Rubius Therapeutics Announces Strategic Update
Company to Focus on Advancing Next Generation Red Blood Cell-Based Cell Conjugation Platform
Initiating Cost-Saving Measures Through Corporate Restructuring; Cash Runway Extended to End of 2023
Discontinuing Ongoing Phase 1 Clinical Trials of RTX-240 and RTX-224 in Advanced Solid Tumors
Investor Teleconference and Webcast Scheduled Today at
“With more than 80 patients dosed across three clinical trials to date,
Next Generation Red Blood Cell-Based Conjugation Platform Overview
The new platform is expected to improve upon the existing benefits of the RED PLATFORM, with the potential for greater efficacy and enhanced versatility, while maintaining a favorable tolerability profile, and reduce the complexity and cost of generating cells by leveraging chemical conjugation to produce Red Cell Therapeutics. Cell conjugation creates a covalent link between the cell surface and the molecule of interest. This approach is intended to:
- deliver a higher effective dose by enabling a longer circulation time and/or administering a higher cell dose;
- be more versatile, enabling the conjugation of different payloads, immunomodulatory agents, small molecules and proteins on the cell for enhanced potency; and
- reduce the cost of goods manufacturing by utilizing blood-banked RBCs versus biologically engineering and differentiating early progenitor cells into reticulocytes that express proteins
These attributes are expected to result in greater efficacy, a similar safety profile given the restricted biodistribution of RBCs to the spleen and vasculature and a significant reduction in overall cost structure.
Business & Strategy Update
To enable continued investment in the new platform, the Company is restructuring its business and implementing a series of cost-saving measures, which extends the Company’s cash runway until the end of 2023. These measures include:
- Implementing a 75% reduction in force, primarily focused on clinical development, manufacturing and general and administrative;
- Discontinuing its ongoing Phase 1 clinical trials of RTX-240 and RTX-224 for the treatment of advanced solid tumors; and
- Exploring the sale of its manufacturing facility in
Smithfield, Rhode Island
- Patients still on trial will continue to be dosed until disease progression or discontinuation (n=6)
The Company will maintain its robust technical development and preclinical oncology and autoimmunity research capabilities to advance the new platform and related preclinical programs.
Overview of Current Clinical Programs
Phase 1 Clinical Trial of Monotherapy RTX-240
Phase 1 Clinical Trial of RTX-240 + Pembrolizumab in Advanced Solid Tumors
Fourteen patients were dosed in the “all comers” dose-escalation portion of the Phase 1 clinical trial evaluating RTX-240 in combination with pembrolizumab in advanced solid tumors. Four patients had stable disease of greater than 12 weeks with one colorectal cancer patient remaining on study with stable disease of greater than 4 months. Two additional patients have been dosed in the non-clear cell RCC (nccRCC) and non-small cell lung cancer (NSCLC) expansion cohorts. Both patients remain on treatment with one nccRCC patient with stable disease greater than 12 weeks and one NSCLC patient who is not yet evaluable for response. The combination of RTX-240 with pembrolizumab continued to be well tolerated with no treatment or investigator-identified immune-related Grade 3/4 AEs and no dose-limiting toxicities.
Phase 1 Clinical Trial of RTX-224 in Select Advanced Solid Tumors
Seven patients have been dosed across two dose cohorts in the Phase 1 clinical trial evaluating RTX-224 in select advanced solid tumors, including non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, urothelial (bladder) carcinoma and triple-negative breast cancer. One patient dosed at the 5e8 Q3W dose level with melanoma remains on study and is not yet evaluable for response. There have been no treatment-related Grade 3/4 AEs and no dose-limiting toxicities.
Investor Teleconference & Webcast
An audio webcast will be available on the Events and Presentations page within the Investors and Media section of the
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding beliefs about and expectation for the restructuring plan described in this release, including associated costs, cost savings and timing, as well as our beliefs about the next generation red blood cell platform, including that it will potentially improve upon the existing benefits of the RED PLATFORM, and its potential for greater efficacy and enhanced versatility. The words “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 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 release, including, without limitation, risks related to the substantial doubt about our ability to continue as a going concern given that we currently do not have adequate financial resources to fund our forecasted operating costs for at least 12 months; our ability to execute on and realize the expected benefits of the restructuring plan described in this release; the amount of debt we have outstanding and the lender’s rights under our loan facility, including the lender’s ability to accelerate amounts outstanding under the loan facility, or exert control over our cash accounts in connection with certain events of default, including a material adverse change in our business; our ability to pursue and secure financing to fund our operations; our ability to maintain our listing on the
Investor and Media Contact
Source: Rubius Therapeutics