Legend Biotech Achieves Milestone Under Collaboration Agreement with Janssen Biotech, Inc. for BCMA CAR-T

On April 21, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported the achievement of a $50 million milestone under its collaboration agreement with Janssen Biotech, Inc. (Janssen) for ciltacabtagene autoleucel (cilta-cel), now marketed in the United States under the brand name CARVYKTI (Press release, Legend Biotech, APR 21, 2022, View Source [SID1234612870]). Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy.

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Legend Biotech entered into the agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales.

The global agreement specifies a 50-50 cost and profit-sharing agreement in all markets, excluding Greater China, where the split is 70 percent for Legend and 30 percent for Janssen. Including the $50 million payment announced above, Legend has achieved $300 million in milestone payments during the collaboration.

About CARVYKTI (Ciltacabtagene autoleucel; cilta-cel)

CARVYKTI is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The CARVYKTI CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.

In December 2017, Legend Biotech Corporation entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

CARVYKTI received U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma in February 2022. In March 2022, CARVYKTI received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). In addition to U.S. Breakthrough Therapy Designation granted in December 2019, cilta-cel received a Breakthrough Therapy Designation in China in August 2020. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019 and from the European Commission in February 2020.

Sangamo Therapeutics Announces Participation at Upcoming Investor Conferences

On April 21, 2022 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will be participating in the following investor conferences (Press release, Sangamo Therapeutics, APR 21, 2022, View Source [SID1234612862]):

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Bank of America Securities Conference
Date: Wednesday, May 11th at 3:00 p.m. Eastern Time
RBC Global Healthcare Conference
Date: Wednesday, May 18th at 3:05 p.m. Eastern Time
H.C. Wainwright Global Investment Conference
Date: Tuesday, May 24th at 7:00 a.m. Eastern Time
Access links for presentations, panels and fireside chats will be available on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will also be available on the Sangamo Therapeutics website after the event.

Vertex to Announce First Quarter 2022 Financial Results on May 5

On April 21, 2022 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its first quarter 2022 financial results on Thursday, May 5, 2022 after the financial markets close (Press release, Vertex Pharmaceuticals, APR 21, 2022, View Source [SID1234612861]). The company will host a conference call and webcast at 4:30 p.m. ET . To access the call, please dial (877) 270-2148 (U.S.) or +1 (412) 902-6510 (International) and reference the "Vertex Pharmaceuticals First Quarter 2022 Earnings Call".

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

Mustang Bio Announces Upcoming MB-106 CD20-Targeted CAR T Data Presentations

On April 21, 2022 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 interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") and chronic lymphocytic leukemia ("CLL"), will be presented at two upcoming conferences: 2022 Tandem Meetings I Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy ("ASTCT") and Center for International Blood & Marrow Transplant Research ("CIBMTR"), taking place April 23 – 26, 2022, in Salt Lake City, Utah ("2022 Tandem Meetings") and the 4th International Workshop on CAR-T and Immunotherapies ("iwCAR-T") taking place on April 28 – May 1, 2022, in Tampa, FL (Press release, Mustang Bio, APR 21, 2022, View Source [SID1234612860]).

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Both presentations will be given by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutchinson Cancer Center ("Fred Hutch") and University of Washington. MB-106 is being developed in a collaboration between Mustang and Fred Hutch.

"We look forward to Dr. Shadman’s upcoming MB-106 presentations as we continue to progress our CD20-targeted CAR T cell therapy program. MB-106 has been demonstrating compelling clinical activity and a favorable safety profile in the ongoing Phase 1/2 trial at Fred Hutch for patients with relapsed or refractory B-NHL and CLL," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "At the 2022 Tandem Meetings, Dr. Shadman will present updated data that includes patients with diffuse large B cell lymphoma and Waldenstrom macroglobulinemia. Additionally, he will present data focused on CLL at iwCAR-T. Looking ahead, Mustang intends to dose the first patient in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s IND this quarter."

Details of the presentations are as follows:

2022 Tandem Meetings
Title: High Efficacy and Low Toxicity of MB-106, a Third Generation CD20 Targeted CAR-T for Treatment of Relapsed/Refractory B-NHL and CLL
Poster Number: 225
Dates and Time: Sunday, April 24, 8:30 – 9:30 p.m. ET
For more information, please visit the 2022 Tandem Meetings website: View Source

iwCAR-T
Session III: CAR-T in CLL
Title: CD20-targeted CAR T in R/R CLL
Date and Time: Saturday, April 30, 1:10 – 2:10 p.m. ET
For more information, please visit the iwCAR-T website: View Source

Mustang is a sponsor of iwCAR-T, an annual workshop / think tank which provides a forum for the world’s leading clinical researchers in CAR T-cell therapy to share perspectives on the evolving understanding of this cell therapy in a clinical context and provide key learnings to help optimize clinical care.

About MB-106 (CD20-targeted autologous 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 at Fred Hutch, and exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody, and MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the planned multicenter phase 1/2 clinical trial to be initiated shortly under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on the trial can be found at using the identifier NCT03277729.

Oncolytics Biotech® to Present at the Bloom Burton & Co. Healthcare Investor Conference

ON April 21, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that Dr. Matt Coffey, President and Chief Executive Officer, will be presenting a corporate overview at the Bloom Burton & Co. Healthcare Investor Conference, which is taking place May 2-3, 2022 at the Metro Toronto Convention Centre, North Building in Toronto, Ontario (Press release, Oncolytics Biotech, APR 21, 2022, View Source [SID1234612843]). Additional details on the presentation can be found below.

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Date: Tuesday, May 3, 2022
Time: 11:00 a.m. ET
Location: Metro Toronto Convention Centre, North Building Hall B
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a meeting request on the conference website, contact your Bloom Burton & Co. representative, or email [email protected].

A live webcast of the Company’s presentation will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months.

About the Conference
The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.