RTX-224 / Rubius Therap - LARVOL DELTA

RTX-224-01: RTX-224 Monotherapy in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=7 | Terminated | Sponsor: Rubius Therapeutics | RTX-224 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared rapidly (w/in 10 min).

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Cutaneous Melanoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • PD-L1

A phase 1/2 study of RTX-224, an engineered red blood cell expressing 4-1BB ligand and membrane-bound IL-12, for the treatment of patients with select advanced solid tumors. (ASCO 2022) - P1/2 | "Multiple technologies will be employed to profile the innate and adaptive responses following RTX-224 treatment. The study is open and enrolling patients in Phase 1."

Clinical • IO biomarker • P1/2 data • Breast Cancer • Cutaneous Melanoma • Genito-urinary Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • CD4 • CD8 • IL12A

RTX-224-01: RTX-224 Monotherapy in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=128 | Active, not recruiting | Sponsor: Rubius Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Breast Cancer • Cutaneous Melanoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • PD-L1

Rubius Therapeutics to Present Trials in Progress Poster for the Phase 1/2 Clinical Trial of RTX-224 in Select Advanced Solid Tumors at the 2022 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "Rubius Therapeutics...announced that the Company will present a Trials in Progress poster presentation for its second broad immune stimulation program, RTX-224, at the American Society of Clinical Oncology (ASCO) Annual Meeting....The Trials in Progress poster presentation will summarize the proposed mechanism of action of RTX-224, preclinical observations to date and the clinical trial design, including the translational medicine approach, for the ongoing Phase 1/2 clinical trial of RTX-224 for the treatment of patients with select advanced solid tumors, including cutaneous melanoma, head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer and urothelial cancer."

Clinical protocol • Breast Cancer • Cutaneous Melanoma • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer

Rubius Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "In the first quarter of 2022, Rubius invested $38.3 million in research and development (R&D) related to its novel RED PLATFORM® and towards expanding and advancing its product pipeline, compared to $27.7 million in the first quarter of 2021. This year-over-year increase was principally due to a $5.3 million increase in costs related to our lead cancer programs, RTX-240, RTX-321 and RTX-224, primarily from clinical research organization (CRO) and internal manufacturing costs incurred in connection with all three programs."

Commercial • Acute Myelogenous Leukemia • Breast Cancer • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

Rubius Therapeutics Reports Updated Clinical Data at AACR from the Ongoing Monotherapy Phase 1 Arm of the Phase 1/2 Clinical Trial of RTX-240 in Advanced Solid Tumors Demonstrating Single-Agent Activity and Favorable Tolerability (GlobeNewswire) - "Upcoming Anticipated Milestones...Report initial Phase 1 clinical results for RTX-321 for the treatment of HPV 16-positive cancers during the second half of 2022; Report initial Phase 1 clinical results for RTX-240 in combination with pembrolizumab in advanced solid tumors and data from the additional NSCLC and RCC patients in the second half of 2022...and Report initial Phase 1 clinical results for RTX-224 for the treatment of advanced solid tumors during the first quarter of 2023."

P1 data • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Rubius Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Increased cells produced per batch by four times in 50L bioreactors from 2020 to 2021, enabling uninterrupted clinical supply for three Phase 1 arms of the RTX-240 clinical trial and Phase 1 RTX-321 trial; Introduced frozen drug substance for RTX-321 and RTX-224, potentially enabling inventory storage of greater than two years...In the fourth quarter of 2021, Rubius invested $39.8 million in research and development...This year-over-year increase was principally due to a $11.0 million increase in costs incurred for the Company’s lead cancer programs, RTX-240 and RTX-321, primarily from clinical research organization (CRO) and internal manufacturing costs incurred in connection with the three arms of its Phase 1/2 clinical trial of RTX-240, for its Phase 1 clinical trial of RTX-321 for the treatment of HPV16-positive cancers and for start-up costs related to its Phase 1 clinical trial of RTX-224."

Commercial • Acute Myelogenous Leukemia • Anal Carcinoma • Bladder Cancer • Breast Cancer • Cervical Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Leukemia • Lung Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

RTX-224 Monotherapy in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=128 | Recruiting | Sponsor: Rubius Therapeutics

Monotherapy • New P1/2 trial • Breast Cancer • Cutaneous Melanoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • PD-L1

Rubius Therapeutics Announces Dosing of First Patient in Phase 1/2 Trial of RTX-224, a Broad Immune Agonist, for the Treatment of Certain Solid Tumors (GlobeNewswire) - "Rubius Therapeutics...announced that the first patient has been dosed in its Phase 1/2 clinical trial of RTX-224 for the treatment of patients with certain relapsed/refractory or locally 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....RTX-224 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to express hundreds of thousands of copies of 4-1BB ligand (4-1BBL) and interleukin-12 (IL-12) on the cell surface."

Trial status • Bladder Cancer • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

Rubius Therapeutics to Highlight the Power of its RED PLATFORM, Significant Advances Across Red Cell Therapeutic Oncology Pipeline and New Type 1 Diabetes Program at Platform and Pipeline Day (GlobeNewswire) - “RTX-240: Additional clinical results are expected from this trial and the Phase 1 arm in relapsed/refractory AML during the first quarter of 2022. The Company plans to initiate single-agent RTX-240 Phase 2 expansion cohorts in select solid tumor types during the first quarter of 2022….RTX-224: Planning to initiate the Phase 1 clinical trial of RTX-224 in patients with certain advanced solid tumors during the first quarter of 2022….RTX-321: Continuing enrollment in Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers. Planning to report initial clinical results during the first quarter of 2022”

New P1 trial • New P2 trial • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

RTX-224, An Engineered Allogeneic Red Cell Therapeutic Expressing 4-1BBL and IL-12, Activates Immune Cells in Blood and Spleen to Promote Tumor Growth Inhibition in Mice (SITC 2021) - "These results align with published data suggesting that activated T cells in the spleen or blood can replenish exhausted tumor-infiltrating cells. Conclusions Taken together, these data unveil the mechanism of action of mRBC-224 and suggest that mRBC-224 activate immune cells in the spleen and blood, leading to their trafficking into the tumor microenvironment to promote efficacy."

Preclinical • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • GZMB • IL12A

Rubius Therapeutics Presents Preclinical Data for RTX-224, a Broad Immune Costimulatory Agonist, at the Society for Immunotherapy of Cancer’s Annual Meeting (GlobeNewswire) - '"The U.S. FDA recently cleared our Investigational New Drug application for RTX-224, and we expect to begin dosing patients during the first quarter of 2022'...The mouse surrogate of RTX-224, mRBC-224, demonstrated potent anti-tumor activity in B16F10 melanoma models, intravenously and subcutaneously, that was associated with pharmacodynamic changes in the tumors, including activated CD8+ T cells, NK cells and macrophages. mRBC-224 distributed mainly in the spleen of tumor-bearing mice 24 hours after one dose. mRBC-224 treatment in mice promoted activation of NK cells, CD8+ T cells and monocytes/macrophages in the blood and spleen of naïve and tumor-bearing mice. RTX‑224 (in vitro) and mRBC‑224 (in vivo) stimulate adaptive (CD8+ T cells and CD4+ T cells) and innate (NK cells and macrophages) immune responses. The combined enhancement of both adaptive and innate immune responses leads to a productive antitumor response as demonstrated in preclinical studies."

IND • Preclinical • Oncology

Rubius Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "U.S. FDA cleared the IND application for RTX-224, Rubius’ third oncology product candidate...Near-Term Catalysts and Operational Objectives: Initiate Phase 1 clinical trial for RTX-224 in advanced solid tumors during the first quarter of 2022."

IND • New P1 trial • Oncology • Solid Tumor

Rubius Therapeutics Announces Preclinical Data for RTX-224, a Broad Immune Costimulatory Agonist, to be Presented at the Society for Immunotherapy of Cancer’s Annual Meeting (GlobeNewswire) - “Rubius Therapeutics, Inc….announced it will present preclinical data for RTX-224, a broad immune costimulatory agonist for the treatment of cancer, at the upcoming Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting which is being held from November 10-14, 2021, in Washington, D.C., and virtually….‘These preclinical data are encouraging, and we plan to submit an Investigational New Drug application to the FDA by year end.’”

IND • Preclinical • Oncology • Solid Tumor

Rubius Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated 2021 Catalysts and Operational Objectives: Present additional clinical data from the RTX-240 solid tumor Phase 1 clinical trial; Select specific solid tumor types that will be pursued in the Phase 2 expansion cohort of RTX-240; Report initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in relapsed/refractory AML; Initiate the Phase 1 clinical trial of RTX-240 in combination with anti-PD-1 therapy in advanced solid tumors in the second half of 2021; Report initial Phase 1 clinical data from RTX-321 for the treatment of HPV 16-positive cancers by the first quarter of 2022; Submit an Investigational New Drug Application for RTX-224 by year-end."

New P1 trial • P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor

Rubius Therapeutics Reports Initial Clinical Data from Ongoing Phase 1/2 Trial of RTX-240 in Patients with Advanced Solid Tumors, Demonstrating Single-Agent Activity (GlobeNewswire) - “Upcoming Anticipated Milestones - In order to realize the full potential of RTX-240, the Company’s other oncology programs and the RED PLATFORM, in the next 12 months, Rubius plans to execute several critical milestones: Present additional clinical results from the RTX-240 solid tumor Phase 1 clinical trial; Select the recommended RTX-240 Phase 2 dose, schedule and specific solid tumor types that will be pursued in the Phase 2 expansion cohort; Report initial clinical results for the second Phase 1 arm of the RTX-240 clinical trial in relapsed/refractory AML; Initiate the Phase 1 clinical trial of RTX-240 in combination with anti-PD-1 therapy in advanced solid tumors in 2H’21; Report initial Phase 1 clinical results for RTX-321 for the treatment of HPV 16-positive cancers by 1Q’22; and Submit an Investigational New Drug Application for RTX-224 by year-end.”

IND • P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor