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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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CAMBRIDGE, Mass. – November 12, 2021 – Nimbus Therapeutics, a biotechnology company designing and developing breakthrough medicines through structure-based drug discovery, today announced the first patient dosed in the first-in-human Phase 1/2 study of their small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, NDI-101150. HPK1 is a key regulator of T cell, B cell and dendritic cell-mediated immune responses, making it a high-priority target in immuno-oncology.

“We are proud to expand our clinical development program with the initiation of this first-in-human trial. The preclinical evidence we’ve seen for our HPK1 inhibitors to date, including in vivo data shared at the 2021 AACR Annual Meeting, has shown significant tumor growth inhibition, both as a single agent and in combination with anti-PD1, and robust and durable effects on immune memory,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “New approaches to expand the promise of immuno-oncology to solid tumors are greatly needed and we’re eager to explore the potential of NDI-101150 to help address this unmet need.”

The Phase 1/2 trial is a multicenter, open-label study that will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adults with advanced solid tumors. It is planned to enroll approximately 106 subjects.

“HPK1 is an important therapeutic target in immuno-oncology because of its role in multiple adaptive immune system components, including T cell, B cell and dendritic cell-mediated immune responses. We are pleased to have progressed a highly-selective HPK1 inhibitor into the clinic,” said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. “Development of this agent was made possible by Nimbus’ computational drug discovery approach, which continues to provide opportunities to develop new medicines in diseases with high unmet medical need.”

About Nimbus Therapeutics

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. The company’s LLC/subsidiary architecture enables diverse and synergistic partnerships to deliver breakthrough medicines. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com

Media Contact

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

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CAMBRIDGE, Mass. – September 30, 2021 – Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, today published research in the Proceedings of the National Academy of Sciences describing the structural basis for isoform-specific inhibition of human CTPS1 (CTP synthase 1). Selective inhibition of CTPS1 is a promising approach for the treatment of autoimmune and other T cell-driven diseases, but little is known about the mechanisms underlying selective versus non-selective inhibition.

Nimbus scientists, in partnership with researchers from the University of Washington and Schrödinger, used cryo-electron microscopy (cryo-EM) to characterize the activity of CTPS inhibitors in binding to, inhibiting and distinguishing between CTPS1 and its isoform CTPS2. The cryo-EM research was funded by Nimbus and led by professor Justin Kollman at the University of Washington.

“We’re proud to have conducted this impactful research in partnership with our valued colleagues at University of Washington and Schrödinger, further building on Nimbus’ long history of fruitful academic collaborations,” said Peter Tummino, Ph.D., Chief Scientific Officer at Nimbus. “The insights we have published will be instrumental in our efforts to develop selective inhibitors of CTPS1 that can potentially offer a powerful new means of treating autoimmune diseases and T cell-driven cancers.”

“A defining feature of Nimbus’ structure-based drug discovery approach is our use of leading-edge computational technology, including cryo-EM, to characterize drug targets in unprecedented detail,” said Scott Edmondson, Ph.D., Senior Vice President and Head of Chemistry at Nimbus. “The discoveries made in this research, together with Nimbus’ expertise in computational chemistry, molecular sciences and disease biology, will inform our ongoing development of highly selective small-molecule CTPS1 inhibitors.”

The paper, entitled “Structural basis for isoform-specific inhibition of human CTPS1,” published online in the Proceedings of the National Academy of Sciences this week: https://www.pnas.org/content/118/40/e2107968118.

About Nimbus Therapeutics

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com

CAMBRIDGE, Mass. – September 14, 2021 – Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, today announced dosing of patients in the Phase 2b study of the company’s oral allosteric TYK2 inhibitor. The study will assess the efficacy, safety, and tolerability of the investigational therapy in patients with moderate to severe plaque psoriasis.

“Nimbus is proud to be embarking on this next phase of clinical study of our TYK2 program, bringing us another step closer to delivering a powerful new treatment option to patients with moderate to severe psoriasis,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “Allosteric TYK2 inhibitors have immense promise as a new class of medicines that can selectively inhibit TYK2 and therefore offer the potential for treating psoriasis and other autoimmune and inflammatory conditions with greater efficacy and fewer safety concerns than previous generations of medications.”

TYK2 inhibition is a promising treatment approach for a wide range of autoimmune and inflammatory diseases thanks to the protein’s central role in both the innate and adaptive immune responses. Nimbus’ allosteric TYK2 inhibitor has demonstrated highly selective inhibition of TYK2 with little evidence of off-target effects, and in Phase 1 studies, demonstrated safety and tolerability with efficacy signals consistent with what is expected of an allosteric TYK2 inhibitor.

The Phase 2b trial (NCT# 04999839) is a randomized, multicenter, double-blind, placebo-controlled study that will evaluate four dosages of the investigational therapy taken orally once per day. It is planned to enroll approximately 250 subjects. Its primary endpoint will be the proportion of patients achieving PASI-75, meaning a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index, at 12 weeks. Additional trial details can be found by visiting ClinicalTrials.gov.

“We are grateful to partner with the leading investigators and medical centers participating in this trial,” said Bhaskar Srivastava, M.D., Ph.D., Vice President of Early Clinical Development at Nimbus. “What Nimbus and our partners do every day helps create new options and hope for patients.”

Nimbus plans to initiate multiple other Phase 2 studies in various autoimmune and inflammatory diseases in 2021 and 2022 to elucidate the full range of potential patient benefit from its oral allosteric TYK2 inhibitor.

Media Contact:

Lisa Raffensperger, (617) 903-8783
Ten Bridge Communications
lisa@tenbridgecommunications.com

About Nimbus Therapeutics

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com

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CAMBRIDGE, Mass. – August 12, 2021 – Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, today announced the extension of its collaboration with Schrödinger, Inc. to discover and design small molecule therapeutics for a number of high-value targets using cutting-edge structure-based drug design approaches.

The agreement extends the collaboration between the two companies, which began in 2009, to advance the usage of computational methods in drug discovery. Since then, the collaboration has generated numerous promising therapeutic candidates, including small molecule inhibitors of acetyl–CoA carboxylase (ACC) and tyrosine kinase 2 (TYK2), which are now in the clinic, and a hematopoietic protein kinase 1 (MAP4K1/HPK1) inhibitor, which Nimbus plans to advance to the clinic later this year.

“Nimbus’ collaboration with Schrödinger over the past 12 years has been groundbreaking, deploying computational horsepower at an unprecedented scale in the industry,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “Schrödinger’s deep computational capabilities, paired with Nimbus’ demonstrated expertise in structural biology, small molecule drug discovery and clinical development, provides fertile ground for designing breakthrough medicines over the next decade.”

“We are very pleased to embark on this new chapter of Schrödinger’s collaboration with Nimbus and to further expand the frontiers of combining physics-based drug discovery with machine learning,” said Ramy Farid, Ph.D., Chief Executive Officer at Schrödinger. “Our collaborative track record underscores the potential of our combined multidisciplinary drug discovery team to design medicines that could provide meaningful benefits for patients.”

About Nimbus Therapeutics

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. The company’s LLC/subsidiary architecture enables diverse and synergistic partnerships to deliver breakthrough medicines. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com 

Media Contact:

Lisa Raffensperger, (617) 903-8783
Ten Bridge Communications
lisa@tenbridgecommunications.com

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– Multiple Phase 2 studies of allosteric TYK2 inhibitor in 2021 and 2022 will investigate ‘pipeline-in-a-product’ potential –

– Financing will also support first-in-human trial of HPK1 inhibitor and advancement of preclinical pipeline –

– Led by BVF Partners L.P., round included participation from new and existing investors –

CAMBRIDGE, Mass. – July 13, 2021 – Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, today announced the closing of a $105 million private financing round. The round was led by BVF Partners L.P. (BVF), with participation from existing investors including RA Capital Management and Atlas Venture. Access Biotechnology, Commodore Capital, Logos Capital, Surveyor Capital (a Citadel company), and a large alternative asset manager joined as new investors in this financing.

“This financing from some of the world’s leading investors is validation of the exciting potential within Nimbus’ product pipeline and the singular expertise Nimbus brings in advancing these products forward.  Spurred by compelling data from studies of our novel allosteric TYK2 inhibitor, we will be embarking upon multiple Phase 2 clinical studies in 2021 and 2022 to elucidate the full range of potential patient benefit from this novel therapeutic,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “Our clinical expertise with this molecule to date combined with our strong capital position make Nimbus uniquely well-resourced to advance this important medicine through the clinic in the years to come.”

In addition to the Phase 2 studies of Nimbus’ allosteric TYK2 inhibitor, the financing will support a first-in-human study of the company’s HPK1 inhibitor candidate in cancer patients with solid tumors, which will begin later this year, and will accelerate preclinical programs against multiple targets in oncology and immunology. The company expects to initiate IND-enabling studies on two novel agents in 2022.

“Nimbus’ pipeline is positioned to deliver multiple clinical readouts over the next 18 months that have the promise to help transform patients’ lives,” said Bruce Booth, D.Phil., co-founder and Chairman of the Board of Nimbus. “We are fortunate to have the support of many new investors joining Nimbus, and we welcome Sam Huang from BVF to the Board.”

“We’re proud to lead this most recent financing round, and we see the tremendous potential of Nimbus’ vision, pipeline, and team,” said Mark Lampert, founder and CEO of BVF.

About Nimbus Therapeutics

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. The company’s LLC/subsidiary architecture enables diverse and synergistic partnerships to deliver breakthrough medicines. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com

Media Contact

Lisa Raffensperger, (617) 903-8783

Ten Bridge Communications

lisa@tenbridgecommunications.com

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CAMBRIDGE, Mass. – May 10^th, 2021 – Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, announced it has appointed Anne McGeorge, M.S., CPA, to its Board of Directors, and as Audit Committee Chair. Ms. McGeorge is a seasoned finance executive with decades of experience advising healthcare and life sciences organizations.

“On behalf of Nimbus’ leadership team and Board, I am delighted to welcome Anne McGeorge to our Board of Directors. Anne’s technical acumen across all areas of finance for both private and public companies will be an asset to our business,” said Bruce Booth, Chairman of Nimbus. Jeb Keiper, Chief Executive Officer of Nimbus added, “As we expand our team and prepare to initiate clinical development of a second program, I am looking forward to partnering with Anne and the rest of the Board to continue to chart the future of Nimbus.”

Ms. McGeorge has more than 35 years of experience advising healthcare and life sciences businesses in areas of financial and strategic growth. She established and served as Managing Partner of Grant Thornton’s Global Health Care and Life Sciences Practices for more than a decade, and prior to that was a partner with both Deloitte and Arthur Andersen. Ms. McGeorge presently serves as Operating Partner at Havencrest Healthcare Partners and on the faculty of University of North Carolina’s School of Public Health. She serves as Board member and Audit Committee Chair for Magenta Therapeutics, SOC Telemed, and CitiusTech, and as Board Chair for Be The Match Foundation. Ms. McGeorge holds a BBA in business administration and accounting from The College of William & Mary and an M.S. in accounting from the University of Virginia.

“Nimbus’ trajectory in recent years has been very exciting to watch, and I’m pleased to be joining the company at such an important stage,” said McGeorge. “Building on the company’s longstanding expertise in drug discovery, Nimbus is now a clinical-stage biotech with wide development capabilities and aspirations, and an unmatched team in place. I’m looking forward to helping shape this great potential for the benefit of Nimbus’ investors and patients.” 

About Nimbus Therapeutics 

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. The company’s LLC/subsidiary architecture enables diverse and synergistic partnerships to deliver breakthrough medicines. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com

Media Contact

Lisa Raffensperger, (617) 903-8783

Ten Bridge Communications

lisa@tenbridgecommunications.com

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– Key hires in clinical and CMC augment Nimbus’ in-house capabilities as a development-stage biotech –

CAMBRIDGE, Mass. – April 21, 2021 – Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, announced the expansion of its development team with the appointment of accomplished professionals in three key development positions: Avinash Phadke, Ph.D., joins Nimbus as Vice President of CMC; Bhaskar Srivastava, M.D., Ph.D., joins as Vice President of Early Clinical Development; and Ajay K. Upadhyay joins as Vice President of Clinical Operations.

“We have begun assembling a world-class development team here at Nimbus. The appointments of Avinash, Bhaskar, and Ajay are central to our growing development capabilities, and enable Nimbus to progress its advancing portfolio through clinical investigation in multiple indications and disease settings,” said Annie C. Chen, M.D., MPH, Nimbus’ Chief Medical Officer and President of Nimbus’ TYK2 subsidiary. “In the near term, in addition to advancing our allosteric tyrosine kinase 2 (TYK2) inhibitor toward Phase 2 testing, we also plan to initiate clinical testing for our highly selective and potent hematopoietic progenitor kinase 1 (HPK1) inhibitor later this year. Nimbus’ deepened development focus, alongside our well-known prowess in small molecule drug discovery, position us to grow and diversify our pipeline in exciting ways in the years to come.”

Dr. Phadke, Nimbus’ Vice President of CMC, joins from Achillion Pharmaceuticals where he held numerous roles of increasing responsibility in chemistry and CMC over his 18-year tenure, most recently as Vice President, Head of CMC. In that role Dr. Phadke developed manufacturing processes for and oversaw the manufacturing of eight small molecule investigational therapeutics across all stages of clinical development scale-up. Dr. Phadke holds a Ph.D. in organic chemistry and B.Sc. in chemistry from Savitribai Phule Pune University and an M.S. in chemistry from the Indian Institute of Technology.

Dr. Srivastava, Nimbus’ Vice President of Early Clinical Development, served most recently as Senior Director, Early Development Translational Science and Medicine in Immunology at the Janssen Pharmaceutical Companies of Johnson & Johnson. In that role he led a team responsible for strategy, design, and execution of early-phase clinical immunology programs. Dr. Srivastava’s previous roles at Janssen included Director of Early Development and Translational Medicine, Immunology, and Director of Medical Affairs in Dermatology. Prior to Janssen, Dr. Srivastava was a practicing dermatologist. He holds an A.B. in biochemical sciences from Harvard University and an M.D. and Ph.D. in immunology from the University of Pennsylvania School of Medicine.

Mr. Upadhyay, Nimbus’ Vice President of Clinical Operations, has held numerous positions across drug development, most recently as president of the consulting firm October Global Solutions Inc. Previously, Mr. Upadhyay served in the Medical Affairs, Americas leadership team at Astellas Pharma, first in the role of Senior Director of Clinical Studies and later as Executive Director of Clinical/Outcomes Sciences. Before Astellas, Mr. Upadhyay was at GlaxoSmithKline for nine years, where he held roles of ascending responsibility in the Oncology R&D Unit and oversaw teams managing the operational implementation of regional and global clinical trials in development and medical affairs across the portfolio. Mr. Upadhyay holds a B.S. in pharmacology and toxicology from Philadelphia College of Pharmacy and an M.S. in Quality Assurance/Regulatory Affairs from Temple University.

About Nimbus Therapeutics

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. The company’s LLC/subsidiary architecture enables diverse and synergistic partnerships to deliver breakthrough medicines. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com

Media Contact

Lisa Raffensperger, (617) 903-8783

Ten Bridge Communications

lisa@tenbridgecommunications.com

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CAMBRIDGE, Mass. – April 9, 2021 – Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, today announced the presentation of data from the company’s HPK1 inhibitor program in a poster at the AACR Annual Meeting held virtually April 10-15, 2021.

Newly disclosed data show that Nimbus’ small-molecule HPK1 inhibitor, NMBS-2, demonstrates significant tumor growth inhibition as a single agent and in combination with anti-PD1 in multiple mouse syngeneic tumor models. In combination with anti-PD1, NMBS-2 restored cytokine secretion from exhausted human T cells and induced robust tumor growth inhibition in the CT-26 model. Furthermore, animals treated with NMBS-2 and anti-PD1 showed complete rejection of subsequently reintroduced CT-26 tumor cells, suggesting the establishment of a robust and durable immune memory.

“Building on our promising findings to date demonstrating the anti-tumor immune activity of NMBS-2, these latest data provide a compelling picture of its potential clinical utility in a range of tumor types — both as a single agent and as a combination therapy with anti-PD1 treatment,” said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. “We’re rapidly progressing IND-enabling studies of NMBS-2 now with plans to initiate first-in-human studies in the second half of 2021.” 

About Nimbus Therapeutics

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. The company’s LLC/subsidiary architecture enables diverse and synergistic partnerships to deliver breakthrough medicines. Nimbus is headquartered in Cambridge, Mass. www.nimbustx.com

Media Contact

Lisa Raffensperger, (617) 903-8783
Ten Bridge Communications
lisa@tenbridgecommunications.com

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