On November 1, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the company has been awarded a grant of approximately $2 million from the National Cancer Institute of the National Institutes of Health ("NIH") (Press release, Mustang Bio, NOV 1, 2021, View Source [SID1234594032]). This two-year award will partially fund the Phase 1, Open Label, Multicenter Trial to Assess the Safety, Tolerability and Efficacy of MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") or chronic lymphocytic leukemia ("CLL").

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In addition, the Office for Human Research Protections has approved Federalwide Assurance ("FWA") for Mustang’s research. FWA is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The NIH grant and FWA validate our scientific efforts as we continue to advance the development of MB-106. This grant will contribute to Mustang’s evaluation of MB-106 in clinical trials with the hope to bring this therapeutic treatment to patients with relapsed or refractory B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia."

Research is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA265616. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division, and exclusively licensed to Mustang in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHL and CLL. Additional information on the trial can be found at View Source using the identifier NCT03277729.

On November 1, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that the company will release its third quarter 2021 financial results after the market closes on Monday, November 15, 2021 (Press release, CohBar, NOV 1, 2021, View Source [SID1234594031]). Management will host a conference call at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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For individuals participating in the Investor Call, please call into the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 15, 2021, through 11:59 p.m. Eastern Time on December 6, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 10161656. The audio recording will also be available at www.cohbar.com during the same period.

On November 1, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, reported that final clinical data from the Phase 1b study, CMP-001-001, of vidutolimod, an advanced generation Toll-like receptor 9 (TLR9) agonist, in combination with pembrolizumab or as a monotherapy will be presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting to be held in person and virtually November 10-14, 2021 (Press release, Checkmate Pharmaceuticals, NOV 1, 2021, View Source [SID1234594030]).

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Presentation Details:

Title: Final analysis: phase 1b study investigating intratumoral injection of Toll-like receptor 9 agonist vidutolimod ± pembrolizumab in patients with PD-1 blockade–refractory melanoma
Presenting Author: John M. Kirkwood
Abstract #: 16269
ePoster #: 950
Location: Virtual Poster Hall Exhibit, November 12, 7:00am – 8:30pm ET

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.