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Evotec SE Announces Confidential Submission of Draft Registration Statement on Form F-1 with the U.S. Securities and Exchange Commission for a Proposed Offering of American Depositary Shares

On August 1 2021 Evotec SE (Frankfurt Stock Exchange; EVT, MDAX/TecDAX, ISIN: DE0005664809, WKN 566480) reported that it confidentially submitted a Registration Statement on Form F-1 ("Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") for a proposed offering and sale in the United States of shares of Evotec represented by American Depositary Shares ("ADSs") (Press release, Evotec, AUG 1, 2021, View Source;announcements/ad-hoc-releases/p/evotec-se-announces-confidential-submission-of-draft-registration-statement-on-form-f-1-with-the-us-securities-and-exchange-commission-for-a-proposed-offering-of-american-depositary-shares-6080 [SID1234585507]). The Registration Statement has not yet become effective and the final number of ADSs to be offered and their price have not yet been determined.

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Evotec’s shares are listed on the regulated market of the Frankfurt Stock Exchange in Germany with additional admission obligations of the Prime Standard Segment. Evotec will seek a secondary listing of the ADSs on the Nasdaq Global Select Market in the United States under the ticker symbol "EVO". The new shares underlying the ADSs will be issued from Evotec’s authorized capital. The first day of trading of the ADSs is expected to occur during the second half of 2021, however, this timing remains subject to change.

The ADSs referred to in this announcement are to be offered only by means of a registration statement on Form F-1 approved by the SEC. In accordance with applicable capital markets requirements, Evotec will announce when the registration statement has been approved by the SEC, including further details, such as final number and price of ADS.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations, or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the U.S. Securities Act of 1933, as amended ("Securities Act"), and other applicable securities laws. This announcement is being issued in accordance with Rule 135 under the Securities Act and other applicable securities laws. This public disclosure of inside information does not constitute a prospectus.

Antengene Announces the Approval of First-in-Class Oral XPO1 Inhibitor Selinexor in South Korea for the Treatment of Relapsed or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma

On August 1, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that through a priority review process, the South Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s New Drug Application (NDA) for the Orphan Drug-designated first-in-class oral inhibitor of XPO1, selinexor (XPOVIO), in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (penta-refractory); and as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment (Press release, Antengene, AUG 1, 2021, View Source [SID1234585496]).

Introduction of a practice-changing therapy for MM and DLBCL patients

Most patients with MM eventually suffer from relapse or become refractory diseases. For patients who have failed in one therapy, diffuse large B-cell lymphoma (DLBCL) has poor prognosis and the chance of cure or long-term disease-free survival declined every time getting worse after treatment. At present, there is no cure for rrMM and rrDLBCL and it is in dire need for safer and more effective therapies.

In October 2020, selinexor was granted an Orphan Drug Designation (ODD) in South Korea, where the term "Orphan Drug" is defined by the MFDS as therapies used to treat diseases affecting 20,000 or fewer patients and therapies used to treat diseases for which no appropriate therapy has been developed, or therapies that have demonstrated significant improvement in safety and/or efficacy compared to existing treatments.

A new mechanism of action with a broad therapeutic window

Selinexor’s novel mechanism of action (MoA) which is based on the selective inhibition of the nuclear export protein XPO1, is different from that of all currently approved therapies. The drug can be combined with various therapies to deliver improved treatment outcomes in these diseases. To date, five selinexor-based regimens have been added to the National Comprehensive Cancer Network (NCCN) Guidelines.

In addition, a number of international multicenter clinical trials in respect of selinexor are jointly carried out in places such as North America, Europe, Australia, Asia. These include the study of XPORT-DLBCL-030 in international multicenter clinical trials in combination with R-GDP for the treatment of rrDLBCL, and the study of SIENDO in international multicenter clinical trials of monotherapy of endometrial neoplasms.

Minyoung Kim, General Manager of Antengene, commented: "We are very encouraged by the MFDS’ approval of selinexor. I am confident that this oral selective inhibitor of nuclear export protein, with its practice-changing therapeutic utility, will improve the quality of life of patients with rrMM and rrDLBCL in South Korea, and bring renewed hope to this patient population."

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion.

LISCure Biosciences Announces Know-How License Agreement and Stock Purchase Agreement with Mayo Clinic

On August 1, 2021 LISCure Biosciences, Inc. ("LISCure") reported that it has entered into a know-how license and development collaboration agreement, and stock purchase agreement with Mayo Clinic to advance LISCure’s microbiome therapeutics in non-alcoholic steatohepatitis (NASH) (Press release, LISCure Biosciences, AUG 1, 2021, View Source [SID1234585495]).

The two entities previously entered a research collaboration agreement in the first half of 2021 for NASH candidates.

Under the agreement, the company will receive Mayo Clinic’s know-how to establish a new drug development of NASH program. As part of the agreement, Mayo Clinic will become a shareholder in LISCure, the first Korean biotech company receiving equity investment from Mayo Clinic.

The two entities will pursue the common goal of maximizing the value of LISCure’s therapeutics in metabolic diseases by expanding research and development activities such as discovering new indications and additional value-added candidates. LISCure plans to minimize trial and error in preparation for phase 2 clinical trial of its NASH candidate in the US in 2022 by jointly cooperating with Mayo Clinic.

"This collaboration will provide innovative treatment opportunities to patients with high medical needs in various metabolic diseases. We are very excited to establish a collaboration with Mayo Clinic," said a company official. "We are also proud of Mayo Clinic becoming our shareholder and look forward to continuing a long-term collaboration."

LISCure plans to enter the global clinical trial for NASH candidate as well as auto-immune disease candidate in the second half of this year, and to initiate clinical trial in the US for the world’s first novel microbe-mediated cancer therapeutics in the first half of 2022.

Polymed raised RMB 50 million in pre-A round financing

On June 30, 2021 Polymed Biopharmaceuticals reported an RMB 50 million pre-A round fundraising invested solely by Matrix Partners China (Press release, Polymed Biopharmaceuticals, JUL 30, 2021, View Source [SID1234630621]). The fund raised from this round will be used for strengthening Polymed’s PROTAC Platform, based on which therapeutic projects are carried out targeting several previously undruggable targets, and for supporting the IND filing activities for PB001/ABR085 which is a novel protein tyrosine kinase inhibitor against EGFR exon 20 insertion mutants.

"We are pleased to gain the support from Matrix Partners China", Dr. Jason Shaoyun Xiang, the founder and CEO of Polymed said. He further said "We will move our pipelines full speed ahead in order to create novel efficacious therapies for patients".

Dr Zhiyun Yu, the managing partner for Matrix Partners said: "Polymed has a strong pipeline from their PROTAC technologies and leading kinase inhibitors with the potential to become FIC or BIC. We are particularly appreciating the potential for further clinical development of these projects.

Takeda Quarterly Financial Report for the Quarter Ended June 30, 2021

On June 30, 2021 Takeda reported Quarterly Financial report (Presentation, Takeda, JUL 30, 2021, View Source [SID1234586800]).