Poseida Therapeutics, Inc., a groundbreaking clinical-stage cell and gene therapy company, recently received a $50 million boost from strategic investor Astellas Pharma US, Inc. in the form of a $25 million common stock purchase and a $25 million one-time payment for strategic rights. This investment marks a pivotal milestone for the company, which is revolutionizing treatments for cancer and rare diseases.
We are thrilled to announce Astellas, a leading global pharmaceutical company, has made a strategic investment in Poseida, further validating our technology and approach. This move indicates an optimistic view of our genetic engineering, cell and gene therapy offerings and reflects the strategic options for our business. Thanks to this investment and our fiscal prudence, we anticipate a longer cash runway.
We are taking what we’ve gleaned from our allogeneic programs and making strategic improvements to our clinical trials, with the ultimate goal of delivering meaningful data updates later this year and a more extensive clinical update in mid-2024.
Allogeneic CAR-T Program Updates & Clinical Trial Learnings
We are thrilled with the fascinating developments the Phase 1 trials of P-BCMA-ALLO1 and P-MUC1C-ALLO1 have brought about. Driven by the data we have obtained, we have already made several beneficial improvements to our allogeneic portfolio. For instance, we have increased conditioning lymphodepletion to industry norms and are considering additional dosing and administration options.
We are also pushing for higher product yields by enhancing our manufacturing process, and our early signals are highly encouraging. Overall, the potential of our allogeneic platform is extremely exciting, and we look forward to continued breakthroughs in this field.
Poseida’s promising new treatment candidate, P-BCMA-ALLO1, could soon revolutionize the treatment of relapsed/refractory multiple myeloma (R/R MM). This allogeneic CAR-T product is currently undergoing Phase 1 clinical trials, with an expected clinical update in 2023, pending approval from Roche.
With newly implemented dosing regimens, limited patient numbers are available for evaluation; however, further progress is anticipated to be revealed mid-2024. We look forward to a future of improved treatments for R/R MM sufferers with the potential advancement of P-BCMA-ALLO1.
Poseida is advancing P-MUC1C-ALLO1, its cutting-edge allogeneic CAR-T product candidate targeting solid tumors, including breast and ovarian cancers. With the implementation of new dosing regimens, the Company is currently evaluating its product in a Phase 1 clinical trial. Progress of this study will be presented at a medical meeting in 2023, followed by a further clinical update in mid-2024. Stay tuned for further updates as the Company works to bring this revolutionary treatment to cancer patients.
Poseida’s P-CD19CD20-ALLO1 is a revolutionary allogeneic CAR-T therapy aimed at treating B-cell malignancies, developed in partnership with Roche. This dual CAR-T therapy, containing two CAR molecules targeting both CD19 and CD20, offers immense potential in overcoming the antigen escape experienced by other therapies.
In June 2023, Poseida received FDA approval for this innovative treatment, making it the first allogeneic dual CAR-T therapy targeting CD19 and CD20. Poseida is geared up to dose the first patient with P-CD19CD20-ALLO1 in early 2024, so we can be hopeful that this could be a breakthrough in cancer treatment.
Gene Therapy Programs
Poseida’s exciting gene therapy collaboration with Takeda came to an end in July 2023, and the Company is currently assessing the merits of its returning Takeda programs and its internal projects to figure out which programs require the most focus. Moreover, the Company is actively exploring business development opportunities to leverage the work of its gene therapy programs. An update on this evaluation will be provided when it is completed.
In July 2023, the FDA showed their commitment to fighting urea cycle diseases caused by congenital mutations in the ornithine transcarbamylase (OTC) gene, granting P-OTC-101 orphan drug designation. P-OTC-101 utilizes a hybrid delivery system, designed to provide a much needed treatment for those affected. With the success of this program, a revised timeline can be expected to move closer towards a conclusion.
Financial Guidance Update
Poseida is now on a strong financial footing, thanks to Astellas’ strategic investment and the disciplined cost control, capital expenditure, and projected payments from its Roche collaboration. This has given us the confidence to stretch our cash runway out to the early 2025. Furthermore, with potential business development opportunities and further upside from the Roche agreement, the outlook for the second half of 2023 looks promising.
About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company pioneering game-changing cell and gene therapies that have the potential to cure certain cancers and rare diseases. Through its revolutionary editing platforms, such as the non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, and advanced gene-delivery nanoparticles and hybrids, the company is making ground-breaking progress in clinical trials of its allogeneic CAR-T cell therapy product candidates and in vivo gene therapy product candidates that target critically underserved patient populations.
Having recently entered into a global strategic collaboration with Roche to unlock the promise of cell therapies, Poseida is the premier destination for discovering the innovations at the forefront of medical care.
The completion of the transactions with Astellas and receipt of the one-time payment could bring great opportunities for the Company. It anticipates critically important milestones with respect to its clinical trials, regulatory submissions, and approvals while planning to maximize potential fees, milestones, and other payments from Roche’s collaboration agreement.
Furthermore, the promised benefits of its technology platforms and product candidates brings expectations of success in development and manufacturing activities. Despite the enthusiasm, risks and uncertainties exist that challenge the Company’s plans and strategy initially presented.
These risks include the inability to satisfy transaction conditions, reliance on third-parties, development and regulatory approval processes, journey to retain key personnel, and Roche’s ability to early terminate the collaboration. The Company must take heed to these situations and remain vigilant as it continues to explore those opportunities.