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Background
Old News
Recent Developments
Upcoming Catalyst
Technicals/Notes
Background
- A clinical-stage biopharma company focused on advancing cell and gene therapies to cure certain types of blood cancers and genetic diseases
- Lead assets (MB-207 and MB-107)= in two pivotal P2 studies as a potential cure for a rare genetic disorder called X-linked severe combined immunodeficiency (XSCID)
- MB-107= for newly diagnosed XSCID patients
- MB-107= for patients previously untreated with hematopoietic stem cell transplantation (HSCT)
- Lead assets (MB-207 and MB-107)= in two pivotal P2 studies as a potential cure for a rare genetic disorder called X-linked severe combined immunodeficiency (XSCID)
- Its developmental approach involves in-licensing assets to mitigate discovery risk, using next-generation technology, partnering with leading academic institutions, and leveraging its “unrivaled” manufacturing capabilities
Old News
- Was granted Rare Pediatric Disease Designation to MB-207; 8/31/20
- MB-207 was granted Orphan Drug Designation (ODD) for the treatment of severe XSCID; 9/22/20
- Licensed the rights to use SIRION Biotech’s LentiBOOST™ technology for developing MB-207 for severe XSCID; 10/6/20
- Terms were undisclosed by SIRION received cash upfront and is eligible for milestones and royalties on any future sales
- Signed a technology transfer agreement with Minaris Regenerative Medicine GmbH enabling GMP clinical manufacturing of MB-107; 11/23/20
- Received a positive opinion from the European Medicines Agency (EMA) towards its ODD application for MB-207 as a treatment for XCSID; 11/24/20
- Presented interim P1/2 data for its CAR-T therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) at a medical conference (ASH); 12/7/20
- Reported 89% overall response rate and 44 % complete response rate
Recent Developments
- FDA lifted the clinical hold on its P2 clinical trial of MB-107; 2/2/21
- The first patient was expected to enroll in 2Q21
- Clinical outcomes in investigator-IND XSCID trials continue to show compelling efficacy
- IND application to test MB-106 in a P1/2 study in blood cancer was approved by the FDA; 5/10/21
- Shaed updated interim P1/2 data for MB-106 in blood cancer; 6/11/21
- 93% overall response rate and 67% complete response rate
- Hosted a KOL webinar to discuss MB-106’s potential as a CAR-T cell therapy; 6/15/21
- Click here to listen to the recording
- Highlights from 1Q21 financial results/business update; 5/14/21
- Announced encouraging clinical updates for MB-107 and MB-207 as treatments for XSCID
- Observed consistent safety/efficacy data pertaining to its gene therapies more than 8-years after the first patient was treated in 2012
- Strong financials with $130M in cash as of 3/31/21 and total opex of $15M in 1Q21
Upcoming Catalyst
- Potential investor conferences in September
- 2Q21 financial results/business update (~8/9/21)
- Potential data updates at medical conferences in 2H21 (Sept-Dec)
Technicals/Notes
Coming soon
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