On November 11, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported its financial results and operational highlights for the quarter ended September 30, 2020 (Press release, Oncolytics Biotech, NOV 11, 2020, View Source [SID1234570618]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"We continue to execute on our clinical and corporate milestones to expand the understanding and clinical benefit of pelareorep," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Clinical AWARE-1 data presented at SITC (Free SITC Whitepaper) 2020 demonstrated the ability of pelareorep to reverse immunosuppressive tumor microenvironments and generate the anti-tumor T cell clones needed for a durable anti-cancer immune memory effect. These findings reinforce the survival benefit observed in a prior phase 2 study and bode well for a successful outcome of our BRACELET-1 trial, which rapidly completed its safety run-in phase and continues to enroll patients. We look forward to delivering additional mechanistic, biomarker, and efficacy data before the end of this year to inform the design of our phase 3 registrational program."

Dr. Coffey continued, "Data from the AWARE-1 and BRACELET-1 trials expand the commercial opportunity of pelareorep into additional indications and breast cancer subtypes, and the IRENE trial will answer if pelareorep can bolster the effectiveness of an anti-PD-1 combination treatment in triple-negative breast cancer patients. Likewise, our collaboration with Roche and AIO will drive the GOBLET phase 1/2 trial to determine if pelareorep can boost the effectiveness of Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with difficult-to-treat GI cancers. Together, these trials will define the potential of pelareorep to synergistically combine with checkpoint inhibitors and increase the number of patients responding to such therapies, as well as validate blood-based biomarkers that may facilitate the patient selection process. Finally, the addition of Dr. Richard Vile, a world-renowned expert in oncolytic viruses and immuno-oncology, to our Scientific Advisory Board, positions Oncolytics to expand the clinical applicability of pelareorep within breast cancer and across multiple cancer indications."

Third Quarter and Subsequent Highlights

Clinical Highlights

Presented new AWARE-1 Findings of Pelareorep-Induced Increases in CelTIL and Generation of Anti-tumor T Cell Clones in HR+/HER2- Breast Cancer Patients
Newly announced AWARE-1 data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Annual Meeting showed that systemic pelareorep administration led to the generation of new anti-viral and anti-tumor T cell clones and an average 14-fold increase in intratumoral CD8 T cells. Data also showed that 70% of patients saw an increase in CelTIL (the study’s primary endpoint), a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical response. These data support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment by demonstrating pelareorep’s ability to induce a robust and potentially long-lasting anti-tumor T cell response in patients with HR+/HER2- breast cancer (link to PR, link to poster). Oncolytics recently completed enrollment of AWARE-1’s first two cohorts and expects to present additional data from the study by year-end.

Initiation of Dosing in Phase 2 IRENE Study
The investigator-sponsored study, which represents an expansion of Oncolytics’ lead breast cancer program into a new disease subtype, will investigate the use of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, IRENE will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response.

Initiated Phase 1/2 GOBLET Study in Collaboration with Roche and AIO
The recently announced multi-center trial will be managed by AIO, a leading academic cooperative medical oncology group based in Germany, and will investigate the use of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers. The study builds on previously reported early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS mutated colorectal cancer patients (link to PR, link to study), as well as a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to validate CEACAM6 and T cell clonality as predictive blood-based biomarkers, which may improve the patient selection process in future registration studies and increase their likelihood of success.

Corporate Highlights

Appointed Richard Vile, Ph.D., to Scientific Advisory Board (SAB)
Dr. Vile, a Professor of Immunology at the Mayo Clinic, is a world-renowned scientist and long-time collaborator of Oncolytics with extensive experience studying pelareorep. Dr. Vile is a recognized key opinion leader whose research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as chimeric antigen receptor (CAR) T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo’s Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunology.

Appointed Thomas C. Heineman, M.D., Ph.D., as Global Head of Clinical Development and Operations
Dr. Heineman has extensive experience leading clinical development at biotech companies, most recently serving as Senior Vice President and Head of Clinical Development at Denovo Biopharma. Prior to his time at Denovo, Dr. Heineman served as Vice President and Head of Clinical Development at Genocea Biosciences and Halozyme Therapeutics, where he was also the Head of Translational Medicine. Dr. Heineman’s experience further extends into big pharma and academia, as he has previously held roles as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine.

Financial Highlights

As of September 30, 2020, the Company reported $26.7 million in cash and cash equivalents. The Company raised $3.6 million during the third quarter through the issuing of common stock through our ATM facility.

Operating expense for the third quarter of 2020 was $2.5 million, compared to $1.8 million in the third quarter of 2019.

R&D expense for the third quarter of 2020 was $3.9 million, compared to $1.7 million in the third quarter of 2019.

Net cash used in operating activities for the third quarter of 2020 was $6.1 million, compared to $4.5 million for the third quarter of 2019.

The net loss for the third quarter of 2020 was $6.7 million, compared to a net loss of $3.5 million in the third quarter of 2019. The basic and diluted loss per share was $0.16 in the third quarter of 2020, compared to a basic and diluted loss per share of $0.16 in the third quarter of 2019.
Anticipated Milestones & Catalysts

Presentation of new AWARE-1 data and analyses: Q4 2020

Announcement of final data from phase 2 NU 18I01 second-line pancreatic cancer study*: H1 2021

Dosing of the first patient in GOBLET study in gastrointestinal cancer: H1 2021
Oncolytics expects to provide updates on the timing of the following milestones over the coming months:

Announcement of interim data from phase 1 WINSHIP 4398-18 multiple myeloma study

Interim safety update for phase 2 BRACELET-1 metastatic breast cancer study

Final biomarker data for AWARE-1 breast cancer study

Complete enrollment in phase 2 BRACELET-1 metastatic breast cancer study

Final data for phase 2 BRACELET-1 metastatic breast cancer study
*Guidance provided by clinical investigators

Update on COVID-19

Company Continues to Efficiently Execute Business Continuity Plan
Oncolytics has developed a robust business continuity plan to ensure the safety of patients, employees, and investigators, as well as the productivity of our clinical programs. We expect that the continued execution of this plan will allow the Company to build on the positive momentum of the past two quarters, despite any COVID-19-related challenges that may arise. Moving forward, we plan to remain in contact with relevant stakeholders and keep the market apprised of any new information that may impact clinical timelines.

Webcast and Conference Call
Management will host a conference call for Analysts and Institutional Investors at 5 pm ET today, November 11, 2020. To access the call, please dial (888) 231-8191 (North America) or (647) 427-7450 (International) and, if needed, provide confirmation number: 678-8931. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (855) 859-2056 (North America) or (416) 849-0833 (International) and using reference code: 678-8931.View Source;tp_key=fb7d246153

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one, followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

For more information about the AWARE-1 study, refer to View Source .

About IRENE
The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression-free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

For more information on the IRENE study, refer to View Source

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and blood-based biomarkers (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts:

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic Pancreatic cancer patients (n=12);
Pelareorep in combination with atezolizumab in 2nd and 3rd line metastatic colorectal cancer patients that are diagnosed as MSI high (microsatellite instability) (n=19);
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).
About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Gastrointestinal Cancer
Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,610 new cases of colon cancer and 43,340 new cases of rectal cancer diagnosed in the U.S. in 20201. Also, for the 2020 year, the American Cancer Society estimates there will be 57,600 new cases of pancreatic cancer2 and 8,590 new cases of anal cancer 3 in the U.S.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On November 11, 2020 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development, reported updated interim results today from a Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with chondrosarcoma (Press release, Inhibrx, NOV 11, 2020, View Source [SID1234570617]). This data will be presented to attendees of the Annual Connective Tissue Oncology Society ("CTOS") Conference on November 20, 2020 (Paper #16). Chondrosarcoma is an orphan disease and bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the European Union. There are currently no therapeutics approved for the treatment of chondrosarcoma.

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Inhibrx’s most advanced program, INBRX-109, is a precision-engineered, tetravalent DR5 agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation.

Of the 12 patients evaluable for efficacy within the ongoing chondrosarcoma expansion cohort to date, disease control was observed in 11 of 12 patients (92%) and 8 of 12 patients (67%) had a decrease in their tumor burden by RECIST.
Two of the patients achieved partial responses with reductions in tumor size of 60% and 32% as of October 2020.
Based on these preliminary results, the observed disease control rate at the four-month follow-up was 8 of 12 subjects (67%) with 7 of 12 patients continuing on study. The longest disease control duration observed to date for a patient in this cohort was 33 weeks, or approximately eight months.
The safety and tolerability profile continued to be favorable with most patients, approximately 90%, experiencing no signs of hepatotoxicity. There have been no new serious or severe adverse events since Inhibrx’s last safety update in July 2020.
The trial is ongoing and an additional 10 patient slots were added, per investigator requests, to the chondrosarcoma cohort.
"I am quite pleased to see prolonged progression free survival in a disease that has been unresponsive to conventional therapies," notes Dr. Sant P. Chawla, one of the principal investigators conducting the Phase 1 trial at the Sarcoma Oncology Center in Santa Monica, California.

"We believe the results in chondrosarcoma, a disease with a significant unmet need, are very promising. We are meeting with the Food and Drug Administration in the near future to discuss the design of a registration-enabling study that we anticipate initiating in the second quarter of next year," said Mark Lappe, CEO for Inhibrx. "Additionally, this month, we will initiate dosing in patients with synovial sarcoma, as well as our first chemotherapy combination cohorts with INBRX-109 in pancreatic adenocarcinoma and epithelioid subtype malignant pleural mesothelioma."

Conference Call Details
Inhibrx will hold a conference call to discuss these results today at 2:30 p.m. PT. Investors may join via the web: View Source or may listen to the call by dialing (1-877-870-4263) from locations in the United States or (1-412-317-0790) from outside the United States. Please refer to Inhibrx, Inc. when calling in. Following the webcast, the presentation may be accessed through a link on the investors section of Inhibrx’s website at View Source The webcast will be available for 60 days following the event. Inhibrx has also updated its corporate presentation which is available on the "Investors" section of its website at www.inhibrx.com.

About INBRX-109
INBRX-109 is a precisely engineered tetravalent single domain antibody (sdAb) based therapeutic candidate that agonizes DR5 to induce tumor selective programmed cell death. A three-part, Phase 1 clinical trial was initiated in November 2018. Part 1, dose escalation, was completed in August 2019 with enrollment of 20 patients. INBRX-109 was well-tolerated, with no significant toxicities observed at doses up to and including the maximum administered dose of 30 mg/kg. No maximum tolerated dose was reached. Part 2, single agent dose expansion, commenced in September 2019, while Part 3, chemotherapy combination cohorts, initiated this month in epithelioid subtype malignant pleural mesothelioma and pancreatic adenocarcinoma.

About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows for the combination of multiple binding units in a single molecule, enabling therapeutic candidates with precisely defined valency or multiple specificities that can achieve enhanced cell signaling or conditional target activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using established processes that are commonly used to produce therapeutic proteins.

On November 11, 2020 Protagonist Therapeutics, Inc. (NASDAQ:PTGX) reported that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the upcoming Jefferies Virtual 2020 London Healthcare Conference (Press release, Protagonist, NOV 11, 2020, View Source [SID1234570616]).

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Presentation details:
Date: Tuesday, Nov. 17, 2020
Time: 5:35 p.m. GMT (12:35 p.m. EST)

A live and archived webcast of the event will be available at View Source and in the Investors section of the Protagonist Therapeutics website at View Source

On November 11, 2020 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC:MCUJF), a cardiovascular pharmaceutical company, reported its results from operations for the quarter ended September 30, 2020 (Press release, Medicure, NOV 11, 2020, View Source [SID1234570615]).

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Quarter Ended September 30, 2020 Highlights:

Recorded total net revenue from the sale of products of $3.5 million during the quarter ended September 30, 2020 compared to $5.5 million for the quarter ended September 30, 2019 and $2.7 million for the quarter ended June 30, 2020 and;
Recorded total net revenue from the sale of AGGRASTAT of $3.4 million during the quarter ended September 30, 2020 compared to $5.3 million for the quarter ended September 30, 2019 and $2.6 million for the quarter ended June 30, 2020 and;
Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended September 30, 2020 was $4,000 compared to adjusted EBITDA of negative $319,000 for the quarter ended September 30, 2019 and $263,000 for the quarter ended June 30, 2020 and
Net loss for the quarter ended September 30, 2020 was $1.0 million compared to $599,000 for the quarter ended September 30, 2019 and net income of $19,000 for the quarter ending June 30, 2020;
Financial Results

The decrease in AGGRASTAT revenues when compared to the same periods in the previous year, as described above, is the result of decreases in the volume of the AGGRASTAT sold in 2020 when compared to 2019, due mainly to less procedures being performed, primarily as a result of the COVID-19 pandemic. In addition, the Company continues to experience pricing pressures from competitors which contributed to the decline in revenues from AGGRASTAT.

ZYPITAMAG contributed $105,000 of revenue for the three months ended September 30, 2020 compared to $78,000 for the three months ended September 30, 2019 and $371,000 for the nine months ended September 30, 2020 compared to $87,000 for the nine months ended September 30, 2019. With improved insurance coverage, the launch of a direct to patient online pharmacy program, including direct to patient marketing, the Company has seen some growth in interest in ZYPITAMAG during 2020. COVID-19 has provided some challenges with access to physicians, however the Company continues to pursue innovative marketing strategies to grow the usage of the product.

Additionally, sodium nitroprusside (SNP), which was first sold commercially during 2020, contributed $5,000 and $53,000, respectively, during the three and nine months ended September 30, 2020. The Company did not earn any revenues from ReDSTM during the three months ended September 30, 2020 compared to net revenue of $117,000 for the three months ended September 30, 2019. Revenues from ReDSTM for the nine months ended September 30, 2020 totaled $89,000 compared to net revenue of $272,000 for the nine months ended September 30, 2019.

Adjusted EBITDA for the three months ended September 30, 2020 was $4,000 compared to negative $319,000 for the three months ended September 30, 2019. The increase in adjusted EBITDA for the three months ended September 30, 2020 is the result of lower selling expenses, partially offset by lower revenues when compared to the same period in 2019.

Adjusted EBITDA for the nine months ended September 30, 2020 was negative $1.0 million compared to negative $1.9 million for the nine months ended September 30, 2019. The improvement in adjusted EBITDA for the nine months ended September 30, 2020 is the result of lower selling and research and development expenses, partially offset by lower revenues when compared to the same period in 2019.

During the three and nine months ended September 30, 2020, the Company recorded $404,000 and $729,000, respectively, in government assistance resulting from the Canada Emergency Wage Subsidy. The funding has been recorded as a reduction of the related salary expenditures with $311,000 and $559,000, respectively, recorded within selling expenses, $52,000 and $95,000, respectively, recorded within general and administrative expenses and $41,000 and $75,000, respectively, recorded within research and development expenses.

Net loss for the three months ended September 30, 2020 was $1.0 million or $0.10 per share compared to net loss of $599,000 or $0.04 per share for the three months ended September 30, 2019. The change in the net income for the three months ended September 30, 2020 is the result of lower revenues, partially offset by lower selling and research and development expenses and changes in foreign exchange gains and losses when compared to the three months ended September 30, 2019.

Net loss for the nine months ended September 30, 2020 was $2.5 million or $0.23 per share compared to $4.3 million or $0.28 per share for the nine months ended September 30, 2019. The change in the net loss for the nine months ended September 30, 2020 is the result of lower revenues and higher cost of goods sold primarily from increased amortization, partially offset by lower selling and research and development expenses and changes in foreign exchange gains and losses when compared to the nine months ended September 30, 2019.

At September 30, 2020, the Company had unrestricted cash totaling $11.9 million down from the $13.0 million of unrestricted cash held as of December 31, 2019. Cash flows used in operating activities for the nine months ended September 30, 2020 totaled $1.1 million compared to $10.9 million for the nine months ended September 30, 2019.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non–cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and nine months ended September 30, 2020 and 2019 results prepared using IFRS, do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Passcode: not required

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On November 11, 2020 GlaxoSmithKline (GSK) plc reported that it will present new data on its first-in-class anti-BCMA (B-cell maturation antigen) multiple myeloma therapy BLENREP (belantamab mafodotin-blmf) at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be hosted virtually from 5-8 December 2020 (Press release, GlaxoSmithKline, NOV 11, 2020, View Source [SID1234570609]). The 13 abstracts include data from GSK’s extensive DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme, which is evaluating belantamab mafodotin in different lines of therapy, and in combination with standard of care and novel therapies.

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Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "BLENREP is a significant advance for patients with relapsed or refractory multiple myeloma who previously had limited treatment options available. We believe that via our ongoing research on belantamab mafodotin in combination with other agents, and in earlier lines of treatment, we have the potential to continue to address the unmet needs of multiple myeloma patients and redefine the way this cancer is treated."

Key studies being presented at ASH (Free ASH Whitepaper) will demonstrate the potential of belantamab mafodotin in combination with standard therapies in earlier lines of treatment and include:

The DREAMM-6 analysis (poster #1419) will report outcomes from the combination of belantamab mafodotin with bortezomib and dexamethasone in patients whose disease has become refractory or relapsed after one or more prior lines of treatment.
ALGONQUIN (oral presentation #725), a supported collaborative study being led by the Canadian Myeloma Research Group, is evaluating the combination of belantamab mafodotin with pomalidomide and dexamethasone in relapsed or refractory patients who were previously treated with two or more prior lines of treatment that must have included lenalidomide and a proteasome inhibitor.
BLENREP was approved earlier this year in the US and EU for the treatment of patients with relapsed/refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Additional data, including new analyses from the pivotal DREAMM-2 study will further the understanding of the safety and tolerability of belantamab mafodotin, including the management of keratopathy/microcyst-like epithelial changes or MECs. The DREAMM-2 study served as the basis of the US and EU approvals. The list of GSK-sponsored presentations at the ASH (Free ASH Whitepaper) meeting include:

DREAMM Analyses

Abstract Name

Presenter

Presentation Details

DREAMM-2: Single-Agent Belantamab Mafodotin (Belamaf) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) – 1-Year Outcomes by Prior Therapies

S. Lonial

Poster #1417

Exposure–Response (E-R) for Ocular Safety Endpoints for Belantamab Mafodotin (Belamaf), a B-Cell Maturation Antigen (BCMA)-Targeting Agent, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) in the DREAMM-2 Study

G. Ferron-Brady

Poster #1420

DREAMM-2: Single-Agent Belantamab Mafodotin (Belamaf) Effects on Patient-Reported Outcome (PRO) Measures in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

R. Popat

Poster #2278

Infusion-Related Reactions (IRRs) in the DREAMM-2 Study of Single-Agent Belantamab Mafodotin (Belamaf) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

A. Nooka

Poster #3221

Recovery of Ocular Events with Longer-term Follow-up in the DREAMM-2 Study of Single-Agent Belantamab Mafodotin (Belamaf) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

S. Lonial

Poster #3224

Patient-Reported Experiences During and Following Treatment with Belantamab Mafodotin (Belamaf) for Relapsed/Refractory Multiple Myeloma (RRMM) in the DREAMM-2 Study

L. Eliason

Poster #3248

DREAMM-5 Platform Trial: Belantamab Mafodotin (Belamaf) in Combination With 4 Different Novel Agents in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

P. Richardson

Poster #2299

DREAMM-7: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) with Bortezomib, and Dexamethasone (B-Vd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

R. Rifkin

Poster #3247

DREAMM-8: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) with Pomalidomide and Dexamethasone (B-Pd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

S. Trudel

Poster #2302

Real-World Multiple Myeloma Data

Abstract Name

Presenter

Presentation Details

Population-level Projections for Multiple Myeloma Patients by Line of Therapy in the USA

G. Kanas

Poster #2300

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[1] In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease.[2] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[3]

About B-cell maturation antigen (BCMA)

The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[4]

About BLENREP

BLENREP is an antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seagen; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

IMPORTANT US SAFETY INFORMATION FOR BLENREP

WARNING: OCULAR Toxicity

BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.

Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.

Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.

WARNINGS AND PRECAUTIONS

Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.

Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).

Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).

Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.

BLENREP REMS: BLENREP is available only through a restricted program under a REMS called the BLENREP REMS because of the risks of ocular toxicity. Notable requirements of the BLENREP REMS include the following:

Prescribers must be certified with the program by enrolling and completing training in the BLENREP REMS.
Prescribers must counsel patients receiving BLENREP about the risk of ocular toxicity and the need for ophthalmic examinations prior to each dose.
Patients must be enrolled in the BLENREP REMS and comply with monitoring.
Healthcare facilities must be certified with the program and verify that patients are authorized to receive BLENREP.
Wholesalers and distributers must only distribute BLENREP to certified healthcare facilities.
Further information is available at www.BLENREPREMS.com and 1-855-209-9188.

Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.

Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.

Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman because it contains a genotoxic compound (the microtubule inhibitor, monomethyl auristatin F [MMAF]) and it targets actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose.

ADVERSE REACTIONS

The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder. Among the 218 patients, 24% were exposed for 6 months or longer.

The safety of BLENREP as a single agent was evaluated in DREAMM-2. Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Among these patients, 22% were exposed for 6 months or longer.

Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).

Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation.

Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%).

Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%).

The most common adverse reactions (≥20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).

USE IN SPECIFIC POPULATIONS

Lactation: There is no data on the presence of belantamab mafodotin-blmf in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.

Females and Males of Reproductive Potential: BLENREP can cause fetal harm when administered to pregnant women. There are no available data on the use of BLENREP in pregnant women to evaluate for drug-associated risk. No animal reproduction studies were conducted with BLENREP.

Pregnancy Testing: Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.

Infertility: Based on findings in animal studies, BLENREP may impair fertility in females and males. The effects were not reversible in male rats but were reversible in female rats.

Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the patients who received BLENREP at the 2.5-mg/kg dose in DREAMM-2 (n = 95), keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.

Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73m2 as estimated by the Modification of Diet in Renal Disease [MDRD] equation). The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m2 not on dialysis or requiring dialysis.

Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin ≤upper limit of normal [ULN] and aspartate aminotransferase (AST) >ULN or total bilirubin 1 to ≤1.5 × ULN and any AST). The recommended dosage of BLENREP has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST).

INDICATION

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The full Prescribing Information, including BOXED WARNING and Medication Guide, is available here.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.