On September 9, 2020 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the microbiome-immunoinflammation axis to develop next-generation therapeutics, reported that it has initiated a new clinical trial with EO2401, an innovative microbiome-antigen (‘OncoMimic’) based cancer immunotherapy candidate, in a second cancer indication (Press release, Enterome, SEP 9, 2020, View Source;first-patient-dosed-in-a-phase-12-trial-with-eo2401-an-innovative-oncomimic-based-immunotherapy-candidate-targeting-adrenal-tumors-301126107.html [SID1234564873]). The new Phase 1/2 clinical trial, named ‘SPENCER’, is investigating EO2401 in combination with an immune checkpoint inhibitor (CPI) as a potential new treatment for adrenal malignancies.

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EO2401 is an innovative, off-the-shelf immune-oncology candidate derived from Enterome’s revolutionary OncoMimic platform. OncoMimics are microbiome-derived peptide antigens that closely mimic antigens expressed by tumor cells; they are selected based on their ability to trigger the rapid activation of memory T-cells that respond to gut bacteria and to direct a targeted cell-killing immune response against the tumor. EO2401 combines three OncoMimics present in cancers such as glioblastoma and adrenal tumors.

Christophe Bonny, Chief Scientific Officer of Enterome, explained: "We have now launched two clinical trials that demonstrate our strategy to potentially address different tumor-types with one combination of OncoMimics. This is because the targeted tumor antigens selected for EO2401 are expressed both in glioblastoma and in adrenal tumors. We are extremely excited by our OncoMimics approach as we believe it can be used to target any tumor antigen, and thus has therapeutic potential across all cancers. We expect the robust immune response driven by EO2401 when combined with a checkpoint inhibitor to generate clinically meaningful efficacy for these hard-to-treat patients."

The SPENCER trial (NCT04187404) is a multicenter, open-label, Phase 1/2 study assessing the safety, tolerability, immunogenicity and preliminary efficacy of EO2401 in combination with a CPI in patients with adrenal tumors (adrenocortical carcinoma and malignant pheochromocytoma/paraganglioma). A maximum of 72 patients are expected to be enrolled at nine clinical sites in Europe and the US.

Eric Baudin, MD is SPENCER’s Global Coordinating Investigator. Dr. Baudin is Associate Professor and Head of the Endocrine Oncology Unit at the Institut Gustave Roussy (Villejuif, France) and is a world-renowned expert regarding adrenal tumors.

Dr. Baudin commented: "Adrenal tumors are rare diseases where patients with both main types, i.e. adrenocortical carcinoma and malignant pheochromocytoma/paraganglioma, are in need of new effective therapies both as initial systemic therapy and as therapy for more advanced disease. We look forward to assessing the potential benefits of the novel immunotherapy approach of EO2401 in combination with a checkpoint inhibitor in this underserved patient population."

Jan Fagerberg, Chief Medical Officer of Enterome, said: "This new trial evaluating EO2401 in patients with adrenal malignancies, is another significant milestone for Enterome. EO2401 is the first off-the-shelf, targeted immunotherapy generated from our unique OncoMimics platform. We are delighted to initiate this second trial with EO2401 and believe that the data we expect to generate from both the SPENCER and ROSALIE studies will position Enterome as a clear leader of next-generation cancer immunotherapies."

Enterome started a first clinical study with EO2401 in patients with glioblastoma in July 2020 and is exploring other immunotherapy opportunities for its OncoMimic platform. The Company plans to initiate the clinical development of its second OncoMimic candidate, EO2463, in patients with B-cell malignancies in 2021.

On September 9, 2020 Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) reported that Executive Chairman Robert J. Coury, together with President Rajiv Malik will present at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference on Wednesday, Sep. 16, 2020, at 4:15 p.m. ET. Upjohn’s Group President Michael Goettler and Upjohn’s Chief Financial Officer Sanjeev Narula will also be in attendance (Press release, Mylan, SEP 9, 2020, View Source [SID1234564901]). Coury, Goettler, Malik and Narula will serve as future executive chairman, chief executive officer, president and chief financial officer of Viatris, respectively.

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Interested parties can access a live webcast of the presentation via the investor relations section of Mylan’s website at investor.mylan.com. An archived version also will be available following the live presentation and can be accessed at the same location for a limited time.

On September 9, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), reported that Michael Bonney, Executive Chair, will participate in the following upcoming conferences in September (Press release, Kaleido Biosciences, SEP 9, 2020, View Source [SID1234564801]). Each conference will involve a fireside chat presentation.

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Event: Morgan Stanley 18th Annual Global Healthcare Conference
Date: Wednesday, Sept. 16, 2020
Time: 12:30 p.m. EDT

Event: Cantor 2020 Virtual Global Healthcare Conference
Date: Thursday, Sept. 17, 2020
Time: 3:20 p.m. EDT

A live webcast of each event will be available in the Investors & Media section of the Kaleido website at View Source Archived replays will be accessible following each event.

On September 9, 2020 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company, reported that it has closed its previously announced registered direct offering to certain institutional investors of 8,865,000 shares of common stock at a price of $0.79 per share (Press release, Apricus Biosciences, SEP 9, 2020, View Source [SID1234564822]). The Company also closed its previously announced concurrent private placement to the investors of unregistered warrants to purchase up to 6,648,750 shares of common stock. The warrants have an exercise price of $0.84 per share of common stock, will be exercisable six months from the date of issuance and will expire five years following the initial date of exercise.

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After deducting the placement agent’s fees and offering expenses, the Company received net proceeds of approximately $6.2 million. Seelos intends to use the net proceeds from the offering for general corporate purposes and to advance the development of its product candidates.

Roth Capital Partners acted as the sole placement agent for the offering.

A shelf registration statement on Form S-3 (File No. 333-221285) relating to the shares of common stock issued in the registered direct offering was previously filed with the Securities and Exchange Commission (the "SEC") on November 2, 2017, amended on December 1, 2017 and declared effective by the SEC on December 7, 2017. Such shares were offered only by means of a prospectus. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the registered direct offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On September 9, 2020 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported that Lloyd M. Segal, President and Chief Executive Officer, will participate in a virtual fireside chat at the Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 15 at 10:15 a.m. ET (Press release, Repare Therapeutics, SEP 9, 2020, View Source [SID1234564843]).

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A live webcast of the fireside can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days following the fireside chat.