Blueprint Medicines Announces Lift of Partial Clinical Hold on Phase 1/2 VELA Trial of BLU-222

Blueprint Medicines Corporation (NASDAQ: BPMC) announced the lifting of a partial clinical hold on its Phase 1/2 VELA trial for BLU-222 by the FDA as of March 28, 2023.

Rhea-AI Summary

Blueprint Medicines Corporation (NASDAQ: BPMC) announced the lifting of a partial clinical hold on its Phase 1/2 VELA trial for BLU-222 by the FDA as of March 28, 2023. This decision follows a previous hold on February 10, 2023 due to reports of visual adverse events in some patients. The company is now working with trial sites to resume patient enrollment, having updated adverse event monitoring protocols. Chief Medical Officer Becker Hewes expressed confidence in BLU-222's potential, emphasizing plans to present initial dose escalation data in the second quarter of 2023.

Positive

• FDA lifted partial clinical hold on VELA trial, allowing patient enrollment to resume.
• Company is confident in the potential of BLU-222 for treating cancers vulnerable to CDK2 inhibition.
• Upcoming presentation of initial dose escalation data expected in Q2 2023.

Negative

• Partial clinical hold previously imposed due to adverse visual events in trial participants.

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CAMBRIDGE, Mass., March 28, 2023 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC) today announced that the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on the Phase 1/2 VELA trial of BLU-222.

On February 10, 2023, Blueprint Medicines announced the FDA placed a partial clinical hold on the VELA trial due to reported visual adverse events, consisting of transient, reversible episodes of light sensitivity and blurred vision, observed in a limited number of patients. Patients already enrolled in the trial have continued receiving study drug. The partial clinical hold is lifted as of March 28, and Blueprint Medicines is working with trial sites to reinitiate patient enrollment.

"With a focus on patient safety, we have worked diligently with the FDA over the last several weeks to resolve the partial clinical hold by updating adverse event monitoring and management procedures. We will now collaborate closely with investigators to resume patient enrollment," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "We are confident in the potential of BLU-222 to improve outcomes in patients with cancers vulnerable to CDK2 inhibition, and we look forward to presenting initial dose escalation data from the VELA trial in the second quarter of 2023."

About Blueprint Medicines

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering our approved medicines to patients in the United States and Europe, and we are globally advancing multiple programs for systemic mastocytosis, lung cancer, breast cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the continuation of participants in Blueprint Medicines' VELA trial, Blueprint Medicines' ability to resume enrollment in the VELA trial, Blueprint Medicines' expectations regarding the benefit-risk profile of BLU-222, the potential of Blueprint Medicines' current or future drug candidates in treating patients with cancers vulnerable to CDK2 inhibition, and the anticipated timing of initial clinical data from the VELA trial. The words "aim," "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: the risk that the partial clinical hold may or may not impact the timing of presentation of initial dose escalation data; the amendments to the trial protocol may impact the timing of the trial or evaluation of the data; preliminary activity and safety data may not be representative of more mature data; the ongoing COVID-19 pandemic may impact Blueprint Medicines' business, operations, strategy, goals and anticipated milestones, including ongoing and planned research and discovery activities, Blueprint Medicines' ability to conduct ongoing and planned clinical trials, or the supply of its current or future drug candidates; the risk of delay of any current or planned clinical trials or the development of our current or future drug candidates; risks related to Blueprint Medicines' ability to successfully demonstrate the safety and efficacy of Blueprint Medicines' drug candidates and gain approval of its drug candidates on a timely basis, if at all; preclinical and clinical results for Blueprint Medicines' drug candidates may not support further development of such drug candidates either as monotherapies or in combination with other agents or may impact the anticipated timing of data or regulatory submissions; the timing of the initiation of clinical trials and trial cohorts at clinical trial sites and patient enrollment rates may be delayed or slower than anticipated; actions of regulatory agencies may affect the initiation, timing and progress of clinical trials; risks related to Blueprint Medicines' ability to obtain, maintain and enforce patent and other intellectual property protection for its products and current or future drug candidates; and the success of Blueprint Medicines' current and future collaborations, financing arrangements, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Blueprint Medicines' filings with the Securities and Exchange Commission (SEC), including Blueprint Medicines' most recent Annual Report on Form 10-K, as supplemented by its most recent Quarterly Report on Form 10-Q and any other filings that Blueprint Medicines has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Blueprint Medicines' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Blueprint Medicines explicitly disclaims any obligation to update any forward-looking statements.

Trademarks

Blueprint Medicines and associated logos are trademarks of Blueprint Medicines Corporation.

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SOURCE Blueprint Medicines Corporation

FAQ

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What is the VELA trial for BLU-222 by Blueprint Medicines?

The VELA trial is a Phase 1/2 clinical trial evaluating the safety and efficacy of BLU-222 in patients with cancers vulnerable to CDK2 inhibition.

When was the partial clinical hold on the VELA trial lifted?

The FDA lifted the partial clinical hold on the VELA trial on March 28, 2023.

What were the reasons for the partial clinical hold on the VELA trial?

The partial clinical hold was placed due to reported visual adverse events, including light sensitivity and blurred vision, in a limited number of patients.

What are the next steps for Blueprint Medicines after lifting the clinical hold?

Blueprint Medicines is working with trial sites to resume patient enrollment in the VELA trial.

When can investors expect initial data from the VELA trial?

Initial dose escalation data from the VELA trial is anticipated to be presented in the second quarter of 2023.