On October 10, 2019 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that the Company will release its financial results for the third quarter ended September 30, 2019 after the market closes on November 6, 2019 (Press release, Nevro, OCT 10, 2019, View Source [SID1234540940]).

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Investors interested in listening to the conference call may do so by dialing (833) 286-5807 in the U.S. or (647) 689-4452 internationally, using Conference ID: 4787437. In addition, a live webcast, as well as an archived recording, will be available on the "Investors" section of the Company’s website at: www.nevro.com.

On October 10, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, and Jotin Marango, M.D., Ph.D., Senior Vice President and Chief Business Officer, will participate at the 5th International Conference on Acute Myeloid Leukemia "Molecular and Translational" Advances in Biology and Treatment, and present preclinical data for CG-806, its oral, first-in-class pan-FLT3/pan-BTK inhibitor, in a poster presentation on October 24th, 2019 in Estoril, Portugal (Press release, Aptose Biosciences, OCT 10, 2019, View Source [SID1234540957]).

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"We are gratified by the enthusiasm of the AML community surrounding our mutation-agnostic kinase inhibitor CG-806," said Dr. Rice. "As we approach initiation of a new clinical study of CG-806 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), we wish to highlight at this ESH conference the ability of CG-806 to suppress multiple oncogenic signals, to potently kill a diverse range of AML cells, including those resistant to various FLT3 inhibitors, and to enhance the activity of other anticancer agents. CG-806 is currently in a Phase 1 a/b clinical trial in patients with B-cell malignancies and to date, no drug-related toxicities have been observed."

CG-806 Poster Presentation Details:

CG-806 Pan-FLT3 / Pan-BTK Inhibitor Simultaneously Suppresses Multiple Oncogenic Signaling Pathways to Treat AML
Date & Time: Thursday, October 24th, 2019, 6:40 p.m. – 8:15 p.m. WEST (1:40 p.m. – 3:15 p.m. EDT)
Session Title: Acute myeloid leukemia – Biology & Translational Research
Abstract Number: 16594
Location: Estoril Congress Center, Avenida Amaral, 2765-192, Estoril, Portugal

The poster will be available on the Aptose website at the beginning of the poster session here.

About CG-806
CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor and is in a Phase 1 clinical trial for the treatment of hematologic malignancies. This small molecule, in-licensed from CrystalGenomics Inc. in Seoul, South Korea, demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of AML in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML and other myeloid malignancies. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent or other non-covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.

On October 10, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported dosing of the first patient in HER2CLIMB-02, a randomized phase 3 clinical trial evaluating investigational agent tucatinib versus placebo, in combination with standard-of-care ado-trastuzumab emtansine (T-DM1, Kadcyla), for patients with locally advanced or metastatic HER2-positive (HER2+) breast cancer (Press release, Seattle Genetics, OCT 10, 2019, View Source [SID1234540924]). This trial is intended to support registration in the U.S. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2.

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"We are building a comprehensive strategy for tucatinib in combination with other medicines across a range of HER2-positive cancers," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are pleased to advance this tucatinib clinical trial with the vision of improving combination outcomes for patients with HER2-positive metastatic breast cancer who receive T-DM1. This trial has the potential to support tucatinib use in earlier lines of therapy."

HER2CLIMB-02 is a multi-center, randomized, double-blind, placebo-controlled phase 3 trial designed to evaluate tucatinib versus placebo, in combination with T-DM1, in patients with unresectable locally-advanced or metastatic HER2+ breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab in any setting. The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints include overall survival, objective response rate and duration of response. The trial is expected to enroll approximately 460 patients. More information about this phase 3 trial, including enrolling centers, is available at www.clinicaltrials.gov.

HER2CLIMB-02 is based on the results from a completed phase 1b study. The manuscript entitled "Tucatinib combined with ado-trastuzumab emtansine in advanced ERBB2/HER2-positive metastatic breast cancer: The results of a phase 1b trial" evaluating tucatinib with the current standard of care HER2-targeted antibody-drug conjugate, T-DM1, in previously treated metastatic HER2-positive breast cancer was published in the July 2018 print edition of JAMA Oncology.

About Tucatinib

Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 directed agents such as trastuzumab.1,2 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, ovarian and gastric cancers. HER2 mediates cell growth, differentiation and survival. Tumors that overexpress HER2 are more aggressive and historically have been associated with poor overall survival compared with HER2-negative cancers. Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

Tucatinib is being evaluated in an ongoing randomized, double-blind, placebo-controlled pivotal trial called HER2CLIMB comparing tucatinib vs. placebo, in combination with capecitabine and trastuzumab in patients with pretreated, unresectable, locally advanced or metastatic HER2-positive breast cancer, including patients with or without brain metastases. In addition, tucatinib is being evaluated in other solid tumor clinical trials, including colorectal cancer.

About HER2-Positive Metastatic Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the aggressive spread of cancer cells. BreastCancer.org estimates 271,270 new cases of invasive breast cancer will be diagnosed in the U.S. in 2019.3 Approximately 25 percent of breast cancers are HER2-positive.4 Historically, HER2 disease has been associated with shorter survival times as well as a higher risk of recurrence and CNS disease (brain metastases). Approximately 30 to 50 percent of HER2-positive breast cancer patients develop brain metastases over time.5,6 Over the past two decades, the approvals of four targeted treatments (trastuzumab, pertuzumab, lapatinib and T-DM1) have led to improved progression-free survival and survival rates of patients with metastatic HER2-positive breast cancer. Despite these advances, there is still a significant need for new therapies that can impact metastatic disease, including brain metastases, and be tolerated for longer periods of time.

On October 10, 2019 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) and Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported the expansion of their global collaboration agreement to evaluate the safety and efficacy of Innovent’s Tyvyt (sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody, in combination with Chi-Med’s surufatinib, a novel inhibitor of vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor 1 (FGFR1) and colony stimulating factor-1 receptor (CSF-1R), in patients with advanced solid tumors (Press release, Innovent Biologics, OCT 10, 2019, https://www.prnewswire.com/news-releases/innovent-and-chi-med-expand-global-collaboration-to-evaluate-the-combination-of-sintilimab-and-surufatinib-in-solid-tumors-300936292.html [SID1234540941]). The expansion builds on the existing global collaboration agreement between the two companies on sintilimab in combination with Chi-Med’s highly selective VEGFR inhibitor, fruquintinib.

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The expansion of the global collaboration will allow Innovent and Chi-Med to jointly explore the potential application of Tyvyt and surufatinib combination therapy in solid tumors with global unmet medical needs. Clinical studies with this new combination will be conducted both in the United States and in China. The combination of Tyvyt and surufatinib is expected to have synergistic anti-tumor effects by simultaneously targeting multiple cell types and signaling pathways in the tumor microenvironment. Preclinical studies have suggested that surufatinib is able to inhibit angiogenesis, block the accumulation of tumor associated macrophages and promote infiltration of effector T cells into tumors, all of which could contribute to improve anti-tumor activity of Tyvyt.

"Sintilimab, co-developed by Innovent and Eli Lilly and Company, has gained broad recognition by the market, due to its profiles in safety and efficacy. Through partnership with other companies, we are exploring more sintilimab-based combination therapies. We already saw some promising results out of such combinations," said Dr. Michael Yu, Chairman and Chief Executive Officer of Innovent. "We are excited to further collaborate with Chi-Med to develop the combination therapy of sintilimab and surufatinib, hoping more patients will benefit from this potential therapy globally."

"We believe that the future of oncology treatments increasingly lies in combining therapies, utilizing multiple mechanisms of action to greatly improve the treatment of solid tumors," said Mr. Christian Hogg, Chief Executive Officer of Chi-Med. "Our unique next-generation anti-angiogenesis VEGFR inhibitors, with high selectivity and tolerability, make them ideal candidates for combinations with immunotherapy agents such as PD-1/L1 monoclonal antibodies. Our existing collaboration with Innovent on fruquintinib is progressing well. We are excited to expand our collaboration to include surufatinib and look forward to bringing the benefits of these combined therapies to more patients in China and around the world."

About Tyvyt (Sintilimab Injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials.

About Surufatinib

Discovered and developed solely by Chi-Med, surufatinib (previously known as HMPL-012 or sulfatinib) is a novel, oral drug candidate that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which both inhibit angiogenesis, as well as CSF-1R, which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib’s unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.

Surufatinib is in several late-stage and proof-of-concept clinical trials in China, for indications such as neuroendocrine tumors and biliary tract cancer. In June 2019, an interim analysis of a Phase III study in patients with non-pancreatic neuroendocrine tumors in China confirmed that the study had met its primary endpoint early. Detailed results from this study were orally presented at the 2019 European Society for Medical Oncology Congress on September 29, 2019, and preparations are underway for a New Drug Application submission in China.

Surufatinib is also in proof-of-concept clinical trials in the United States. Chi-Med currently retains all rights to surufatinib worldwide.

On October 10, 2019 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company reported that originated and continues to develop collagenase-based therapies with a first in class collagenase-based product marketed as XIAFLEX in the U.S. and Xiapex in Europe, named life sciences industry veteran Kevin Buchi chief executive officer of BioSpecifics. He will also serve on the company’s board of directors (Press release, BioSpecifics Technologies, OCT 10, 2019, https://www.prnewswire.com/news-releases/biospecifics-technologies-corp-names-j-kevin-buchi-as-chief-executive-officer-300936191.html [SID1234540925]).

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"We are extremely pleased to have Kevin join BioSpecifics as chief executive officer. The board of directors believes that Kevin’s diversified life sciences leadership experience and business acumen will drive transformative vision and strategy for generating both near- and long-term shareholder value," said Jenn Chao, Chair of the Executive Search Committee.

"I am thrilled to be joining BioSpecifics. This is a unique company with very significant opportunities to further advance its collagenase-based therapies both commercially and clinically," said Mr. Buchi. "There are several key milestones on the near-term horizon including a potential third marketed indication for XIAFLEX, with the BLA filing submitted in early September for the treatment of cellulite, and the continued growth of the XIAFLEX commercial franchise and development portfolio."

Mr. Buchi is currently the chairman of the board of directors at Dicerna Pharmaceuticals and a director of Amneal Pharmaceuticals and Benitec Biopharma Ltd. Mr. Buchi was most recently president and chief executive officer at TetraLogic Pharmaceuticals from 2012 to 2016. Previously, he served as Impax Laboratories’ interim President and chief executive officer from December 2016 to March 2017. Earlier, he served as corporate vice president of Global Branded Products at Teva Pharmaceutical from 2011 to May 2012. Mr. Buchi also served as chief executive officer of Cephalon, which was acquired by Teva in October 2011. He had been at the company since 1991. Mr. Buchi holds a Masters of Management degree from the J.L. Kellogg Graduate School of Management from Northwestern University and a B.A. in Chemistry from Cornell University.