Board Change • Mar 10
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 6 new directors. 4 experienced directors. 2 highly experienced directors. 2 independent directors (3 non-independent directors). Member of Scientific Advisory Board Bob Langer is the most experienced director on the board, commencing their role in 2014. Independent Director Francis Cuss was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Anuncio • Feb 07
Rubius Therapeutics Receives Non-Compliance Letter from Nasdaq On February 6, 2023, Rubius Therapeutics, Inc. was notified by the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) that, based upon the Company’s non-compliance with the $1.00 bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1) as of January 23, 2023, and the Staff’s determination that the Company is a “public shell” as that term is defined in Nasdaq Listing Rule 5101, the Company would be delisted at the opening of business on February 15, 2023 unless the Company timely requests a hearing before a Nasdaq Hearings Panel (the “Panel”) to address the deficiencies and present a plan to regain compliance. The Company plans to timely request a hearing before the Panel, which request will stay any further delisting action by the Staff at least pending the ultimate outcome of the hearing and the expiration of any extension that may be granted by the Panel. The Company’s common stock will remain listed and eligible for trading on Nasdaq at least pending the ultimate conclusion of the hearing process. As previously disclosed, on July 27, 2022, the Company received written notice from the Staff indicating that, based upon the closing bid price for the Company’s common stock for the previous 30 consecutive business days, the Company no longer satisfied the minimum bid price requirement for continued listing on The Nasdaq Global Select Market and, in accordance with the Nasdaq Listing Rules, was afforded a 180-calendar day grace period, through January 23, 2023 to regain compliance with the rule. The Company did not regain compliance with minimum bid price requirement by January 23, 2023 and, given the Staff’s separate determination that the Company is a public shell, the Staff did not grant the Company a second grace period to do so. Board Change • Nov 17
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 7 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Bob Langer is the most experienced director on the board, commencing their role in 2014. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Anuncio • Oct 18
Rubius Therapeutics, Inc. Announces Resignation of David Epstein as a Member of the Board Rubius Therapeutics, Inc. that on October 17, 2022, David Epstein resigned from his position as a member of the Board and any committees thereof, effective immediately. Mr. Epstein's resignation was not due to any disagreement with the Company on any matter relating to the Company's operations, policies, or practices. Anuncio • Sep 14
Rubius Therapeutics Announces Strategic Update Rubius Therapeutics, Inc. announced plans to restructure the Company and align resources to advance its next generation red blood cell-based cell conjugation platform. 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. Anuncio • Aug 13
Rubius Therapeutics, Inc. Announces Resignation of Natalie Holles as Member of the Board of Directors Rubius Therapeutics, Inc. announced that on August 9, 2022, Natalie Holles resigned from her position as a member of the Board of Directors of the Company and any committees thereof, effective immediately. Anuncio • Aug 02
Rubius Therapeutics Receives Non-Compliance Letter from Nasdaq On July 27, 2022, Rubius Therapeutics, Inc. (the Company") received a deficiency letter from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that, for the last 30 consecutive business days, the bid price for the Company's common stock had closed below the $1.00 per share minimum bid price requirement for continued inclusion on the Nasdaq Global Select Market pursuant to Nasdaq Listing Rule 5450(a)(1) (the Minimum Bid Price Requirement"). The Nasdaq deficiency letter has no immediate effect on the listing of the Company's common stock, and its common stock will continue to trade on the Nasdaq Global Select Market under the symbol RUBY" at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a period of 180 calendar days, or until January 23, 2023, to regain compliance with the Minimum Bid Price Requirement. If, at any time ending January 23, 2023, the bid price for its common stock closes at $1.00 or more for a minimum of 10 consecutive business days as required under the applicable rule, the Staff will provide written notification to the Company that it has regained compliance with the Minimum Bid Price Requirement, unless the Staff exercises its discretion to extend this ten-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company does not regain compliance with the Minimum Bid Price Requirement by the applicable date, the Company may be eligible for an additional 180 calendar day compliance period. To qualify, the Company would need to transfer the listing of its common stock to the Nasdaq Capital Market, provided that it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards of the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement. To effect such a transfer, the Company would also need to pay an application fee to Nasdaq and provide written notice to the Staff of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split if necessary. As part of its review process, the Staff will make a determination of whether it believes the Company will be able to cure the deficiency. Should the Staff conclude that the Company will not be able to cure the deficiency, the Staff will provide written notification to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff's delisting determination to a Nasdaq Listing and Hearing Review Panel. However, there can be no assurance that, if the Company receives a delisting notice and appeals the delisting determination by the Staff to the panel, such appeal would be successful. The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance with the Minimum Bid Price Requirement. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement. Anuncio • Jul 15
Rubius Therapeutics, Inc. Appoints Susanne Schaffert to Its Board of Directors Rubius Therapeutics, Inc. announced the appointment of Susanne Schaffert, Ph.D., to its board of directors. Dr. Schaffert brings more than 25 years of experience across clinical development, marketing and sales, finance and commercialization in the global pharmaceutical and biotechnology industries, with a focus on oncology, immuno-oncology and cell therapy. Dr. Schaffert most recently served as President of Novartis Oncology. Rubius announced that Anne Prener, M.D., Ph.D., is stepping down from her role on the board of directors, effective immediately. Dr. Schaffert spent 27 years at Novartis, most recently as President of Novartis Oncology. Before that, she spent six years in Novartis’ Oncology Business as a member of the Global Novartis Oncology Leadership Team, including as Region Head, Novartis Oncology Europe, where she successfully launched and marketed key products in lung, breast and renal cancer as well as hematology. She also served as President and Chair of Accelerated Advanced Applications (AAA), launching Lutathera®, a radioligand therapy for the treatment of certain cancers, in the U.S. and E.U. Also during her tenure in Novartis’ Oncology Business, she was instrumental in the GSK Oncology integration. From 2010-2013, Dr. Schaffert was Head of Investor Relations, and before that, she served as Global Franchise Head for Immunology and Transplantation. Dr. Schaffert first joined Novartis Germany in 1995 and held a series of positions in Sales and Marketing with increasing responsibilities in both national and global functions. Dr. Schaffert holds a Ph.D. with honors in Organic Chemistry and an M.Sc. in Chemistry, both from the University of Erlangen (Germany). Anuncio • May 26
Rubius Therapeutics Appoints Noubar Afeyan as Chairman of its Board of Directors Rubius Therapeutics, Inc. announced the appointment of Noubar Afeyan, Ph.D., co-founder and member of the board of directors of Rubius Therapeutics and chief executive officer of Flagship Pioneering, as chairman of its board of directors. David Epstein who has served as chairman since 2017 will remain a member of the board. Anuncio • Apr 09
Rubius Therapeutics, Inc. 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 Rubius Therapeutics, Inc. announced updated clinical data from the ongoing monotherapy Phase 1 arm of the Phase 1/2 clinical trial of RTX-240 in patients with advanced solid tumors at the American Association for Cancer Research Annual Meeting. Updated Data from the Phase 1 Trial of RTX-240 in Patients with Advanced Solid Tumors: Nine dose cohorts (n=34) were completed in the monotherapy solid tumor arm of the trial at the time of the data cutoff on March 4, 2022, with 34 patients evaluable for safety (primary outcome measure) and 27 patients evaluable for efficacy (secondary outcome measure). Enrollment continues in the 5e10 Q3W dose cohort. As of the cutoff date, disease control was observed in 10 patients (1 partial response, 2 unconfirmed partial responses and 7 with stable disease), 9 of whom had experienced disease progression on prior anti-PD-1/anti-PD-L1 therapy. There were three best responses of partial response (PR) in non-small cell lung cancer (NSCLC), anal cancer and uveal melanoma patients: An unconfirmed PR (uPR) with 41% decrease of all target lesions and a notable decrease of an external protruding chest wall mass in a patient with non-small cell lung cancer (NSCLC) whose disease had progressed on prior anti-PD-L1 therapy; A confirmed PR with a 54% reduction in the target lesions in a patient with metastatic anal cancer whose disease had progressed on anti-PD-L1 therapy; and An uPR with 100% decrease of the target hepatic lesion and resolution of multiple non-target hepatic lesions in a patient with metastatic uveal melanoma whose disease had progressed on anti-PD-1 therapy. Stable disease was observed in 5 patients, including 3 with metastatic NSCLC and 2 with renal cell carcinoma (RCC) across the 3e10 cohorts, supporting the Company’s decision to expand the Phase 1 arm of RTX-240 plus pembrolizumab to NSCLC and RCC patients. One patient each with NSCLC and RCC remained on monotherapy treatment with SD greater than 6 months as of the cutoff date. As of the cutoff date, RTX-240 has been shown to have been generally well tolerated with no treatment-related or investigator-identified immune-related Grade 3/4 adverse events (AEs) and no dose-limiting toxicities. Based on the totality of clinical, tolerability and pharmacodynamic data, a recommended monotherapy Phase 2 dose of 5e10 cells administered every 3 weeks was selected. This dose will be further explored in the combination expansion cohort of NSCLC and RCC patients. Rubius also announced final clinical results from the Phase 1 arm of monotherapy RTX-240 in relapsed/refractory AML. As of the cutoff date of March 4, 2022, seventeen patients were enrolled across 4 dose levels. No DLTs were observed and there were 3 treatment-related Grade 3/4 adverse events. There were no investigator-reported immune-related AEs. Five patients had SD greater than 3 months, and 1 patient had a significant blast count reduction (53% to 6%). Upcoming Anticipated Milestones: To evaluate the full potential of RTX-240, Rubius’ other oncology programs and the RED PLATFORM, Rubius plans to execute several critical milestones within the next 12 months and has sufficient cash runway into the second half of 2023: 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; Select a clinical candidate for the first autoimmune program in type 1 diabetes during 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. Anuncio • Mar 31
Rubius Therapeutics, Inc., Annual General Meeting, May 12, 2022 Rubius Therapeutics, Inc., Annual General Meeting, May 12, 2022, at 09:00 US Eastern Standard Time. Agenda: To consider the election of Class l Directors Nominees; to ratify the appointment of PricewaterhouseCoopers LLP as Rubius Therapeutics, Inc’s independent registered public accounting firm for the fiscal year ending December 31, 2022; to approve, on a non-binding, advisory basis, the compensation of our named executive officers for the year ended December 31, 2021 (say-on-pay vote); and to consider and act upon a non-binding, advisory vote on the frequency of future advisory votes to approve the compensation of our named executive officers. Anuncio • Feb 15
Rubius Therapeutics, Inc. to Report Q4, 2021 Results on Feb 25, 2022 Rubius Therapeutics, Inc. announced that they will report Q4, 2021 results Pre-Market on Feb 25, 2022 Anuncio • Jan 14
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 Rubius Therapeutics, Inc. 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. This is a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study to determine the safety and tolerability, pharmacokinetics, maximum tolerated dose and a recommended Phase 2 dose and dosing regimen of RTX-224 in adult 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. The trial will also assess pharmacodynamic changes in immune cell populations relative to baseline and anti-tumor activity. The study will include a monotherapy dose escalation phase followed by an expansion phase in specified tumor types during the Phase 2 portion of the trial. Anuncio • Dec 17
Rubius Therapeutics to Highlight the Power of RED PLATFORM®, Significant Advances Across Red Cell Therapeutic Oncology Pipeline and New Type 1 Diabetes Program at Platform and Pipeline Day Rubius Therapeutics, Inc. announced significant advances from its RED PLATFORM and across its pipeline of Red Cell Therapeutics (RCTs) at the Company’s first Pipeline and Platform Day. Achieved clinical validation of the RED PLATFORM with initial clinical results from the single-agent RTX-240 Phase 1 clinical trial in advanced solid tumors, reported in March 2021. RCTs are well tolerated, induce the desired biological effect and generate clinical benefit in certain patients with advanced solid tumors. Advancing next generation aAPCs with loadable MHC Class I, enabling the presentation of multiple antigens on a single RCT and broadening the potential patient population with a library of HLA types. Enabling rapid and repeatable parallel generation of therapeutic candidates with the programmable RED PLATFORM. The platform creates multiple modalities for the treatment of cancer and autoimmune disease and the ability to express hundreds of thousands of copies of therapeutic proteins on or within the cell to access numerous immune pathways. RTX-240: Established clinical proof of concept of RTX-240 in advanced solid tumors, based on initial results reported in March 2021, potentially increasing the likelihood of clinical success across the oncology pipeline. Escalating the dose of single-agent RTX-240 in the Phase 1 solid tumor clinical trial to three doses of 5e10 followed by one dose 1e10 until disease progression or unacceptable toxicity, based on no dose-limiting toxicities observed to date, a clear dose response in the increase of NK cells and other pharmacodynamic effects. 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. Continuing dose escalation in the RTX-240 Phase 1 combination study with pembrolizumab in patients with advanced solid tumors. 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. Investigational New Drug application cleared. Anuncio • Jul 16
Rubius Therapeutics Announces Publication of RTX-240 Preclinical Data in Cancer Immunology, Immunotherapy Rubius Therapeutics, Inc. announced the publication of preclinical data in the peer-reviewed journal Cancer Immunology, Immunotherapy, for its lead clinical oncology program, RTX-240, for the treatment of adults with advanced solid tumors and relapsed/refractory acute myeloid leukemia. The paper entitled “Anti-Tumor Effects of RTX-240: an Engineered Red Blood Cell Expressing 4-1BB Ligand and Interleukin-15” highlights preclinical findings, which demonstrate that RTX-240 activates and expands CD8+ T cells and NK cells in vitro and in vivo generating potent anti-tumor activity in both a colorectal and melanoma model. About RTX-240: RTX-240, Rubius Therapeutics' lead oncology program, is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and IL-15TP (trans-presentation of IL-15 on IL-15Ra) in their native forms. RTX-240 is designed to broadly stimulate the immune system by activating and expanding both NK and memory T cells to generate a potent anti-tumor response. About the RTX-240 Phase 1/2 Clinical Trial: This is a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study designed to determine the safety and tolerability, pharmacokinetics, maximum tolerated dose, a recommended Phase 2 dose and dosing regimen of RTX-240. The trial will also assess the pharmacodynamics of RTX-240 measured by changes in T and NK cell number and function relative to baseline and anti-tumor activity. The trial has three separate Phase 1 arms: an ongoing monotherapy dose escalation arm in adults with relapsed/refractory or locally advanced solid tumors, an ongoing monotherapy dose escalation arm in adults with relapsed/refractory acute myeloid leukemia, and a combination therapy dose escalation arm with pembrolizumab in adults with relapsed/refractory or locally advanced solid tumors. The monotherapy arm of the trial in advanced solid tumors includes a Phase 2 expansion in specified tumor types. Anuncio • Jun 25
Rubius Therapeutics, Inc. Announces First Patient Dosed with RTX-240 in Combination with KEYTRUDA® in Ongoing Phase 1/2 Clinical Trial for Treatment of Advanced Solid Tumors Rubius Therapeutics, Inc. announced that the first patient has been dosed in a new phase 1 arm of the ongoing phase 1/2 clinical trial of RTX-240 in combination with KEYTRUDA® (pembrolizumab) for the treatment of patients with relapsed/refractory or locally advanced solid tumors. To be eligible for the trial, patients must have disease that is relapsed or refractory to an anti-PD-1 or PD-L1 therapy. RTX-240 is engineered to express a co-stimulatory molecule, 4-1BB ligand, and a cytokine, IL-15TP, on the cell’s surface, and is designed to broadly stimulate the immune system by activating and expanding both natural killer (NK) cells and T cells to generate a potent anti-tumor response. Pembrolizumab is a humanized monoclonal immunoglobulin G4 antibody (IgG4 mAb) with high specificity of binding to the programmed cell death protein-1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Based on in vitro data, pembrolizumab has high affinity and potent receptor blocking activity for PD-1. Pembrolizumab is indicated for the treatment of patients across several indications as monotherapy and in combination with numerous therapies. This is a phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study designed to determine the safety and tolerability, pharmacokinetics, maximum tolerated dose and a recommended phase 2 dose and dosing regimen of RTX-240. The trial will also assess the pharmacodynamics of RTX-240 measured by changes in T and NK cell number and function relative to baseline and anti-tumor activity. The trial has three separate phase 1 arms: an ongoing monotherapy dose escalation arm in adults with relapsed/refractory or locally advanced solid tumors, an ongoing monotherapy dose escalation arm in adults with relapsed/refractory acute myeloid leukemia, and a combination therapy dose escalation arm with pembrolizumab in adults with relapsed/refractory or locally advanced solid tumors. The monotherapy arm of the trial in advanced solid tumors includes a phase 2 expansion in specified tumor types. Anuncio • May 21
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 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. Anuncio • May 13
Rubius Therapeutics Announces Publication of RTX-321 Preclinical Data in Nature Communications Rubius Therapeutics, Inc. announced the publication of preclinical data in the peer-reviewed journal Nature Communications, for its lead artificial antigen-presenting (aAPC) cell program, RTX-321, for the potential treatment of human papillomavirus (HPV) 16-positive cancers. RTX-321 is an allogeneic, off-the-shelf Red Cell Therapeutic product candidate that is engineered as an aAPC with a dual mechanism of action: to boost HPV 16-specific CD8+ T cell responses and promote broad stimulation of both innate and adaptive immune responses. 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. The paper entitled “Engineered red blood cells as an off-the-shelf allogeneic anti-tumor therapeutic” highlights preclinical findings demonstrating that the surrogate model of RTX-321 induced a target antigen-specific immune response, epitope spreading, memory formation as well as broad immune stimulation. This suggests that in patients, an effective immune response could be generated against multiple HPV antigens, and potentially enable the patient’s own immune system to remember a cancer’s identity, which could lead to long-term protection from tumor recurrence. Anuncio • Mar 17
Rubius Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $200.000008 million. Rubius Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $200.000008 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 6,896,552
Price\Range: $29 Anuncio • Mar 16
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 Rubius Therapeutics, Inc. announced initial clinical, pharmacodynamic and tumor trafficking data from its ongoing Phase 1/2 clinical trial of RTX-240 in patients with advanced solid tumors. The Company also shared tumor trafficking data from one patient with relapsed/refractory acute myeloid leukemia (AML) in the second Phase 1 arm of the study. The Company believes these data provide initial proof-of-concept of the RED PLATFORM® by providing evidence that red blood cells can be engineered to mimic the human immune system and stimulate adaptive and innate immunity to generate clinical responses in cancer patients with refractory disease. Initial Efficacy Data - Five (5) dose cohorts were completed in the solid tumor trial at the time of the data cutoff on February 28, 2021 (n=16), with 16 patients evaluable for safety (primary outcome measure) and 15 patients evaluable for efficacy (secondary outcome measure) based on RECIST v1.1. The study is continuing to enroll patients and despite the fact that dose optimization is still ongoing, RTX-240 generated: A confirmed partial response (PR) with a 54% reduction in the target lesions at the 1e8 dose administered every 4 weeks in a patient with metastatic anal cancer whose disease had progressed on anti-PD-L1 therapy. Treatment of this patient was ongoing 8 months following the first dose at data cutoff; An unconfirmed PR with complete resolution of the target hepatic lesion and resolution of 14/15 hepatic lesions at the 1e10 dose administered every 4 weeks in a patient with metastatic uveal melanoma whose disease had progressed on anti-PD-1 therapy. Treatment of this patient was ongoing 4 months following the first dose at data cutoff; and Stable disease (SD) was observed in 6 patients, including 4 individual patients with stable disease for at least 12 weeks: Non-small cell lung cancer (disease stabilization for 12 weeks with treatment ongoing as of the data cutoff); Soft tissue sarcoma (disease stabilization for 4 months); Pancreatic cancer (disease stabilization for 3 months); and Prostate cancer (disease stabilization for 4 months). Initial Safety Data - The most common treatment-related Grade 1/2 adverse events were fatigue (n=4), chills, nausea, decreased appetite and arthralgias all reported in 3 patients each. There were no treatment-related Grade 3/4 adverse events, no dose-limiting toxicities and a single Grade 1 event of liver toxicity. Ten (10) immune-related adverse events (irAE) were observed among 5 patients with no reported treatment-related Grade 3/4 irAEs. Grade 2 treatment-related irAEs included pneumonitis (n=1), adrenal insufficiency (n=1) and hypothyroidism (n=1). Pharmacodynamic Data - In addition to evaluating safety and preliminary efficacy data, the trial is evaluating the pharmacodynamic effects of RTX-240: RTX-240 stimulated innate and adaptive immunity as demonstrated by the activation and/or expansion of NK or memory CD8+ T cells in all patients, with 9/16 patients showing activation and expansion in both cell types. There was an overall trend towards a dose response in absolute NK cell numbers (expansion); Detailed NK cell analysis showed an increased percentage of CD16+CD56dim (mature NK cells) and CD56bright (immature NK cells) across dose levels. These cell subtypes are associated with cytotoxicity and cytokine production respectively; and RTX-240 induced expression of key NK cell activation receptors, including NKp30 and the ratio of cells expressing the activation receptor NKG2D versus the inhibitory receptor NKG2A. This specific signature of NK cell receptor expression may allow selection of specific tumor types with predicted sensitivity to RTX-240. Tumor Infiltration Data - Immune cell trafficking into the tumor microenvironment (TME) was assessed by tumor biopsies from participating patients with solid tumors (optional; n=4) and AML (standard of care; n=1). Trafficking of T and NK cells into the TME was observed in 3/5 patients (1.6 to 10-fold increases), including one patient each with metastatic mesothelioma, metastatic soft tissue sarcoma and refractory AML. Tumor infiltration was not observed in patients with ovarian cancer (n=1) and heavily pretreated melanoma (n=1); There was increased expression of PD-L1 observed in 3/4 patients with solid tumors, suggesting an improved immune-permissive TME; and In one patient with AML, trafficking of T and NK cells into the bone marrow was associated with increases in the cellularity of the marrow. 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. Anuncio • Mar 11
Rubius Therapeutics Announces Clinical Results from the Ongoing Phase 1/2 Clinical Trial of RTX-240 Rubius Therapeutics, Inc. announced that the company will present clinical results from its ongoing Phase 1/2 study of RTX-240 in advanced solid tumors during Week One of the American Association for Cancer Research (AACR) Virtual Annual Meeting being held from April 10-15, 2021. Posters will be available online on the first day of the conference on April 10 and will remain available for viewing through June 21, 2021. In January of 2021, the company shared key takeaways from the first five cohorts (n=14) of the RTX-240 Phase 1/2 clinical trial for the treatment of advanced solid tumors. Key takeaways from the initial data included (as of January 2021): No treatment-related Grade 3 or Grade 4 adverse events and no dose limiting toxicities observed (n=14); All patients showed activation of NK or T cells or both cell types (n=14); In the majority of patients (n=8), all of the following were observed across dose levels: Activation of NK cells, activation of T cells, expansion of NK cells and expansion of T cells. Is New 90 Day High Low • Mar 11
New 90-day high: €12.50 The company is up 89% from its price of €6.60 on 10 December 2020. The German market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.018 per share. Anuncio • Feb 10
Rubius Therapeutics, Inc. to Report Q4, 2020 Results on Feb 23, 2021 Rubius Therapeutics, Inc. announced that they will report Q4, 2020 results Pre-Market on Feb 23, 2021 Is New 90 Day High Low • Jan 27
New 90-day high: €8.10 The company is up 109% from its price of €3.88 on 28 October 2020. The German market is up 16% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 12% over the same period. Anuncio • Jan 12
Rubius Therapeutics, Inc. Provides an Operational Update Rubius Therapeutics, Inc. provided an operational update and announced its 2021 objectives. Pablo J. Cagnoni, M.D., chief executive officer, will present these updates and review 2020 achievements on January 13, 2021, at 8:20 a.m. EST at the virtual 39th Annual J.P. Morgan Healthcare Conference. By showing that RTX-240 is activating and expanding NK and T cells, Rubius Therapeutics believes that the full data set from the Phase 1 clinical trial will unlock the potential of the RED PLATFORM across the entire pipeline of Red Cell Therapeutics for the treatment of cancer.RTX-240 Phase 1/2 Clinical Trial for the Treatment of Advanced Solid Tumors and Relapsed/Refactory Acute Myeloid Leukemia (AML). RTX-240 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand and IL-15TP (trans-presentation of IL-15 on IL-15R) in their native forms. RTX-240 is designed to broadly stimulate the immune system by activating and expanding both NK and memory T cells to generate a potent anti-tumor response. To date, Rubius has completed dosing of 5 cohorts (n=14) in the Phase 1/2 RTX-240 solid tumor clinical trial. Trial enrollment continues in additional cohorts. Key takeaways from initial data to date show: No treatment-related Grade 3 or Grade 4 adverse events and no dose limiting toxicities observed (n=14). All patients showed activation of NK or T cells or both cell types (n=14). In the majority of patients (n=8), all of the following were observed across dose levels: Activation of NK cells, activation of T cells, expansion of NK cells and expansion of T cells. As more patients are enrolled and data mature, the Company expects to disclose additional clinical results, including. additional safety and tolerability data; biomarkers associated with the activation and expansion of NK and T cells in peripheral blood. immune cell trafficking into tumors assessed by optional tumor biopsies from participating patients; and potential responses as measured by objective response rate. Enrollment continues in the Phase 1 clinical trial of RTX-240 in relapsed/refractory AML. RTX-321 Artificial Antigen-Presenting Cell (aAPC) Development Program for Human Papillomavirus (HPV) 16-Positive Cancers. RTX-321 is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions. The Investigational New Drug (IND) application has been cleared and patients are being screened in the Phase 1 clinical trial of RTX-321 in advanced HPV 16+ cancers, including cervical cancer, head and neck cancer and anal cancer. Recognizing the importance of controlling manufacturing to produce consistent and reproducible product at greater scale, Rubius acquired, renovated and operationalized a manufacturing facility in Smithfield, RI. The site has achieved the following milestones: Provided consistent cGMP supply for the two Phase 1 arms in the ongoing RTX-240 clinical trial in advanced solid tumors and relapsed/refractory AML. Increased productivity in manufacturing of cGMP supply of RTX-240 in 50L bioreactors. Increased liquid in-vial shelf life from 28 to 52 days for RTX-240. Continuously met red blood cell identity (CD233+, mean corpuscular hemoglobin, purity, enucleation cell population) and target product profile criteria (protein expression, cell viability) for clinical supply lots Completed engineering runs and now producing cGMP supply for the Phase 1 clinical trial of RTX-321 for advanced HPV 16-positive cancers. Introduced frozen drug substance for the first time as part of the IND application for RTX-321, resulting in a truly off-the-shelf cellular therapy with a potential shelf life of up to several years. Following liquid reformulation, RTX-321 drug product has an in-vial shelf life of 52 days. Significant potential to expand manufacturing capabilities based on future supply needs and for potential commercial production. The Company presented preclinical oncology data for RTX-240 and RTX-321 at the following conferences: Society for Immunotherapy of Cancer (SITC) Annual Meeting; Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting; American Association for Cancer Research (AACR) Tumor Immunology Conference; and American Society of Gene & Cell Therapy 23rd Annual Meeting. Is New 90 Day High Low • Dec 15
New 90-day high: €7.90 The company is up 87% from its price of €4.22 on 16 September 2020. The German market is up 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Nov 24
New 90-day high: €4.92 The company is up 17% from its price of €4.20 on 26 August 2020. The German market is up 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Anuncio • Nov 10
Rubius Therapeutics Presents Preclinical Data for Lead Red Cell Therapeutic Clinical Oncology Program, Rtx-240, at the Society for Immunotherapy of Cancer’s Annual Meeting Rubius Therapeutics, Inc. announced the presentation of new preclinical data supporting its lead clinical oncology program, RTX-240, at the Society for Immunotherapy of Cancer’s (SITC)Annual Meeting. The meeting is being held virtually from November 9-14, 2020. RTX-240 is an allogeneic, off-the-shelf Red Cell Therapeutic that is engineered to mimic the human immune system by stimulating adaptive and innate immunity to generate an anti-tumor immune response. Rubius Therapeutics is currently enrolling patients in the Phase 1/2 clinical trial of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors. In addition, RTX-240 is being evaluated in a second Phase 1 arm of the clinical trial for the treatment of patients with relapsed/refractory acute myeloid leukemia. RTX-240, an Allogeneic Engineered Red Blood Cell Expressing 4-1BBL and IL-15TP, Promotes NK Cell Functionality In Vitro and In Vivo; RTX-240 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BBL and IL-15TP (trans-presentation of IL-15 on IL-15Ra) on the cell surface in their native forms. RTX-240 is designed to stimulate innate and adaptive immunity by activating NK cells and T cells inside the patient’s body to generate an anti-tumor immune response. RTX-240 preclinical data demonstrated, RTX-240 led to increased CD8 T cell and NK cell expansion and activation in vitro compared to the combination of a 4-1BB agonist antibody plus recombinant IL-15 which was directly correlated with the percentage of 4-1BBL and IL-15TP expressed on the cell surface, RTX-240 expanded CD56dim NK cells, a cell population with high cytotoxicity, RTX-240 promoted NK cell-killing of a myeloid leukemia cell line, K562, and this was accompanied by increased NK cell degranulation and activation, A murine surrogate for RTX-240, mRBC-240, promoted significant expansion of CD8 T cells and NK cells in vivo in a murine model of colorectal cancer (CT26) and mRBC-240 demonstrated potent antitumor activity in a B16F10 melanoma model that was directly correlated with the expansion of terminally differentiated NK cells in the tumors. Anuncio • Nov 07
Rubius Therapeutics, Inc. Announces Dosing of First Patient with Relapsed/Refractory Acute Myeloid Leukemia in the Ongoing Phase 1/2 Clinical Trial of RTX-240 Rubius Therapeutics, Inc. announced that the first patient with acute myeloid leukemia (AML) has been dosed in its ongoing Phase 1/2 clinical trial of RTX-240, an allogeneic cellular therapy product candidate that is being evaluated for the treatment of patients with relapsed/refractory or locally advanced solid tumors or relapsed/refractory AML. The ongoing clinical study of RTX-240 has two Phase 1 arms, one in all solid tumors and the other in relapsed/refractory AML. RTX-240 is engineered to stimulate innate and adaptive immunity by activating natural killer (NK) cells and T cells inside the patient’s body to generate a potent anti-tumor immune response. RTX-240 is engineered to simultaneously express hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and the cytokine interleukin-15 (IL-15TP) to broadly stimulate both powerful arms of the immune system to generate anti-tumor immunity. Anuncio • Oct 30
Rubius Therapeutics, Inc. to Report Q3, 2020 Results on Nov 09, 2020 Rubius Therapeutics, Inc. announced that they will report Q3, 2020 results at 9:00 AM, Eastern Standard Time on Nov 09, 2020 Is New 90 Day High Low • Oct 21
New 90-day low: €3.84 The company is down 22% from its price of €4.92 on 23 July 2020. The German market is down 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 14% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Sep 25
New 90-day low: €3.92 The company is down 33% from its price of €5.85 on 26 June 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Anuncio • Aug 04
Rubius Therapeutics, Inc. to Report Q2, 2020 Results on Aug 10, 2020 Rubius Therapeutics, Inc. announced that they will report Q2, 2020 results at 9:00 AM, Eastern Standard Time on Aug 10, 2020