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Regeneron Announces Presentation at the 39th Annual J.P. Morgan Healthcare Conference

On December 16, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast its presentation at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 (Press release, Regeneron, DEC 16, 2020, View Source [SID1234572961]). The presentation is scheduled for 8:20 a.m. Eastern Time and may be accessed from the "Investors & Media" page of Regeneron’s website at View Source An archived version of the webcast will be available for at least 30 days.

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Zimmer Biomet Announces Quarterly Dividend for Fourth Quarter of 2020

On December 16, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the fourth quarter of 2020 (Press release, Zimmer Holdings, DEC 16, 2020, View Source [SID1234572960]). The cash dividend of $0.24 per share is payable on or about January 29, 2021 to stockholders of record as of the close of business on December 28, 2020.

Aethlon Medical Announces First Patient Treated in First-in-Human Clinical Trial of HEMOPURIFIER® in Head and Neck Cancer

On December 16, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, reported that the first patient has been treated in the Company’s first-in-human Early Feasibility Study (EFS) evaluating the HEMOPURIFIER in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (Press release, Aethlon Medical, DEC 16, 2020, View Source [SID1234572958]). The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA. (Hemopurifier Plus Pembrolizumab in Head and Neck Cancer – Full Text View – ClinicalTrials.gov).

The EFS, which is the device equivalent of a Phase 1 clinical trial for a drug or biologic, is a single center, open label trial in 10 to 12 subjects. The study is evaluating the HEMOPURIFIER for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA), which is a first-line therapy for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The primary endpoint for the study is safety of the HEMOPURIFIER in a clinical setting. Secondary endpoints include efficacy based on response rates, progression-free and overall survival, and changes in exosome concentration after HEMOPURIFIER treatment.

In cancer, exosomes have been shown to participate in the development and advancement of disease. Exosomes derived from tumor cells may promote immune suppression and seed the spread of metastasis. These tumor derived exosomes may also inhibit the activity of immuno-oncology drugs such as KEYTRUDA. Tumor derived exosomes are not currently addressed with any approved therapy.

Dan Zandberg, M.D., Medical Oncologist and Hematologist at UPMC Hillman Cancer Center, Associate Professor of Medicine at the University of Pittsburgh School of Medicine and Principal Investigator of the study, stated, "We are excited to have treated the first head and neck cancer patient with the HEMOPURIFIER. While KEYTRUDA can markedly improve outcome in some head and neck cancer patients, the majority of patients still do not respond. If clearance of exosomes with the HEMOPURIFIER prior to treatment with KEYTRUDA can increase the number of patients who are able to respond to KEYTRUDA, it could represent an important advance in the treatment of this disease. This trial represents the first step in this evaluation."

Charles J. Fisher, Jr., M.D., Chief Executive Officer of Aethlon, stated, "We are delighted to be working with Dr. Zandberg and his colleagues at the University of Pittsburgh and UPMC Hillman to treat the first head and neck cancer patient with the HEMOPURIFIER. By reducing the presence of immune suppressive exosomes from the circulatory system of head and neck cancer patients prior to treatment with KEYTRUDA, we believe the HEMOPURIFIER could have the potential to improve patient outcomes in this disease. The initiation of this first-in-human study addressing cancer-associated exosomes is a significant step towards evaluating the HEMOPURIFIER for potentially improving the efficacy of KEYTRUDA in head and neck cancer."

Qualigen Therapeutics, Inc. Announces $12 Million Registered Direct Offering

On December 16, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) ("Qualigen" or the "Company"), reported it has entered into a definitive agreement with a single institutional investor for the purchase and sale for $12,000,000 of (i) 2,370,786 Common Shares, (ii) 1,000,000 Pre-Funded Warrants (iii) 1,348,314 Common Warrants exercisable immediately and (iv) 842,696 Common Warrants exercisable six (6) months after issuance at a combined purchase price of $3.56 in a registered direct offering (Press release, Qualigen, DEC 16, 2020, View Source [SID1234572956]). The Common Warrants will have an exercise price of $4.07 per share and have a term of two years. The closing of the offering is expected to occur on or about December 18, 2020, subject to the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-232798) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall 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 registration or qualification under the securities laws of any such state or jurisdiction.

Amphivena Therapeutics Announces First Patient Dosed in the Phase 1 Dose Expansion of AMV564

On December 16, 2020 Amphivena Therapeutics, a clinical-stage oncology company focused on developing a platform of bivalent T-cell engagers that restore anti-cancer immunity in patients, reported the first patient has been dosed in the Phase 1 dose expansion study evaluating AMV564, an investigational, first-in-class agent that depletes myeloid derived suppressor cells (MDSC) and activates T cells, in adult patients with selected solid tumor indications (Press release, Amphivena Therapeutics, DEC 16, 2020, View Source [SID1234572955]).

The dose escalation phase of the first-in-human, multicenter, open-label study of AMV564 in solid tumors was initiated in October 2019 and established the safety, PK profile and clinical activity of AMV564 including a confirmed RECIST complete response.

The dose expansion study will explore AMV564 as a monotherapy in tumor-specific cohorts selected to enrich for patients with actionable antigens. The primary objectives of the study are to further characterize the safety and tolerability and to evaluate preliminary efficacy of AMV564 monotherapy administered subcutaneously.

"AMV564 has demonstrated an excellent safety profile and encouraging preliminary activity in heavily pretreated patients, and we look forward to seeing how this novel mechanism translates to clinical benefit in selected cancer patient populations including patients with inadequate benefit from checkpoint inhibitors, representing an area of high unmet need," said Curtis Ruegg, Ph.D., President and Chief Executive Officer of Amphivena Therapeutics.

The trial is being conducted at a planned 15 sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04128423).

About AMV564

AMV564 relieves immune suppression via targeted depletion of immunosuppressive MDSC and drives T cell activation and polarization to restore anti-cancer immunity. To date, over 95 patients have received AMV564 across three Phase 1 clinical trials for patients with solid tumors, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS).