On November 1, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on October 29, 2021, the Company participated in a productive Type A Meeting with the US Food and Drug Administration (FDA) (Press release, Sesen Bio, NOV 1, 2021, View Source [SID1234594029]). The purpose of the meeting was to discuss questions related to Chemistry, Manufacturing and Controls (CMC) raised in the FDA’s Complete Response Letter (CRL) regarding the Company’s Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (CMC Type A Meeting).

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During the CMC Type A Meeting, the Company and the FDA reviewed issues related to CMC to be further discussed during the review of the BLA for Vicineum upon potential resubmission. The Company believes it has a clear understanding of what additional information regarding CMC is required for resubmission of the BLA.

Additionally, although not an issue raised in the CRL, the FDA confirmed that Vicineum manufactured using the proposed commercial process is comparable to Vicineum used in prior clinical trials. The FDA also confirmed that Sesen Bio can utilize Vicineum manufactured during process validation for any potential future clinical trials needed to address issues raised in the CRL, and that these potential trials can proceed while addressing CMC issues.

"We are pleased by the collaborative dialogue with the FDA during our CMC Type A Meeting," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Our team looks forward to continued progress as we prepare for the Clinical Type A Meeting, and we remain committed to working diligently to fulfill our mission of saving and improving the lives of patients by bringing new treatment options to market."

As previously disclosed, Sesen Bio is preparing for a separate Type A Meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL (Clinical Type A Meeting), which the Company expects to occur later this year. The Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immunooncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On November 1, 2021 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 third quarter 2021 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, NOV 1, 2021, View Source [SID1234594028]).

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"We are delighted with the ARCALYST launch performance in recurrent pericarditis. The continued momentum underscores the dedication of our first-rate team as well as the unmet need for patients with this debilitating disease," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "In addition to our ongoing commercial efforts, we are executing on our clinical-stage pipeline. Mavrilimumab demonstrated potentially best-in-class mortality reduction in a Phase 2 study in non-mechanically ventilated patients with COVID-19-related ARDS, and Phase 3 data are on track for the first quarter of 2022. We are also conducting a dose-ranging Phase 2b study of vixarelimab in prurigo nodularis with data expected in the second half of 2022. Furthermore, we expect to initiate a Phase 2 proof-of-concept trial of KPL-404 in rheumatoid arthritis by the end of 2021."

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

ARCALYST net revenue for the third quarter of 2021 was $12.1 million.
More than 200 physicians have prescribed ARCALYST for recurrent pericarditis since approval.
More than 90% of completed patient enrollment cases for recurrent pericarditis were approved for coverage.
Kiniksa has achieved broad access for its recurrent pericarditis target population in the United States, with greater than 190 million lives receiving favorable coverage.
Two thirds of ARCALYST prescriptions for recurrent pericarditis have been written for 12 months of therapy.
Recent data from the ongoing Phase 3 clinical trial of ARCALYST in recurrent pericarditis (RHAPSODY) showed median duration of continuous ARCALYST therapy at the 1-year anniversary of the Long-Term Extension portion of the trial of approximately 20 months.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

Mavrilimumab has demonstrated broad utility across multiple indications including COVID-19-related acute respiratory distress syndrome (ARDS) and giant cell arteritis (GCA).
Kiniksa expects data from the Phase 3 clinical trial of mavrilimumab in hospitalized non-mechanically ventilated patients with COVID-19-related ARDS in the first quarter of 2022.
The primary efficacy endpoint for the Phase 3 trial is the proportion of patients alive and without mechanical ventilation at Day 29. A key secondary efficacy endpoint is mortality at Day 29.
Phase 2 clinical data in hospitalized non-mechanically ventilated patients with COVID-19-related ARDS showed mavrilimumab reduced the risk of mechanical ventilation or death by 65% versus placebo at Day 29.
Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

Kiniksa expects data from the dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis in the second half of 2022.
The primary efficacy endpoint for the Phase 2b trial is the percent change from baseline in the weekly-average Worst-Itch Numeric Rating Scale (WI-NRS) at Week 16.
KPL-404 (monoclonal antibody inhibitor of signaling between CD40 and CD154)

Kiniksa plans to initiate a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis in the fourth quarter of 2021.
The Phase 2 trial is designed to evaluate the efficacy, dose response, pharmacokinetics, and safety of chronic subcutaneous dosing in rheumatoid arthritis over 12 weeks.
The pharmacokinetic lead-in of the Phase 2 trial is designed to provide optionality to evaluate the therapeutic potential of KPL-404 across a range of other autoimmune diseases with pathologies believed to be mediated by the CD40-CD154 pathway.
Financial Results

Total net revenue for ARCALYST product sales in the third quarter of 2021 was $12.1 million.
Net loss for the third quarter of 2021 was $30.5 million, compared to a net loss of $43.8 million for the third quarter of 2020.
Total operating expenses for the third quarter of 2021 were $42.8 million, compared to $43.2 million for the third quarter of 2020.
Non-cash, share-based compensation expense for the third quarter of 2021 was $6.2 million, compared to $5.6 million for the third quarter of 2020.
As of September 30, 2021, the company had cash, cash equivalents, and short-term investments of $200.2 million and no debt.
Financial Guidance

Kiniksa expects ARCALYST net revenue for the fourth quarter of 2021 to be between $16.0 million and $17.0 million.
Kiniksa continues to expect that its cash, cash equivalents and short-term investments will fund its current operating plan into 2023.
Upcoming Scientific Conference Presentations

Presentations of new data from several of Kiniksa’s pipeline programs are planned at the upcoming American College of Rheumatology (ACR) Convergence 2021, being held virtually from November 3, 2021 to November 9, 2021. In addition, encore presentations of RHAPSODY data are planned. Details of the pipeline presentations are as follows:
Marc Corbera-Bellalta, Ph.D., University of Barcelona, will give an oral presentation titled, Transcriptomic Changes Induced by Mavrilimumab versus Tocilizumab in ex-vivo Cultured Arteries from Patients with Giant-cell Arteritis.
Sebastian Unizony, MD, Massachusetts General Hospital, will present a poster entitled, Utility of CRP and ESR in the Assessment of Giant Cell Arteritis Relapse in a Phase 2 Trial of Mavrilimumab.
Manoj Samant, Ph.D., Kiniksa Pharmaceuticals, will present a poster entitled, Safety, Tolerability, Pharmacokinetics, Receptor Occupancy, and Suppression of T-cell-Dependent Antibody Response in a Phase 1 Study with KPL-404, an anti-CD40 Monoclonal Antibody.
Kiniksa plans to present details on the RESONANCE registry in pediatric and adult patients with recurrent pericarditis at the American Heart Association (AHA) Scientific Sessions 2021, being held virtually from November 13, 2021 to November 15, 2021. Details of the presentation are as follows:
Sushil Allen Luis, MD, Mayo Clinic, will present a poster entitled, Including the Patient’s Perspective in the Planning of Data Collection in the Recurrent Pericarditis Registry, RESONANCE.
Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 am ET on Monday, November 1, 2021 to discuss third quarter 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 1699563. 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.

On November 1, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported its participation in upcoming medical and scientific conferences. Candel President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci, and E. Antonio Chiocca, MD, PhD, FAANS, principal investigator for the CAN-3110 clinical trial, will present data and overviews pertaining to the company’s oncolytic viral immunotherapies at the 13th International Oncolytic Virus Conference (Press release, Candel Therapeutics, NOV 1, 2021, View Source [SID1234594027]). In addition, Patrick Y. Wen, MD, principal investigator, will present data on CAN-2409 from a phase 1 clinical trial in high-grade glioma at the 26th Annual Meeting of the Society for Neuro-Oncology (SNO).

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Details are as follows:

13th International Oncolytic Virus Conference Meeting
Date and Time: Friday, November 5, 2021, at 4:11 pm MT
Presenter: E. Antonio Chiocca, MD, PhD, FAANS
Oral Presentation Title: First in Human Clinical Trial of CAN-3110, An Oncolytic HSV Expressing ICP34.5, in Humans with Glioblastoma
Session Title: Scientific Session 5: Clinical Trials 1
13th International Oncolytic Virus Conference Meeting
Date and Time: Saturday, November 6, 2021, at 7:00 pm MT
Presenter: Paul Peter Tak, MD, PhD, FMedSci
Virtual Presentation Title: Leveraging Viral Oncolytic Immunotherapy Platform to Tip the Balance in Favor of the Immune System
Session Title: Special Session
26th Annual Meeting of the Society for Neuro-Oncology (SNO)
Date and Time: Friday, November 19, 2021, at 3:45 pm ET
Presenter: Patrick Y. Wen, MD
Oral Presentation Title: Phase 1 Clinical Trial of Oncolytic Viral Immunotherapy with CAN-2409 + Valacyclovir in Combination with Nivolumab and Standard of Care (SOC) in Newly Diagnosed High-Grade Glioma (HGG)
Abstract Number: CTIM-13
Details from the presentations will be available on the Candel website at View Source

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in healthy adult brain tissue.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma.

For more information on this clinical study, please visit View Source

On November 1, 2021 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported that it will report financial results and provide an update on recent progress on its development programs pre-market on November 8, 2021 (Press release, Reata Pharmaceuticals, NOV 1, 2021, View Source [SID1234594026]).

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Reata’s management will host a conference call on November 8, 2021, at 8:30 a.m. ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using the access code: 052919. The webcast link is View Source

Third quarter financial results to be discussed during the call will be included in an earnings press release that will be available on the Company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source.

On November 1, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will host a virtual "Spotlight Event" on Wednesday, November 10, 2021 at 11:00 a.m. Eastern Time (Press release, UroGen Pharma, NOV 1, 2021, View Source [SID1234594025]). The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC), and the Company’s earlier-stage clinical programs including UGN-301 and UGN-302.

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In addition to presentations from UroGen’s Chairman Arie Belldegrun, M.D. and members of the Company’s senior management team, the program will include a Key Opinion Leader panel discussion on the treatment of NMIBC.

Please register for the webinar on the Company’s website at www.urogen.com under the Events & Presentations section of the Investor Relations site (View Source).

Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Third Quarter 2021 Financial Results

Additionally, the Company announced that it will report third quarter 2021 financial results on Monday, November 15, 2021, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

The webcast will be 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 30 days.