On June 1, 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 the closing of its global offering of an aggregate of 4,600,000 ordinary shares (including in the form of American Depositary Shares (ADSs)), which includes the full exercise of the underwriters’ option to purchase 600,000 additional ADSs (Press release, argenx, JUN 1, 2020, View Source [SID1234560762]). The global offering consisted of (i) a public offering of 2,010,057 ADSs in the United States and certain other countries outside the European Economic Area (EEA) at a price to the public of $121.00 and (ii) a concurrent private placement of 2,589,943 of ordinary shares in the EEA at an offering price of €109.18. The gross proceeds from the global offering were approximately $557 million (approximately €502 million).

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Morgan Stanley, Cowen, BofA Securities and Evercore acted as joint bookrunning managers for the offering. Kempen acted as lead manager for the offering and Wolfe Capital Markets and Advisory acted as co-manager.

The securities were offered 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 was filed with the SEC on November 6, 2019 and a final prospectus supplement relating to the securities was filed with the SEC on November 8, 2019 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the global offering may be obtained for free from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, New York 10014, United States, Attention: Prospectus Department; 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; 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]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200.

In addition, argenx announced today the listing of and the commencement of dealings in its 4,600,000 new ordinary shares (including those underlying the ADSs) on the regulated market of Euronext Brussels, effective today, November 12, 2019.

On June 1, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the U.S. Food and Drug Administration has cleared the investigational new drug (IND) application for its Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, Opdivo (nivolumab), Bristol Myers Squibb’s PD-1 immune checkpoint inhibitor and BMS-986207, Bristol Myers Squibb’s investigational anti-TIGIT antibody, in patients with advanced solid tumors (Press release, Compugen, JUN 1, 2020, View Source [SID1234558790]).

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The triple combination study is designed to evaluate the simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen’s DNAM axis hypothesis and biomarker-driven approach in patients with advanced
solid tumors, including those that may be refractory or non-responsive to standard-of-care immune checkpoint inhibitors. The study is expected to commence in the second half of 2020.

"This study complements our clinical strategy designed to evaluate the blockade of PVRIG as a monotherapy and in combination with intersecting DNAM axis components to fully elucidate the role of this potentially foundational axis for cancer immunotherapy," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The encouraging clinical data from the ongoing COM701 Phase 1 study evaluating our discovered target PVRIG, and the emerging clinical validation of the TIGIT pathway, leave us increasingly enthusiastic about our science-driven clinical approach evaluating these two complementary yet distinct pathways in combination with PD-1. Importantly, as the only company with wholly-owned clinical candidates against both PVRIG and TIGIT, we are uniquely positioned to address the role of the DNAM axis."

Henry Adewoye, M.D., Senior Vice President and Chief Medical Officer of Compugen, added, "This study evaluating COM701 in combination with BMS-986207 and nivolumab fits our overall clinical development strategy of advancing novel therapies in cancers with high unmet medical need. We have previously reported partial responses with COM701 as monotherapy and in combination with nivolumab in patients with extremely challenging to treat cancer types, such as MSS platinum resistant primary peritoneal cancer and MSS-CRC. These preliminary clinical data support our preclinical work indicating that PVRIG and PD-1 are distinct pathways and that inhibition of the two may result in clinical benefit to patients. The triple combination will further test our science-driven hypothesis that PVRIG, TIGIT, and PD-1 are non-redundant inhibitory pathways and that their simultaneous blockade is expected to further enhance anti-tumor immune responses and broaden the patient population responsive to cancer immunotherapies. We look forward to collaborating with Bristol Myers Squibb on this important study."

Under this IND, the Company intends to initiate an open-label Phase 1/2 trial designed to evaluate the safety, tolerability and preliminary antitumor activity of COM701 in combination with Opdivo and BMS-986207 during dose escalation, as well as anti-tumor activity in selected tumor types in the expansion cohorts. Dose levels for Opdivo and BMS-986207 combinations have already been determined through prior testing by Bristol Myers Squibb, allowing for dose escalation of COM701 with fixed doses of Opdivo and BMS-986207.

About COM701
COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, and blocks the interaction with its ligand, PVRL2. TIGIT, an immune checkpoint discovered computationally by Compugen in 2009, and PVRIG constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory receptor on T cells and NK cells. Preclinical data suggest that the blockade of PVRIG induces a robust anti-tumor immune response and demonstrates synergistic activity when used in combination with inhibitors of TIGIT and/or PD-1. Currently, COM701 is being evaluated in a Phase 1 clinical study. Data from the ongoing study have shown that COM701 is well-tolerated and demonstrated preliminary signals of anti-tumor activity in a heavily pretreated patient population.

On June 1, 2020 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that Liz Barrett, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020, at 3:30 PM Eastern Time (Press release, UroGen Pharma, JUN 1, 2020, View Source [SID1234560730]).

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A live audio webcast of the event will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of the webcast will be available on the website for approximately two weeks.

On June 1, 2020 Nanjing Legend Biotech reported that it has set a proposed range of $18-$20 per ADS for the offering, which would raise $350 million and value Legend at $2.6 billion (Press release, Legend Biotech, JUN 1, 2020, View Source [SID1234560746]). In 2017, Legend surprised the world when its anti-BCMA CAR-T therapy produced a 94% overall response rate in pretreated multiple myeloma patients. Six months later, Janssen Pharma paid $350 million upfront to partner the candidate. Janssen has added another $110 million in milestones so far, and it could make up to $1.3 billion in remaining payments.

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On June 1, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that two posters updating results from the company’s two Phase 2 clinical trials of VAL-083 will be presented at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II to be held June 22-24, 2020 (Press release, DelMar Pharmaceuticals, JUN 1, 2020, View Source [SID1234558791]).

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Details regarding the posters to be presented in the Phase 2 Trials in Progress session are as follows:

Title: "Phase 2 trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma"
Lead Author: Dr. Zhong-Ping Chen, Sun Yat-sen University Cancer Center
Poster Number: CT273
Summary: This poster will include data from the company’s ongoing Phase 2 trial of VAL-083 being conducted at Sun Yat-sen University Cancer Center as a first line therapy, and includes updates on enrollment, safety and efficacy.

Title: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the recurrent or adjuvant setting"
Lead Author: Dr. Barbara O’Brien, M.D. Anderson Cancer Center
Poster Number: CT272
Summary: This poster will include data from the company’s ongoing Phase 2 trial of VAL-083 being conducted at M.D. Anderson Cancer Center as a treatment in the recurrent and adjuvant settings, and includes updates on enrollment, safety and efficacy.

Additional posters relevant to VAL-083 to be available from the conference include:

Session: Mechanisms of DNA Damaging Therapeutics
Title: "Dianhydrogalactitol (VAL-083) synergizes with topoisomerase inhibitors to overcome homologous recombination repair activity in glioblastoma and prostate cancer cells"
Poster Number: 1369

Session: DNA-reactive Agents and Other
Title: "Dianhydrogalactitol (VAL-083) exhibits strong efficacy in GBM tumors with different (epi)genetic background and treatment history"
Poster Number: 5231

All abstracts can be accessed via View Source!/9045.

About VAL-083
VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source