On March 8, 2022 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines designed to bring the curative power of stem cell transplants to more patients, reported financial results for the fourth quarter and full-year ended December 31, 2021, and recent program highlights (Press release, Magenta Therapeutics, MAR 8, 2022, View Source [SID1234609650]).
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"We expect 2022 will be a year of trial execution and value-creating data readouts, and we are particularly pleased to have dosed our first patient in the MGTA-117 clinical trial," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "The first patient has completed the initial safety assessment period which allows for additional patients to be dosed in the cohort. We anticipate sharing further information on this dose-escalation trial in 2022. Earlier this year, we announced our second targeted conditioning program, a CD45 antibody-drug conjugate, and expect to provide important IND-enabling preclinical data for the program in the second half of 2022. We are also advancing our preparations for the MGTA-145 stem cell mobilization program in sickle cell disease and optimization of dosing and administration. We believe our portfolio of programs has the potential to address a broad spectrum of diseases including hematology-oncology, rare genetic diseases, and autoimmune diseases and we look forward to advancing them for improved patient outcomes."
2021 Highlights and Recent Program Progress:
MGTA-117: Targeted Conditioning
The first patient has been dosed and has completed the initial safety assessment in the Phase 1/2 clinical trial in patients with relapsed/refractory acute myeloid leukemia and myelodysplasia-excess blasts. Additional patients may now be dosed in the first cohort of this dose-escalation clinical trial, which is open for recruitment at multiple centers. The trial will evaluate the tolerability, pharmacokinetics, pharmacodynamics, and safety following a single dose of MGTA-117, which includes target engagement, drug clearance, cell depletion, and safety measurements. Data are expected this year.
2021 Data Highlights:
2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: An oral presentation described a successful anti-CD-117 antibody-drug conjugate (ADC) targeted conditioning regimen contributed to a successful transplant of gene-modified stem cells in primates with durable engraftment. A poster presentation described preclinical mouse data that supports the use of a CD117-targeted ADC in combination with lymphodepletion to condition prior to allogeneic hematopoietic stem cell (HSC) transplant.
2021 Transplantation and Cellular Therapy (TCT) Annual Meeting and the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting: Announced preclinical data showing MGTA-117 increased median survival in murine models of acute myeloid leukemia as compared head-to-head with a multi-day, standard-of-care regimen using cytarabine.
CD45-ADC: Second Targeted Conditioning Program
Magenta has initiated investigational new drug (IND) application-enabling studies with data from a dose-ranging toxicology study expected in the second half of 2022. Due to the expression of CD45 on stem cells and immune cells, Magenta’s CD45-ADC is designed to selectively target and deplete stem cells and lymphocytes, which could allow patients with autoimmune diseases and blood cancers to avoid the use of chemotherapy prior to stem cell transplant.
2021 Data Highlights:
2021 TCT Annual Meeting: A poster presentation showed conditioning with single-agent CD45-ADC enabled complete chimerism in a full mismatch allogeneic HSC transplant murine model.
MGTA-145: Stem Cell Mobilization and Collection for Hematopoietic Stem Cell Transplantation and Gene Therapy
We are currently advancing our preparations for the MGTA-145 stem cell mobilization program in clinical trials in sickle cell disease and optimization of dosing and administration in healthy subjects with data expected in the second half of 2022.
2021 Data Highlights:
2021 ASH (Free ASH Whitepaper) Annual Meeting: A poster presentation described a Phase 2 investigator-initiated clinical study with multiple myeloma patients that showed MGTA-145, in combination with plerixafor, mobilized a sufficient number of stem cells for autologous transplantation. All patients who underwent transplantation had successful engraftment and all patients followed to day 100 post-transplantation showed durable engraftment. The regimen was generally well-tolerated.
Upcoming Events:
Participating in the Cell Therapy Panel Discussion at the Cowen Healthcare Conference on Wednesday, March 9, 2022, at 9:10 am. A live webcast will be available on the Investors & Media section of Magenta’s website at View Source
Presenting at EBMT Annual Meeting on March 22, 2022, two encore posters:
Single Agent CD117-Targeted Antibody Drug Conjugate in Combination with Lympho-Depleting Antibodies Enables Allogenic Hematopoietic Stem Cell Transplantation in Mice without Chemotherapy or Radiation, Program code P688
CD117 Antibody Drug Conjugate-Based Conditioning Enables Efficient Engraftment of Gene-Modified CD34+ Cells in a Rhesus Gene Therapy Model, Program code P689
Presenting at the TCT Meeting, April 26, 2022, an oral encore presentation entitled:
MGTA-145 + Plerixafor Provides GSCF-Free Rapid and Reliable Hematopoietic Stem Cell Mobilization for Autologous Stem Cell Transplant in Patients with Multiple Myeloma: A Phase 2 Study
Financial Results:
Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2021, were $176.9 million, compared to $148.8 million as of December 31, 2020. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the fourth quarter of 2023.
Research and Development Expenses: Research and development expenses were $13.1 million in the fourth quarter of 2021, compared to $12.3 million in the fourth quarter of 2020. The increase was driven primarily by increased process development activities to support future manufacturing for MGTA-145 offset by a decrease in manufacturing costs related to activities supporting our IND application that was filed in June 2021. The increase was also due to an increase in research and development headcount.
General and Administrative Expenses: General and administrative expenses were $7.0 million for the fourth quarter of 2021, compared to $6.8 million for the fourth quarter of 2020.
Net Loss: Net loss was $19.3 million for the fourth quarter of 2021, compared to net loss of $18.2 million for the fourth quarter of 2020.