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Mustang (MBIO) Soars 477% on Data From Rare Blood Cancer Study
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Mustang Bio (MBIO - Free Report) reported updated results from a cohort of an ongoing phase I/II study evaluating its lead clinical candidate MB-106 in patients with Waldenstrom macroglobulinemia (WM), a rare form of blood cancer.
Data from the study showed that treatment with MB-106 exhibited a favorable safety and efficacy profile in WM patients, all (n=10) of whom were heavily pre-treated/refractory to BTK inhibitors.
Per management, participants treated with MB-106 achieved an overall response rate (ORR) of 90%, including three complete responses (CR) and six partial responses. The last patient achieved stable disease. One of the patients who achieved CR remains in remission at 31 months, with an immunoglobulin M (IgM) level that declined rapidly to the normal range after treatment with MB-106. The therapy also achieved a favorable safety profile in these patients.
Mustang Bio presented the above results at the European Hematology Association 2024 Hybrid Congress (EHA2024).
Post the above announcement, the share price rose nearly 477% on Jun 17. Investors were impressed with the safety and efficacy results, as it showed that treatment with MB-106 has the potential to improve the quality of responses over time. These results are also an improvement over those announced last year in June. At the time, the study had enrolled only six patients who achieved an ORR of 83%, including two CRs.
Year to date, Mustang Bio’s stock has lost 44.4% compared with the industry’s 7.1% fall.
Currently, there are no FDA-approved CAR T treatments for WM indication. Mustang believes that MB-106 has the potential to address a significant unmet need. The FDA granted orphan drug designation to MB-106 in WM indication in 2022.
If approved, MB-106 will also be the first FDA-approved therapy or standard of care for WM patients in the third-line setting.
A CD20-targeted autologous CAR T cell therapy, MB-106, is being developed in the above-mentioned phase I/II study to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (B-NHLs) and chronic lymphocytic leukemia (CLL). Management also intends to expand the therapy’s potential in autoimmune indications, with an early-stage study planned to start before this year’s end.
A popular drug approved in WM indication is Imbruvica, which is jointly marketed by pharma giants J&J (JNJ - Free Report) and AbbVie (ABBV - Free Report) . The AbbVie-J&J partnered drug was the first FDA-approved therapy in WM indication. A BTK inhibitor, AbbVie/J&J’s Imbruvica is also approved by the FDA in CLL and small lymphocytic lymphoma (SLL) indications.
ABBV and J&J co-exclusively market Imbruvica in the United States. However, J&J has an exclusive license to market the drug outside the United States and shares profits from the drug’s ex-U.S. sales with AbbVie.
Another drug approved to treat WM is Brukinsa, which is marketed by BeiGene (BGNE - Free Report) . Also a BTK inhibitor, the BeiGene drug is approved to treat other indications like CLL, SLL, mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Image: Bigstock
Mustang (MBIO) Soars 477% on Data From Rare Blood Cancer Study
Mustang Bio (MBIO - Free Report) reported updated results from a cohort of an ongoing phase I/II study evaluating its lead clinical candidate MB-106 in patients with Waldenstrom macroglobulinemia (WM), a rare form of blood cancer.
Data from the study showed that treatment with MB-106 exhibited a favorable safety and efficacy profile in WM patients, all (n=10) of whom were heavily pre-treated/refractory to BTK inhibitors.
Per management, participants treated with MB-106 achieved an overall response rate (ORR) of 90%, including three complete responses (CR) and six partial responses. The last patient achieved stable disease. One of the patients who achieved CR remains in remission at 31 months, with an immunoglobulin M (IgM) level that declined rapidly to the normal range after treatment with MB-106. The therapy also achieved a favorable safety profile in these patients.
Mustang Bio presented the above results at the European Hematology Association 2024 Hybrid Congress (EHA2024).
Post the above announcement, the share price rose nearly 477% on Jun 17. Investors were impressed with the safety and efficacy results, as it showed that treatment with MB-106 has the potential to improve the quality of responses over time. These results are also an improvement over those announced last year in June. At the time, the study had enrolled only six patients who achieved an ORR of 83%, including two CRs.
Year to date, Mustang Bio’s stock has lost 44.4% compared with the industry’s 7.1% fall.
Currently, there are no FDA-approved CAR T treatments for WM indication. Mustang believes that MB-106 has the potential to address a significant unmet need. The FDA granted orphan drug designation to MB-106 in WM indication in 2022.
If approved, MB-106 will also be the first FDA-approved therapy or standard of care for WM patients in the third-line setting.
A CD20-targeted autologous CAR T cell therapy, MB-106, is being developed in the above-mentioned phase I/II study to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (B-NHLs) and chronic lymphocytic leukemia (CLL). Management also intends to expand the therapy’s potential in autoimmune indications, with an early-stage study planned to start before this year’s end.
A popular drug approved in WM indication is Imbruvica, which is jointly marketed by pharma giants J&J (JNJ - Free Report) and AbbVie (ABBV - Free Report) . The AbbVie-J&J partnered drug was the first FDA-approved therapy in WM indication. A BTK inhibitor, AbbVie/J&J’s Imbruvica is also approved by the FDA in CLL and small lymphocytic lymphoma (SLL) indications.
ABBV and J&J co-exclusively market Imbruvica in the United States. However, J&J has an exclusive license to market the drug outside the United States and shares profits from the drug’s ex-U.S. sales with AbbVie.
Another drug approved to treat WM is Brukinsa, which is marketed by BeiGene (BGNE - Free Report) . Also a BTK inhibitor, the BeiGene drug is approved to treat other indications like CLL, SLL, mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Zacks Rank
Mustang Bio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.