RTX-321 / Rubius Therap - LARVOL DELTA

RTX-321 Monotherapy in Patients With HPV 16+ Tumors (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Rubius Therapeutics | RTX-321 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared from circulation rapidly (w/in 10 min).

Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Infectious Disease • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD8 • HLA-A

RTX-321 Monotherapy in Patients With HPV 16+ Tumors (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Rubius Therapeutics | Recruiting ➔ Active, not recruiting | N=63 ➔ 9

Enrollment change • Enrollment closed • Monotherapy • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Infectious Disease • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD8 • HLA-A

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

Rubius Therapeutics Recaps 2021 Achievements and Outlines 2022 Objectives Across the RED PLATFORM at the 40th Annual J.P. Morgan Healthcare Conference (GlobeNewswire) - "Anticipated 2022 Catalysts and Operational Objectives...Present additional clinical results from the Phase 1 arm of the RTX-240 Phase 1/2 clinical trial in advanced solid tumors and the Phase 1 arm in relapsed/refractory acute myeloid leukemia (AML) during the first quarter of 2022; Initiate RTX-240 Phase 2 expansion cohorts in select solid tumor types during the first quarter of 2022; Report initial clinical results from the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers during the second half of 2022; Present initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in combination with pembrolizumab in patients with advanced solid tumors during the second half of 2022"

P1 data • Trial status • Acute Myelogenous Leukemia • Cervical Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

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

Rubius Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Near-Term Catalysts and Operational Objectives: (i) Present additional clinical data from the RTX-240 solid tumor Phase 1 clinical trial at the end of 2021 or during the first quarter of 2022; Select specific solid tumor types that will be pursued in the Phase 2 expansion cohorts of RTX-240; (ii) Report initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in relapsed/refractory AML at the end of 2021 or during the first quarter of 2022; and (iii) Report initial Phase 1 clinical data from RTX-321 for the treatment of HPV 16-positive cancers by the first quarter of 2022."

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

[VIRTUAL] A phase 1 study of RTX-321, an engineered red blood cell as an artificial antigen-presenting cell expressing HLA-A*02 with the HPV-16 E7 peptide and 4-1BB ligand with membrane-bound IL-12 for the treatment of HPV 16-positive cancers. (ASCO 2021) - P1 | "Translational studies will investigate the activation and expansion of HPV16 E7 antigen-specific responses as well as broad innate and adaptive responses in multiple peripheral blood samples over the first 3 cycles of therapy as well as in optional paired tumor biopsies . At this time, the study is open and enrolling patients in the first dose escalation cohort (NCT04672980)."

P1 data • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HLA-A • IL12A

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 to Present Trials in Progress Poster on the Phase 1 Clinical Trial of RTX-321 for HPV 16-Positive Cancers at the 2021 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - “Rubius Therapeutics, Inc…announced that the Company will present a Trials in Progress poster presentation for its lead artificial antigen-presenting (aAPC) cell program, RTX-321, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually from June 4-8, 2021. The Trials in Progress poster presentation will summarize the proposed mechanism of action of RTX-321, preclinical observations to date and the clinical trial design, including translational medicine methodology, for the Company’s ongoing Phase 1 clinical trial of RTX-321 for the treatment of HPV 16-positive cancers, including cervical cancer, anal cancer, and head and neck cancer.”

Clinical protocol • Preclinical • Anal Carcinoma • Cervical Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology

Rubius Therapeutics Announces Publication of RTX-321 Preclinical Data in Nature Communications (GlobeNewswire) - "Preclinical Data Demonstrate RTX-321 Potently Activates and Expands HPV 16-Reactive Anti-Tumor T Cells and Provides Broad Immune Stimulation...Rubius Therapeutics is currently enrolling patients with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including cervical cancer, head and neck squamous cell carcinoma (HNSCC) and anal cancer, in a Phase 1 clinical trial...plan to share initial clinical results from our Phase 1 clinical trial in the first quarter of 2022."

P1 data • Preclinical • Anal Carcinoma • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology

Engineered red blood cells as an off-the-shelf allogeneic anti-tumor therapeutic. (PubMed, Nat Commun) - "The allogeneic aAPC, RTX-321, comprised of human leukocyte antigen-A*02:01 presenting the human papilloma virus (HPV) peptide HPV16 E7, 4-1BBL, and IL-12 on the surface, activates HPV-specific T cells and promotes effector function in vitro. Thus, RTX-321 is a potential 'off-the-shelf' in vivo cellular immunotherapy for treating HPV + cancers, including cervical and head/neck cancers."

Journal • Cervical Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • IL12A

Rubius Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial of RTX-321 for the Treatment of HPV 16-Positive Cancers (GlobeNewswire) - "Rubius Therapeutics, Inc...announced that the first patient has been dosed in the Phase 1 clinical trial of RTX-321 for the treatment of human papilloma virus (HPV) 16-postive cancers...The Phase 1 clinical trial of RTX-321 is enrolling patients with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including cervical cancer, head and neck squamous cell carcinoma (HNSCC) and anal cancer....'For patients with advanced HPV 16-positive cancers, the prognosis remains poor with few treatment options beyond the first-line setting,” said Howard A. 'Skip' Burris..."

Trial status • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology

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

Rubius Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated 2021 Catalysts and Operational Objectives...Continue to produce cGMP material for the RTX-240 and RTX-321 clinical trials; Present an integrated clinical program for RTX-240, including plans for expansion cohorts, and plans for the Company’s oncology pipeline"

Clinical • Acute Myelogenous Leukemia • Cervical Cancer • Gynecologic Cancers • Hematological Malignancies • Oncology • Solid Tumor

Rubius Therapeutics Provides Operational Update and Outlines 2021 Objectives at the 39th Annual J.P. Morgan Healthcare Conference (GlobeNewswire) - "Anticipated 2021 Catalysts and Operational Objectives: (i) Present additional clinical data for the Phase 1 RTX-240 solid tumor trial in early 2021; (ii) Continue to enroll patients with AML in the second Phase 1 arm of the RTX-240 clinical trial; (iii) Dose the first patient in the RTX-321 clinical trial in HPV-positive tumors."

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

RTX-321 Monotherapy in Patients With HPV 16+ Tumors (clinicaltrials.gov) - P1; N=63; Recruiting; Sponsor: Rubius Therapeutics

Clinical • Monotherapy • New P1 trial • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Infectious Disease • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Rubius Therapeutics Reports Third Quarter 2020 Financial Results and Strong Execution Across the Pipeline (GlobeNewswire) - "Filed an IND with U.S. FDA for RTX-321 for the treatment of HPV 16-positive cancers; Conducting manufacturing in support of planned GMP clinical supply needs for the RTX-321 clinical trial"

Clinical • IND • Oncology • Solid Tumor

Rubius Therapeutics Presents Preclinical Data for RTX-321, a Red Cell Therapeutic Oncology Product Candidate for HPV-Positive Cancers, Demonstrating its Dual Mechanism of Action (GlobeNewswire) - "'Our preclinical data demonstrate...that RTX-321 has a dual mechanism of action by not only functioning as an antigen-presenting cell to boost HPV 16 antigen-specific T cell responses, but also promoting broad immune system stimulation of both innate and adaptive immunity...This dual mechanism of action is a key part of the developmet of epitope spreading, meaning that RTX-321 may induce the expansion of an immune response to secondary epitopes, or antigens, that are not expressed on RTX-321, as well as the development of a potent memory response, potentially enabling the body to remember a cancer’s identity...'"

Preclinical • Oncology • Solid Tumor

Rubius Therapeutics Reports Second Quarter 2020 Financial Results and Positive Progress Across Pipeline (GlobeNewswire) - "Investigational New Drug Application on Track by Year-End for RTX-321 for HPV-Positive Cancers."

IND • Oncology

Rubius Therapeutics Provides Update on Clinical Trial Progress for its Lead Oncology Product Candidate RTX-240 and Announces Planned Leadership Transition (GlobeNewswire) - "Rubius Therapeutics, Inc…announced that it has completed dosing of the first dose-escalation cohort with no observed adverse events to date in the Phase 1/2 clinical trial of RTX-240. RTX-240 is an allogeneic cellular therapy for the treatment of patients with relapsed/refractory or locally advanced solid tumors…a second oncology Investigational New Drug Application planned for RTX-321 in HPV-positive cancers by year-end…"

Enrollment closed • IND • Oncology • Solid Tumor

[VIRTUAL] In vivo efficacy and pharmacodynamic analysis of RTX-321, an engineered allogeneic artificial antigen presenting red cell therapeutic (AACR-II 2020) - "Together, these data confirm that RCT-aAPC can induce activation of antigen-specific CD8 T cells which can translate to tumor regression. Rubius plans to file an Investigational New Drug application for RTX-321 in HPV16+ advanced solid tumors in 2020."

IO Biomarker • Late-breaking abstract • PK/PD data • Preclinical • Head and Neck Cancer • Oncology • Solid Tumor • CD8 • IFNG • IL12A • IL2RA • PD-1

Rubius Therapeutics Highlights Preclinical Data for RTX-321, a Red Cell Therapeutic Oncology Product Candidate for HPV-Positive Cancers, at the American Association of Cancer Research Virtual Annual Meeting II (GlobeNewswire) - "Rubius Therapeutics...announced the presentation of preclinical data supporting its lead artificial antigen-presenting cell (aAPC) program, RTX-321, for the potential treatment of human papillomavirus (HPV) 16-positive cancers during the American Association for Cancer Research (AACR) Virtual Annual Meeting II....'These preclinical data presented at AACR suggest that RTX-321 may promote epitope spreading, meaning that RTX-321 may induce the expansion of an immune response to secondary epitopes, or antigens, that are not expressed on RTX-321. This finding is important because it suggests that RTX-321 may create a broad and effective immune response against multiple tumor antigens...We plan to file the Investigational New Drug application for this program by the end of 2020.”"

IND • Preclinical • Oncology • Solid Tumor

Rubius Therapeutics to present preclinical data for RTX-321, a Red Cell Therapeutic Oncology product candidate for HPV-positive cancers at the American Association of Cancer Research Annual Meeting (GlobeNewswire) - "Rubius Therapeutics...announced that the Company plans to present preclinical data supporting its lead artificial antigen-presenting cell (aAPC) program, RTX-321, for the potential treatment of human papillomavirus (HPV) 16-positive cancers, during the American Association for Cancer Research (AACR) Virtual Annual Meeting II. The meeting is being held from June 22-24, 2020, and all posters will be available online on the first day of the conference....'We also expect to show that RTX-321 similarly activates and expands HPV 16-specific human T cells in vitro to become immune-effector cells. Together, these data suggest that RTX-321 may lead to durable responses in patients with HPV 16-positive cancers. We plan to file an Investigational New Drug application for RTX-321 by the end of 2020.”"

IND • Preclinical • Oncology • Solid Tumor