Beck LA, et al. 2022;doi:10.1007/s40257-022-00685-0. Disclosures: Beck reports being an investigator and/or consultant for AbbVie, Allakos, Arena Pharmaceuticals, AstraZeneca, Benevolent AI, DermTech, Galderma, Incyte, Janssen, Kiniksa Pharmaceuticals, LEO Pharma, Lilly, Novartis, Numab Therapeutics, Pfizer, Principia Biopharma, RAPT Therapeutics, Regeneron Pharmaceuticals, Ribon Therapeutics, Sanofi, Sanofi-Aventis, Stealth BioTherapeutics and Union Therapeutics; and owning stock in 3M, Gilead, Medtronic and Moderna. Please see the study for all other authors’ relevant financial disclosures. ADD TOPIC TO EMAIL ALERTS
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A dosing change from once a week to every other week did not diminish the long-term efficacy or safety of dupilumab in certain patients with atopic dermatitis, according to analysis findings. “Moderate to severe atopic dermatitis (AD) often requires long-term management with systemic therapies,” Lisa A. Beck, MD, of the department of dermatology at the University of Rochester Medical Center in Rochester, New York, and colleagues wrote. The interim analysis evaluated the findings of an open-label extension study investigating the safety and efficacy of a change in dosing schedule of dupilumab (Dupixent, Sanofi Genzyme/Regeneron) in this patient population. Participants transitioned from weekly dupilumab 300 mg to a dose every other week. The analysis included 2,677 enrolled and treated patients. Beck and colleagues reported that 352 of those patients completed efficacy assessments through week 204, while 202 completed follow-up safety assessments through week 244. Patients complied with treatment at a rate of 98.1%, according to self-reported data. There were no changes in the safety profile of dupilumab as compared with previous trials. Nasopharyngitis, AD, upper respiratory tract infections, oral herpes, conjunctivitis, injection-site reactions and headaches each occurred in 5% or fewer patients. Efficacy results from week 204 showed that mean EASI scores were 2.46 (standard deviation [SD], ± 3.98), which the researchers noted was a 91.07% change from parent study baseline. Pruritis Numerical Rating Scale scores were 2.1 (SD, ± 1.83), which represented a mean percent change from the parent study baseline of 68.74%. Among 226 patients who transitioned from once-weekly to every-other-week dosing, efficacy of dupilumab was maintained. The open-label nature of the study, along with the lack of a control arm, may limit the applicability of these findings. In addition, a smaller subset of patients received the approved every-other-week dose. “These results support dupilumab as continuous long-term treatment for adults with moderate to severe AD,” the researchers concluded. Read more about

Every-other-week dose of dupilumab safe, effective over long term

Ribon Therapeutics Announces Presentations at the American Association for Cancer Research 2022 Annual Meeting
- New clinical biomarker data from Phase 1 monotherapy trial of RBN-2397 provide evidence for immune cell infiltration in patient tumors upon treatment, providing strong rationale for combining with immune checkpoint inhibitors
- Preclinical studies provide further insight into the cancer cell-intrinsic mechanism of RBN-2397’s antitumor activity
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, today announced that an oral presentation and poster presentation for RBN-2397, the Company’s lead development candidate, was presented today, April 11, 2022, at the American Association for Cancer Research (AACR) Annual Meeting 2022 taking place in New Orleans, Louisiana. RBN-2397 is a small molecule inhibitor of PARP7 being evaluated in multiple clinical trials for the treatment of cancer. “We are pleased to present additional clinical and preclinical data from our RBN-2397 program that provides further evidence that PARP7 inhibition induces a tumor-specific immune response by activating Type I interferon signaling pathways,” said Prakash Raman, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. “Combining RBN-2397 with immune checkpoint inhibitors is anticipated to further potentiate the immune response in a variety of tumor types, and we look forward to evaluating this in our ongoing Phase 1b/2 trial of RBN-2397 in combination with pembrolizumab in patients with squamous cell carcinoma of the lung.”
Details for the AACR Annual Meeting 2022 presentations are as follow:
Poster presentation:
Abstract Title: RBN-2397, a novel, potent, and selective PARP7 inhibitor, induces tumor-intrinsic type I interferon responses and adaptive immunity in patient tumors
Abstract ID: 1836
Date & Time: Monday, April 11, 2022, from 1:30 p.m. to 5:00 p.m. CDT
Summary:
RBN-2397 induces tumor-specific interferon pathway activation and increases immune cell infiltration into patient tumors being evaluated in a Phase 1 trial of RBN-2397 as a monotherapy, providing evidence for the induction of an adaptive immune response. This data confirms the tumor-intrinsic, immunomodulatory mechanism of action of RBN-2397, and supports additional studies of RBN-2397 in combination with immune checkpoint inhibitors. Oral presentation:
Abstract Title: PARP7 inhibitor RBN-2397 increases tumoral IFN signaling leading to various tumor cell intrinsic effects and tumor regressions in mouse models
Abstract ID: 2154

Ribon Therapeutics Announces Presentations at the American Association for Cancer Research 2022 Annual Meeting

- New clinical biomarker data from Phase 1 monotherapy trial of RBN-2397 provide evidence for immune cell infiltration in patient tumors upon treatment, providing strong rationale for combining with immune checkpoint inhibitors
- Preclinical studies provide further insight into the cancer cell-intrinsic mechanism of RBN-2397’s antitumor activity
April 11, 2022 04:05 PM Eastern Daylight Time
CAMBRIDGE, Mass.--( BUSINESS WIRE )--Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, today announced that an oral presentation and poster presentation for RBN-2397, the Company’s lead development candidate, was presented today, April 11, 2022, at the American Association for Cancer Research (AACR) Annual Meeting 2022 taking place in New Orleans, Louisiana. RBN-2397 is a small molecule inhibitor of PARP7 being evaluated in multiple clinical trials for the treatment of cancer. “We are pleased to present additional clinical and preclinical data from our RBN-2397 program that provides further evidence that PARP7 inhibition induces a tumor-specific immune response by activating Type I interferon signaling pathways,” said Prakash Raman, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. “Combining RBN-2397 with immune checkpoint inhibitors is anticipated to further potentiate the immune response in a variety of tumor types, and we look forward to evaluating this in our ongoing Phase 1b/2 trial of RBN-2397 in combination with pembrolizumab in patients with squamous cell carcinoma of the lung.”
Details for the AACR Annual Meeting 2022 presentations are as follow:
Poster presentation:
Abstract Title: RBN-2397, a novel, potent, and selective PARP7 inhibitor, induces tumor-intrinsic type I interferon responses and adaptive immunity in patient tumors
Abstract ID: 1836
Date & Time: Monday, April 11, 2022, from 1:30 p.m. to 5:00 p.m. CDT
Summary:
RBN-2397 induces tumor-specific interferon pathway activation and increases immune cell infiltration into patient tumors being evaluated in a Phase 1 trial of RBN-2397 as a monotherapy, providing evidence for the induction of an adaptive immune response. This data confirms the tumor-intrinsic, immunomodulatory mechanism of action of RBN-2397, and supports additional studies of RBN-2397 in combination with immune checkpoint inhibitors. Oral presentation:
Abstract Title: PARP7 inhibitor RBN-2397 increases tumoral IFN signaling leading to various tumor cell intrinsic effects and tumor regressions in mouse models
Abstract ID: 2154
Date & Time: Monday, April 11, 2022, from 2:30 p.m. to 4:30 p.m. CDT
Summary:
In preclinical cancer models, RBN-2397 leads to tumor regression by activation of Type I interferon signaling resulting in antitumor immunity, as well as tumor intrinsic mechanisms including cellular senescence, interference with autophagy, and changes in tumor cell metabolism
The data demonstrate that both tumor intrinsic and immune system mediated effects of RBN-2397 contribute to its antitumor activity. The AACR presentations are available on its corporate website via the following link: https://ribontx.com/publications/ . About RBN-2397
RBN-2397 is an orally available small molecule inhibitor of PARP7 being developed for the treatment cancer. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors and in a Phase 1b/2 clinical trial in combination with pembrolizumab. PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers. About Ribon Therapeutics
Ribon Therapeutics is a clinical stage biotechnology company developing therapeutics targeting novel enzyme families activated under cellular stress conditions that contribute to disease. Ribon’s portfolio includes two oral first-in-class clinical programs, RBN-2397 (a PARP7 inhibitor) and RBN-3143 (a PARP14 inhibitor), targeting broad indications in oncology and inflammatory diseases. The company explores novel areas of biology to develop effective treatments for patients with limited therapeutic options and has active clinical programs in oncology and inflammatory disease. Leveraging our proprietary BEACON+ (Blocking the Enzyme Activity Component of NAD+) platform, we are building a pipeline of selective, small molecule inhibitors to numerous NAD+-utilizing enzymes, beginning with monoARTs (mono-ADP-ribosyltransferase), which have applications across multiple therapeutic areas. Ribon is located in Cambridge, Massachusetts. For more information, visit https://ribontx.com/ . Contacts

--RBN-2397 is a novel first-in-class oral PARP7 inhibitor that increases immune cell infiltration into tumors and is expected to improve outcomes of patients treated with immune checkpoint inhibitors
March 29, 2022 07:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.--( BUSINESS WIRE )--Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, today announced the first patient has been dosed in the Phase 1b/2 study of RBN-2397 in combination with the anti-PD-1 checkpoint inhibitor therapy, pembrolizumab, in patients with squamous cell carcinoma of the lung (SCCL). RBN-2397 is a small molecule inhibitor of PARP7 being evaluated in multiple clinical trials for the treatment of cancer. “RBN-2397 is a selective PARP7 inhibitor designed to activate the Type I interferon response in tumor cells and overcome a major limitation of immune checkpoint inhibitors (ICI). Combining RBN-2397 with an anti-PD-1 ICI is expected to treat a variety of tumor types including SCCL, a devastating disease representing the second most common form of non-small cell lung cancer,” said Prakash Raman, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. “The initiation of the Phase 1b/2 study of RBN-2397 with pembrolizumab will enable us to further understand the potential utility of this combination therapy.”
“PARP7 is amplified and highly expressed in SCCL and certain other solid tumors. We have seen encouraging results from our ongoing Phase 1 trial of RBN-2397 as a monotherapy, which is currently evaluating a number of defined expansion cohorts, including patients with SCCL,” said Sudha Parasuraman, M.D., Chief Medical Officer, Ribon Therapeutics. “The RBN-2397- pembrolizumab combination is anticipated to drive activated T cells into tumors with the potential to overcome resistance to ICIs. We look forward to evaluating this biology-driven combination in the clinical setting for patients with SCCL who are in need of new therapeutic options.”
About RBN-2397
RBN-2397 is an orally available small molecule inhibitor of PARP7 being developed for the treatment cancer. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors and in a Phase 1b/2 clinical trial in combination with pembrolizumab. PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers. About Ribon Therapeutics
Ribon Therapeutics is a clinical stage biotechnology company developing therapeutics targeting novel enzyme families activated under cellular stress conditions that contribute to disease. Ribon’s portfolio includes two oral first-in-class clinical programs, RBN-2397 (a PARP7 inhibitor) and RBN-3143 (a PARP14 inhibitor), targeting broad indications in oncology and inflammatory diseases. The company explores novel areas of biology to develop effective treatments for patients with limited therapeutic options and has active clinical programs in oncology and inflammatory disease. Leveraging our proprietary BEACON+ (Blocking the Enzyme Activity Component of NAD+) platform, we are building a pipeline of selective, small molecule inhibitors to numerous NAD+-utilizing enzymes, beginning with monoARTs (mono-ADP-ribosyltransferase), which have applications across multiple therapeutic areas. Ribon is located in Cambridge, Massachusetts. For more information, visit https://ribontx.com/ . Contacts

Ribon Therapeutics Announces Initiation of Phase 1b/2 Study of RBN-2397 in Combination with Pembrolizumab in Patients with Squamous Cell Carcinoma of the Lung

Ribon’s portfolio now includes two first-in-class clinical programs, RBN-2397 and RBN-3143, targeting broad indications in oncology and inflammatory diseases
March 22, 2022 07:00 AM Eastern Daylight Time
CAMBRIDGE, Mass.--( BUSINESS WIRE )--Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, today announced that it initiated the healthy volunteer portion of its Phase 1, first-in-human, single ascending dose and multiple ascending dose (SAD/MAD) safety and pharmacokinetic study of RBN-3143. RBN-3143 is a novel, orally administered, first-in-class inhibitor of PARP14 with potential as a therapy in a range of inflammatory diseases, with an initial focus in atopic dermatitis. PARP14 is highly expressed in tissues of inflammatory diseases, aiding the infiltration of inflammatory cells such as eosinophils and neutrophils, the reduction of which has potential advantages over current therapies. “Today’s news of the initiation of RBN-3143, our second program to move into the clinic, is an important advancement for Ribon that broadens our Company’s portfolio to now include first-in-class programs in both oncology and inflammatory diseases, leveraging our pioneering research in the role of NAD+-utilizing enzymes in stress support pathways,” said Prakash Raman, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. “As a first-in-class, oral small molecule inhibitor of PARP14, RBN-3143 has the potential to be a differentiated therapy for the treatment of numerous inflammatory diseases. We look forward to progressing this important study.”
“Based upon our extensive research and expertise evaluating NAD+-utilizing enzymes in stress support pathways, we identified that PARP14 expression is elevated in multiple tissues undergoing chronic inflammation, including atopic dermatitis, psoriasis, and asthma,” said Heike Keilhack, Ph.D., Chief Scientific Officer, Ribon Therapeutics. “By inhibiting PARP14, RBN-3143 has the potential to broadly treat inflammatory diseases with an oral agent. In preclinical inflammatory disease models, we observed that oral dosing with RBN-3143 led to a decrease of key inflammatory cytokines and cells such as eosinophils and neutrophils as well as significant improvement of disease symptoms. Further, RBN-3143 was safe and well-tolerated in preclinical studies. We look forward to further investigating the clinical profile of RBN-3143 to understand its potential to help patients with unmet needs.”
About PARP14
PARP14 is a NAD+-utilizing monoART (mono-ADP-ribosyltransferase) controlling cell signaling and regulating protein function. PARP14 expression is elevated in tissues of various inflammatory diseases, but it is not highly expressed in normal tissues. High PARP14 expression leads to the increase of first order cytokines, specifically alarmins, and second order cytokines, Th2 and Th17 cytokines, and ultimately the increase in disease tissue eosinophils and neutrophils which drive pathology. About RBN-3143
RBN-3143, a first-in-class, oral small molecule inhibitor of PARP14, has the potential to be a differentiated therapy for the treatment of numerous inflammatory diseases. This is the second program emerging from the BEACON+ platform to enter clinical development. Selective inhibition of PARP14 leads to a decrease in alarmins and dampening of the IL-17 and IL-4/13 signaling pathways. Ribon has demonstrated efficacy in multiple preclinical models of inflammatory disease. RBN-3143 is currently being evaluated in a Phase 1 clinical study in healthy volunteers and atopic dermatitis patients. About Ribon Therapeutics
Ribon Therapeutics is a clinical stage biotechnology company developing therapeutics targeting novel enzyme families activated under cellular stress conditions that contribute to disease. The company explores novel areas of biology to develop effective treatments for patients with limited therapeutic options and has active clinical programs in oncology and inflammatory disease. Leveraging our proprietary BEACON+ (Blocking the Enzyme Activity Component of NAD+) platform, we are building a pipeline of selective, small molecule inhibitors to numerous NAD+-utilizing enzymes, beginning with monoARTs (mono-ADP-ribosyltransferase), which have applications across multiple therapeutic areas. Ribon is located in Cambridge, Massachusetts. For more information, visit https://ribontx.com/ . Contacts

Ribon Therapeutics Initiates First-in-Human Phase 1 Clinical Study of RBN-3143 for the Treatment of Atopic Dermatitis

Ono Pharmaceutical (TYO: 4528) engages in the production, purchase, and sale of pharmaceutical and diagnostic reagents focusing on prescription pharmaceuticals. Its products include respiratory, digestive, urinary, chemotherapy, hormone, vitamins, and metabolic drugs. The company is headquartered in Osaka, Japan.

Ono Pharmaceuticals

Cambridge , MA -- February 2 , 2021 -- Ribon Therapeutics , a clinical stage oncology company developing therapeutics targeting stress support pathways , today announced it has entered into an exclusive license agreement with Ono , for the development and commercialization of RBN-2397 in Japan , South Korea , Taiwan and ASEAN countries .

Ribon Therapeutics Announces License Agreement with Ono Pharmaceutical Co., Ltd. to Develop and Commercialize RBN-2397 In Japan, South Korea, Taiwan and ASEAN Countries – Ribon Therapeutics

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Ribon Therapeutics specializes in the development and discovery of monoPARP (mono ADP-ribose polymerase) inhibitors to block cancer cells' fundamental ability to survive under stress.

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