On February 22, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported the promotion of John Goldberg, M.D. to Chief Medical Officer (Press release, Oncorus, FEB 22, 2022, View Source [SID1234608807]). Dr. Goldberg joined Oncorus in October 2018 as Senior Vice President of Clinical Development with responsibilities including oversight of all clinical studies, drug development and regulatory strategies.

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"We are delighted to announce John’s promotion to Chief Medical Officer as he has been an integral part of our company’s progress thus far. His first-hand experience as a practicing oncologist with over 15 years of experience enrolling patients into clinical trials, coupled with expertise across a range of immunotherapies, have been crucial to our pipeline progress and we are incredibly pleased to have his continued guidance in this new role," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We look forward to John’s leadership as we continue to advance our viral immunotherapy candidate, ONCR-177, through the clinic with additional data from multiple cohorts expected later this year, in addition to progressing our ONCR-GBM program and selectively self-amplifying viral RNA (vRNA) product candidates ONCR-021 and ONCR-788."

"It’s an honor to take on the role of Chief Medical Officer at Oncorus, and I’m incredibly excited and motivated by the unique opportunity that Oncorus has to make a meaningful difference in cancer patients’ lives via its dual platform approach to unleashing the full potential of viral immunotherapies," said Dr. Goldberg. "Both the HSV and selectively self-amplifying vRNA platforms create a uniquely diverse pipeline rooted in compelling science and promising future growth. I believe that Oncorus has the potential to meaningfully impact the current standard of care in oncology, and, in partnership with the rest of the executive team, I look forward to advancing this innovative technology."

Dr. Goldberg has served as Senior Vice President of Clinical Development since he joined Oncorus in 2018. Prior to joining Oncorus, Dr. Goldberg served as Senior Medical Director of H3 Biomedicine, a developer of genomics-based cancer therapies. While at H3 Biomedicine, he supervised the clinical development of H3B-8800, the first-in-human spliceosome modulator. Previously, Dr. Goldberg held clinical roles in cancer drug development, leading the pediatric oncology Phase 1 program at the University of Miami and working as Medical Director for Agenus. His immunotherapy experience includes first-in-human neo-antigen vaccines, dendritic cell vaccine and GVAX trials, as well as check point inhibitors and costimulatory agonists. Dr. Goldberg is also a pediatric oncologist with 15 years of experience treating children with cancer and enrolling patients in clinical trials. He received his pediatric hematology oncology training from the Dana-Farber Cancer Institute and Children’s Hospital Boston and his general pediatrics training from the University of Rochester. Dr. Goldberg holds an M.D. from the University of Massachusetts Medical School and a A.B. in Biological Sciences from the University of Chicago. In addition to his current role at Oncorus, Dr. Goldberg is a Medical Advisory Board Member for the Sarcoma Foundation of America and a member of the Advisory Group at MassBio.

On February 22, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Thursday, March 3, 2022, at 5:00 p.m. ET to discuss a corporate update and financial results for the fourth quarter and full year 2021 (Press release, Oncolytics Biotech, FEB 22, 2022, View Source [SID1234608806]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 507-590#.

On February 22, 2022 NuCana plc (NASDAQ: NCNA) reported it has completed enrollment of the number of patients in the ongoing Phase III NuTide:121 study required to conduct the second interim analysis, which is expected to occur in the second half of 2022 after the 644th patient has completed 28 weeks of follow-up (Press release, Nucana BioPharmaceuticals, FEB 22, 2022, View Source [SID1234608805]). The NuTide:121 study is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer. As previously announced, NuCana expects to conduct the first interim analysis after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022.

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NuCana believes that a statistically significant improvement in the Objective Response Rate (ORR) at either of the first two interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. At the first interim analysis, an improvement in ORR of approximately 14% or more in the Acelarin plus cisplatin arm compared to the gemcitabine plus cisplatin arm would be statistically significant. Due to the larger number of patients included in the second interim analysis, an improvement in ORR of approximately 9% or more would be statistically significant. Recruitment in the NuTide:121 study, which is intended to enroll up to 828 patients, is ongoing and NuCana believes subsequent analyses could provide the confirmatory data to support full (regular) approval.

"We are delighted with the pace of enrollment in the NuTide:121 study especially against the backdrop of the Covid pandemic," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "With the enrollment of the 644th evaluable patient, we are now in position to complete two pre-specified interim analyses in 2022."

Mr. Griffith continued: "In the ABC-08 study of first-line patients with biliary tract cancer, Acelarin plus cisplatin achieved an ORR of 44% among the evaluable population. This compared favorably to the ORR of 26% achieved among evaluable patients treated with gemcitabine plus cisplatin in the ABC-02 study, which established this regimen as the global standard of care. Biliary tract cancer is a devastating disease and we believe Acelarin could represent a new option to help address the significant unmet need for more effective medicines."

About NuTide:121

NuTide:121 is a global, multi-center, 1:1 randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. The primary endpoints of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR) and the FDA-approved protocol includes three interim analyses. Based on the statistical analysis plan, and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, accompanied by positive trends in other endpoints, has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in the United States. Under this scenario, the NuTide:121 study would continue and the Company believes it could use the data from subsequent analyses as the confirmatory data required to support full (regular) approval. There are currently no agents approved for the first-line treatment of patients with biliary tract cancer.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, are a group of cancers originating in the biliary tract. The biliary tract is comprised of the gallbladder and interconnecting ducts responsible for the transport of bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 16,000 of those diagnoses in the United States. There are currently no agents approved for the first-line treatment of patients with advanced biliary tract cancer; however, the worldwide standard of care in these patients is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.

On February 22, 2022 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that it will host a conference call and webcast on Monday, February 28, 2022 at 8:00 a.m. ET to report financial results for the fourth quarter and year ended December 31, 2021 and provide business updates (Press release, Mersana Therapeutics, FEB 22, 2022, https://ir.mersana.com/news-releases/news-release-details/mersana-therapeutics-host-conference-call-announcing-fourth-3 [SID1234608804]).

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To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 7999454. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On February 22, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) ("Kiniksa"), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported fourth quarter and full-year 2021 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, FEB 22, 2022, View Source [SID1234608803]).

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"The successful launch of ARCALYST in recurrent pericarditis has been marked by continuous growth in prescriber adoption, expansion in payer coverage, and strong patient adherence," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "In 2022, we anticipate continued robust commercial execution and the further advancement of our clinical-stage pipeline. We expect data from the Phase 2b study of vixarelimab in prurigo nodularis in the second half of this year and will continue to enroll the Phase 2 trial of KPL-404 in rheumatoid arthritis. Our collaboration with Huadong Medicine provides non-dilutive capital and the opportunity to accelerate the development of ARCALYST and mavrilimumab in areas complementary to our existing autoinflammatory cardiovascular business."

Corporate Update

·Kiniksa and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine) reported a strategic collaboration to develop and commercialize ARCALYST and mavrilimumab in the Asia Pacific Region, excluding Japan.
-Kiniksa will receive $22 million upfront and is eligible to receive up to approximately $640 million in specified development, regulatory and sales-based milestones. Kiniksa is also eligible to receive tiered percentage royalties ranging from the low-teens to the low-twenties on annual net sales.

Portfolio Execution

ARCALYST (IL-1α and IL-1β cytokine trap)

·ARCALYST net revenue was $18.7 million for the fourth quarter of 2021 and $38.5 million since launch on April 1, 2021.
·Kiniksa’s ARCALYST collaboration achieved profitability in the fourth quarter of 2021, following three quarters of commercial availability for recurrent pericarditis.
·More than 300 prescribers have written for ARCALYST for recurrent pericarditis since launch, with more than 50 repeat prescribers.
·Approximately 95% of completed patient enrollment cases for recurrent pericarditis were approved for coverage in the fourth quarter of 2021.
·Approximately 70% of recurrent pericarditis patients who started ARCALYST in the second quarter of 2021 were still on therapy at the end of 2021.

Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

·Kiniksa is evaluating the development of mavrilimumab in cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated and that have synergies with the company’s existing commercial infrastructure.
·Kiniksa does not plan to initiate a Phase 3 trial for mavrilimumab in giant cell arteritis (GCA).

Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

·Kiniksa expects data from the Phase 2b dose-ranging clinical trial of once-monthly subcutaneous vixarelimab in prurigo nodularis in the second half of 2022.
-Kiniksa previously reported that the Phase 2a clinical trial of vixarelimab in prurigo nodularis had achieved its primary and secondary efficacy endpoints.

KPL-404 (monoclonal antibody inhibitor of CD40-CD154 signaling)

·Kiniksa is conducting a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to enable potential development in a spectrum of autoimmune diseases believed to be mediated by the CD40-CD154 pathway.
·In January 2022, Kiniksa provided KPL-404 to the University of Maryland School of Medicine to be used experimentally as part of an immunosuppressive regimen administered in connection with a transplant of a genetically-modified pig heart into an adult human with end-stage heart disease who was not eligible for a standard allogeneic heart transplant.

Financial Results

·Net revenue from ARCALYST product sales in the fourth quarter and full-year 2021 was $18.7 million and $38.5 million, respectively.
-ARCALYST became commercially available through Kiniksa on April 1, 2021.
·Net loss for the fourth quarter of 2021 was $36.3 million, compared to a net loss of $53.7 million for the fourth quarter of 2020. Net loss for the full-year 2021 was $157.9 million, compared to a net loss of $161.4 million for the full-year 2020.
·Total operating expenses for the fourth quarter of 2021 were $54.9 million, compared to $52.9 million for the fourth quarter of 2020. Total operating expenses for the full-year 2021 were $195.2 million, compared to $157.4 million for the full-year 2020.
–Collaboration expense in the fourth quarter and full-year 2021 was $0.84 million. Kiniksa did not report a collaboration expense in 2020.
–Non-cash, share-based compensation expense for the fourth quarter of 2021 was $6.1 million, compared to $6.3 million for the fourth quarter of 2020. Non-cash, share-based compensation expense for the full-year 2021 was $25.2 million, compared to $20.9 million for the full-year 2020.
·Kiniksa ended 2021 with $182.2 million of cash, cash equivalents and short-term investments and no debt.

Financial Guidance

·Kiniksa expects ARCALYST net revenue for the full-year 2022 to be between $115 million and $130 million.
·Kiniksa continues to expect that its cash and cash equivalents will fund its current operating plan into 2024.

Upcoming Scientific Conference Presentations

·Presentations of new rilonacept and recurrent pericarditis data are planned at the upcoming American College of Cardiology (ACC) 71st Annual Scientific Session & Expo, being held in Washington DC and virtually from April 2, 2022 to April 4, 2022. Details of the presentations are as follows:
–Paul Cremer, MD, Cleveland Clinic, will present a poster entitled, Neutrophil to Lymphocyte Ratio for Tracking Inflammation and Recurrence in Patients with Recurrent Pericarditis: Post Hoc Assessment of a Phase 3 Trial, RHAPSODY.
–Ajit Raisinghani, MD, University of California San Diego, will present a poster entitled, Real-World Experience and Unmet Needs in the Current Management of Recurrent Pericarditis: A Physician Survey and Medical Chart Review.

Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 am ET on Tuesday, February 22, 2022, to discuss fourth quarter and full-year 2021 financial results and to provide a corporate update.

Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 8145539. To access the webcast, please visit the Investors and Media section of Kiniksa’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.