Mustang Bio - MBIO STOCK NEWS

Mustang Bio (NASDAQ: MBIO) will host a key opinion leader call on December 9, 2020, at 1:00 p.m. EST to present interim Phase 1/2 data on MB-106, an innovative CAR T cell therapy targeting relapsed or refractory B-cell non-Hodgkin lymphoma. The call will feature Drs. Mazyar Shadman and Brian Till from Fred Hutchinson Cancer Research Center, discussing clinical findings and a modified cell manufacturing process. Additionally, Mustang will provide a corporate update and address audience questions following the presentations.

Mustang Bio (NASDAQ: MBIO) received a positive opinion from the European Commission for Orphan Drug Designation for its lentiviral gene therapy targeting X-linked severe combined immunodeficiency (XSCID). This designation applies to both MB-107 and MB-207 therapies. Key advantages include protocol assistance and 10 years of market exclusivity in the EU. Mustang is preparing for pivotal clinical trials for these treatments and expects to initiate them soon. Additionally, an agreement with Minaris Regenerative Medicine enables GMP manufacturing for clinical trials in Europe.

Mustang Bio (NASDAQ: MBIO) has partnered with Minaris Regenerative Medicine for the GMP clinical manufacturing of its MB-107 lentiviral gene therapy targeting X-linked severe combined immunodeficiency (XSCID) in Europe. The collaboration will facilitate technology transfer and support clinical trials for this rare genetic disorder, which affects 1 in 225,000 births. MB-107 is currently in Phase 1/2 trials in the U.S. with plans for a pivotal trial in Europe. Mustang aims to provide this therapy to patients internationally, targeting topline data by late 2022.

Mustang Bio, Inc. (NASDAQ: MBIO) reported its third-quarter financial results for 2020, highlighting significant regulatory achievements. The FDA granted Rare Pediatric and Orphan Drug Designations for its gene therapy candidates MB-107 and MB-207 to treat X-linked severe combined immunodeficiency (XSCID). Mustang noted promising clinical progress in CAR T cell therapies, particularly with MB-106, showing efficacy without toxicity in non-Hodgkin lymphoma patients. Financially, Mustang's cash reserves decreased from $86.4 million to $76.3 million year-over-year, and the net loss increased to $13.0 million, or $0.23 per share.

Mustang Bio (NASDAQ: MBIO) announced that interim data on MB-106, a CAR T cell therapy for relapsed or refractory B-cell non-Hodgkin lymphoma, will be presented at the 62nd ASH Annual Meeting. The data includes responses from four patients treated after a manufacturing revision, showing two complete and one partial remission. The therapy demonstrated an encouraging safety profile, with no dose-limiting toxicities and only one case of cytokine release syndrome. Mustang aims to provide further updates on additional patients treated since the revision.

Mustang Bio (NASDAQ: MBIO) announced the presentation of promising data from a Phase 1 trial on MB-105, a CAR T therapy targeting prostate cancer. Conducted by Dr. Tanya Dorff at City of Hope, the trial showed a remarkable 94% reduction in prostate-specific antigen (PSA) in a 73-year-old male patient after failing eight prior therapies. The treatment resulted in near-complete reduction of metastasis and was manageable regarding cytokine release syndrome. Mustang's CEO expressed optimism for further trial progress and additional data expected in 2021.

Mustang Bio, Inc. (NASDAQ: MBIO) announced that initial Phase 1 data on their PSCA-targeted CAR T therapy, MB-105, will be presented at the virtual 27th Annual Prostate Cancer Foundation Scientific Retreat from October 20-23, 2020. This therapy targets patients with PSCA-positive metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 trial can enroll up to 33 patients, focusing on side effects and optimal dosing, with secondary endpoints assessing treatment response and survival outcomes. The data presentation will take place on October 23, 2020.

Mustang Bio has entered a licensing agreement with SIRION Biotech to use LentiBOOST™ technology in developing MB-207, a lentiviral gene therapy targeting patients with X-linked severe combined immunodeficiency (XSCID). The agreement includes an undisclosed upfront payment, milestone payments, and royalties on future sales. Mustang aims to file an IND with the FDA to start a pivotal Phase 2 trial for MB-207 in the coming months, building on prior clinical research. The therapy is expected to improve clinical outcomes in patients needing re-treatment post-hematopoietic stem cell transplantation.

Mustang Bio (NASDAQ: MBIO) announced that its CEO, Manuel Litchman, will participate in a fireside chat at Chardan's Virtual 4th Annual Genetic Medicines Conference on October 5, 2020, at 1:00 p.m. EDT. The live chat can be accessed via Mustang's Investor Relations page, with an archived replay available for 30 days post-event. Mustang Bio focuses on developing cell and gene therapies for hematologic cancers, solid tumors, and rare genetic diseases, collaborating with top medical institutions to advance CAR T therapies and gene therapy for XSCID.