P-MUC1C-ALLO1 / Roche - LARVOL DELTA

P-MUC1C-ALLO1-001: P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects with Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Active, not recruiting | Sponsor: Poseida Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Colorectal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Phase I trial of P-MUC1C-ALLO1 allogeneic CAR-T cells in advanced epithelial malignancies (ESMO-IO 2024) - P1 | "P-MUC1C-ALLO1 is available "off-the-shelf" and is being evaluated in a phase 1 clinical trial (NCT05239143) in advanced epithelial malignancy patients (pts).Methods The trial utilizes 3+3 dose escalation to test P-MUC1C-ALLO1 doses from 0.75 to 15 × 106 cells/kg and several lymphodepletion (LD) regimens that explore increasing doses of cyclophosphamide (cy) combined with fludarabine (flu). No DLTs were reported in any other study arms.Conclusions P-MUC1C-ALLO1 is an "off-the-shelf" allogeneic CAR-T with a manageable toxicity profile in heavily pre-treated solid tumor patients. Updated safety and efficacy data will be presented at the conference."

CAR T-Cell Therapy • Metastases • P1 data • Oncology • Solid Tumor • B2M

Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy candidates and related platform technologies (GlobeNewswire) - "Roche...announced today that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc....Based in San Diego, California, Poseida’s R&D portfolio includes pre-clinical and clinical-stage off-the-shelf (also referred to as allogeneic) CAR-T therapies across several therapeutic areas including haematological malignancies, solid tumours, and autoimmune disease, as well as manufacturing capabilities and technology platforms....Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of Poseida common stock at a price of US $9.00 per share in cash at closing plus a non-tradeable CVR to receive certain milestone payments of up to an aggregate of US $4.00 per share in cash, representing a total equity value of approximately US $1.0 billion at closing and representing a total deal value of up to US $1.5 billion."

M&A • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Addressing historical barriers for CAR-T in solid tumors through a broad array of bold, innovative technologies enabled by the Company's platform (PRNewswire) - "P-MUC1C-ALLO1 is Poseida's lead solid tumor CAR-T program...New preclinical data suggest adding low-dose methotrexate to standard lymphodepletion may enhance CAR-T expansion and persistence...Poseida will highlight its allogeneic CAR-TCR-T cells to address antigen heterogeneity in solid tumors. The Company recently presented new preclinical data demonstrating enhanced potency to better target solid tumors at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. Preclinical data highlight the potential of a combination of CAR-TCR-T cell treatment followed by a T cell engager (TCE). In this model, MUC1C-CAR and NY-ESO-1-TCR T cells effectively controlled a primary tumor (MUC1C+/NY-ESO-1+/CD70-), and later were reactivated and re-directed by a CD70 TCE to control challenge by a secondary tumor (MUC1C-/NY-ESO-1-/CD70+)."

Preclinical • Oncology • Solid Tumor

P-MUC1C-ALLO1-001: P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Poseida Therapeutics, Inc. | N=100 ➔ 180

CAR T-Cell Therapy • Enrollment change • Metastases • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Poseida Therapeutics Provides Updates and Financial Results for the Second Quarter of 2024 (PRNewswire) - "Upcoming Milestones: P-BCMA-ALLO1 in relapsed/refractory multiple myeloma (RRMM): new data anticipated for presentation at the International Myeloma Society 21st Annual Meeting, being held September 25-28, 2024, in Rio de Janeiro. Additional clinical updates are planned for the second half of 2024, subject to coordination with Roche; P-MUC1C-ALLO1 in solid tumors: clinical update planned for the second half of 2024; P-CD19CD20-ALLO1 in B-cell malignancies: interim data update anticipated in the second half of 2024, subject to coordination with Roche."

P1 data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Poseida Therapeutics Provides Updates and Financial Results for the First Quarter of 2024 (PRNewswire) - "Anticipated Milestones: (i) P-BCMA-ALLO1 in RRMM: clinical update planned for the second half of 2024 subject to coordination with Roche; (ii) P-MUC1C-ALLO1 in solid tumors: clinical update planned for the second half of 2024; (iii) P-CD19CD20-ALLO1 in B-cell malignancies: interim data update anticipated in the second half of 2024 subject to coordination with Roche."

P1 data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Multiple Myeloma • Solid Tumor

Solid tumor patients require higher cyclophosphamide (cy) dose than multiple myeloma (MM) patients to achieve adequate lymphodepletion (LD) necessary to enable allogeneic CAR-T expansion (AACR 2024) - P1 | "LD arm S used cy 300 mg/m2 + fludarabine (flu) 30 mg/m2 × 3 days, followed by CAR-T. Increasing cy dose to 500 or 1,000 mg/m2 improves CK for P-BCMA-ALLO1 pts due to enhanced LD depth. For P-MUC1C-ALLO1 pts, increasing cy to 500 does not improve LD depth or CK compared to 300. This difference suggests the need for higher LD doses in ST pts than MM pts to achieve optimal CK."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • IL15 • MUC1

Poseida Therapeutics Provides Updates and Financial Results for the Fourth Quarter and Full Year 2023 (Poseida Therap Press Release) - "P-MUC1C-ALLO1: The Company plans to review initial clinical findings from the Phase 1 clinical trial in solid tumors at AACR related to cell expansion and lymphodepletion regimens....In addition to the AACR presentation, the Company plans to present a more fulsome clinical update at an appropriate forum in the second half of 2024."

P1 data • Oncology • Solid Tumor

Poseida Therapeutics Highlights Recent Progress, Strategic Priorities and Anticipated 2024 Key Milestones (PRNewswire) - "In 2024, Poseida plans to continue development of P-BCMA-ALLO1 in partnership with Roche. This includes continuing the strong enrollment in the Phase 1 study, refinement of dosing regimen for both cell dose and lymphodepletion chemotherapy, sharing additional details on clinical trial expansion strategies and continuing product supply efforts. The Company plans to present additional clinical data updates for P-BCMA-ALLO1 at scientific meetings in 2024, subject to coordination with Roche...P-MUC1C-ALLO1 is an allogeneic, TSCM-rich CAR-T product candidate....Poseida plans to provide a data update at a scientific meeting in the first half of 2024."

P1 data • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

MUC1-C INTEGRATES CHRONIC ACTIVATION OF INTERFERON PATHWAYS WITH CHROMATIN REMODELING IN TREATMENT RESISTANCE OF TRIPLE-NEGATIVE BREAST CANCER (SABCS 2023) - P1 | "In support of these results, targeting MUC1-C in wild-type BRCA1/2 TNBC cells enhanced carboplatin-induced DNA damage and loss of self- renewal capacity. In addition, MUC1-C was necessary for DNA damage resistance, self-renewal and tumorigenicity of olaparib-resistant BRCA1-mutant TNBC cells...As one example, an allogeneic anti-MUC1-C CAR T cell using MAb 3D1 sequences is undergoing Phase I evaluation for the treatment of MUC1-C-expressing cancers (NCT05239143: P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects with Advanced or Metastatic Solid Tumors). In addition, anti-MUC1-C huMAb3D1-MMAE ADCs are under development by the NCI NExT Program for IND-enabling studies and performing early phase clinical trials in patients with TNBC."

IO biomarker • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • IDO1 • IFIH1 • IRF1 • MUC1 • PBRM1 • STAT1 • STING

Astellas and Poseida Therapeutics Announce Strategic Investment to Support Poseida's Commitment to Redefining Cancer Cell Therapy (PRNewswire) - "Astellas Pharma Inc...and Poseida Therapeutics, Inc...today announced a strategic investment to support the advancement of Poseida's commitment to redefining cancer cell therapy....Under the terms of the transaction agreements, Astellas will invest a total of $50 million, including $25 million to acquire 8,333,333 shares of common stock of Poseida (approximately 8.8% of the outstanding common stock of Poseida) at $3.00 per share in a private placement and a one-time $25 million payment for a right of exclusive negotiation and first refusal to license one of Poseida's clinical stage programs: P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy in development for multiple solid tumor indications."

Licensing / partnership • Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Thoracic Cancer

Poseida Therapeutics Announces Strategic Investment by Astellas and Provides Business Update (PRNewswire) - "Poseida Therapeutics, Inc...today announced a $50 million strategic investment by Astellas, which is comprised of the purchase of 8,333,333 shares of common stock at $3.00 per share for an aggregate purchase price of $25 million and an additional $25 million one-time payment for certain strategic rights, and provided a business update...'Based on these findings, we are adjusting guidance on data updates and look forward to sharing clinical data highlighting some of these enhancements at a medical meeting later this year, with plans for a more robust clinical update to follow in mid-2024'....Poseida expects to dose the first patient with P-CD19CD20-ALLO1 in early 2024."

Clinical • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Poseida Therapeutics Provides Updates and Financial Results for the First Quarter of 2023 (PRNewswire) - "P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers...The Company currently expects to present further clinical updates for the program at a medical meeting in 2023; P-BCMA-ALLO1 is an allogeneic CAR-T product candidate being developed to target relapsed/refractory multiple myeloma...The Company currently expects to present further clinical updates for the program at a medical meeting in 2023; P-CD19CD20-ALLO1 is a preclinical allogeneic CAR-T product...The Company expects to file an IND for P-CD19CD20-ALLO1 in mid-2023; The Company is advancing its P-FVIII-101 preclinical program partnered with Takeda, which is in development for the in vivo treatment of Hemophilia A....The Company is presenting preclinical data from this program at the upcoming American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting being held in Los Angeles on May 16-20, 2023."

IND • P1 data • Preclinical • Genetic Disorders • Hematological Malignancies • Hemophilia • Multiple Myeloma • Oncology

Development of an allogeneic CAR-T targeting MUC1-C (MUC1, cell surface associated, C-terminal) for epithelial derived tumors (ESMO-IO 2022) - P1 | "In early phase I experience, P-MUC1C-ALLO1 is safe and tolerable with an early signal of efficacy at a low starting dose. P-MUC1C-ALLO1 phase I trial enrollment is on-going."

IO biomarker • Breast Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2 • MUC1

Poseida Therapeutics Hosts Third Annual Virtual R&D Day Highlighting Novel Pipeline Assets and Latest Technology Innovations (PRNewswire) - "Poseida Therapeutics...announced that the Company plans to highlight its clinical and preclinical pipeline progress during a virtual R&D Day to be held today at 10:00am ET / 7:00am PT....The Company will recap early clinical data presented at the European Society for Medical Oncology Immuno-Oncology Annual Congress in December 2022 (ESMO I-O) on both of its Phase 1 allogeneic cell therapy programs: P-MUC1C-ALLO1, a wholly-owned CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers, and P-BCMA-ALLO1, a CAR-T product candidate partnered with Roche targeting relapsed/refractory multiple myeloma."

P1 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Solid Tumor

Poseida Therapeutics Hosts Third Annual Virtual R&D Day Highlighting Novel Pipeline Assets and Latest Technology Innovations (PRNewswire) - "Poseida Therapeutics, Inc....announced that the Company plans to highlight its clinical and preclinical pipeline progress during a virtual R&D Day to be held today at 10:00am ET / 7:00am PT....Allogeneic Cell Therapy Programs: The Company will recap early clinical data presented at the European Society for Medical Oncology Immuno-Oncology Annual Congress in December 2022 (ESMO I-O) on both of its Phase 1 allogeneic cell therapy programs: P-MUC1C-ALLO1, a wholly-owned CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers, and P-BCMA-ALLO1, a CAR-T product candidate partnered with Roche targeting relapsed/refractory multiple myeloma. The Company plans to present additional updates on both trials at a medical conference in 2023. The Company will present preclinical data on additional emerging allogeneic CAR-T programs including P-CD19CD20-ALLO1, P-CD70-ALLO1 and P-ckit-ALLO1."

P1 data • Preclinical • Breast Cancer • Gynecologic Cancers • Hematological Malignancies • Multiple Myeloma • Oncology • Ovarian Cancer • Solid Tumor

Poseida Therapeutics to Present Early Data from Phase 1 Trials of P-MUC1C-ALLO1 and P-BCMA-ALLO1 at ESMO Immuno-Oncology 2022 Annual Congress (PRNewswire) - P1 | N=100 | NCT05239143 | Sponsor: Poseida Therapeutics, Inc. | "In the poster titled 'Development of an allogeneic CAR-T targeting MUC1-C (MUC1, cell surface associated, C-terminal) for epithelial derived tumors'...will highlight: As of the cutoff date of November 14, 2022, the study had dosed seven patients with epithelial-derived cancers, including esophageal, colorectal, breast, pancreatic and prostate carcinomas, of which four were evaluable for response. Only one patient with breast cancer has been dosed to date; this patient with HR+, HER2- breast cancer, with four prior lines of treatment, achieved a partial response at a dose of 0.75x10⁶ cells/kg. Two other patients with heavily pretreated gastrointestinal tumors (colorectal and pancreatic cancer) achieved stable disease at a dose of 0.75x10⁶ cells/kg and 2x10⁶ cells/kg each."

P1 data • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Phase 1 study of P-MUC1C-ALLO1 allogeneic CAR-T cells in patients with epithelial-derived cancers (SITC 2022) - P1 | "Up to 100 patients will be enrolled into 4 arms of single and cyclic administrations using two different lymphodepletion (LD) regimens (cyclophosphamide/fludarabine ± rituximab). This study continues to recruit subjects and updated data will be presented. Trial Registration NCT05239143 Ethics Approval Ethics approvals have been obtained from the clinical sites enrolling patients: Sarah Cannon Research Institute Denver CO (IORG0010151); NEXT Oncology San Antonio TX (IORG0005674); University of California, San Francisco, CA (IORG0000135)"

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • B2M • Cancer antigen 27-29 • CASP9 • DHFR

Poseida Therapeutics Provides Updates and Financial Results for the Third Quarter of 2022 (PRNewswire) - "Program Updates: MUC1-C Program - Poseida is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial and plans to share an initial early clinical data update on the program at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) 2022 Annual Congress, which is taking place in Geneva, Switzerland and online in December 2022."

P1 data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Urothelial Cancer

Poseida Therapeutics to Present Trial in Progress Poster for Phase 1 P-MUC1C-ALLO1 Study at the Society for Immunotherapy of Cancer Annual Meeting (PRNewswire) - "Poseida Therapeutics...announced that it will present a Trial in Progress poster at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting....The poster presentation will highlight the trial design, dosing regimen, and study protocol for the Company's ongoing Phase 1 clinical trial of P-MUC1C-ALLO1. The multi-center, open-label, dose escalation study is evaluating patients with locally advanced or metastatic epithelial derived solid tumors that are refractory to standard of care therapy or ineligible or refused another existing treatment....The Company expects to report initial clinical data from this trial by the end of 2022 or early 2023."

Clinical protocol • P1 data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Urothelial Cancer

Poseida Therapeutics Provides Updates and Financial Results for the Second Quarter of 2022 (PRNewswire) - "The Company anticipates an IND filing and initiation of a Phase 1 clinical trial for P-CD19CD20-ALLO1 in the first half of 2023; The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and this program is now partnered with Roche. Poseida expects initial clinical data from its Phase 1 clinical trial in the second half of 2022 subject to coordination with its partner, Roche; Poseida is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial, with an initial clinical data update on the program expected in the second half of 2022."

IND • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Poseida Therapeutics Announces Publication Highlighting Potential of Cas-CLOVER as an Efficient and Robust Gene Editing System for Developing Allogeneic CAR-T Products (PRNewswire) - "Poseida Therapeutics, Inc....'This publication validates the precision of our proprietary Cas-CLOVER system, which is utilized in the manufacture of our fully allogeneic product candidates currently in clinical trials, including P-BCMA-ALLO1 for relapsed/refractory multiple myeloma and P-MUC1C-ALLO1 for multiple solid tumor indications'....In these published studies, Cas-CLOVER was used for multiplexed gene editing in resting T cells, which resulted in allogeneic product candidates with a high percentage (45%-70%) of desirable T stem cell memory (Tscm) cells. Using next-generation sequencing, off-target activity was measured at a rate between 0.012% and 0.089%, which is significantly lower than many other gene editing platforms. In addition, off-target translocations, which are undesirable chromosomal abnormalities, approached the lower limit of detection at a frequency of less than 0.01%."

Clinical data • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Poseida Therapeutics Provides Updates and Financial Results for the Fourth Quarter and Full Year 2021 (PRNewswire) - "P-BCMA-ALLO1 is the Company's first allogeneic CAR-T program, currently being evaluated in patients with relapsed/refractory multiple myeloma (R/R MM) with initial clinical data expected in the second half of 2022....The Phase 1 clinical trial of P-MUC1C-ALLO1 is proceeding following IND clearance in the fourth quarter of 2021, and an update on the program is expected in the second half of 2022."

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Poseida Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck