Press Release Details

Magenta Therapeutics Announces First Subjects Dosed in Phase 1 Clinical Trial of MGTA-145, a First-Line Stem Cell Mobilization Product Candidate

April 24, 2019

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 24, 2019-- Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, today announced that it has dosed the first subjects in a Phase 1 study of MGTA-145. Magenta intends to develop MGTA-145 in autoimmune diseases, blood cancers and genetic diseases.

More than 85 percent of the 65,000 transplants in the US and Europe each year use mobilized hematopoietic stem cells as a cell source. MGTA-145 is a biologic chemokine factor that Magenta is developing as a first-line therapy for stem cell mobilization. MGTA-145 is designed to enable single-day mobilization and collection of high numbers of stem cells without G-CSF, the current standard of care. MGTA-145 works synergistically with plerixafor, another stem cell mobilization product.

The Phase 1 study will investigate the safety and tolerability of MGTA-145 alone and in combination with plerixafor in healthy volunteers and establish recommended Phase 2 doses. The study will also measure the number of hematopoietic stem cells in the blood after dosing with MGTA-145 alone and in combination with plerixafor.

“There is a clear need for a better first-line stem cell mobilization agent for both patients and donors that does not involve the use of G-CSF,” said John DiPersio, M.D., Ph.D., Professor of Medicine, Washington University School of Medicine. “G-CSF requires five to seven days of injections in order to provide adequate numbers of stem cells for transplant. There are significant side effects associated with G-CSF, including severe bone pain that may require the use of narcotic pain medications. A significant portion of patients do not mobilize an adequate number of stem cells with G-CSF alone and require a second drug and more days of stem cell collection. Further, approximately fifty percent of donors decline to donate for patients undergoing allogeneic transplant, in part because of the burden associated with donation with current mobilization regimens.”

“MGTA-145 was developed based on our understanding of the physiological mechanisms that control stem cell mobilization. Preclinical data suggest that MGTA-145 in combination with plerixafor could reliably provide a robust number of stem cells in a single day for both autologous and allogeneic stem cell transplant. The cells that are mobilized have been shown to contain a large number of high-quality stem cells, which is associated with better disease outcomes,” said John Davis, M.D., M.P.H., Chief Medical Officer, Magenta Therapeutics. “We believe that MGTA-145 has the potential to become a new first-line standard of care for stem cell mobilization that could improve stem cell collection for more patients and donors.”

Forward-Looking Statement
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions can be used to identify forward-looking statements.

The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other risks set forth under the caption “Risk Factors” in Magenta’s Registration Statement on Form S-1, as updated by Magenta’s most recent Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Magenta believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.

Moreover, except as required by law, neither Magenta nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Source: Magenta Therapeutics

Magenta Therapeutics:
Manisha Pai, Vice President, Communications & Investor Relations

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