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Kymab appoints Simon Sturge as Chief Executive Officer

On April 8, 2019 Kymab, a clinical-stage biopharmaceutical company developing antibody-based therapeutics, reported the appointment of Simon Sturge as its new CEO, effective May 1, 2019 (Press release, Kymab, APR 8, 2019, View Source [SID1234537017]). Simon succeeds David Chiswell, who remains a scientific adviser to the Company.

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"We are delighted that such an experienced leader as Simon will lead Kymab to its next stage of growth," said Martin Nicklasson, Non-Executive Chair. "Led by Simon, Kymab will continue to progress its innovative portfolio of products through the clinic and to market, driving our strategy to transform patients’ lives. This appointment is part of Kymab’s strategy to position itself for long-term success, building on the incredibly strong R&D foundation of the Company. We’d also like to thank David for many years of leadership at Kymab as CEO and previously as Chair – his leadership has been instrumental to the Company’s evolution."

Mr. Sturge brings to Kymab over 30 years of international leadership experience in both the biotechnology and pharmaceutical industry. He joins Kymab from Merck KGaA, where he was Executive Vice President Global Strategy, Business Development & Global Operations. Previously, he was Chief Operating Officer of Merck Healthcare, responsible for company’s global commercial and manufacturing operations. Over the past five years, he has been responsible for the continued growth in global sales at Merck KGaA, as well as the commercial launches of BAVENCIO (anti-PD-L1 avelumab) in solid tumours and MAVENCLAD (cladribine) for relapsing multiple sclerosis. Prior to joining Merck KGaA, Mr. Sturge served as Corporate Senior Vice President, Biopharmaceuticals at Boehringer Ingelheim, where he had responsibility for the research, development and commercialisation of the company’s global biosimilar portfolio. Before that, he held CEO roles at a number of healthcare companies including Celltech Biologics, and he served as founder and CEO of Ribotargets, which was acquired by British Biotech and subsequently renamed Vernalis.

"I am excited to have this opportunity to head Kymab at such a transformative time in its development," said Simon Sturge. "With its competitive antibody research platforms and evolving clinical pipeline, Kymab is well positioned as it progresses into an integrated discovery and development company."

"It has been rewarding to guide Kymab through a period of significant growth. Kymab is now a recognized leader in the antibody space, with an extensive pipeline and two lead candidates in the clinic," said Dave Chiswell, former CEO of Kymab. "I have known Simon for some years and I am pleased to hand over the reins to him. Simon is highly experienced and well positioned to lead Kymab and its exceptional staff, pipeline and partnerships, as it continues to discover and develop transformative antibody therapies for patients in need."

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.

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.