On March 22, 2021 Tavotek Biotherapeutics reported it has raised over $20M in Round A1 and Round A2 financing in the preceding two months (Press release, Tavotek, MAR 22, 2021, View Source [SID1234576982]). YuanBio Venture Capital led the A1 finance round followed by Oriza Holdings, Ming BioVentures, and New Alliance Capital. Series A2 financing was jointly invested by GF Xinde, CTS Capital, and Lanhu Capital. The two rounds of financing will be used to accelerate the CMC production and IND filings of three antibody drugs (Tavo111, Tavo103, and Tavo101) developed by the company based on its TavoPrecise antibody platform. In addition, the funding will also be used to strengthen its bispecific / multispecific antibody pipelines and the development of multicyclic intracellular peptide (MIP) programs.

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Tavotek Biotherapeutics, established in early 2019, received its initial Round A investment from Apricot Capital. Tavotek is committed to using innovation to improve the well-being of patients with unmet medical needs. Presently, the company has two R&D centers: one in Lower Gwynedd, Pennsylvania and another in Suzhou, China. The core team members have decades of successful drug development experiences at multinational pharmaceutical firms (J&J, Abbott, GSK, Eli Lilly) which include many blockbuster drugs with annual sales of more than $1 billion.

Tavotek’s research platforms are built upon three breakthrough technologies: TavoSelect (an innovative Phage Display Library that generates conformational selective human full-length and single domain antibodies); TavoPrecise (a differentiated engineering platform for next generation tissue-specific biologics); and TavoMIP (a multicyclic peptide platform that makes undruggable targets more accessible). With the new infusion of capital, Tavotek is developing novel biologics targeting oncology and autoimmune diseases for patients. The company plans to bring three innovative antibodies into human clinical trials in late 2021 with another three assets to IND in 2022.

On March 22, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that PEPAXTO (melphalan flufenamide) has been included in the new Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network (NCCN) in Oncology (Press release, Oncopeptides, MAR 22, 2021, View Source [SID1234576981]). PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

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"The NCCN Guidelines are a trusted resource for clinicians in the management of oncology patients," says Marty J Duvall, Chief Executive Officer at Oncopeptides AB. "We are grateful that melphalan flufenamide is included in these guidelines and believe that they will facilitate the management of previously treated multiple myeloma patients, who need additional treatment options".

NCCN is an alliance of 30 cancer centers in the United States. Over the past 25 years, NCCN has developed an integrated suite of tools to improve the quality of cancer care. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) document evidence-based, consensus-driven management to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes. To learn more about the NCCN Guidelines and Clinical Resources you may visit www.nccn.org.

About melphalan flufenamide

Melphalan flufenamide, also known as melflufen, is the first anticancer peptide-drug conjugate for patients with relapsed or refractory multiple myeloma. Melphalan flufenamide uses innovative technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound. Due to its high lipophilicity, melphalan flufenamide is distributed into cells. Melphalan flufenamide is designed to leverage aminopeptidases, which are overexpressed in multiple myeloma cells and cause the release of cytotoxic agents. Melphalan flufenamide is administered once monthly, by a thirty-minute infusion.

In the US, PEPAXTO (melphalan flufenamide) is indicated in combination with dexamethasone for the treatment of adult patients with triple class refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-monoclonal directed antibody. PEPAXTO is a registered trademark in the U.S.

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.