On January 23, 2019 B-MoGen Biotechnologies, Inc. and CytoSen Therapeutics reported a research collaboration to develop the next generation of gene-modified Natural Killer Cell (NK) therapies (Press release, B-MoGen Biotechnologies, JAN 23, 2019, View Source [SID1234554014]). B-MoGen will utilize its expertise in genetic design and its patented non-viral gene delivery platform in conjunction with CytoSen’s nanoparticle expansion platform to improve efficacy and reduce cost of NK cell therapeutics.

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"We are very excited and look forward to teaming up with CytoSen to utilize our scientific expertise and engineering work with CARs and TCRs to help develop NK treatments in the human therapeutics space," said Jeff Liter, President and CEO of B-MoGen. "CytoSen’s innovation, science and pioneering technology is a perfect fit with B-MoGen’s genome engineering experience and technology."

CytoSen’s CEO Dr. Trent Carrier stated, "I am thrilled to see the leveraging of the combined technologies and scientific proficiency of CytoSen and B-MoGen to produce ever more effective NK cell therapeutics. These next generation enhanced NK cells will be put forth in the fight against cancers with the highest unmet medical need."

Both companies are experiencing rapid growth by providing cutting edge science and technical know-how to help create life changing human disease therapies. This partnership looks to enable the creation and delivery of new NK cell therapies for cancer patients.

On January 23, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported receipt of notification from the U.S. Food and Drug Administration (FDA) that the Company’s ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV) has been placed on partial clinical hold (Press release, Advaxis, JAN 23, 2019, View Source [SID1234532835]). The FDA’s recent communication, received late last week, states that the partial hold is related to their requests for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters. The Agency did not cite any safety issues related to the trial and all currently enrolled patients will continue to receive treatment, per the trial protocol. However, no new patients can enroll in AIM2CERV until resolution of this partial hold.

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"FDA’s review of the AXAL Investigational New Drug (IND) application was prompted by our proposal to modify the AIM2CERV trial’s analysis plan to include, among other things, allowance for a second formal interim analysis for both safety and efficacy," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "The primary focus of the items raised by the Agency relates to providing additional clarifying details for CMC information previously provided in support of Phase 3 development and which will help support a future Biologics License Application. We have already begun efforts to address the Agency’s requests for information and are working to respond as promptly as we can." He concluded, "Our AXAL product has demonstrated a manageable safety profile in the over 400 patients we have dosed to date and we look forward to enrolling new patients in our AIM2CERV trial after FDA agrees that the information we submit is responsive to its requests."

On January 23, 2019 On January 23, 2019, Rexahn Pharmaceuticals, Inc. (the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Oppenheimer & Co. Inc. (the "Representative"), as representative of the underwriters, in connection with its previously announced public offering (the "Offering") of 10,750,000 shares (the "Shares") of the Company’s common stock, $0.0001 par value per share (the "Common Stock") and warrants (the "Warrants") to purchase up to an aggregate of 10,750,000 shares of Common Stock (the "Warrant Shares") (Filing, 8-K, Rexahn, JAN 23, 2019, View Source [SID1234532907]). The Shares and the Warrants were sold together as a fixed combination, with each Share being accompanied by a Warrant to purchase one share of Common Stock at a combined price to the public of $0.80. The Warrants are exercisable commencing on the date of issuance, will expire on January 25, 2024 and will have an exercise price of $0.80 per share, subject to certain adjustments. The warrants will be issued in physical form.

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The Offering was made pursuant to a Registration Statement (No. 333-218285) on Form S-3, which was originally filed by the Company with the Securities and Exchange Commission on May 26, 2017 and subsequently amended on June 23, 2017 and July 6, 2017, and declared effective on July 11, 2017.

The Offering closed on January 25, 2019 and the Company received net proceeds of approximately $7.6 million after deducting underwriting discounts and commissions and estimated expenses payable by the Company associated with the offering. The Company intends to use the net proceeds of the Offering for further development of its lead clinical programs, including the funding of its clinical development programs for RX-3117 and RX-5902, and for working capital and general corporate purposes.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

On January 23, 2019 Philogen S.p.A. (a privately-owned company) reported that they have entered into a collaboration and license agreement with Celgene, to discover and develop a new class of immunomodulatory therapeutics (Press release, Philogen, JAN 23, 2019, View Source [SID1234532836]).

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"We are extremely pleased to establish a new collaboration with Celgene, a leader in the discovery and development and commercialization of innovative therapies for patients with high unmet medical needs," commented Dr. Duccio Neri, Philogen’s CEO.

On January 23, 2019 PTC Therapeutics, Inc. (Nasdaq: PTCT) reported the pricing of a public offering of 6,720,000 shares of its common stock at a public offering price of $30.20 per share, before underwriting discounts (Press release, PTC Therapeutics, JAN 23, 2019, View Source [SID1234532837]). All of the shares in the offering are to be sold by PTC. In addition, PTC has granted the underwriter an option for a period of 30 days to purchase up to an additional 1,008,000 shares of common stock at the public offering price, less the underwriting discount.

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RBC Capital Markets is acting as the sole book-running manager for the offering.

PTC expects to close the offering on or about January 25, 2019, subject to satisfaction of customary closing conditions.

An automatically effective shelf registration statement on Form S-3 relating to the shares of common stock offered in the public offering has been filed with the Securities and Exchange Commission (the "SEC") and is available on the SEC’s website at www.sec.gov. A final prospectus supplement relating to and describing the terms of the offering also will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents PTC has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more complete information about PTC and the offering. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281; telephone: (877) 822-4089; email: [email protected].

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 the registration or qualification under the securities laws of such state or jurisdiction.