On December 9, 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 it will host a key opinion leader ("KOL") webinar on MB-106, the Company’s CD20-targeted, autologous CAR T cell therapy for the treatment of B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL"), on Thursday, December 16, 2021, at 2:30 p.m. Eastern Time (Press release, Mustang Bio, DEC 9, 2021, View Source [SID1234596694]).

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The webinar will feature a presentation by Mazyar Shadman, M.D., M.P.H., Associate Professor at the Fred Hutchinson Cancer Research Center ("Fred Hutch") and a physician at Seattle Cancer Care Alliance, who will discuss updated interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 for patients with relapsed or refractory B-NHLs and CLL. These data were selected for presentation at the the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting ("ASH2021"), which is being held December 11-14, 2021. Dr. Shadman, along with colleague Brian Till, M.D., also an Associate Professor at Fred Hutch and physician at Seattle Cancer Care Alliance, will be available to answer questions following the formal presentations.

Mustang Bio’s management team will provide additional details on the planned MB-106 Phase 1/2 clinical trial to be conducted under Mustang’s Investigational New Drug ("IND") application. The U.S. Food and Drug Administration accepted Mustang’s IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for relapsed or refractory B-NHLs and CLL.

To register for the event, please click here.

About Dr. Shadman
Mazyar Shadman, M.D., M.P.H., is an Associate Professor at the University of Washington ("UW") and Fred Hutch as well as a physician at Seattle Cancer Care Alliance. He is a hematologic malignancies expert who specializes in treating patients with lymphoma and CLL.

Dr. Shadman is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cells), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies.

Dr. Shadman received his M.D. from Tehran University in Iran. He finished an internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his fellowship training in hematology and medical oncology at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for the National Cancer Institute’s cancer research training program at Fred Hutch, where he studied cancer epidemiology.

About Dr. Till
Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW as well as a physician at Seattle Cancer Care Alliance. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.

Note: Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

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-NHLs and CLL. Additional information on the trial can be found at View Source using the identifier NCT03277729.

On December 9, 2021 Sesen Bio (Nasdaq:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported its anticipated regulatory path forward for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) following its Clinical Type A meeting with the US Food and Drug Administration (FDA), which occurred on December 8, 2021 (Clinical Type A Meeting) (Press release, Sesen Bio, DEC 9, 2021, View Source [SID1234596692]).

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Following the productive Clinical Type A Meeting, the Company believes it has greater clarity regarding the requirements for resubmission of the BLA and the trial design, which may include these elements:

A randomized clinical trial assessing the safety and efficacy of Vicineum compared to investigators’ choice of intravesical chemotherapy;
Trial may include both patients who have received adequate BCG1 and patients who have received less-than-adequate BCG;
Company encouraged to submit the final VISTA trial results with the resubmission; and
Anticipated randomized trial design is aligned with guidance the Company has received from the European Medicines Agency, which may help to coordinate the regulatory paths forward for Vicineum in the US and the European Union.
The Company expects to hold a Type C meeting with the FDA in early 2022 to discuss the protocol for the additional clinical trial.

"We are pleased to have greater clarity on the regulatory path forward to resubmit the BLA and ultimately bring Vicineum to market if approved," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Our team looks forward to working productively with regulators as we continue to focus on our mission of saving and improving the lives of patients."

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 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (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 immuno-oncology 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 December 9, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported new preclinical and preliminary clinical results for ATA2271, a next-generation autologous chimeric antigen receptor (CAR) T-cell therapy targeting mesothelin (MSLN) (Press release, Atara Biotherapeutics, DEC 9, 2021, View Source [SID1234596690]). These promising early safety and functional persistence data were presented by collaborators at Memorial Sloan Kettering Cancer Center as a mini-oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Congress 2021, in Geneva, Switzerland.

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ATA2271 is an investigational, autologous, second-generation CAR-T immunotherapy that is designed to treat certain aggressive solid tumors, including malignant pleural mesothelioma (MPM). Even with successful completion of a combination of chemotherapy, aggressive surgical resection and radiation therapy, the median survival of treated patients in this report is only 9-17 months. ATA2271 incorporates Atara’s novel inclusion of armoring, in the form of a PD-1 DNR construct, to overcome checkpoint inhibition and a 1XX costimulatory domain on the CAR to enhance expansion and functional persistence of the CAR T-cells.

"CAR T-cell therapies have made incredible in-roads in the treatment of hematological malignancies, but new technology and targeting approaches are needed to apply these gains to aggressive solid tumors," said Cokey Nguyen, Senior Vice President and Chief Scientific Officer at Atara. "We are extremely encouraged by these early data assessing ATA2271 in advanced mesothelioma from a first-in-human (FIH) Phase 1 study. Early findings represent the first report of CAR T cells persisting over four weeks in a solid tumor microenvironment without need for additional agents, such as checkpoint inhibitors."

As reported in the full abstract available on the ESMO (Free ESMO Whitepaper) website, results from the evaluation of ATA2271 demonstrate the safety, functional persistence and activation of the CAR T cells. These studies, led by Prasad S. Adusumilli, MD, and collaborators at MSK provide both in vitro and in vivo evidence of the preclinical safety, improved functional characteristics and enhanced anti-tumor efficacy of ATA2271 and promising preliminary safety and persistence data in patients with MPM.

Specifically, in vitro functional studies show potent antitumor activity of ATA2271 following repeat antigen stimulation, with enhanced expansion observed in cells equipped with a PD-1 dominant negative receptor (PD1DNR) that provides T-cell intrinsic checkpoint blockade compared to CAR T-cells with a modified CD3z (1XX) alone. These data support the design of ATA2271, which expresses a dominant negative version of PD-1 receptor, to maintain function in the presence of suppressive checkpoint ligands commonly associated with solid tumor microenvironments. In addition, results further support the combination of next-gen CAR design (1XX) plus PD1 DNR armoring technology in differential enrichment of cytokine production involving cytokine signaling, effector immune responses, leukocyte activation and differentiation. Furthermore, in vivo, intrapleural administration of ATA2271 CAR T-cells in mice (n=8) eradicated mesothelioma and prolonged survival. Functional persistence of ATA2271 in vivo was evident by resistance to tumor reestablishment following 10 rechallenges.

In the ongoing Phase 1 dose finding study (NCT04577326), intrapleural administration of ATA2271 was found to be well-tolerated at lowest dose levels with no CAR T-cell related adverse events (AEs) of Grade >2 observed and no AEs of Grade >3 to date in the study. All four patients had received at least four prior lines of therapy. Importantly, ATA2271 CAR T-cells persisted in patients’ peripheral blood for greater than four weeks and was associated with upregulated effector cytokines.

Mini-Oral Presentation Details:

Title: Promoting Functional Persistence in Solid Tumor CAR T-cell Therapy: Mesothelin-targeted CAR (M28z1XXPD1DNR) with T-cell Intrinsic PD1 Dominant Negative Receptor

Presenting Author: Prasad S. Adusumilli, MD, FACS, Memorial Sloan Kettering Cancer Center, New York, NY
Date & Time: Thursday, December 9, 2021, at 11:05 a.m. CET / 5:05 a.m. EST / 2:05 a.m. PST
Abstract Number: 46MO
Session: Mini Oral Session
Location: Palexpo Congress Centre, Room C
About Atara’s Mesothelin CAR T Franchise

Atara’s preclinical pipeline is rapidly expanding with novel technologies and next-generation, multi-targeted CAR T immunotherapies through collaborations with Moffitt Cancer Center and Memorial Sloan Kettering Cancer Center.

In December 2020, Bayer and Atara announced an exclusive worldwide license agreement for next-generation, mesothelin-directed CAR T-cell therapies for the treatment of solid tumors. The agreement includes the development candidate ATA3271, an armored next generation allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for the treatment of high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small cell lung cancer.

Both ATA2271 and ATA3271 incorporate Atara’s novel inclusion of armoring in the form of a PD-1 DNR construct to overcome checkpoint inhibition and a 1XX costimulatory domain on the CAR to enhance expansion and functional persistence of the CAR T-cells. ATA3271 leverages Atara’s EBV T-cell platform and is currently in IND-enabling studies.

MSK Disclosures: Dr. Prasad S. Adusumilli has intellectual property interests and other financial interests related to Atara. MSK has intellectual property rights and associated interests by virtue of licensing agreements between MSK and Atara.

On December 9, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it will present multiple posters on its lead program, ST101, at the 2021 San Antonio Breast Cancer Symposium, being held in San Antonio, Texas in a hybrid format (in-person and virtual), December 7-10, 2021 (Press release, Sapience Therapeutics, DEC 9, 2021, View Source [SID1234596689]).

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Presentation details for the posters are as follows:

Presentation Title: Phase 1 study of ST101, a first-in-class peptide antagonist of CCAAT/-binding protein β (C/EBPβ), in patients with advanced solid tumors, with a phase 2 expansion in patients with hormone receptor positive breast cancer (HR+ BC)
Date/Time: Thursday, December 9, 2021 5:00 PM-6:30 PM CT

Presentation Title: C/EBPβ antagonist peptide, ST101, as a novel therapeutic for breast cancer
Date/Time: Friday, December 10, 2021 7:00 AM-8:30 AM CT

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation for the treatment of glioma by the European Commission.

On December 9, 2021 Bavarian Nordic A/S (OMX: BAVA) ("Bavarian Nordic" or the "Company") reported that it has in connection with the directed issue and private placement registered with the Danish Business Authority, a capital increase of a nominal value of DKK 63,736,800 (6,373,680 shares of DKK 10 each) (the "New Shares"), representing 9.94% of the registered share capital prior to the capital increase (the "Offering") (Press release, Bavarian Nordic, DEC 9, 2021, View Source [SID1234596688]).

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The New Shares have been issued under a temporary ISIN code and are expected to be admitted to trading and official listing under the permanent ISIN code DK0015998017 on Nasdaq Copenhagen A/S with effect from 10 December 2021. After registration of the share capital increase, the share capital of Bavarian Nordic amounts to nominally DKK 704,683,930 divided into 70,468,393 shares of DKK 10 each. The total number of voting rights in Bavarian Nordic are 70,468,393.

The New Shares rank pari passu with the Company’s existing shares and carry the same dividend and other rights. Each New Share carries one vote at the Company’s general meetings.

Reference is made to company announcements no. 40 and 41 of 6 December 2021.

The amendments to the Company’s articles of association required by the capital increase have been registered today with the Danish Business Authority and an updated version can be found at bavarian-nordic.com.

JOINT GLOBAL COORDINATORS AND JOINT BOOKRUNNERS
Citigroup Global Markets Limited and Nordea Danmark, filial af Nordea Bank Abp, Finland acted as Joint Global Coordinators and Joint Bookrunners in connection with the Offering (jointly the "Joint Global Coordinators and Joint Bookrunners").

Kromann Reumert and Latham & Watkins LLP acted as Danish and U.S. legal advisors respectively to the Company. Plesner acted as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.