On January 22, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has commenced an offering of up to 7,250,000 American Depositary Shares ("ADSs") representing 7,250,000 ordinary shares in an underwritten public offering in the United States. All ADSs to be sold in the proposed offering will be offered by Autolus (Press release, Autolus, JAN 22, 2020, View Source [SID1234553524]). Autolus also intends to grant the underwriters a 30-day option to purchase up to an additional 1,087,500 ADSs at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

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J.P. Morgan Securities LLC and Jefferies LLC are acting as joint book-running managers for the offering. William Blair & Company, L.L.C. is acting as lead manager. H.C. Wainwright & Co., LLC is acting as co-manager.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained for free from either of the joint book-running managers for the offering, J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at +1 866 803 9204 or by email at [email protected]; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at [email protected]. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of Regulation (EU) 2017/1129 and will not have been reviewed by any competent authority in any member state in the European Economic Area.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On January 22, 2020 Genprex Inc (NASDAQ:GNPX) reported that the US Food and Drug Administration has granted Fast Track Designation for its Oncoprex immunogene therapy to treat lung cancer (Press release, Genprex, JAN 22, 2020, View Source [SID1234553519]).

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Investors cheered the news, pushing the company’s stock up by 276% to $1.35 a share in recent morning trading in New York.

The FDA gave its approval to the therapy combination with EGFR inhibitor osimertinib — AstraZeneca PLC’s (NYSE:AZN) Tagrisso. The drug had worldwide sales in 2018 of $1.86 billion, $2.31 billion in the first nine months of 2019 and is currently AstraZeneca’s highest grossing product for the treatment of non-small cell lung cancer (NSCLC) patients with EFGR mutations that progressed after treatment with osimertinib alone.

Oncoprex is comprised of the TUSC2 (Tumor Suppressor Candidate 2) gene complexed with a lipid nanoparticle. TUSC2 is the active agent in Oncoprex.

Genprex said it has treated more than 50 lung cancer patients with Oncoprex in Phase I and II clinical trials. The company believes the data from these trials are encouraging as to both safety and efficacy.

"Genprex is excited to receive this important FDA designation," said Genprex CEO Rodney Varner.

On January 22, 2020 Hansa Biopharma reported that it will publish its Year-End report 2019 at 8:00 a.m. CET on February 6, 2020 (Press release, Hansa Biopharma, JAN 22, 2020, https://www.prnewswire.com/news-releases/hansa-biopharma-to-host-conference-call-to-provide-year-end-report-2019-and-business-update-300990986.html [SID1234553428]). All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 2:00 p.m. CET. The event will be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota, and the presentation will be held in English.

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Slides used in the presentation will be live on the company website during the call under "Events & Webcast," and will also be made available online after the call.

On January 22, 2020 INHIBITOR Therapeutics, Inc. (OTCQB: INTI), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to inhibit progression of cancerous and non-cancerous proliferation disorders, reported that the company has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate an IND-opening clinical study as a two-part, multi-center, randomized, double-blind, placebo-controlled, Phase 2b clinical trial that will evaluate the efficacy and safety of SUBA-Itraconazole capsules dosed in combination with docetaxel and prednisone in patients with metastatic castrate resistant prostate cancer (mCRPC) (Press release, Inhibitor Therapeutics, JAN 22, 2020, View Source [SID1234553427]).

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The Phase 2b trial is named PREDICT (Prostate Response Evaluating Docetaxel Itraconazole Combination Therapy). The PREDICT trial is expected to be carried out across approximately 35 sites in six countries in North America, Western Europe and Eastern Europe.

Approximately 23,000 men in the U.S. are diagnosed each year with late-stage mCRPC that no longer responds well to androgen deprivation therapy (ADT) or previous treatment with chemotherapy or newer stand-alone anti-androgen therapies such as abiraterone, enzalutamide or apalutamide. SUBA-Itraconazole will be tested to determine its potential to address an unmet need in these patients, who exhibit disease progression or who have discontinued the other therapies due to toxicity or other reasons.

Nicholas J. Virca, INHIBITOR’s President and CEO, said: "Following a face-to-face End-of-Phase-2 meeting with FDA last October and our submission of an IND application thereafter, I am pleased to announce that we have received IND clearance for our PREDICT trial. FDA confirmed that we can follow the 505(b)(2) regulatory pathway and, assuming positive results demonstrating an improvement in radiographic progression-free survival (rPFS) as our primary endpoint, also indicated that the general design and planned analysis of our study would adequately address the objectives necessary to support an eventual New Drug Application (NDA) submission for this indication. FDA also indicated that the final analysis of the key secondary endpoint of overall survival (OS) can occur following submission of the NDA for approval in the United States."

Mr. Virca continued: "I would once again like to acknowledge the efforts of our regulatory and clinical team members during 2019 to achieve this level of progress for our SUBA-Itraconazole Prostate program. We look forward to further updating our shareholders as we take subsequent steps to move this program into the clinic."

About Itraconazole in Prostate Cancer

In late-stage prostate cancer, up-regulation of the Hedgehog pathway in cells results in oncogene expression, which can interfere with the binding of ADT drugs to the androgen receptor (AR), causing biochemical resistance leading to mCRPC. Itraconazole acts on the essential Hedgehog signaling pathway component called smoothened (SMO) in human cells in a different manner than the FDA-approved drug vismodegib by preventing the ciliary accumulation of SMO normally caused by the Hedgehog pathway. Itraconazole also has a much shorter half-life than vismodegib, which may be the reason it appears to have fewer side effects than what has been reported for vismodegib in recent publications regarding its use in treating basal cell carcinoma. Thus, INHIBITOR believes that itraconazole may be more suitable than vismodegib for use in combination with chemotherapy due to its lower toxicity profile. Itraconazole has been tested as a treatment for mCRPC in a multi-institutional Phase 2 trial led by a prominent U.S. university and published in 2013. This trial showed that 90% of men with prostate specific antigen (PSA)-doubling times of less than 6 months, who achieved therapeutic levels of itraconazole, showed promising PSA reductions that correlated significantly with rPFS. INHIBITOR also believes that the improved bioavailability of SUBA-Itraconazole may provide additional benefits to prostate cancer patients in two ways: 1) by achieving higher therapeutic levels of itraconazole at lower doses than those reported in the 2013 Phase 2 study, which used the generic formulation of the drug, and 2) by reducing the dose of chemotherapy based on enhanced uptake of docetaxel in the presence of itraconazole.

No assurances can be given, however, that the clinical study referenced herein will be found by FDA to be sufficient for an NDA filing or, even if the NDA is accepted for filing, that the NDA will ultimately be approved by FDA.

On January 22, 2020 CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), reported that the company’s Board of Directors has promoted Burke T. Barrett to the position of Chief Executive Officer (CEO), effective January 19, 2020 (Press release, CardioFocus, JAN 22, 2020, View Source [SID1234553426]). Mr. Barrett previously served as CardioFocus’ President and Chief Operating Officer (COO).

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"The Board of Directors are proud to announce Burke’s promotion to CEO," said Paul LaViolette, Executive Chairman of CardioFocus. "From the outset, Burke has played an integral role in the development of the HeartLight platform as well as CardioFocus as a company. He is intimately familiar with our technology, employees, investors, customers, regulators, vendors and distributors, and is the perfect person to lead the company as we introduce the breakthrough HeartLight X3 System to the global AFib market."

"I am as excited as ever about the future of CardioFocus given the impressive clinical and commercial results coming out of Europe with our HeartLight X3 System," said Mr. Barrett. "We are pleased to showcase the System at the 25th Annual International AF Symposium being held in Washington D.C. this week and plan to provide an update about the regulatory path and timeline for introduction of the System into the U.S. market in the coming weeks."

Mr. Barrett has over 30 years of experience in the medical device industry. He joined CardioFocus in 2002, and during his more than 15 years with the company has held roles of increasing responsibility from Vice President through to President and COO. Prior to joining CardioFocus, Mr. Barrett was Vice President of Clinical Operations at Cyberkinetics Neurotechnology Systems, Inc., a public medical device company that achieved first-in-man success in novel, implantable brain-computer interfaces. He also served at Cyberonics as the Vice President, Business and Technology Development. Previously, Mr. Barrett held positions in business development, clinical & regulatory affairs, and quality auditing at Biofield Corporation, Dornier Medical Systems, and Bausch & Lomb. Mr. Barrett is a co-inventor on numerous issued and pending patent applications. From 2010-2013 he served as the industry representative on the Food and Drug Administration’s (FDA) Circulatory Systems Device Advisory Panel. He received bachelor’s degrees in chemical engineering and chemistry from Syracuse University and a Master of Business Administration from Kennesaw University in Atlanta.