On March 22, 2021 Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, reported full FDA approval of the DOORwaY90 Study, a trial evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres Y-90 resin microspheres in patients with unresectable hepatocellular carcinoma (HCC) (Press release, Sirtex Medical, MAR 22, 2021, View Source [SID1234576980]).

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Unique to other recently published Y-90 studies, DOORwaY90, which stands for "Duration of Objective Response with Arterial Y-90," is the first prospective, multicenter study to utilize and delineate personalized dosimetry treatment planning and to define actionable post-treatment dosimetric verification for endpoint assessment. The study will assess the duration of response (DoR) and objective response rate (ORR) of SIR-Spheres.

Outside the United States, SIR-Spheres are indicated for the treatment of patients with advanced non-operable liver cancer, including HCC. "Our therapy is used for treatment in HCC in more than 50 countries, with years of safety and efficacy," said Kevin Smith, Chief Executive Officer at Sirtex. "The DOORwaY90 Study has the potential to expand the FDA-approved indication for use of SIR-Spheres in the U.S., which would mark an incredible achievement in patient care."

The DOORwaY90 Study is being led by co-principal investigators Cheenu Kappadath, PhD, and Dr. Armeen Mahvash. "We are honored to participate in this important study that could greatly impact the treatment of HCC patients in the United States," noted Dr. Mahvash, Professor in the Department of Interventional Radiology Division of Diagnostic Imaging at the University of Texas MD Anderson Cancer Center. "We look forward to working closely with Sirtex in executing and reporting the findings of DOORwaY90."

DOORwaY90 is a 15-center, 100-patient, U.S.-based open label, single arm study run in accordance with Good Clinical Practice (cGCP). The study population consists of patients with Barcelona Clinic Liver Cancer (BCLC) Stage A, B1 and B2 who are not eligible for resection or ablation at the time of study entry. For each patient, an eligibility review committee will review diagnostic imaging and confirm final eligibility and treatment planning prior to treatment. Enrollment is expected to begin in early Q2 2021.

HCC is often diagnosed when potentially curative resection or transplantation is not feasible. SIRT has the potential to deliver a lethal dose of radiation to hepatic tumors, while sparing surrounding healthy liver tissue. In countries outside the U.S., SIRT has been successfully used to bridge patients to transplantation or downstage HCC to within transplantation criteria or resection.

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.

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.

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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.

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]).

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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.

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]).

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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.