On May 26, 2020 Stand Up To Cancer research reported A recent FDA approval provides a new treatment option for patients with an aggressive form of prostate cancer (Press release, SU2C, MAY 26, 2020, View Source [SID1234558462]). The drug, called olaparib, is a precision therapy that targets certain molecular qualities of advanced prostate cancer in patients with genetic mutations that often lead to aggressive cancers, including BRCA1 and BRCA2.

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A collaborative ‘Dream Team’ of scientists funded by Stand Up To Cancer and the Prostate Cancer Foundation contributed to the research that led to the approval of olaparib for advanced prostate cancer.

"I’m delighted that the Dream Team’s work has led to a therapy that will impact patients with aggressive forms of prostate cancer," said Arul Chinnaiyan, MD, PhD Dream Team leader and professor of Pathology and Urology at the University of Michigan. "Our research was the first to demonstrate that over 20% of patients with metastatic prostate cancer have mutations in genes such as BRCA1 or BRCA2 and that over 10% of these mutations are inherited, which led to the clinical trials that tested olaparib as a potential treatment for these patients."

Prostate cancer is the second most common cancer in American men, following skin cancer. Furthermore, black men are at increased risk of a prostate cancer diagnosis, and significantly greater risk of dying from prostate cancer compared to whites. In 2020, close to 200,000 men will be diagnosed with new cases of prostate cancer, and about 33,000 men will die from the disease. A common therapy for prostate cancer lowers the levels of male hormones in the body with drugs or by removal of the testes. However, some men develop castration-resistant disease, meaning that the cancer is able to grow and continue to spread despite hormone therapy. As the cancer grows, it may also metastasize to parts of the body outside the prostate.

"New treatments are urgently needed for metastatic castration-resistant prostate cancer, which is particularly aggressive and difficult to treat," said SU2C Scientific Advisory Committee Vice-Chair William Nelson, MD, PhD, director of the Sidney Kimmel Comprehensive Cancer Research, Johns Hopkins University and a recognized expert in prostate cancer. "Stand Up To Cancer is proud to have contributed to the development of this targeted treatment option for people whose prostate cancer has progressed to this stage."

Uncovering the genetic and molecular characteristics of metastatic castration-resistant prostate cancer is key to finding novel treatments. The Dream Team analyzed DNA from metastatic castration-resistant prostate cancer samples gathered from eight clinical trials. In a study published in the journal Cell, the team showed that several genetic mutations, including BRCA1 and BRCA2, are prevalent in 23% of patients with metastatic castration-resistant prostate cancer.

"Prior to our research, certain genetic mutations such as BRCA1 were connected mainly to breast and ovarian cancer," said Chinnaiyan. "Our findings led us to question if drugs utilized for BRCA-positive breast and ovarian cancers – such as olaparib – could also be utilized for prostate cancer patients with the same genetic mutations, which launched an effort to test olaparib in clinical trials for men with prostate cancer."

Chinnaiyan and the Dream Team presented their initial findings at the annual SU2C Scientific Summit in 2015. Another Dream Team of SU2C scientists focused on women’s cancers immediately offered data from prior testing of drugs, including olaparib, that have been used successfully for women’s cancers with the same BRCA1 and BRCA2 mutations. "This type of collaboration is characteristic of SU2C," said Sung Poblete, PhD, RN, SU2C CEO. "Sharing this data saved the Prostate Cancer Dream Team nearly $500,000 and six months of work, allowing this compelling research to be accelerated to benefit patients faster."

Collaborating with colleagues testing olaparib in a clinical trial, the Dream Team analyzed each patient’s DNA for the genetic mutations they had identified in their previous studies. The trial results, published in the New England Journal of Medicine, revealed that metastatic castration-resistant prostate cancer patients with genetic mutations such as BRCA1 and BRCA2 often responded preferentially to olaparib. These results led to olaparib receiving a ‘Breakthrough Therapy Designation’ from the FDA, which laid the groundwork for the recent FDA approval of olaparib in metastatic prostate cancer.

Olaparib is a type of drug called a PARP inhibitor. PARP is a group of enzymes used by cells to repair damaged DNA. Olaparib suppresses PARP’s function, which inhibits DNA repair in cells with genetic DNA repair mutations such as BRCA1 or BRCA2. In many cases, this causes the cells with DNA repair mutations to die while sparing healthy cells.

The FDA approved olaparib for homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer on May 19, 2020.

The research that supported this FDA approval was funded in part by the SU2C−Prostate Cancer Foundation Prostate Dream Team: Precision Therapy of Advanced Prostate Cancer.

The Dream Team focused on women’s cancers that contributed drug testing data was the SU2C PI3K Dream Team: Targeting the PI3K Pathway in Women’s Cancers.

On May 26, 2020 Boston Scientific Corporation (NYSE: BSX) reported to participate in the Jefferies 2020 Virtual Healthcare Conference on June 2 (Press release, Boston Scientific, MAY 26, 2020, View Source [SID1234558461]).

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Joe Fitzgerald, executive vice president and president, Rhythm Management; Kenneth Stein, M.D., senior vice president and chief medical officer, Global Health Policy and Rhythm Management; Mark Bickel, vice president, controller, Rhythm Management; and Susie Lisa, vice president, Investor Relations will participate in a 25-minute question-and-answer session with the host analyst beginning at approximately 8 a.m. EDT.

A live webcast and replay of the webcast will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of the event.

On May 26, 2020 NantKwest, Inc. (NASDAQ: NK) and ImmunityBio, Inc., reported that Patrick Soon-Shiong, M.D., Chairman and CEO of both companies, will present at the Jefferies Virtual Healthcare Conference on June 3, 2020 at 4:30 pm ET (Press release, Altor BioScience, MAY 26, 2020, View Source [SID1234558460]).

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The presentation will be webcast live and can be accessed through the NantKwest and ImmunityBio websites, NantKwest.com and ImmunityBio.com. An archived replay will be available on the websites for approximately 30 days.

On May 26, 2020 EORTC reported that Although there are effective treatments for advanced gastrointestinal tumours (GISTs) most patients with this rare disease will eventually become resistant to them (Press release, EORTC, MAY 26, 2020, View Source [SID1234558458]). Finding a drug that will help those patients where treatment has failed is therefore a priority. Now, for the first time, EORTC researchers have identified that the oral agent cabozantinib has clinically relevant anti-tumour activity in patients whose disease was progressing despite treatment with two other anticancer drugs. The research is published in The European Journal of Cancer.

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"Based on very promising findings from my laboratory in self-made, patient-derived mouse models of GIST, we designed a multicentre European clinical trial using cabozantinib in patients who had come resistant to imatinib (Glivec) and sunitinib (Sutent)," said Professor Patrick Schöffski, Head of the Department of General Medical Oncology, University Hospitals Leuven, and of Laboratory for Experimental Oncology, KU Leuven, Leuven Cancer Institute, Leuven, Belgium, who led the investigation for the EORTC Soft Tissue and Bone Sarcoma Group.

"The excellent results of this Phase 2 trial are fully in line with our preclinical data in self-made mouse models of human GIST and confirm once again the predictive character of mouse xenograft work. The working hypothesis that cabozantinib is active in advanced GIST was confirmed, as the trial met its primary endpoint, without any new safety signal detected."

GIST is a rare tumour that occurs most commonly in the stomach or small intestine, and the most common sarcoma in the gastrointestinal tract. The tumours grow from specialised cells found in the gastrointestinal tract called interstitial cells of Cajal (ICCs). GISTs are usually found in adults aged between 40 and 70, but can also occur at younger ages, and even in children.

In the seven-country, academic, investigator-initiated clinical study, 50 patients started treatment with cabozantinib between February 2017 and August 2018. Among the first 41 who were evaluable, 24 had no worsening of disease (‘progression-free’) at week 12. At the end of the trial, the disease had been controlled in 41 of the patients, whereas in eight the disease had progressed despite treatment with cabozantinib, and one was not evaluable – an impressive disease control rate of 82%, particularly when considering the fact that patients had already failed two other established anticancer agents.

Now that clinically relevant anti-tumour activity of cabozantinib has been demonstrated in patients with advanced GIST in whom other treatments had failed, the researchers suggest that the drug should become available for such patients outside clinical trials. "The oral agent was active in all genetically-defined subsets of patients in this trial. The impressive findings of this study should be followed by a more definitive, randomised, blinded Phase 3 trial comparing cabozantinib with placebo or another available agent," says Prof Schöffski.

Reference

1Activity and safety of the multi-target tyrosine kinase inhibitor cabozantinib in patients with metastatic gastrointestinal stromal tumour after treatment with imatinib and sunitinib: European Organisation for Research and Treatment of Cancer phase II trial 1317 ‘CaboGIST’".

P. Schoffski; O. Mir; B. Kasper; Z. Papai; J-Y Blay; A. Italiano; C. Benson; K. Kopeckova; N. Ali; P. Dileo; A. LeCesne; F. Menge; S.Cousin; E.Wardelmann; A. Wozniak; S. Marreaud; S. Litiere; F. Zaffaroni; A. Nzokirantevye; I. Van den Bempt; H. Gelderblom. European Journal of Cancer, Volume 134, July 2020, Pages 62-74,View Source

On May 26, 2020 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that it has commenced a global offering of $500 million (approximately €458.3 million) of ordinary shares, which may be represented by American Depository Shares ("ADSs") (Press release, argenx, MAY 26, 2020, View Source [SID1234558457]).

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The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are expected to close simultaneously.

In addition, argenx intends to grant the underwriters of the offering a 30-day option to purchase additional ordinary shares (which may be represented by ADSs) in an aggregate amount of up to 15% of the total number of ordinary shares (including represented by ADSs) proposed to be sold in the offering, on the same terms and conditions.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX." and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX.".

J.P. Morgan, Cowen and BofA Securities are acting as joint bookrunning managers for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities being offered in the United States 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 being offered in the United States may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected].

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made following pricing of the offering. A prospectus for the listing of the ordinary shares on Euronext Brussels consisting of a universal registration document dated 31 March 2020, an amendment to the aforementioned universal registration document, a securities note and a summary (together, the "Listing Prospectus") will be filed with the Dutch regulator (Stichting Autoriteit Financiële Markten) (the "AFM") for approval and passporting to Belgium in accordance with article 25 of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (as amended, the "Prospectus Regulation"). Upon approval, the Listing Prospectus together with a Dutch translation of the summary will be made available on the website of argenx (www.argenx.com) and copies may be obtained for free from argenx upon request at [email protected] or by telephone at (32) 9 310 34 19.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.