Mustang Bio, Inc. - MBIO STOCK NEWS

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.

Mustang Bio has initiated a Phase 1/2 clinical trial for its MB-102 (CD123-targeted CAR T cell therapy) on patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, acute myeloid leukemia, and high-risk myelodysplastic syndrome. The trial aims to assess safety, maximum tolerated doses, and efficacy, with outcomes measured at 28 days post-infusion. This marks a significant milestone for Mustang, being the first trial using cells processed in their own facility. Additional details are available on clinicaltrials.gov.

Mustang Bio (NASDAQ: MBIO) announced that the FDA granted Orphan Drug Designation to MB-207, its lentiviral gene therapy for X-linked severe combined immunodeficiency (XSCID) patients previously treated with hematopoietic stem cell transplantation (HSCT). This designation provides incentives including tax credits and market exclusivity for seven years upon FDA approval. Mustang plans to initiate pivotal clinical trials for MB-207 in Q4 2020, targeting this rare disease that affects 1 in 225,000 births. MB-207 is currently in a Phase 1/2 clinical trial.

Mustang Bio (NASDAQ: MBIO) announced that the FDA granted Rare Pediatric Disease Designation to MB-207, a lentiviral gene therapy for X-linked severe combined immunodeficiency (XSCID). This designation is for patients previously treated with hematopoietic stem cell transplantation (HSCT) who require re-treatment. If Mustang's Biologics License Application is approved, it may qualify for a priority review voucher. MB-207 is undergoing a Phase 1/2 trial for patients over two years old at the NIH, with an IND filing for a multi-center Phase 2 trial expected in Q4 2020.

Mustang Bio (NASDAQ: MBIO) reported its Q2 2020 financial results, revealing a net loss of $14.6 million or $0.32 per share, up from $10.4 million or $0.29 per share in Q2 2019. The company raised approximately $37.2 million through a public offering in June 2020. Mustang continues to advance its clinical pipeline, initiating a Phase 1/2 trial for its MB-102 CAR T cell therapy. Furthermore, the company anticipates filing for its MB-207 gene therapy trial by Q4 2020, targeting topline data in the second half of 2022. As of June 30, 2020, cash reserves totaled $86.4 million.