifically to the unique B-cell receptor ("BCR") on the surface of an individual patient’s malignant tumor cells. The peptide is then inserted into the antigen-binding domain of a CAR, and a subsequent transduction/transfection process is used to engineer the patient’s T cells into a CAR T format which redirects the patient’s T cells to attack the tumor. Essentially, the XCART screening platform is the inverse of a typical CAR T screening protocol wherein libraries of highly specific antibody domains are screened against a given target. In the case of XCART screening, the target is itself an antibody domain, and hence highly specific by its nature. The XCART technology creates the possibility of personalized treatment of lymphomas utilizing a CAR with an antigen-binding domain that should only recognize, and only be recognized by, the unique BCR of a particular patient’s B-cell lymphoma.

An expected result for XCART is limited off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

Under the terms of the acquisition, Xenetic acquired all outstanding shares of Hesperix S.A., a newly-formed Swiss entity to which all XCART owners and inventors other than Scripps have assigned their rights to XCART, and exclusively licensed Scripps’ rights in the technology, in exchange for an aggregate 625,000 shares of Xenetic common stock.

Maxim Group LLC served as the strategic advisor to Xenetic and provided a fairness opinion to the special committee of the Board of Directors of Xenetic in connection with the acquisition.

About the Offering

Under the terms of the underwriting agreement, Xenetic sold 2,300,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and also issued warrants to purchase up to an aggregate of 2,300,000 shares of the Company’s common stock. Each share of common stock was sold together with one warrant to purchase one share of common stock at a combined price to the public of $6.50 per share and warrant. The gross proceeds to Xenetic from the underwritten public offering were approximately $15.0 million before deducting underwriting fees and other offering expenses.

Xenetic also has granted to the underwriter a 45-day option to purchase up to an additional 345,000 shares of common stock and/or warrants to purchase up to 345,000 shares of common stock, at the public offering price less discounts and commissions. On July 19, 2019, the underwriter exercised its overallotment option with respect to 160,000 warrants resulting in additional proceeds of $1,600.

The warrants are immediately exercisable at a price of $13.00 per share of common stock and will expire five years from the date of issuance. The warrants are expected to begin trading on the Nasdaq Capital Market on July 19, 2019 or as soon thereafter as practicable, under the symbol "XBIOW." The warrants also provide that if the weighted-average price of common stock on any trading day on or after 30 days after issuance is lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one share of common stock.

Maxim Group LLC acted as sole book-running manager in connection with the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus relating to the shares of common stock, pre-funded warrants and warrants was filed by Xenetic Biosciences, Inc. with the SEC. Copies of the prospectus relating to the underwritten offering can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

On July 22, 2019 Genmab A/S (CSE: GEN, Nasdaq: GMAB) reported the closing of its initial public offering of American Depositary Shares ("ADSs") in the United States (the "Offering") and the increase of its share capital by 2,850,000 ordinary shares as a consequence of the issuance of 2,850,000 ordinary shares (the "New Shares") with a nominal value of DKK 1 per share in the form of 28,500,000 ADSs in the Offering (Press release, Genmab, JUL 22, 2019, View Source [SID1234537646]). The subscription price of DKK 1,181.80 per New Share equals the public offering price of $17.75 per ADS at the U.S. dollar/DKK exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one, and the gross total proceeds from the issuance of the New Shares amounts to US$505,875,000 (DKK 3,368.1 million).

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As previously announced, on July 18, 2019, BofA Merrill Lynch, Morgan Stanley and Jefferies, as representatives of the several underwriters, notified Genmab of the underwriters’ exercise in full of their option to purchase up to an additional 4,275,000 additional ADSs, representing 427,500 ordinary shares (the "Option Shares"), to cover any over-allotments (the "Option") at the price of $17.75 per ADS, corresponding to a subscription price of DKK 1,181.80 per Option Share at the U.S. dollar/DKK exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one. The Option is expected to close on July 23, 2019.

Following the registration of the New Shares today with the Danish Business Authority, Genmab’s share capital amounts to DKK 64,540,143 divided into 64,540,143 ordinary shares with a nominal value of DKK 1 each and following the registration of the Option Shares on July 23, 2019 (or early thereafter), Genmab’s share capital will amount to DKK 64,967,643 divided into 64,967,643 ordinary shares with a nominal value of DKK 1 each. The New Shares account for 4.4% of Genmab’s total share capital and after the closing of the Option, the New Shares and the Option Shares together will account for 5.0% of Genmab’s total share capital.

The New Shares and the Option Shares rank pari passu with Genmab’s existing shares and carry the same dividend and other rights. Each New Share and Option Share carries one vote at Genmab’s general meetings. Genmab only has one class of shares. The ADSs do not carry the same rights as Genmab’s ordinary shares and are not entitled to receive a dividend or vote as ordinary shares, except to the extent provided for through the depositary as record holder of the ordinary shares underlying the ADSs as set forth in the deposit agreement governing the ADSs.

Genmab’s ordinary shares are currently listed on Nasdaq Copenhagen under the symbol "GEN" and the ADSs are listed on the Nasdaq Global Select Market under the symbol "GMAB." We have requested that Nasdaq Copenhagen change the symbol for our ordinary shares from "GEN" to "GMAB" to become effective in connection with the admission to trading of the New Shares on Nasdaq Copenhagen, expected to occur on July 23, 2019. The New Shares have been issued today and are expected to be admitted to trading and official listing on Nasdaq Copenhagen on July 23, 2019 with the permanent ISIN code DK0010272202.

The amendments to Genmab’s articles of association as a consequence of the registration of the New Shares have been registered today with the Danish Business Authority and have been published on Genmab’s website.

The registration statement on Form F-1 relating to the Offering was declared effective by the U.S. Securities and Exchange Commission on July 17, 2019.

BofA Merrill Lynch, Morgan Stanley and Jefferies acted as joint book-running managers for the Offering. Guggenheim Securities and RBC Capital Markets acted as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen acted as co-managers for the Offering. A copy of the final prospectus relating to the Offering may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the final prospectus related to the Offering are also available at www.sec.gov. No Danish prospectus was issued or offered.

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

On July 22, 2019 Cerus Corporation (Nasdaq:CERS) reported that its second quarter 2019 results will be released on Thursday, August 1, 2019, after the close of the stock market (Press release, Cerus, JUL 22, 2019, View Source [SID1234537645]). The company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2898719. The replay will be available approximately three hours after the call through August 15, 2019.

On July 22, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that it is partnering with the VA Maryland Health Care System’s Baltimore VA Medical Center and the Baltimore Research and Education Foundation, a non-profit affiliate, in its ongoing prostate cancer Cchek study (Press release, Anixa Biosciences, JUL 22, 2019, View Source [SID1234537644]). Led by Dr. Minhaj Siddiqui, chief of Urology at the VA Maryland Health Care System and Associate Professor and Director of Urologic Oncology and Robotic Surgery at the University of Maryland School of Medicine, study enrollment is expected to begin in August of this year and will include men who are at risk for prostate cancer in a yearlong study that seeks to advance the Check liquid biopsy for prostate cancer.

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"We are pleased to be working with Dr. Siddiqui and the VA Maryland Health Care System as we continue development of our artificial intelligence based prostate cancer liquid biopsy," stated Dr. Amit Kumar, President and CEO of Anixa.