Form 6-K ARGENX SE For: Dec 07

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of December 2019

 

Commission File Number: 001-38097

 

 

ARGENX SE

(Translation of registrant’s name into English)

 

 

Willemstraat 5
4811 AH, Breda, the Netherlands

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F  x     Form 40-F  o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

 

 

 

argenx SE

 

On December 7, 2019, argenx SE (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

The information contained in this Current Report on Form 6-K, including Exhibit 99.1, is incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-225370) and S-8 (File No. 333-225375).

 

Exhibit		Description
99.1		Press Release dated December 7, 2019

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

		ARGENX SE
Date: December 7, 2019		By:	/s/ Dirk Beeusaert
			Dirk Beeusaert
			General Counsel

 

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Exhibit 99.1

 

 

argenx Announces Receipt of First Milestone Payment under Janssen Collaboration and Provides Data Update from Phase 1 Dose Escalation Trial of Cusatuzumab in Acute Myeloid Leukemia at ASH Annual Meeting

 

·                  argenx to receive $25 million from Janssen for achievement of enrollment milestone in first Phase 2 trial under collaboration

 

December 7, 2019

 

Breda, the Netherlands / Ghent, Belgium — 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, today announced the receipt of a development milestone payment from Janssen and the presentation of updated data from the Phase 1 dose escalation trial of cusatuzumab in combination with azacytidine for the treatment of newly diagnosed acute myeloid leukemia (AML) at the 61st American Society of Hematology (ASH) Annual Meeting.

 

argenx will receive the first development milestone payment of $25 million from its global collaboration and license agreement with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson. The milestone payment was triggered by the achievement of a prespecified enrollment threshold in the first trial to start under the collaboration. This dose-confirming Phase 2 pivotal CULMINATE trial of cusatuzumab is being conducted in combination with azacytidine for the treatment of newly diagnosed elderly patients with AML who are unfit for intensive chemotherapy.

 

“This milestone payment marks the progress made across our global collaboration with Janssen. Two trials are now underway in newly diagnosed populations with more trials expected to intiate next year in different AML settings and subpopulations. We continue to believe in the potential of the CD70/CD27 axis as a novel approach within the AML treatment landscape. The data update today further support the use of cusatuzumab in combination to treat this vulnerable patient population,” commented Tim Van Hauwermeiren, Chief Executive Officer of argenx.

 

Key Highlights from ASH

 

Adrian Ochsenbein, M.D. from the University of Bern presented translational data in support of the dual modes of action of cusatuzumab, including the blocking of CD70/CD27 signaling to stop proliferation of leukemic stem cells and cell killing via Fc-dependent, complement-dependent cytotoxicity and enhanced antibody-dependent cellular cytotoxicity (ADCC) via POTELLIGENT® technology. Dr. Ochsenbein also showed updated data as of the new cut-off date of February 2019 from the Phase 1 dose escalation trial of cusatuzumab in combination with azacytidine in 12 newly diagnosed elderly patients with AML who are unfit for intensive chemotherapy.

 

 

·                  100% of patients achieved a response including eight with a complete response (CR), two with a complete response with incomplete hematologic recovery (CRi), and two with a partial response (PR); 83% of patients achieved either a CR or CRi

·                  Of the nine CR/CRi patients evaluable for minimal residual disease (MRD) negativity, four achieved MRD negativity using a threshold of 10-3 which is consistent with the previous data cut-off in October 2018

·                  Four patients have remained in the study for at least 12 months

·                  Three patients from the study have been re-classified with risk category based on new mutation information or a reassessment of existing mutation information

·                  Cusatuzumab continued to be well-tolerated in patients with AML across the different doses

 

In addition to the CULMINATE trial in the newly diagnosed unfit AML population, cusatuzumab is also being evaluated in a Phase 1b platform study to explore combinations with standard AML therapies with the first trial exploring combinations of venetoclax, cusatuzumab and azacytidine.

 

About argenx

 

argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe auto-immune diseases and cancer. The company is focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. argenx’s ability to execute on this focus is enabled by its suite of differentiated technologies. The SIMPLE Antibody™ Platform, based on the powerful llama immune system, allows argenx to exploit novel and complex targets, and its three complementary Fc engineering technologies are designed to expand the therapeutic index of its product candidates.

 

www.argenx.com

 

For further information, please contact:

 

Beth DelGiacco, Vice President, Investor Relations

+1 518 424 4980

[email protected]

 

Joke Comijn, Director Corporate Communications & Investor Relations (EU)

+32 (0)477 77 29 44

+32 (0)9 310 34 19

[email protected]

 

Forward-looking Statements

 

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance.

 

 

argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.