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Autolus Announces Proposed Public Offering in the United States

On April 8, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it intends to offer and sell 4,000,000 American Depositary Shares ("ADSs") representing 4,000,000 ordinary shares in an underwritten public offering in the United States (Press release, Autolus, APR 8, 2019, View Source [SID1234535077]). All ADSs to be sold in the proposed offering will be offered by Autolus. Autolus also intends to grant the underwriters a 30-day option to purchase up to an additional 600,000 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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Goldman Sachs & Co. LLC and Jefferies LLC are acting as joint book-running managers for the offering. Wells Fargo Securities, LLC and William Blair & Company, L.L.C. are acting as lead managers.

The proposed offering will be made only by means of a prospectus. A copy of the preliminary prospectus related to the offering can be obtained from either of the joint book-running managers for the offering, Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at +1 866 471 2526 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 Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant EU member state) and will not have been reviewed by any competent authority in any EU member state.

A registration statement on Form F-1 relating to the public offering of the ADSs described above has been filed with the U.S. Securities and Exchange Commission (the "SEC") but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. 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.

Actinium’s Leading Clinical, Preclinical, Production and IP Efforts Related to Actinium-225 Highlighted at Preeminent Targeted Alpha Therapy International Symposium

On April 8, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) reported highlighted its broad presence at the 11th Targeted-Alpha-Therapy International Symposium (TAT) that was held on April 1 – 4, 2019 in Ottawa, Canada (Press release, Actinium Pharmaceuticals, APR 8, 2019, View Source [SID1234535076]). Two oral and four poster presentations related to Actinium’s AWE or Antibody Warhead Enabling technology platform and clinical programs were featured at the symposium while Actinium’s Chief Scientific Officer, Dr. Dale Ludwig, participated in a panel titled, "The Renaissance of Radio Pharmaceuticals – A Commercial Perspective". Actinium has extensive experience with targeted alpha therapy including clinical data in over 100 patients from four clinical trials and extensive intellectual property, know-how and trade secrets related to Ac-225 or Actinium-225 applications and manufacturing.

Actinium utilizes Ac-225, a potent alpha-particle emitting isotope, for generating ARCs or Antibody Radiation Conjugates used in several clinical trials including its pivotal Actimab-MDS program and combination trials of Actimab-A with venetoclax. In addition, Ac-225 is an important radionuclide warhead used in Actinium’s AWE technology platform that is being utilized in an ongoing collaboration research partnership with Astellas Pharma, Inc.

In the poster presentation at TAT, Actinium highlighted several studies that evaluated the feasibility of accelerator produced Ac-225 in comparison to "thorium cow" generator produced Ac-225 that is used most commonly today. Studies demonstrated that labeling efficiency for the anti-CD33 monoclonal antibody lintuzumab was comparable between accelerator and generator produced Ac-225. Further, radiochemical purity was determined to be comparable, at 98.5% for accelerator produced material and 98.7% for generator produced material. In addition to radiochemical purity, accelerator produced Ac-225 demonstrated comparable immunoreactivity, a critical quality attribute, to that of generator produced Ac-225. Finally, comparable levels of anti-leukemic cell killing were observed irrespective of the Ac-225 source. Actinium has filed intellectual property related to the utilization of Ac-225 produced by an accelerator, which is in addition to granted patents related to the production of Ac-225 in a cyclotron.

Research commissioned by Actinium to evaluate the biodistribution of accelerator produced Ac-225 was presented in a separate poster presentation. The results of these studies using pharmacokinetic models determined that accelerator produced Ac-225 labeled to lintuzumab had a negligible impact in the context of therapy compared to generator produced Ac-225. In addition, an oral presentation highlighted Ac-225 labeled daratumumab, a CD38 antibody blockbuster therapy for patients with multiple myeloma that is marketed by Johnson & Johnson as Darzalex. The studies featured in the oral presentation observed enhanced potency, cell killing and tumor control with Ac-225 labeled daratumumab compared to naked daratumumab alone.

Dr. Dale Ludwig, Actinium’s Chief Scientific Officer, said, "It was exciting to have such broad representation of Actinium’s alpha therapy efforts at TAT, as it is the leading conference for alpha particle-based therapies. Leveraging our AWE platform, we have significantly increased our research and development efforts and have worked to rapidly translate this work into the clinic as we have done with our combination trials with venetoclax and targeted Ac-225. As we look to the future, we are delighted to have the opportunity to work with next-generation Ac-225 from the DOE and demonstrate its feasibility for ARC applications. We plan to continue advancing the field of Ac-225 research and clinical development in several strategic areas including next-generation ARC’s and combinations with other therapeutic modalities while continuing to expand our intellectual property estate in these applications."

Actinium recently announced that its patent portfolio now consists of 111 issued and pending patents in the U.S. and internationally, contained within 28 patent families, that cover key areas of Actinium’s business including ARC generation, composition of matter, formulations, methods of administration for solid and liquid cancers and radionuclide production including the manufacturing of Ac-225.

Sandesh Seth, Actinium’s Chairman and CEO, said, "Our broad presence at this year’s TAT is emblematic of Actinium’s commitment to leading the field of Actinium-225 based targeted alpha therapy. Recognizing the potential of alpha therapies, we strategically apply our research and development activities around our AWE technology platform and clinical development capabilities to advance novel ARC’s for indications with unmet needs. Leveraging our extensive clinical experience with Ac-225, we are excited to have crafted an ARC pipeline encompassing targeted conditioning, combinations and targeted therapeutics across multiple patient populations. As a result, we are addressing a large cumulative patient population that we see as unmatched by other therapies. With our strong and growing IP portfolio, enhanced capabilities and integrated research and development capabilities I am confident in our ability to continue to build our leadership position in Ac-225 based therapies."

IMMUNOMEDICS ANNOUNCES PROMOTION AGREEMENT WITH JANSSEN FOR ERDAFITINIB IN THE U.S

On April 8, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that it has entered into a promotion agreement in which Immunomedics will provide detailing services to Janssen Biotech Inc. (Janssen), for erdafitinib in the U.S (Press release, Immunomedics, APR 8, 2019, View Source [SID1234535071]).

"We are delighted to be collaborating with Janssen and we look forward to working closely with the Janssen team to help promote erdafitinib," said Brendan Delaney, Chief Commercial Officer of Immunomedics. "We have built strong commercial capabilities at Immunomedics and this agreement allows us to leverage our experienced oncology sales force to educate the U.S. market on this potential new treatment option for patients with metastatic urothelial cancer upon FDA approval."

Under the terms of the agreement, Immunomedics’ sales team will provide product detailing from the launch of erdafitinib until the end of the First Quarter 2020, but only requires Immunomedics to support the product in first position detail until the FDA approval of sacituzumab govitecan. Immunomedics is eligible to receive low double digit royalties and milestone payments based on U.S. sales throughout 2019 and 2020, subject to sales thresholds in each year, respectively.

A New Drug Application (NDA) for erdafitinib is currently under review by the U.S. Food and Drug Administration for the treatment of patients with locally advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational, once-daily, pan-FGFR kinase inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018

Forbius to Present at the 18th Annual Needham Healthcare Conference

On April 8, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that Ilia Tikhomirov, CEO of Forbius, will be presenting at the 18th Annual Needham Healthcare Conference (Press release, Forbius, APR 8, 2019, View Source [SID1234535070]).

Mr. Tikhomirov’s presentation will take place Tuesday, April 9th at 1:30 PM EST in Track 1, 3rd floor, at the Westin Grand Central Hotel in New York.

Conclusion of Exclusive Licensing and Capital Tie-up Agreements Concerning “Telomelysin (OBP-301),” Oncolytic Viral Immunotherapy

On April 8, 2019 Oncolys BioPharma Inc. (hereafter, "Oncolys") and Chugai Pharmaceutical Co., Ltd. (hereafter, "Chugai") reported the both companies have entered into an agreement that Oncolys will grant an exclusive license, with sublicensing rights, to Chugai concerning the development, manufacturing and marketing in Japan and Taiwan for "Telomelysin (OBP-301)" (hereafter, "Telomelysin") an oncolytic viral immunotherapy which is currently under development by Oncolys (Press release, Chugai, APR 8, 2019, View Source [SID1234535069]). In addition, licensing agreement that grants exclusive option rights concerning the worldwide development, manufacturing and marketing of Telomelysin, excluding Japan, Taiwan, China, Hong Kong and Macau to Chugai has also been concluded. Moreover, both companies agreed that Oncolys will newly issue common stock worth approximately 800 million yen, and Chugai will accept all the stocks. The start of this licensing agreement and the payment accompanying the issuance of new shares by third-party allotment are planned on April 24, 2019.

Chugai shall pay 550 million yen as an upfront payment for the exclusive licensing agreement, with sublicensing rights, in Japan and Taiwan. If a certain level of efficacy has been confirmed in the clinical study of Telomelysin, and in case Chugai exercised the exclusive option rights described above, the total value of the licensing agreement which Chugai shall pay to Oncolys will be 50 billion yen or more. In addition, after the launch of Telomelysin, Chugai shall pay to Oncolys, sales royalties according to Chugai’s amount of sales of Telomelysin, apart from the total value of the licensing agreement.

The capital and business tie-up agreement described in this release is announced separately by Oncolys on April 8, 2019, in the "Notice of Capital and Business Alliance and Issuance of New Shares through Third Party Allotment."

Comments by the Management
Yasuo Urata, President & CEO, Oncolys BioPharma Inc.
"Chugai is an expert in the development of oncology drugs including antibody pharmaceuticals, and we feel that we were able to form the best partnering in developing Telomelysin, an oncolytic viral immunotherapy. Telomelysin is an oncolytic virus drug originated in Japan, and we are extremely delighted that Chugai had highly valued the clinical effects of the drug against esophageal cancer. We hope that Chugai will greatly expand the indications of Telomelysin, going forward."

Tatsuro Kosaka, President and CEO, Chugai Pharmaceutical Co., Ltd.
"Telomelysin is an oncolytic viral immunotherapy with a novel mode of action, expected to provide new value to oncology patients. We are committed to maximize the value of this new innovative drug created by Oncolys in order to deliver it to patients as quickly as possible, and also expand its indications to other types of cancer, by considering the combination with cancer immunotherapies, which could provide true value to patients and their families. We strongly believe that Chugai, as one of the shareholders of Oncolys, can contribute to increasing corporate and shareholder values of Oncolys in the medium- to long-term perspective."

Oncolys believes that the conclusion of this licensing agreement and the third-party allocation of shares will contribute to enhancing its corporate value as well as shareholder value. At this point, however, the concrete amount of impact they would have on Oncolys’ business performance of the term ending December 2019 is unclear. The impact on the consolidated financials for the fiscal year ending December 2019 of Chugai is expected to be minimal.
As written in the financial statements for the business term ended December 2018, released on February 8, 2019, Oncolys has not announced its business performance forecasts for the term ending December 2019, since the company views it difficult to calculate appropriate and reasonable numerical value due to the existence of numerous uncertain factors that impact the business performance at this point.