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Nimbus eligible to receive up to $496 million, inclusive of research funding and potential milestone payments, in addition to royalties on net sales

AMPK activation is a promising strategy to treat disorders of dysregulated metabolism

CAMBRIDGE, Mass. – October 11, 2022 – Nimbus Therapeutics, a clinical-stage company that is working to design and develop breakthrough medicines through its powerful computational drug discovery engine, today announced it has entered into a research collaboration and exclusive, worldwide license agreement with Eli Lilly and Company (Lilly) for the development and commercialization of novel targeted therapies that activate a specific isoform of AMPK for the treatment of metabolic diseases.

Leveraging Nimbus’s computational drug discovery engine and expertise in structure-based drug design, Nimbus is uniquely positioned to develop isoform-selective small molecule activators of AMPK with potential therapeutic application to a broad range of metabolic disorders.

“AMPK is a high-value target for the treatment of metabolic diseases, and drug developers have faced challenges for many years in identifying isoform-selective AMPK activators for tissue-specific therapeutic interventions. Nimbus has established a successful track record in developing and progressing highly-selective small molecules to the clinic against hard-to-interrogate targets, which is a demonstration of the power of our computational and structural approach to drug discovery,” said Peter Tummino, Ph.D., Chief Scientific Officer at Nimbus. “We are excited to partner with Lilly and benefit from their deep expertise in metabolic diseases, including diabetes, obesity and related disorders.”

“We look forward to collaborating with this innovative team at Nimbus, which has an established record of developing highly-specific small molecule modulators against important therapeutic targets,” said Ruth Gimeno, Ph.D., Lilly’s Senior Vice President, Diabetes Research and Clinical Investigation. “Developing therapies together that target AMPK helps address a critical need and is part of Lilly’s ongoing efforts to expand treatment options available to patients with metabolic disorders.”

Under the collaboration, Nimbus will be responsible for research activities, and Lilly will be responsible for development and commercialization activities worldwide. Financial consideration for Nimbus includes a series of payments, funding and milestones spread through research, development and commercialization, potentially reaching up to $496 million in total. Nimbus is eligible to receive tiered royalties on global net sales ranging from mid single- to low double-digits.

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company working to design and develop breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contacts:

Chris Railey, (617) 834-0936
Ten Bridge Communications

chris@tenbridgecommunications.com

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 – Financing supports ongoing Phase 2b clinical trials of NDI-034858 (allosteric TYK2 inhibitor) and initiation of Phase 3; ongoing Phase 1/2 clinical trials of NDI-101150 (HPK1 inhibitor); and advancement of multiple preclinical programs –

 – Bain Capital Life Sciences and SV Health Investors participating as new investors –

CAMBRIDGE, Mass. – September 12, 2022 – Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the closing of a $125 million private financing. The round involves participation from new investors Bain Capital Life Sciences and SV Health Investors, along with existing investors including Access Biotechnology, Atlas Venture, BVF Partners L.P., Bill Gates, Lightstone Ventures, Pfizer Ventures, RA Capital Management and SR One.

“The strong support from investors in this financing validates the promise and differentiation of Nimbus’ current portfolio of clinical and preclinical programs, and the success of our productive drug discovery engine,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “I’m pleased to welcome SV Health Investors and Bain Capital Life Sciences to Nimbus’ investor syndicate at this very exciting time in our history, and look forward to generating and sharing critical data for our medicines in development in the near term.”

The financing will support the completion of the ongoing Phase 2b clinical trials of NDI-034858, Nimbus’ oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in moderate-to-severe plaque psoriasis and active psoriatic arthritis, the initiation of psoriasis Phase 3 trials, as well as the initiation of additional Phase 2b clinical trials of NDI-034858 in other autoimmune indications, including inflammatory bowel disease (IBD) and lupus.

The financing also will support the ongoing Phase 1/2 clinical trials of NDI-101150, Nimbus’ hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with solid tumors, as well as preclinical development of programs targeting Casitas B-lineage lymphoma b (Cbl-b) and Werner syndrome helicase (WRN), along with ongoing discovery efforts across a range of targets.

“We’re proud to lead this financing round to advance Nimbus’ exciting pipeline of clinical and preclinical candidates,” said Nikola Trbovic, Ph.D., Partner at SV Health Investors. “Nimbus has a remarkable track record of success in discovering and developing differentiated small molecule therapies to address substantial unmet medical needs, and we’re excited to support their current portfolio of programs.”

In addition to this financing, Nimbus has recently appointed Gorjan Hrustanovic, Ph.D., Managing Director of BVF Partners, L.P., to its Board of Directors. Dr. Hrustanovic serves on a number of other public and private biotech boards, and trained in cancer biology and translational medicine at the University of California, San Francisco.

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. Nimbus combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus has designed, discovered and developed a diverse portfolio of clinical and preclinical programs focused on inflammatory and autoimmune disorders, cancer and metabolic diseases, including three internally discovered compounds that have advanced into clinical trials. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

About SV Health Investors

SV Health Investors is a leading healthcare fund manager committed to investing in tomorrow’s healthcare breakthroughs. The SV family of funds invests across stages, geographic regions, and sectors, with expertise spanning biotechnology, dementia, healthcare growth, healthcare technology and public equities. With over $2.5 billion in assets under management and a transatlantic presence with offices in Boston and London, SV has built an extensive network of talented investment professionals and experienced industry veterans. Since its founding in 1993, SV has invested in more than 200 companies with more than 90 of these having achieved successful acquisitions or IPOs. For learn more about SV Health Investors, please visit www.svhealthinvestors.com.

About Bain Capital Life Sciences

Bain Capital Life Sciences (www.baincapitallifesciences.com) invests in pharmaceutical, biotechnology, medical device, diagnostic, and life science tool companies across the globe, with a focus on companies that both drive medical innovation across the value chain and enable that innovation to improve the lives of patients with unmet medical needs. The differentiated skillset of Bain Capital Life Sciences team enables it to deliver targeted capital land value-added strategic support to companies around critical phases of growth and inflections in value. Since 1984, Bain Capital has employed a strategic and analytical approach to identify attractive investment opportunities and partner with management teams to transform and improve their businesses. During this time, Bain Capital has developed global reach, deep expertise, and a proven track record in the life sciences industries across private equity, public equity, credit, venture capital, and real estate.

 Media Contact

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com

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CAMBRIDGE, Mass. – August 24, 2022 – Nimbus Therapeutics, a clinical-stage company that is working to design and develop breakthrough medicines through its powerful computational drug discovery engine, today presented research describing the chemical structure of NDI-034858, the company’s investigational oral allosteric TYK2 (tyrosine kinase 2) inhibitor now in two Phase 2b clinical studies for moderate-to-severe plaque psoriasis and active psoriatic arthritis.

The data, presented in an oral session at the American Chemical Society Fall 2022 meeting, describe how Nimbus leveraged structural biology and computational chemistry insights to produce a novel TYK2 inhibitor with a potential best-in-class profile with respect to potency, selectivity and optimized pharmacokinetics/pharmacodynamics properties.

“Challenges in selectivity often arise when the easily druggable target sites are structurally similar to those of other proteins, as is the case with the TYK2 catalytic site. For this reason, we intentionally designed NDI-034858 to target the allosteric JH2 binding site, where key amino acid differences between TYK2 and JAKs 1, 2, and 3 can be exploited to dramatically favor binding to TYK2 over those other closely related kinases,” said Scott Edmondson, Ph.D., Senior Vice President and Head of Chemistry at Nimbus. “Preclinical and clinical data to date support this approach, showing that NDI-034858 can achieve high target inhibition at low clinical doses without evidence of the adverse safety effects observed with JAK inhibition.”

NDI-034858 was developed using structure-based drug design, an approach that applies computational chemistry and other analytical technologies to high-resolution protein-ligand co-crystal structures. Development focused on maximizing the small molecule’s therapeutic benefit by achieving highly selective inhibition of the pseudokinase JH2 domain of TYK2. This allosteric interaction results in very high selectivity compared to the other homologous proteins in the Janus Kinase (JAK) family of non-receptor tyrosine kinases.

“Nimbus’ TYK2 program is an excellent example of our leadership in structure-based drug design. By combining advanced computational methods together with our structural biology and medicinal chemistry expertise, we are able to identify and exploit unique binding pockets on our target proteins to achieve exquisite selectivity,” said Peter Tummino, Ph.D., Chief Scientific Officer at Nimbus. “This approach forms the basis of Nimbus’ diversified portfolio of differentiated candidates in oncology, autoimmune diseases, and metabolic disorders, including our clinical-stage HPK1 program in immuno-oncology and promising preclinical work across numerous targets.”

In a Phase 1 clinical study, NDI-034858 demonstrated a good tolerability profile and evidence of clinical and pharmacodynamic activity across multiple measures of disease pathology in psoriasis. Notably, it has been shown in cellular assays to be significantly more selective than Bristol Myers Squibb’s TYK2 inhibitor deucravacitinib.

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company working to design and develop breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

About the Nimbus TYK2 Program

TYK2 is an important signal-transducing kinase that mediates immune signaling and is important in both adaptive and innate immune cells. TYK2 inhibition is a potentially promising treatment approach for a wide range of autoimmune and inflammatory diseases due to the protein’s central role in both the innate and adaptive immune responses. Nimbus is conducting a number of Phase 2 clinical studies to evaluate its novel allosteric TYK2 inhibitor, including an ongoing moderate-to-severe plaque psoriasis (NCT04999839) study and an ongoing psoriatic arthritis (NCT05153148) study. Additional trial details can be found by visiting ClinicalTrials.gov.

Media Contact

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com

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Pharmacokinetic profile supports potential for once-daily dosing in moderate-to-severe psoriasis 

Wide range of doses explore higher ranges of TYK2 inhibition in the clinic than reported by other agents 

CAMBRIDGE, Mass. – May 19, 2022 – Nimbus Therapeutics, a clinical-stage company that is working to design and develop breakthrough medicines through its powerful computational drug discovery engine, today announced the presentation of new data from multiple Phase 1 clinical studies of its investigational oral allosteric tyrosine kinase 2 (TYK2) inhibitor, NDI-034858, in both healthy volunteers and patients with moderate-to-severe psoriasis. The data will be presented in a poster session at the 2022 Society for Investigative Dermatology (SID) Annual Meeting, being held May 18-21, 2022, in Portland, OR.

Data presented at SID reflect analyses of pharmacokinetics, pharmacodynamics, tolerability and clinical activity of NDI-034858. As previously reported, NDI-034858 was observed to be generally well tolerated, and it showed a dose-dependent trend in exploratory clinical activity. The pharmacokinetic profile of NDI-034858 observed in healthy volunteers supports the potential for once-daily dosing, with 50 mg expected to cover IC90 for 24 hours. Additionally, an analysis of the biochemical selectivity of NDI-034858 using proprietary structure-based computational modeling found that Nimbus’ TYK2 inhibitor was highly selective, with approximately 13,000 times more selectivity than deucravacitinib.

“Nimbus’ oral allosteric TYK2 inhibitor has demonstrated exceptional functional selectivity, and has an encouraging clinical activity profile and a favorable tolerability profile. Notably, there is evidence that a single amino acid difference at the allosteric binding pocket may enable greater TYK2 selectivity of NDI-034858 over deucravacitinib,” said Bhaskar Srivastava, M.D., Ph.D., Senior Vice President, Clinical Development at Nimbus. “These results support continued development of this investigational drug candidate as a potential oral treatment option for patients with autoimmune diseases.”

The poster, titled “Characterization of pharmacokinetics, pharmacodynamics, tolerability and clinical activity in Phase 1 studies of the novel allosteric tyrosine kinase 2 (TYK2) inhibitor NDI-034858,” will be presented on Thursday, May 19, from 4:30-6:30 p.m. PT.

Phase 2b clinical studies to evaluate NDI-034858 in moderate-to-severe plaque psoriasis (NCT04999839) and active psoriatic arthritis (NCT05153148) are ongoing.

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company working to design and develop breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

About the Nimbus TYK2 Program

TYK2 is an important signal-transducing kinase that mediates immune signaling and is important in both adaptive and innate immune cells. TYK2 inhibition is a potentially promising treatment approach for a wide range of autoimmune and inflammatory diseases due to the protein’s central role in both the innate and adaptive immune responses. Nimbus is conducting a number of Phase 2 clinical studies to evaluate its novel allosteric TYK2 inhibitor, including an ongoing moderate-to-severe plaque psoriasis (NCT04999839) study and an ongoing psoriatic arthritis (NCT05153148) study. Additional trial details can be found by visiting ClinicalTrials.gov.

Media Contacts:

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com

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CAMBRIDGE, Mass. – April 13, 2022 – Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the expansion of its leadership team with the appointments of Zak Huang as Vice President, Regulatory Affairs, and Gabrielle Poirier as Vice President, Clinical Operations. Nimbus also announced that Bhaskar Srivastava, M.D., Ph.D. has been promoted to Senior Vice President, Clinical Development.

“We’re pleased to welcome Zak and Gabby to Nimbus at such an exciting phase of our company’s growth, and to continue to augment our in-house clinical development expertise. Their breadth of experience in clinical and regulatory leadership will be an asset to our team as we continue to progress three active clinical trials for our novel inhibitors of TYK2 and HPK1,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “I also wish to congratulate Bhaskar on his promotion. Since joining Nimbus he has helped to sharpen our clinical development strategy and to position Nimbus to expand our TYK2 franchise into clinical trials on additional autoimmune and inflammatory diseases.”

“Our highly selective, allosteric TYK2 inhibitor, NDI-034858, has demonstrated favorable tolerability and promising exploratory efficacy in our Phase 1 trials. We are grateful to the patients and investigators in our ongoing Phase 2 studies,” commented Dr. Srivastava.

Dr. Srivastava joined Nimbus in 2021 as Vice President, Early Clinical Development. He previously held senior clinical development roles at the Janssen Pharmaceutical Companies of Johnson & Johnson, where he led a group of physician-scientists responsible for the strategy, design and execution of early-phase clinical programs across indications in dermatology and rheumatology. A board-certified dermatologist, Dr. Srivastava spent five years in clinical practice and was Assistant Professor of Dermatology at the Yale School of Medicine. He holds a bachelor’s degree in biochemical sciences from Harvard University and an M.D. and Ph.D. in immunology from the Perelman School of Medicine at the University of Pennsylvania.

Dr. Huang, Nimbus’ Vice President, Regulatory Affairs, joins from CSL Behring, where he served as Head of Global Product Regulatory Strategy and, subsequently, Head of China R&D, successfully building high-performing teams and driving development and regulatory strategies of new products. His prior regulatory leadership experience includes an 11-year tenure with Merck & Co., where he led global regulatory strategies across multiple therapeutic areas. He earned medical degrees from Nanjing Medical University and practiced medicine as a physician in China.

Ms. Poirier, Nimbus’ Vice President, Clinical Operations, served most recently as Vice President of Clinical Operations for Entasis Therapeutics, where she was responsible for strategic and operational planning of all clinical trials. Her career in biopharma spans more than 20 years, including clinical operations leadership roles with Proteostasis Therapeutics, Alexion Pharmaceuticals, Ironwood Pharmaceuticals and Vertex Pharmaceuticals. Ms. Poirier earned a bachelor’s degree in business administration from Southern New Hampshire University.

Media Contact:

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company that designs and develops breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

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CAMBRIDGE, Mass. – April 8, 2022 – Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, is sharing preclinical data, released today, on its Casitas B-lineage lymphoma b (Cbl-b) inhibitor, NTX-801, at the American Association for Cancer Research (AACR) 2022 Annual Meeting, being held April 8-13, 2022, in New Orleans, LA.  

Cbl-b is an E3 ubiquitin ligase that is expressed in immune cells and, in the context of cancer, acts as a brake on the immune system, functioning as an intracellular checkpoint that negatively regulates T-cell activation, natural killer cell activity and immune response through degradation of specific proteins. Taken together, these factors make Cbl-b inhibition a potentially promising target for immuno-oncology.  

Nimbus employed a structure-based drug design approach to identify small molecule inhibitors of Cbl-b. The inhibitor NTX-801 demonstrated strong immune cell activation and robust and statistically significant tumor growth inhibition in a mouse syngeneic tumor model. In combination with anti-PD-1, it resulted in robust anti-tumor activity, increased survival, and several complete responses, as defined by no measurable tumor in the murine tumor model.  

“Preventing Cbl-b activity from dampening immune responses has long been seen as a promising potential way to enhance anti-tumor immunity. The preclinical data we are presenting today at AACR support the promise of Cbl-b inhibition as a means of activating the immune response in vivo,” said Peter J. Tummino, Chief Scientific Officer. “We look forward to further characterizing the Cbl-b inhibitors we have identified, and continuing to advance Cbl-b inhibition toward the clinic as a novel immuno-oncology approach.”  

The details of the poster presentation are as follows: 

Title: Discovery of NTX-801, a Cbl-b inhibitor with antitumor activity in syngeneic models 
Session Category: Immunology  
Session Title: Immune Checkpoints  
Session Date and Time: Sunday, April 10, 2022, 1:30 PM – 5:00 PM ET  
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 38 
Poster Number: 28 

About Nimbus Therapeutics 

Nimbus Therapeutics is a clinical-stage company that designs and develops breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com. 

Media Contact: 

Chris Railey
Ten Bridge Communications
chris@tenbridgecommunications.com   

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CAMBRIDGE, Mass. – March 28, 2022 – Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it will present preclinical data from its Casitas B-lineage lymphoma b (Cbl-b) program at the American Association for Cancer Research (AACR) 2022 Annual Meeting, being held April 8-13, 2022 in New Orleans, LA.

Cbl-b is validated as an immuno-oncology target; the enzyme catalyzes the ubiquitination of substrate proteins to regulate multiple signaling events in a variety of cell types, including immune cells.  Nimbus undertook a structure-based drug design approach to identify NTX-801, a Cbl-b inhibitor. In an in vivo PD model, NTX-801 was observed to enhance cytokine responses.  In a syngeneic mouse model, NTX-801 demonstrated tumor growth inhibitory activity.

Details of the AACR presentation are as follows:

Abstract Control Number: 4649
Abstract Title: Discovery of NTX-801, a potent Cbl-b inhibitor with antitumor activity in syngeneic models
Session Title: Preclinical Immunotherapy

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company that designs and develops breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contacts:

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com 

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CAMBRIDGE, Mass. – March 25, 2022 – Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today presented data from the Phase 1b clinical trial of its investigational oral allosteric tyrosine kinase 2 (“TYK2”) inhibitor, NDI-034858, in patients with moderate-to-severe plaque psoriasis at the 2022 American Academy of Dermatology (AAD) Annual Meeting.

The study enrolled 26 patients with moderate-to-severe plaque psoriasis and was completed in April 2021. Patients received once-daily doses of either NDI-034858 (5mg, 10mg, or 30mg) or placebo over 28 days. As a Phase 1 study, the primary objective was evaluation of safety, and NDI-034858 was observed to be generally well tolerated. No serious adverse events were observed and no trends of adverse events were noted with increasing drug exposure. Most treatment-emergent adverse events were mild or moderate in severity.

Nimbus’ data indicate that treatment with NDI-034858 resulted in improvement across multiple measures of disease pathology and normalization of molecular and inflammatory pathways dysregulated in psoriasis. Additionally, NDI-034858 showed a dose-dependent trend in exploratory clinical activity, measured by mean percent decrease in Psoriasis Area and Severity Index score at four weeks.

In patients treated with NDI-034858, investigators observed decreased thickness of lesional skin epidermis and decreased Ki67 expression (a marker of cell proliferation), as well as resolution of elevated keratin-16 expression. mRNA analyses of skin biopsies showed decreased expression of several psoriasis-related genes and up to 50% improvement in the expression of skin transcriptomes previously associated with psoriasis in lesional skin through microarray analysis. The poster, titled “Analysis of histologic, molecular and clinical improvement in moderate-to-severe psoriasis: Results from a Phase 1b trial of the novel allosteric TYK2 inhibitor NDI-034858,” is on display through March 27, 2022.

“TYK2 plays a central role in both innate and adaptive immune responses and we believe is a promising target for treating a wide range of autoimmune and inflammatory diseases,” said Bhaskar Srivastava, M.D., Ph.D., Vice President of Early Clinical Development at Nimbus. “We are pleased to see the advancement of our allosteric TYK2 inhibitor program, which we believe supports our further development of this candidate as a potential oral treatment option for patients with moderate-to-severe plaque psoriasis.” 

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company that designs and develops breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

About the Nimbus TYK2 Program

TYK2 is an important signal-transducing kinase that mediates immune signaling and is important in both adaptive and innate immune cells. TYK2 inhibition is a potentially promising treatment approach for a wide range of autoimmune and inflammatory diseases due to the protein’s central role in both the innate and adaptive immune responses.

Nimbus is conducting two clinical studies to evaluate its novel allosteric TYK2 inhibitor, including an ongoing moderate-to-severe plaque psoriasis (NCT04999839) study and the recently initiated active psoriatic arthritis (NCT05153148) study. The psoriatic arthritis Phase 2b trial is a randomized, multicenter, double-blind, placebo-controlled study that will evaluate three dose levels of the investigational therapy taken orally once per day. It is planned to enroll approximately 260 subjects, with a primary endpoint of proportion of subjects achieving at least an American College of Rheumatology 20 response at week 12. Additional trial details can be found by visiting ClinicalTrials.gov.

Media Contacts:

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com 

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CAMBRIDGE, Mass. – February 3, 2022 – Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the successful generation of multiple, high-resolution protein structures of Werner syndrome helicase (WRN). WRN is a helicase required for DNA replication and repair and a validated target for tumors with microsatellite instability (MSI). Nimbus’ proprietary WRN structures reveal protein motion and provide insights into novel mechanisms of inhibition that have yielded confirmed hits progressing to lead-like chemical matter.

“Our progress in discovery efforts against WRN is a prime demonstration of how Nimbus’ structure-guided approach could enable the identification of both active-site and allosteric inhibitors, even against targets that have historically been challenging to drug,” said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. “While precedence for pharmacological helicase inhibition is limited, WRN is amenable to structural biology, which provides a strong opportunity to develop agents to treat this important subset of solid tumors.”

In addition to the progress Nimbus has made against WRN helicase, Nimbus announced the expansion of its leadership team in computational chemistry with the appointment of Daniel Price, Ph.D., to the newly created role of Executive Director, Head of Computational Chemistry. In this role, Dr. Price will direct the strategic implementation and expansion of Nimbus’ computational capabilities as part of its structure-based drug discovery approach.

“Nimbus’ computational drug discovery engine is distinguished by its ability to integrate a broad set of computational technologies with world-class capabilities in molecular sciences, including biophysics, biochemistry and structural biology, and a deep expertise in medicinal chemistry,” said Dr. Tummino. “The addition of Dan to our leadership team will further bolster our integration of the most advanced computational tools available with our broad drug discovery and therapeutic area expertise.”

Prior to joining Nimbus, Dr. Price spent over 15 years at GlaxoSmithKline, most recently as Director, Computational Chemistry. During his tenure at GSK, he contributed to the discovery of four clinical-stage drug candidates in four distinct therapy areas. In addition to his expertise in structure-based drug discovery and ligand-based drug discovery, Dr. Price has specialized experience in kinase targeting, cross-domain informatics, and ADME modeling. He earned his Ph.D. in molecular biophysics and biochemistry from Yale University and his bachelor’s degree in chemical engineering from the University of Colorado, Boulder. He completed his postdoctoral research fellowship at the Scripps Research Institute.

“Nimbus is a recognized leader in the field of drug discovery, and I’m excited to continue expanding the company’s capabilities in combining cutting-edge computational technology with deep molecular sciences expertise,” said Dr. Price. “I look forward to working alongside Nimbus’ talented team in advancing the company’s diverse portfolio of potential breakthrough medicines.”

Media Contacts:

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com 

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company that designs and develops breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

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CAMBRIDGE, Mass. – January 6, 2022 – Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through its powerful computational discovery engine, today announced initiation of a Phase 2b study of the company’s investigational oral allosteric TYK2 inhibitor in patients with active psoriatic arthritis. The study represents the second of Nimbus’ planned clinical trials within its TYK2 franchise, alongside a Phase 2b study in moderate-to-severe plaque psoriasis, which initiated dosing in August 2021.

“Nimbus is excited to commence this new TYK2 clinical study as part of our efforts to evaluate patient impact of our oral allosteric TYK2 inhibitor,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “We believe allosteric TYK2 inhibitors offer immense promise as a new class of medicines that are designed to selectively inhibit TYK2 and potentially treat serious autoimmune and inflammatory conditions.”

Nimbus’ allosteric TYK2 inhibitor has demonstrated highly selective inhibition of TYK2 with little evidence of off-target effects in preclinical studies. In Phase 1 studies, Nimbus’ allosteric TYK2 inhibitor has been generally well tolerated and has shown exploratory signals of clinical activity consistent with what is expected of an allosteric TYK2 inhibitor. Nimbus will be presenting data from its Phase 1 studies at the upcoming American Academy of Dermatology annual meeting in March 2022.

“Nimbus is pleased to initiate the second Phase 2b trial with our allosteric TYK2 inhibitor and to further expand our potential impact in addressing serious autoimmune and inflammatory conditions,” said Bhaskar Srivastava, M.D., Ph.D., Vice President of Early Clinical Development at Nimbus. “Many patients with active psoriatic arthritis are not adequately treated, and there is a need for safe and effective oral treatment options.”

Furthermore, Nimbus Therapeutics and Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb, reached an agreement resolving all legal claims and business interests between the two companies pertaining to Nimbus’ TYK2 inhibitor. Nimbus retains all rights to its TYK2 inhibitor program and remains solely responsible for continuing progress through clinical development.

Nimbus will present at the virtual 40th Annual J.P. Morgan Healthcare Conference at 9:00 a.m. ET / 6:00 a.m. PT on Monday, January 10, 2022. CEO Jeb Keiper will provide an overview of the company’s progress and anticipated milestones for 2022 and beyond.

Media Contact:

Chris Railey, (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com 

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage company that designs and develops breakthrough medicines through its powerful and comprehensive computational drug discovery engine. Nimbus’ pipeline is comprised of multiple potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and have proven difficult for drug makers to tackle. Nimbus is headquartered in Cambridge, MA. To learn more about Nimbus, please visit www.nimbustx.com.

About the Nimbus TYK2 Program

TYK2 (tyrosine kinase 2) is an important signal-transducing kinase that mediates immune signaling and is important in both adaptive and innate immune cells. TYK2 inhibition is a potentially promising treatment approach for a wide range of autoimmune and inflammatory diseases due to the protein’s central role in both the innate and adaptive immune responses.

Nimbus presently has two active clinical trials evaluating its novel allosteric TYK2 inhibitor, an ongoing moderate-to-severe plaque psoriasis (NCT04999839) study and the recently initiated active psoriatic arthritis (NCT05153148) study. The psoriatic arthritis Phase 2b trial is a randomized, multicenter, double-blind, placebo-controlled study that will evaluate three dose levels of the investigational therapy taken orally once per day. It is planned to enroll approximately 260 subjects, with a primary endpoint of proportion of subjects achieving at least an American College of Rheumatology (ACR) 20 response at week 12. Additional trial details can be found by visiting ClinicalTrials.gov.

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