On November 6, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and nine months ended September 30, 2019 (Press release, Odonate Therapeutics, NOV 6, 2019, View Source [SID1234550528]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of September 30, 2019, Odonate had $204.2 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate’s June 2019 underwritten public offering, less net cash used in operating activities of $72.1 million. Odonate’s net loss for the three and nine months ended September 30, 2019 was $26.6 million and $84.0 million, or $0.88 and $3.15 per share, respectively, compared to $23.9 million and $60.2 million, or $0.98 and $2.47 per share, respectively, for the same periods in 2018.

"We are pleased to have recently announced the completion of enrollment in CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "We expect to report top-line results from CONTESSA in the third quarter of 2020."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

On November 6, 2019 Omeros Corporation (NASDAQ: OMER), reported that the company will issue its third quarter 2019 financial results for the period ended September 30, 2019, on Tuesday, November 12, 2019, after the market closes (Press release, Omeros, NOV 6, 2019, View Source [SID1234550527]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call Details
To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 9699377. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9699377.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and select "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On November 6, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the third quarter ending September 30, 2019, and provided an update on the Company’s recent and future developments (Press release, VBI Vaccines, NOV 6, 2019, View Source [SID1234550526]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"All subjects in the Sci-B-Vac pivotal Phase 3 CONSTANT study have now completed clinical visits, including follow-up visits for safety, a milestone that confirms the timeline to top-line data expected early January 2020," said Jeff Baxter, VBI’s president and CEO. "Further, the third quarter of 2019 saw meaningful progression of our cancer vaccine immunotherapeutic candidate, VBI-1901, with the dosing of the first patient in Part B of the ongoing Phase 1/2a study in recurrent glioblastoma patients, the expanded scope of the study with the clinical collaboration to assess VBI-1901 in combination with GSK’s AS01B adjuvant system, and the presentation of robust additional immunogenicity data from Part A of the study to further correlate the immunologic responses with the tumoral and clinical responses. We also completed an equity raise totaling $37.4 million in net proceeds, strengthening our balance sheet as we enter this period of significant clinical data readouts."

Recent Highlights and Upcoming Milestones

Sci-B-Vac: Trivalent Prophylactic Hepatitis B Vaccine

Presentation of PROTECT Phase 3 Data:

The positive top-line data from the PROTECT Phase 3 study, as announced in June 2019, was presented in a late-breaking oral presentation at ID Week 2019, detailing the robust seroprotection data that showed seroprotection rates (SPR) of Sci-B-Vac compared with Engerix-B were statistically significantly higher in all key subgroup analyses of adults age ≥ 18 years, regardless of age, gender, diabetic status, body mass index, and smoking status.

The data will also be presented in a late-breaker poster presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting on November 11, 2019. This presentation will highlight the immunogenicity and safety data of the study, including the successfully met co-primary endpoints and the rapid and higher SPR and antibody responses to Sci-B-Vac compared with Engerix-B.

CONSTANT Phase 3 Data:

CONSTANT, a second Phase 3 study of Sci-B-Vac enrolling approximately 2,850 subjects, is a double-blind, four-arm, randomized, controlled study designed to demonstrate lot-to-lot consistency for immune responses, as measured by geometric mean concentration (GMC) of antibodies across three independent consecutively-manufactured lots of Sci-B-Vac. In October, all study subjects completed clinical visits, including follow-up visits for safety, confirming the timeline to top-line data which is expected early January 2020.

VBI-1901 – Glioblastoma (GBM) Vaccine Immunotherapeutic Candidate

In September, VBI became the first biopharma company to collaborate with GlaxoSmithKline (GSK) to assess its AS01B adjuvant system as part of a therapeutic cancer vaccine candidate. As part of the collaboration, VBI plans to add an additional study arm to Part B of the ongoing Phase 1/2a clinical study in recurrent GBM. Part B of the study is now planned to be a two-arm, open-label study, enrolling 20 first-recurrent GBM patients to receive VBI-1901 in combination with either GM-CSF, as per Part A of the study, or AS01B as immunomodulatory adjuvants.

New data from Part A, the dose-escalation phase, of the ongoing Phase 1/2a clinical study in recurrent GBM patients was presented at the World Vaccine Congress Europe in October. This data highlighted additional biomarkers – reduction of harmful, immunosuppressive regulatory T-cells (Tregs) and expansion of beneficial CD4+ T-helper cells against both antigens in VBI-1901, gB and pp65 – that strengthen the correlation between the vaccine-induced T-cell responses and the tumoral and clinical responses observed in three out of six (3/6) patients in the high-dose cohort that had evidence of stable disease by magnetic resonance imaging (MRI).

Enrollment of the 10 patients in the VBI-1901 with GM-CSF arm was initiated at the end of July. Initial data is expected to be presented at a medical meeting later this year.

BRII-179 (VBI-2601) – Hepatitis B Immunotherapeutic Candidate

As part of the collaboration with Brii Biosciences (Brii Bio), VBI and Brii Bio plan to initiate the enrollment of a Phase 1b/2a proof-of-concept study in subjects with chronic hepatitis B later in Q4 2019, which would enable an initial human proof-of-concept data readout in the second half of 2020.

Third Quarter 2019 Financial Results

Cash Position: VBI ended the third quarter of 2019 with $53.0 million in cash and cash equivalents compared to $59.3 million as of December 31, 2018.
Net Cash Used in Operating Activities: Net cash used in operations for the nine months ended September 30, 2019 was $40.2 million compared to $38.0 million for the same period in 2018.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $3.5 million for the nine months ended September 30, 2019 compared to $3.6 million for the same period in 2018. This spend is largely related to the completion of the modernization and capacity increase of the facility in Rehovot, Israel. This work began in 2018 and completed on schedule in May 2019, during which period the facility was temporarily closed.
Revenue: Revenue in the third quarter of 2019 was $0.6 million, compared to $0.3 million for the same period in 2018. The increase was primarily due to R&D services revenues earned pursuant to the therapeutic hepatitis B collaboration and license agreement with Brii Biosciences.
Research and Development (R&D): R&D expenses were $5.4 million for the third quarter of 2019, compared to $10.5 million for the same period in 2018. The decrease was primarily due to the decrease in clinical expenses due to the completion of the Sci-B-Vac Phase 3 PROTECT study.
General and Administrative (G&A): G&A expenses were $9.4 million for the third quarter of 2019, compared to $3.5 million for the same period in 2018. The increase was primarily a result of the impairment charge relating to goodwill of $6.3 million offset by a decrease in legal fees and a reduction in public company costs.
Net Loss: Net loss and net loss per share for the third quarter of 2019 were $16.2 million and $0.15, respectively, compared to a net loss of $15.4 million and a net loss per share of $0.24 for the third quarter of 2018.

On November 6, 2019 UroGen Pharma Ltd. (Nasdaq:URGN) reported that it will report third quarter 2019 financial results on Tuesday, November 12, 2019, prior to the open of the market (Press release, UroGen Pharma, NOV 6, 2019, View Source [SID1234550525]). The announcement will be followed by a live audio webcast and conference call at 8:30AM Eastern Time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Audio Webcast

The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately two weeks.

Dial-In Information

Live (U.S. / Canada): 1 (888) 771-4371
Live (International): 1 (847) 585-4405
Confirmation number: 49159339

On November 6, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that it will present clinical and pharmacodynamic biomarker data from the solid tumor combination cohorts of the ongoing ALX148 Phase 1 clinical program at the SITC (Free SITC Whitepaper) 34th Annual Meeting [Abstract P449] (Press release, ALX Oncology, NOV 6, 2019, View Source [SID1234550524]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of September 23, 2019, eighty-two patients with advanced malignancies were administered ALX148 in combination with standard regimens of either trastuzumab (n=30) or pembrolizumab (n=52). Objective responses were observed in expansion cohorts for response-evaluable patients with gastric/gastroesophageal junction cancer (G/GEJ) and squamous cell carcinoma of the head and neck (HNSCC). A summary of results is described below.

Patients with HER2 positive G/GEJ (n=19) whose tumors had progressed on prior systemic therapy, including HER2-targeted therapy, demonstrated an objective response rate (ORR) of 21% and a disease control rate (DCR) of 26%.
Patients with HNSCC (n=20) whose tumors had progressed on prior platinum therapy, demonstrated an ORR of 20% and a DCR of 30%. In checkpoint inhibitor-naïve subjects (n=10), an ORR of 40% and a DCR of 40% were observed.
ALX148 was well tolerated with no maximum tolerated dose reached. Treatment-related adverse events were mostly of low grade and frequency.

Complete CD47 target occupancy was observed throughout the dosing interval with no impact on circulating immune cell populations following ALX148 combination treatments.
Immunohistochemistry analysis using paired pre- and on-study tumor biopsies showed a statistically significant increase in intratumoral macrophages in pembrolizumab and trastuzumab combinations, and an increase in intratumoral CD8+ cells in combination with pembrolizumab.

RNA expression analysis from paired tumor biopsies suggest increased dendritic cells, cytotoxic cells, as well as gene signatures associated with antigen presentation, myeloid cell activity and tumor inflammation following ALX148 in combination with pembrolizumab.

"These exciting clinical responses and pharmacodynamic changes within the tumor microenvironment observed with ALX148 combinations support our hypothesis that blocking CD47 with an Fc-inactive molecule can enhance the anti-cancer innate and adaptive immune response in patients with advanced solid tumor malignancies," said Jaume Pons, Ph.D., President and Chief Executive Officer of ALX Oncology. "ALX148 as a myeloid checkpoint inhibitor has the potential to become a new cornerstone of immune therapy. We continue to advance ALX148 development in populations in need of novel treatments."