On August 4, 2022 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines designed to bring the curative power of stem cell transplant to more patients, reported financial results for the second quarter ending June 30, 2022, and recent program highlights (Press release, Magenta Therapeutics, AUG 4, 2022, View Source [SID1234617583]).
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"We continue to execute across the portfolio while maintaining our prioritized spending and program investment. We look forward to collecting additional data from multiple cohorts in our MGTA-117 Phase 1/2 dose escalation clinical trial and plan to disclose interim results in Q4 2022," said Jason Gardner, President and Chief Executive Officer of Magenta Therapeutics. "As our CD45 antibody drug conjugate program continues to progress with concept-validating preclinical data, we expect to be able to provide an overview of the program’s clinical development plan and its anticipated timelines later this year as well. Finally, we are excited about initiating the MGTA-145 stem cell mobilization clinical trial in sickle cell disease at leading research hospitals to understand MGTA-145’s potential for better mobilization that could result in better outcomes for patients with this debilitating disease."
Program Highlights:
MGTA-117 Phase 1/2 Clinical Trial Progression and Data Disclosure Expectations
MGTA-117 is Magenta’s most advanced targeted conditioning product candidate. The program is in a Phase 1/2 clinical trial in patients with relapsed/refractory acute myeloid leukemia, or AML, and myelodysplastic syndromes, or MDS. MGTA-117 is an anti-CD117 antibody conjugated to an amanitin payload, and it is designed to target CD117, also known as c-Kit, which is highly expressed on hematopoietic stem cells and leukemic cells.
The MGTA-117 clinical trial continues to make progress with additional clinical trial site activations, patient identification, patient screening and enrollment.
Magenta expects clinical data from additional dose-escalation cohorts will support its earlier reported clinical observations from Cohort 1, which indicated evidence of MGTA-117’s potential to bind CD117+ cells, reduce CD117+ erythroid progenitor cells in the bone marrow, reduce leukemic blasts in the bone marrow, rapidly clear the body and maintain a favorable tolerability profile.
Magenta expects to report interim clinical data from multiple dose-escalation cohorts from the clinical trial in Q4 2022.
Magenta anticipates using the interim clinical data from this trial to engage with regulatory authorities to plan for the transition of the trial into transplant-eligible AML patients. Although the timing and scope of the discussion with regulators will be determined by the available clinical data, Magenta anticipates engagement with regulators in Q4 2022.
Magenta also expects the interim clinical data to inform next steps towards development of MGTA-117 as a conditioning agent for autologous gene therapy, including existing clinical collaboration partnerships in hemoglobinopathies and lysosomal storage disorders, with Beam Therapeutics and AVROBIO, Inc. respectively.
Magenta will participate in both the BTIG 2022 Virtual Biotechnology Conference on Monday, August 8th, 2022 and the Gene Modulation Panel Discussion at the 2022 Wedbush PacGrow Healthcare Conference, to be held virtually, on Tuesday, August 9th, 2022 at 9:45 a.m. ET. A live webcast of the Gene Modulation Panel can be accessed via the Magenta Therapeutics website at View Source
CD45-Antibody Drug Conjugate (ADC): Second Targeted Conditioning Program
CD45 is broadly expressed on hematopoietic cells and Magenta’s CD45-ADC is designed to selectively target and deplete both stem cells and lymphocytes, and is intended to enable patients with blood cancers and autoimmune diseases to avoid the use of chemotherapy prior to stem cell transplant.
Magenta has recently completed the in-life portion of a dose-ranging toxicology study and will use the resulting data to inform dosing for its planned GLP toxicology study. Other IND-enabling activities and plans are ongoing. Magenta expects to provide a further update on the CD45 program in Q4 2022.
MGTA-145 Stem Cell Mobilization and Collection
Magenta is developing MGTA-145, in combination with plerixafor, to improve the process by which stem cells are stimulated out of the bone marrow and into the bloodstream, so they are available for collection for future re-infusion, known as stem cell mobilization, which is required for all transplants and ex vivo gene therapy applications.
Magenta has initiated a Phase 2 clinical trial in sickle cell disease (SCD) at multiple clinical trial sites. The clinical trial operates in collaboration with bluebird bio to evaluate the utility of MGTA-145, in combination with plerixafor, for the mobilization and collection of stem cells in patients with SCD where mobilization and collection are difficult and there is a clear unmet medical need. Magenta expects initial data from this trial in Q4 2022.
Financial Results:
Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2022, were $139.4 million, compared to $176.9 million as of December 31, 2021. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund its current operational plan into Q2 2024.
Research and Development Expenses: Research and development expenses were $11.6 million in the second quarter of 2022, compared to $11.1 million in the second quarter of 2021. The increase was driven primarily by higher preclinical and manufacturing costs to support our IND enabling studies for CD45-ADC, offset by a decrease in costs related to our completed Phase 2 investigator-initiated clinical trial in multiple myeloma patients.
General and Administrative Expenses: General and administrative expenses were $6.5 million for both the second quarter of 2022 and the second quarter of 2021.
Net Loss: Net loss was $17.3 million for the second quarter of 2022, compared to net loss of $16.9 million for the second quarter of 2021.