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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

On April 8, 2019 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its first quarter 2019 financial and operating results on Tuesday, May 7, 2019, before the U.S. financial markets open (Press release, Regeneron, APR 8, 2019, https://www.prnewswire.com/news-releases/regeneron-to-report-first-quarter-2019-financial-and-operating-results-and-host-conference-call-and-webcast-on-may-7-2019-300826362.html [SID1234535060]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call Information
To access this call, dial (800) 708-4539 (U.S.) or (847) 619-6396 (International). A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On April 8, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported an update on recent pipeline and regulatory progress during a Key Opinion Leader (KOL) Symposium focused on the potential of TAVO (IL-12 / tavokinogene telseplasmid) on Friday, April 5, 2019 in New York City (Press release, OncoSec Medical, APR 8, 2019, View Source [SID1234535045]). The KOL Symposium featured presentations from Adil Daud, M.D. and H. Kim Lyerly, M.D.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Daud is the lead U.S. investigator for KEYNOTE-695, Clinical Professor of Medicine and Dermatology at University of California, San Francisco (UCSF), and Director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center. Dr. Lyerly is the George Barth Geller Professor for Research in Cancer at Duke University Medical Center and Director of the Duke Comprehensive Cancer Center. Both Dr. Daud and Dr. Lyerly have worked extensively with IL-12 for the past 20 years. Each presentation provided key insights on the importance of IL-12. Dr. Daud also provided his observations regarding TAVO’s two ongoing KEYNOTE clinical trials and Dr. Lyerly highlighted his upcoming work combining TAVO with HER2 in breast cancers.

Discussing KEYNOTE-695, Dr. Daud noted the following:

A key differentiating factor with KEYNOTE-695 relative to other studies which have published data regarding checkpoint non-responder is that KEYNOTE-695 is enrolling only those patients who have definitively progressed on anti-PD-1 therapy by RECIST v1.1. The expected response rate to anti-PD-1 therapy in the KEYNOTE-695 patient population is approximately 6% and therefore the responses having been observed thus far on the study are encouraging. Dr. Daud commented, "There are checkpoint non-responders and then there are other checkpoint non-responders and I just want to highlight the rigor of the patients that are being enrolled here [in KEYNOTE-695]. We are talking about patients who have had RECIST progression on PD-1 treatment and then go on our trial where they have PD-1 plus TAVO, and then have a RECIST response, so it’s just a different kind of population."
Responding patients on KEYNOTE-695 had extensive progressive disease prior to TAVO+ KEYTRUDA treatment and responses have been observed in both treated and untreated lesions. The duration of response is consistent with an immunologic response. Dr. Daud stated, "So what we’ve seen so far and what’s been publicly disclosed has been pretty encouraging. … These are patients with extensive progressive disease and we’ve seen responses both in treated and in untreated lesions on them. And the duration of response is consistent with an immunologic response, not an ablative response to treatments."
TAVO’S safety profile continues to be encouraging and there are no apparent systemic side effects. Dr. Daud commented, "Our safety profile continues to be excellent. One of the impressive things about TAVO treatment is that, remember I told you that cytokine treatment is toxic and systemic cytokine treatment is pretty toxic. What is interesting about TAVO is that patients can have TAVO treatment and basically 30 minutes later go back to work. There isn’t any nausea, there are no systemic side effects to speak of. There can be some grade 1 lesion pain or lesion discomfort, some bleeding, some local redness and irritation, but that is pretty much it in terms of side effect profile. So you could imagine that it’s combinable."
KEYNOTE-695 is approximately 40% enrolled and on track to complete enrollment by year-end.
Dr. Daud also commented on KEYNOTE-890, OncoSec’s Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO in combination with Merck’s KEYTRUDA (pembrolizumab). Dr. Daud stated, "So just to give you a highlight on another trial that’s ongoing, that’s the KEYNOTE-890, which is a breast cancer trial combining TAVO plus KEYTRUDA, and patients with breast cancer. And again, these seem – without going too far into details about patients, so these are patients who have visceral disease, who have also had skin disease. And also have accessible treatable lesions. And we’ve just seen some amazing responses in this trial and will be presenting these as the year goes on."

Dr. Lyerly discussed the importance of IL-12 and OncoSec’s technology:

Dendritic cells are the critical cells necessary for transferring antigens and stimulating antigen specific T cells again, which is the basis for cancer immunotherapy. The key cytokine for activated and fully matured dendritic cells is IL-12 production. Systemic use of IL-12 generated systemic toxicities, which seemed to preclude its use, requiring a technical solution to exquisite delivery. OncoSec’s technology affords a potential solution to the problem of systemic use of IL-12.
A variety of IL-12 delivery mechanisms, including viruses and other strategies for direct gene transfer have been explored; however, OncoSec’s plasmid delivery system directs IL-12 expression to the tumor microenvironment which has advantages over these other mechanisms.
In his independent research, he has previously demonstrated the power of IL-12 as a therapeutic against breast cancer and could be foundational, even as primary treatment in early stages of cancer.
"Imagine if you will that if you had the opportunity to deliver IL-12, stimulate systemic antitumor immunity that would provide lifetime benefit to you," said Dr. Lyerly, "Would you not include that in your initial treatment regime? So rather than simply thinking about the treatment of end-stage cancers, we began to explore the potential of IL-12 delivery and really developing systemic antitumor immunity to prevent recurrences and attack these cancers and again this is ongoing work with one of the reasons we were excited about the potential for the OncoSec technical solution."

For a full transcript of the KOL Symposium, please visit www.oncosec.com. An archived replay of the webcast is available in the Investor Relations section of OncoSec’s website at ir.oncosec.com.

On April 8, 2019 PharmaMar (MSE:PHM) reported that attended the third bi-annual meeting on small cell lung cancer, organized by the International Association for the Study of Lung Cancer (IASLC) (Press release, PharmaMar, APR 8, 2019, View Source [SID1234535048]). During this meeting, Anna Farago M.D., Ph.D., coPrincipal Investigator of the ATLANTIS trial from Massachusetts General Hospital in Boston, presented the latest data from the ATLANTIS trial with Zepsyre (lurbinectedin) in combination with doxorubicin for the treatment of recurrent small cell lung cancer, in an oral presentation on Friday 5th April. This is a specialized meeting, which presents information on the clinical trials of the most promising therapies for the treatment of small cell lung cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ATLANTIS trial of lurbinectedin in combination with doxorubicin compared to topotecan or the combination CAV (cyclophosphamide, adriamycin and vincristine), randomized 1 to 1, recruited 613 patients in 160 centers in 20 countries, with Spain, Germany and the United States the countries with the highest number of patients recruited. The primary objective of the study is overall survival (OS).

Also for the treatment of second line small cell lung cancer, PharmaMar recently announced positive results for its monotherapy trial with lurbinectedin. The results of this study will be made public during an oral presentation at the next ASCO (Free ASCO Whitepaper) congress.

Legal warning

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.