On March 5, 2020 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection, provided a business update and reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Corvus Pharmaceuticals, MAR 5, 2020, View Source [SID1234555220]).

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!

"In 2019, we continued to efficiently advance our pipeline and exited the year with three candidates in clinical trials," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We have presented updated data for each of these programs at major medical meetings and our academic collaborators are beginning to publish data from our studies in peer-reviewed journals, including a key publication for ciforadenant, our most advanced product, in Cancer Discovery in January. This article presented results demonstrating responses in patients with advanced refractory renal cell cancer and also reported on the identification of the Adenosine Gene Signature, a novel predictive biomarker."

"We presented data from our ongoing Phase 1/1b clinical trial with ciforadenant in prostate cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancer Symposium (ASCO GU) meeting in February 2020 and on CPI-818 at the T-Cell Lymphoma Forum in January 2020. We look forward to reporting more mature data from these trials during the year."

Recent Achievements

CPI-444: A2A Receptor Antagonist of Adenosine

Publication of peer-reviewed study in Cancer Discovery covering results in 68 patients with advanced refractory renal cell cancer (RCC) treated with ciforadenant monotherapy and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The publication describes the discovery of the Adenosine Gene Signature, which was shown in the study to identify patients most likely to respond to treatment with ciforadenant. In the study, for patients with available tumor biopsies, Adenosine Gene Signature positive patients had a 17% overall response rate by RECIST criteria vs 0% in Adenosine Gene Signature negative patients.
Enrolled additional patients (25 to date) with advanced refractory RCC in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Tecentriq intended to further evaluate the findings of the 68 patient study published in Cancer Discovery. To date, the results appear consistent with earlier results that Adenosine Gene Signature positive patients are more likely to respond to ciforadenant.
Presentation of safety and preliminary efficacy data in 35 patients with advanced refractory metastatic castrate resistant prostate cancer (mCRPC) treated with ciforadenant monotherapy and in combination with Tecentriq at the ASCO (Free ASCO Whitepaper) GU Cancer Symposium in February 2020. The preliminary data indicated that ciforadenant is active in mCRPC, and that the Adenosine Gene Signature correlated with CD73 expression in tumor biopsies.
CPI-006: Anti-CD73 Antibody

Oral presentation summarizing the safety and immunologic effects of CPI-006 in a phase 1/1b clinical trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2019. The presentation reported the in vivo effects of CPI-006 on B-cell activation, function and migration, supporting a new immuno-oncology approach with CPI-006 via activation of immune cells and the inhibition of adenosine production.
The trial will enroll up to 350 patients with advanced cancer evaluating CPI-006 as a single agent and in combination with ciforadenant or pembrolizumab.
Selected recommended dose of 18 mg/kg, or a fixed dose of 1200 mg, and initiated the disease expansion phase in the monotherapy and in combination with ciforadenant arms of the study. CPI-006 was well tolerated at all levels, with no dose limiting toxicities (doses ranged from 1 to 18 mg/kg).
Initiated enrollment in the combination cohort of CPI-006 and pembrolizumab.
Preliminary anti-tumor activity has been seen in mCRPC and renal cell cancer using monotherapy and in combination with ciforadenant.
CPI-818: A small molecule ITK inhibitor

Presentation of safety, pharmacokinetics and immunologic effects of CPI-818 in patients with refractory T-cell lymphomas in a poster at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019 and in an oral session at the T-Cell Lymphoma Forum in January. These studies demonstrated that CPI-818 blocked proliferation of lymphoma cells in vitro.
The presentation at the T-Cell Forum reported on Phase 1 data in 16 patients. No dose limiting toxicities were observed at doses up to 600 mg oral, twice per day. Two patients with cutaneous T-cell lymphoma (CTCL) have shown improvement and 11 patients remained on the study as of the data cut-off date of January 2020.
Receptor occupancy studies indicate that complete occupancy may occur with doses of 600 mg twice per day.
Financial Results
As of December 31, 2019, Corvus had cash, cash equivalents and marketable securities totaling $78.0 million. This amount compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018. Corvus expects full year 2020 net cash used in operating activities to be between $39 million and $42 million.

Research and development expenses for the three months and full year ended December 31, 2019 totaled $8.9 million and $38.0 million, respectively, compared to $8.4 million and $38.6 million for the same periods in 2018. In the fourth quarter of 2019, the increase of $0.5 million was primarily due to an increase in outside CPI-006 and CPI-818 costs, partially offset by a decrease in outside ciforadenant costs. For the full year 2019, the decrease of $0.6 million was primarily due to a decrease in outside ciforadenant costs, partially offset by an increase in outside CPI-006 and CPI-818 costs and an increase in personnel costs.

The net loss for the three months and year ended December 31, 2019 was $11.0 million and $46.7 million, respectively, compared to $10.5 million and $46.9 million for the same periods in 2018. Total stock compensation expense for the three months and year ended December 31, 2019 was $1.7 million and $7.3 million, respectively, compared to $1.8 million and $7.1 million for the same periods in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, March 5, 2020, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter 2019 financial results. The conference call can be accessed by dialing 1-800-263-0877 (toll-free domestic) or 1-720-543-0197 (international) and using the conference ID 3380789. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days following the call.

On March 5, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported that the Company will release its fourth quarter and full year 2019 financial results after the market closes on Thursday, March 12, 2020 (Press release, Synlogic, MAR 5, 2020, View Source [SID1234555219]). The press release will be followed by a conference call at 5:00 pm ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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!

The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 4089293. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.

On March 5, 2020 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Thursday, March 12, 2020 at 4:30 p.m. Eastern Time to discuss financial results for the fourth quarter and year ended December 31, 2019 and to provide a business update (Press release, CymaBay Therapeutics, MAR 5, 2020, View Source [SID1234555218]).

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, please dial 855-327-6837 from the U.S. and Canada, or 631-891-4304 internationally, Conference ID# 10008868. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On March 5, 2020 Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, reported that the U.S. Patent and Trademark Office will issue U.S. Patent 10,596,190 entitled "Method for Reducing Ototoxicity in Pediatric Patients Receiving Platinum-Based Chemotherapy (Press release, Fennec Pharmaceuticals, MAR 5, 2020, View Source [SID1234555217])." As suggested by the title, the patent captures the use of Fennec’s PEDMARK product to reduce the ototoxic effects of cisplatin in pediatric patients, particularly in the age group of five years or younger. This is U.S Food and Drug Administration (FDA) Orange Book eligible U.S. patent, and reflects Fennec’s strategy to expand and diversify its intellectual property portfolio to obtain protection for the PEDMARK product.

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!

PEDMARK was granted Orphan Drug Designation by the FDA in 2004. This designation, along with the U.S. Patent 10,596,190, strengthens the position of PEDMARK as the potential first and only treatment for the prevention of platinum induced ototoxicity in pediatric patients.

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated annually that over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

In February 2020, Fennec completed its rolling submission of a New Drug Application (NDA) to the FDA for PEDMARK and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined). PEDMARK received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018. Further, PEDMARK has received Orphan Drug Designation in the U.S. for this setting.

On March 5, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported a corporate update, its outlook for 2020, and financial results for the fourth quarter and twelve months ended December 31, 2019 (Press release, VBI Vaccines, MAR 5, 2020, View Source [SID1234555215]).

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!

Annual Note from Jeff Baxter, President and CEO:

"Over the last 18 months, VBI has transformed into a company committed to changing the landscape of hepatitis B (HBV) by improving prevention and working to develop a functional cure. HBV is a significant global public health issue with an increasing disease burden – by example, the acute HBV infection rate in the US increased by 20.7% in 2015, rising for the first time since 2006, with the sharpest increases occurring largely in states that have been impacted most by the ongoing opioid epidemic1. More than that, HBV is often an asymptomatic virus – it is estimated that as many as 67% of people with chronic HBV in the US are unaware of their infection status2. All of this underlines the importance of vaccination against HBV.

"Our trivalent hepatitis B vaccine, Sci-B-Vac, has successfully completed the pivotal Phase 3 program, demonstrating its ability to safely and rapidly elicit robust immune responses, conferring seroprotection in adults, including those who have been harder to protect, namely older adults, diabetics, and obese individuals. We are now working with the FDA and other regulatory agencies to prepare for submissions of regulatory approval applications in the US, Europe, and Canada, beginning in the fourth quarter of 2020. We believe Sci-B-Vac has the potential to be an efficacious, safe, and cost-effective option for all adults seeking protection against HBV.

"While we believe prevention is always better, and more cost-effective, we also recognize the importance of a cure for HBV. Recent estimates of people chronically-infected with HBV worldwide range from 240 million to 350 million, with over 2 million in the US alone3; globally, more than 2 billion people have ever been infected with HBV, acutely or chronically4. The race to develop a functional cure for HBV is competitive, but we believe consensus amongst experts is building that an immunotherapeutic would be needed to achieve long-term immunologic control and restore the body’s defense against HBV. With our new trivalent formulation that enhances T-cell response, we believe VBI-2601 (BRII-179) is well-positioned to be the immunotherapeutic component of a functional cure. Initial data from the ongoing Phase 1b/2a clinical study for VBI-2601, conducted with our partner Brii Biosciences (Brii Bio), are expected in the second half of 2020.

"In our other programs, we are integrating our cytomegalovirus (CMV) expertise with our proprietary enveloped virus-like particle (eVLP) technology to develop therapeutic cancer vaccines and prophylactic vaccines. Our lead eVLP program, VBI-1901, targets the most aggressive form of adult brain cancer, glioblastoma (GBM), a CMV-associated solid tumor. GBM is a devastating disease leaving patients with few treatments options. Encouraging data from the ongoing Phase 1/2a study in recurrent GBM patients were presented throughout 2019, with demonstrated correlations between immunologic responses, tumor responses (assessed through MRI scans), and clinical responses (survival data). As a testament to the strength of the early data, we entered into a collaboration with GlaxoSmithKline (GSK) to clinically evaluate the combination of VBI-1901 with GSK’s proprietary AS01B adjuvant system, a highly-innovative adjuvant system that has contributed to positive results in GSK’s shingles vaccine, Shingrix. We expect additional data from Part B of the ongoing Phase 1/2a study throughout 2020. We hope to continue to see encouraging results from VBI-1901 as we work hard to provide meaningful benefit to these patients.

"There were numerous clinical milestones throughout 2019, but we believe 2020 will be an even more transformational year for the company. The VBI team in the US, Canada, and Israel are working hard to address significant unmet medical needs, and we believe this dedication and focus on successfully achieving fundamentals will drive shareholder value. We appreciate the continued shareholder support as well as that of our partners and volunteers who participate in our clinical trials, and we look forward to continued advancement and achievement in 2020 and beyond."

Recent Key Program Achievements and Projected Upcoming Milestones:

Sci-B-Vac: Trivalent Prophylactic HBV Vaccine

●June 2019 and January 2020 : Announcement of positive top-line results from both pivotal Phase 3 studies which, combined, showed:

oNon-inferiority of seroprotection rate (SPR) in all adults ≥ age 18 compared with Engerix-B;
oSuperiority of SPR in adults ≥ age 45 compared with Engerix-B;
oHigher SPR in all key subgroup analyses of adults ≥ 18 years, including by age, gender, body mass index, diabetic status, and smoking status, compared with Engerix-B;
oHigher SPR at all time points compared to Engerix-B and, in CONSTANT, non-inferiority of SPR after 2 doses of Sci-B-Vac compared with 3 doses of Engerix-B in adults age 18-45 years;
oLot-to-lot manufacturing consistency; and
oSafety and tolerability consistent with the known safety profile of Sci-B-Vac, with no new safety risks identifies and no safety signals observed.

●Q2 2020 : Pre-BLA discussions expected with the FDA.
●Q4 2020 : Submission of applications for regulatory approvals in the US, Europe, and Canada expected to begin.

VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

●November 2019 : Initiation of enrollment in Phase 1b/2a study in patients with chronic HBV infection. The Phase 1b/2a is a randomized, controlled study designed to assess the safety, tolerability, antiviral, and immunological activity of VBI-1901 (BRII-179). The study is expected to enroll up to 65 patients and is sponsored by our partner Brii Bio.
●H2 2020 : Initial human proof-of-concept data expected from Phase 1b/2a study.

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

●June 2019, November 2019, and March 2020: Encouraging data from the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM patients were announced, demonstrating that:

oVBI-1901 is well-tolerated at all doses tested, with no vaccine-related safety signals observed;
oTwo patients in the high-dose cohort of Part A experienced a 60% reduction in the size of the primary tumor;
oIn the high-dose cohort of Part A, vaccine response correlated with clinical response, with a 12-month overall survival (OS) rate of 83% (n=5/6) for vaccine responders vs. 33% (n=3/9) for non-responders – vaccine responders also saw a 6.25-month improvement in median OS (14.0 months) compared with vaccine non-responders (7.75 months); and
oEarly tumor and immunologic responses in Part B aligned with responses and benefit observed in Part A.

●September 2019 : Announcement of collaboration with GSK to clinically evaluate VBI-1901 in combination with AS01B as a second arm in Part B of the ongoing Phase 1/2a study in first-recurrent GBM patients
●February 2020 : Enrollment initiated in VBI-1901 + GSK’s AS01B study arm
●Q2 2020 : Expanded immunologic, tumor, and clinical data expected from Phase 2a VBI-1901 + GM-CSF study arm
●Q4 2020 : Initial immunologic and tumor response data expected from Phase 2a VBI-1901 + AS01B study arm

Financial Results for the Three and Twelve Months Ended December 2019

●Cash Position: VBI ended the fourth quarter of 2019 with $44.2 million cash and cash equivalents compared with $59.3 million as of December 31, 2018.
●Net Cash Used in Operating Activities: Net cash used in operating activities for the full year 2019 was $48.7 million, compared to $45.5 million for the same period in 2018.
●Cash Used for Purchase of Property and Equipment: The purchase of property and equipment in 2019 was $3.7 million, compared to $6.0 million in 2018, and was primarily in Rehovot, Israel, as part of the modernization and capacity increase of the manufacturing facility. As part of this process, manufacturing at the facility in Rehovot, Israel, was temporarily shut-down in 2018 and re-commenced in May 2019. Following completion of the modernization and capacity increase, VBI received the certificate of Good Manufacturing Practice (GMP) compliance from the Israeli Ministry of Health in January 2020.
●Revenue: Revenue for the three months ended December 31, 2019 and for the full year 2019 was $0.6 million and $2.2 million, respectively, compared to $2.7 million and $3.4 million for the same time periods in 2018, respectively. The decrease in revenue was due to decreased named-patient product sales in Europe in 2019. Additionally, there was a decrease as a result of the license revenue earned as part of the License Agreement with Brii Bio in 2018, but this was offset by an increase in R&D services revenue in 2019 as part of the same agreement with Brii Bio.
●Research and Development (R&D): R&D expenses for the fourth quarter and full year 2019 were $4.3 million and $26.3 million, respectively, compared to $10.1 million and $38.5 million for the same periods in 2018, respectively. The decrease in R&D spend in 2019 was primarily due to a decrease in costs as the Phase 3 program for Sci-B-Vac neared completion.
●General and Administrative (G&A): G&A expenses for the fourth quarter and full year 2019 were $3.8 million and $14.1 million, respectively, compared to $9.9 million and $20.5 million for the same periods in 2018, respectively. The decrease in G&A expense in 2019 was primarily due to a $6 million payment made in 2018 to re-obtain Sci-B-Vac distribution rights in Asia, with no similar payment made during 2019. Other variances include decreased administrative expenses and the re-allocation of expenses from G&A back to Cost of Goods in 2019 related to the temporary Rehovot facility closure.
●Impairment Charge: There was an impairment charge of $6.3 million in 2019 related to goodwill, compared to $0.3 million in 2018.
●Net Loss: Net Loss and net loss per share for the year ended December 31, 2019 were $54.8 million and $0.46, respectively, compared to a net loss of $63.6 million and a net loss per share of $0.97 for the year ended December 31, 2018.