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Therapeutic Solutions International Announces Immunological Mechanism of Action of StemVacs-V™ iPSC Derived Cancer Immunotherapeutic

On March 22, 2021 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported that new data demonstrating its StemVacs-V iPSC derived dendritic cell product stimulates two distinct immunological mechanisms responsible for its anticancer activity in animal studies (Press release, Therapeutics Solutions International, MAR 22, 2021, View Source;stemvacs-v-ipsc-derived-cancer-immunotherapeutic-301252742.html [SID1234576979]).

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In a series of experiments, Company scientists observed that mice bearing B16 melanoma treated with StemVacs-V possessed an increased T cell response towards the tumor associated antigen Brother of the Regulator of Imprinted Sites. Additionally, examination of tumors regressing as a result of StemVacs-V treatment, revealed increased macrophage and natural killer cell infiltration. Depletion of either T cells or natural killer cells in treated mice abrogated the cancer-reducing activity of StemVacs-V.

"As we advance our stem derived product towards FDA filing, it is critical to demonstrate not only reproducible efficacy but also distinct mechanisms of action" said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International. "We are particularly excited by the dual mechanism of action displayed by StemVacs-V, suggesting possible advantages to other cancer therapies which usually only stimulate either adaptive or innate immunity."

"Although current immunotherapies such as checkpoint inhibitors have resulted in remissions in numerous types of advanced cancers, these approaches still fail to produce a meaningful response in tumors considered immunologically "cold"" said Famela Ramos, Vice President of Business Development for the Company. "Given that tumors which respond to checkpoint inhibitors are usually characterized by natural killer cell infiltration, we are currently exploring the possibility of utilizing StemVacs-V as a sensitizer for other FDA approved immunotherapies."

"We are extremely excited about the rapid rate our team is advancing the StemVacs-V product, which promises to be a type of immunotherapy that is: a) easy to produce in large quantities; b) can be tailored to specific biological characteristics of different cancers; and c) appears safe and highly potent in existing animal studies" said Timothy Dixon, President and CEO of the Company.

Eucure Biopharma Announces Breakthrough Phase I Results for Anti-CTLA-4 Therapy in Combination with Junshi Biosciences’ Anti-PD-1

On March 22, 2021 Eucure Biopharma, a subsidiary of Biocytogen focused on developing proprietary immuno-oncology antibodies, reported that its anti-CTLA-4 antibody (YH001), in combination with Junshi Biosciences’ anti-PD-1 monoclonal antibody, Toripalimab Injection (TUOYI), has demonstrated encouraging anti-tumor activity in a dose-escalation Phase I clinical trial in Australia (Press release, Eucure, MAR 22, 2021, View Source [SID1234576978]). The study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of YH001 therapy in combination with Toripalimab in patients with solid tumors.

A 64-year-old male with a gastroesophageal junction tumor and liver/lung metastases who failed three prior lines of chemotherapy was enrolled in the 0.3 mg/kg dose cohort on September 17, 2020. The subject received one cycle (21 days) of YH001 monotherapy, followed by combination therapy with 240 mg Toripalimab for 7 cycles (21 weeks). Imaging assessments at 8 weeks post study treatment indicated stable disease with a 12.7% reduction in the summary of diameter of all target lesions relative to baseline. At 15 weeks post study treatment, imaging assessments indicated a partial response, with a 60.9% reduction in the summary of diameter of all target lesions relative to baseline. No dose-limiting toxicity events were observed, and only a Grade 1 adverse event (fatigue) was reported.

"We are very pleased to see patients experiencing partial remission of tumor target lesions in this clinical study, which is progressing smoothly in Australia," said Dr. Yuelei Shen, Chairman of Biocytogen and CEO of Eucure Biopharma. Dr. Shen added that a YH001 trial in China will commence "as soon as possible, so as to bring effective and innovative products to Chinese patients."

About YH001

YH001 is an anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) humanized monoclonal antibody that blocks the interaction between CTLA4 and CD80/CD86. YH001 can trigger antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to remove CTLA-4 expressing cells, especially regulatory T cells, to enhance T-cell-mediated antitumor responses. Preclinical data indicates that YH001 outperforms Ipilimumab (a currently approved CTLA-4 drug) in CTLA-4 binding affinity and inducing ADCC activity.

About Toripalimab (TUOYI)

Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering over fifteen indications have been conducted globally, including in China and the US. On December 17, 2018, Toripalimab obtained conditional approval from the National Medical Products Administration (NMPA) for second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The supplemental NDA of Toripalimab for second-line treatment of metastatic urothelial carcinoma was accepted and received priority review designation from the NMPA in May and July 2020, respectively. In September 2020, Toripalimab was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma. In December 2020, Toripalimab was included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for Toripalimab in combination with chemotherapy for first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In addition, the NMPA granted toripalimab conditional approval for treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Currently, Toripalimab has been granted 1 Breakthrough, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

Jazz Pharmaceuticals Announces Participation at the 10th Annual J.P. Morgan Napa Valley Forum

On March 22, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will webcast its corporate presentation at the 10th Annual J.P. Morgan Napa Valley Forum (Press release, Jazz Pharmaceuticals, MAR 22, 2021, View Source [SID1234576977]).

Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update on Monday, March 29, 2021, at 12:00 p.m. EST / 5:00 p.m. GMT.

A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

Seneca Biopharma Reports 2020 Yearend Results

On March 22, 2021 Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, reported its financial results for the year ended December 31, 2020 (Press release, Seneca Biopharma, MAR 22, 2021, View Source [SID1234576976]).

Business Highlights for 2020 to date.

During 2020, the Company achieved the following business milestones:

Entered into a definitive Merger Agreement with Leading BioSciences, Inc. (LBS), a privately held company focused on developing novel therapeutics to improve human health through therapeutic protection of the gastrointestinal mucosal barrier.
Completed offerings resulting in net proceeds of over $14.7 million.
Continued progress on the Company’s out-licensing effort to partner NSI-566 and reached an agreement to license NSI-189.
Announced the completion of the last subject’s follow-up assessment in the Company’s non-GCP Phase II trial evaluating NSI-566, for the treatment of chronic ischemic stroke.
Financial Results for the Year Ended December 31, 2020

Cash Position and Liquidity: At December 31, 2020, cash was approximately $10.5 million as compared to approximately $5.1 million at December 31, 2019.

Operating Loss: Operating loss for the year ended December 30, 2020 was $10.7 million compared to a loss of $8.6 million for the comparable 2019 period. The increase in operating loss for 2020 was due to an increase in G&A expenses which reflects an enhanced management structure to support corporate objectives as well as professional fees in connection with the proposed merger, when compared to the same period of 2019.

Net Loss: Net loss for the year ended December 31, 2020 was $16.3 million, or $1.17 per share, compared to a loss of $8.4 million, or $3.80 per share on a post-reverse stock-split basis, for the same period in 2019. The 2020 increase in net loss was primarily attributed to an increase in G&A, as noted above, and a non-cash expense of $5.6 million related to the January 2020 warrant inducement offering.

Anixa Biosciences Increases Previously Announced Bought Deal Offering of Common Stock to $22.5 Million

On March 22, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa" or the "Company"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 4,285,715 shares of common stock of the Company at a public offering price of $5.25 per share, less underwriting discounts and commissions (Press release, Anixa Biosciences, MAR 22, 2021, View Source [SID1234576975]). The Company also has granted the underwriter a 30-day option to purchase up to an additional 642,857 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about March 25, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds of the offering are expected to be approximately $22.5 million, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by the Company and excluding the exercise of the underwriter’s option to purchase additional shares. The Company intends to use the net proceeds from this offering for general corporate purposes, including, but not limited to, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to its technologies, and licensing activities related to current and future product candidates and working capital.

The shares of common stock are being offered pursuant to an effective registration statement on Form S-3 (File No. 333-232067) that was filed with the U.S. Securities and Exchange Commission ("SEC") on June 11, 2019 and declared effective on June 21, 2019. The shares of common stock may be offered only by means of a prospectus supplement forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and, upon filing, may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (212) 856-5711.

This press release shall not constitute an offer to sell or a 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.