Vor Bio Initiates In-house Clinical Manufacturing at Cambridge, MA Headquarters

Rhea-AI Summary

Vor Bio has opened a new in-house clinical manufacturing facility in Cambridge, MA, to enhance the production of engineered hematopoietic stem cells (eHSCs) and CAR-T therapies targeting blood cancers. This facility aims to improve integration across teams, reduce manufacturing time and cost, and boost operational efficiency for ongoing clinical trials. The facility includes four cleanrooms and is designed to comply with Good Manufacturing Practice (cGMP) standards. The company plans to support the IND submission for VCAR33 by mid-2023.

Positive

• New in-house clinical manufacturing facility enhances production capabilities.
• Facility co-located with headquarters improves team integration.
• Potential reduction in manufacturing time and costs for clinical trials.
• Designed to meet cGMP standards, ensuring quality for product candidates.

Negative

• None.

Facility to support clinical manufacturing for Vor Bio’s novel cell and genome engineering pipeline while reducing the time and cost required to manufacture its eHSC and CAR-T product candidates

CAMBRIDGE, Mass., Sept. 28, 2022 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today announced the opening of its new in-house clinical manufacturing facility in Cambridge, Mass. co-located in the Company’s current headquarters. The new facility is designed to support Vor Bio’s development of potentially transformative engineered hematopoietic stem cells (eHSCs) and CAR-T cell therapeutic candidates for patients with blood cancers.

Investment in internal manufacturing is a key competitive advantage for cell and gene therapy companies. The ability to co-locate the facility at the Company’s Cambridge, headquarters improves integration and collaboration across teams and is ideal for attracting talent. The Vor Bio facility will enable end-to-end oversight of drug product for planned clinical trials, initially manufacturing clinical supply to support the IND for VCAR33^allo, which is on-track for submission in the first half of 2023. The Company also plans to technology transfer the production of VOR33 to the site.

“Initiating manufacturing at our own in-house facility represents an exciting and important milestone for Vor Bio,” said Michael Pinaud, Head of GMP Operations. “Integrating internal research, process development, analytical development, manufacturing, and quality control testing capabilities under one roof, enables us to provide efficient transfer of knowledge and maintain strategic control of manufacturing capacity, and reduce the time and cost required to manufacture complex cell therapy clinical candidates.”

Internalizing manufacturing has been a key part of Vor Bio’s strategy to increase efficiency and control and decrease overall expenditure of its manufacturing process. This may translate into higher scalability, a lower cost of goods, and optimized turnaround times for integration into routine clinical practice.

Vor Bio has completed construction and initiated operations in a multi-product facility made up of four cleanrooms in ballroom-style configurations, alongside two quality control laboratories, six process and analytical laboratories, and associated warehouse space. The facility has been designed to be current Good Manufacturing Practice (cGMP) compliant.

The new clinical manufacturing facility is part of a recently expanded lease agreement that contributes to the Company’s increasing footprint in Cambridge.

About Vor Bio
Vor Bio is a clinical-stage cell and genome engineering company that aims to change the standard of care for patients with blood cancers by engineering hematopoietic stem cells to enable targeted therapies post-transplant. For more information, visit: www.vorbio.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “plan,” “potential,” “project,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio’s statements regarding its upcoming milestones, including timing with respect to initial clinical data for VOR33, submission of an IND for the VCAR33^ALLO program, receipt of data from the Phase 1/2 NMDP-sponsored trial evaluating VCAR33^AUTO, the submission of an IND for the VOR33 + VCAR33 Treatment System, the impact of its in-house clinical manufacturing facility being operational on its manufacturing costs and capacity and recruitment efforts, as well as its cash, cash equivalents and investments, cash runway and expected capital requirements. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: Vor Bio’s ability to successfully integrate research, process development, analytical development, manufacturing, and quality control testing capabilities at its new in-house clinical manufacturing facility; its ability to successfully transfer its technology to this facility; its ability to maintain strategic control of this facility; the actual impact of this facility being operational on its manufacturing costs and capacity and recruitment efforts; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of its product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.

Contact: 
Investors & Media
Sarah Spencer
+1 857-242-6076 
sspencer@vorbio.com

FAQ

What is the purpose of Vor Bio's new facility opened in September 2022?

The new facility supports clinical manufacturing for engineered hematopoietic stem cells and CAR-T therapies, aiming to reduce production time and costs.

What therapies is Vor Bio focusing on with its new manufacturing facility?

Vor Bio is focusing on engineered hematopoietic stem cells (eHSCs) and CAR-T cell therapies for blood cancers.

When is Vor Bio planning to submit the IND for VCAR33?

Vor Bio plans to submit the IND for VCAR33 in the first half of 2023.

How does Vor Bio's new facility impact its manufacturing process?

The facility allows for end-to-end oversight, integration of research and manufacturing, and aims to reduce overall costs and improve scalability.

What compliance standards does Vor Bio's new facility meet?

The facility is designed to be compliant with Good Manufacturing Practice (cGMP) standards.