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– NDI-101150 treatment associated with increase in activated CD8+ T cells and dendritic cell infiltration in tumors and an acceptable safety profile –

– Treatment with NDI-101150 monotherapy resulted in preliminary evidence of clinical benefit in five patients, including one complete response, one partial response, and three cases of durable stable disease –

BOSTON, Mass. – May 23, 2024 – Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced the presentation of new positive data from the company’s ongoing Phase 1/2 clinical trial of NDI-101150, a novel, oral small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor in development for the treatment of advanced solid tumors (NCT05128487). Results are being highlighted in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL.

The Phase 1/2 multicenter, open-label trial is designed to assess NDI-101150 as a monotherapy (50-200 mg dose) and in combination with 200 mg pembrolizumab in the treatment of adults with advanced solid tumors. The results being presented at the ASCO Annual Meeting include updated data from 44 patients in the dose escalation cohorts (n=38 on monotherapy, n=6 on combination therapy) and additional data from 15 patients in the dose expansion cohorts. Results, as of March 18, 2024, showed:

• Treatment with NDI-101150 monotherapy was associated with clinical benefit in five out of 30 (16.7%) response-evaluable patients.
• One patient with renal cell carcinoma (RCC) in the dose escalation cohort exhibited a complete response, and one patient with RCC in the dose expansion cohort exhibited a partial response. Both patients were pre-treated with multiple lines of therapies including checkpoint inhibitors.
• Three patients with RCC, pancreatic cancer and endometrial cancer, respectively, maintained durable stable disease (SD) for more than six months while on treatment (21 months for the patient with RCC).
• In the RCC patient population, six out of eight response-evaluable patients had a best overall response of SD or better.
• NDI-101150 showed an increase in activated CD8+ T cells and dendritic cell infiltration in on-treatment patient biopsies compared to archival biopsies, consistent with nonclinical studies of NDI-101150 showing immune cell infiltration and robust anti-tumor activity in murine syngeneic tumor models.
• NDI-101150 is well-tolerated and the overall safety of NDI-101150 remains acceptable.

“We are encouraged by these results being presented at ASCO and additional observations to date showing monotherapy clinical benefit and an acceptable safety profile of NDI-101150, further validating HPK1 as a differentiated next-generation immunotherapy target for people living with advanced solid tumors in need of new effective treatment options,” said Nathalie Franchimont, M.D., Ph.D., Chief Medical Officer at Nimbus. “HPK1 inhibition is a promising therapeutic approach as it is shown to activate T cells, B cells and dendritic cells to mount a robust anti-tumor response, whereas currently approved checkpoint inhibitors activate T cells. NDI-101150 is a potent and highly selective HPK1 inhibitor that has the potential to achieve significant tumor growth inhibition and make a meaningful difference for patients.”

The study abstract is available on the ASCO website here and the details of the poster presentation are as follows:

Title: Phase 1/2 Trial of the HPK1 Inhibitor NDI-101150 as Monotherapy and in Combination with Pembrolizumab: Clinical Update

Lead Author: Marcus Noel, M.D.

Date: Saturday, June 1, 2024

Time: 9:00 a.m. – 12:00 p.m. CT

Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Abstract Number: 3083

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. The company advances promising research based on a unique strategy that combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions, and metabolic diseases. The company is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contact

Cindy Fung, PhD

Nimbus Therapeutics

cindy.fung@nimbustx.com

BOSTON–(BUSINESS WIRE)–Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced the appointment of Anita Scheuber, M.D., Ph.D., as Senior Vice President, Therapeutic Area Head, Oncology. In this role, Dr. Scheuber will lead the company’s clinical development strategy in oncology, including advancing its ongoing clinical program targeting hematopoietic progenitor kinase 1 (HPK1) and preclinical program targeting Werner syndrome helicase (WRN), as well as guiding early discovery efforts in oncology.

“We are delighted to welcome Anita to the executive team as we enter a new stage of growth at Nimbus with plans to further expand our focus in oncology,” said Nathalie Franchimont, M.D., Ph.D, Chief Medical Officer at Nimbus. “Her deep expertise and leadership in global clinical development will be a significant advantage for us as we build our pipeline of promising, highly potent and selective small molecules including our WRN program, which is expected to enter the clinic next year.”

Dr. Scheuber joins Nimbus with more than 15 years of experience in the pharmaceutical industry leading oncology clinical development strategy and execution on more than a dozen programs. She has extensive experience in small molecule and immuno-oncology drug development, ranging from early discovery and pre-candidate selection to late-stage development across different tumor types at both small biotechnology and large pharmaceutical companies. Most recently, she provided strategic consulting to biotechnology companies, developing clinical development strategies for multiple early-stage oncology assets. Previously, she served as Vice President and Head of Clinical Development, Oncology at Trillium Therapeutics (acquired by Pfizer in 2021). She also previously served as Vice President of Clinical Development, Oncology at Boston Pharmaceuticals. Before that, she held leadership roles of increasing responsibility at Pfizer and GSK. Dr. Scheuber earned her M.D. from the University of Zurich and her Ph.D. in Neurosciences from Pierre and Marie Curie (now Sorbonne) University in Paris. She completed a post-doctoral fellowship at Harvard Medical School and residencies at Cantonal Hospital in Lucerne and University Hospital Zurich in Switzerland.

“Nimbus has a proven track record of success in setting new standards in precision drug targeting and molecule engineering, bringing a new generation of potentially transformative medicines to patients in need of better treatment options. I am particularly impressed by the compelling data emerging from the company’s HPK1 Phase 1/2 clinical study showing preliminary monotherapy efficacy in patients with advanced solid tumors, and best-in-class potential of the WRN program,” said Dr. Scheuber. “With several important milestones ahead including new data from the HPK1 trial and initiation of the first-in-human WRN trial, I look forward to working closely with the team to build new levels of momentum in our oncology programs moving forward.”

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. The company advances promising research based on a unique strategy that combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions, and metabolic diseases. The company is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com.

BOSTON, Mass. – March 12, 2024 – Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced that Katharine Knobil, M.D., has been appointed to the Company’s Board of Directors. Dr. Knobil is a seasoned executive with more than 20 years of experience in pharmaceutical research and product development including global clinical research, medical affairs, and patient safety.

“We are honored to welcome Dr. Knobil to our Board of Directors as we embark on the next exciting chapter at Nimbus with plans to accelerate and expand our development programs in multiple therapeutic areas including oncology, immunology, and metabolism. Her leadership and breadth of expertise across clinical development at both small biotechnology and large pharmaceutical companies, including progressing several therapies through to commercialization, will be invaluable as we advance our programs into the clinic,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “We look forward to working closely with Dr. Knobil to achieve our vision of bringing novel, clinically proven small molecules to millions of patients in need.”

Dr. Knobil has led multiple research and development efforts that have resulted in regulatory approvals and launches of several commercial therapies. She most recently served as Chief Medical Officer at Agilent Technologies, where she established an industry-leading medical affairs organization and was responsible for integrating the voice of patients into business and clinical development strategy and decision-making. Previously, she was Chief Medical Officer and Head of Research and Development at Kaleido Biosciences. Before that, Dr. Knobil spent more than 20 years at GlaxoSmithKline (GSK) in roles of increasing responsibility, most recently serving as Chief Medical Officer. In this role, she led medical governance across the pharmaceutical, vaccines, and consumer business units. Her responsibilities also included evidence generation to support the value of new therapies for patients, healthcare providers, and payers. Dr. Knobil is currently a member of the Board of Directors at Marker Therapeutics (NASDAQ: MRKR) and Pliant Therapeutics (NASDAQ: PLRX). She earned her B.A. in biology from Cornell University, an M.D. from the University of Texas Southwestern Medical School, and completed her residency at the University of Michigan Medical School and her fellowship in pulmonary and critical care medicine at Johns Hopkins University School of Medicine.

“Nimbus has built a robust R&D organization that has demonstrated continued success in advancing promising discovery-stage science to product development. The recent acquisition of the company’s TYK2 inhibitor program by Takeda further reinforces the strength of their unique business model and powerful drug discovery approach. I am excited to join the team, especially given their track record and significant potential to deliver novel medicines that target the underlying causes of many difficult-to-treat diseases,” said Dr. Knobil. “I look forward to partnering with the executive leadership team and other members of the Board to help drive continued progress in pipeline development and initiation of new clinical programs.”

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. The company advances promising research based on a unique strategy that combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions, and metabolic diseases. The company is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contact

Cindy Fung, PhD
Nimbus Therapeutics
cindy.fung@nimbustx.com

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– SIK and cGAS are key autoimmune regulators well suited for Nimbus’ structure-based drug design approach –

– Company to present pipeline update at the 42^nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 7:30 am PT –

BOSTON, Mass. – January 5, 2024 – Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, announced the advancement and expansion of its pipeline with the addition of discovery programs targeting innate immunity pathways. These programs, targeting the salt-inducible kinase (SIK) family and cyclic GMP-AMP synthase (cGAS), represent promising opportunities to leverage Nimbus’ industry-leading computational and structure-based drug design expertise to develop highly selective, potent medicines addressing areas of significant unmet need.

“Building on the success of our TYK2 program, we are broadening our drug discovery engine to unlock new difficult-to-drug targets with compelling biology,” said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. “SIK and cGAS are critical targets in highly prevalent diseases that are well suited to Nimbus’ structure-based drug design approach. We look forward to advancing our discovery and development programs across oncology, immunology, and metabolism to deliver transformative medicines to patients.”

Nimbus is advancing its Phase 1/2 trial (NCT05128487) of NDI-101150, a small molecule inhibitor of hematopoietic progenitor kinase 1 (HPK1), and has reported positive dose escalation data showing potential monotherapy clinical benefit for patients with solid tumors. Furthermore, the company expects to initiate IND-enabling activities this year for its oncology program targeting Werner syndrome helicase (WRN). In collaboration with Eli Lilly and Company, Nimbus continues to progress the development of novel targeted therapies that activate AMPK to potentially treat a broad range of metabolic disorders.

Nimbus continues to expand its platform capabilities with ongoing investments in cutting-edge technology for drug discovery. Alongside proprietary computational tools which the company has developed in-house, Nimbus’ platform leverages state-of-the-art technology through collaborations such as its recently announced partnership with Anagenex, a leader in generative AI for drug design.

Jeb Keiper, M.S., MBA, Nimbus’ Chief Executive Officer, will provide an overview of the company’s progress and pipeline and anticipated milestones for 2024 and beyond at the 42^nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 7:30 am PT.

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’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions, and metabolic diseases. Nimbus is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contact

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

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BOSTON, Mass., December 18, 2023 – Anagenex and Nimbus Therapeutics (Nimbus) today announced they have initiated a research collaboration. Anagenex, a pioneering drug discovery company pairing large-scale data generation with proprietary artificial intelligence (AI), will work closely with Nimbus to discover small molecule drugs for multiple challenging targets.

Through this multi-target collaboration, the companies will apply Anagenex’s AI driven parallel biochemistry platform to generate billions of experimentally measured datapoints for each of Nimbus’ nominated targets. Anagenex will then use the resulting data to train proprietary AI models that will generatively design 100 million new target-specific molecules to experimentally probe structure activity relationships at an unprecedented scale and speed ultimately identifying highly selective and potent drug candidates. Under the terms of the agreement, Anagenex will receive an upfront payment and will be eligible for option and R&D milestone payments from Nimbus on each of the programs under the collaboration.

“We are thrilled to be partnering with Nimbus, one of the original and most successful computationally aided drug discovery and development companies,” said Nicolas Tilmans, CEO of Anagenex. “We’re very excited to join forces with them in attacking new targets beyond oncology a few hundred million compounds at a time.”

“Anagenex’s platform is highly synergistic with Nimbus’ computational and structure-based drug discovery expertise,” said Peter Tummino, Ph.D., Nimbus’ Chief Scientific Officer. “At Nimbus, we have prioritized important but difficult-to-drug targets across multiple therapy areas. This new collaboration with Anagenex perfectly complements our broader efforts across early discovery to advance new small molecule medicines against these targets with the goal of improving patients’ lives.”

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’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com.

About Anagenex

Anagenex is pairing large-scale data generation with AI to discover the next generation of small molecule medicines. Driven by over 100 billion proprietary measurements, Anagenex’s platform leverages AI to design and synthesize target-specific compounds for testing in two weeks, creating a virtuous cycle between real lab experiments and computational tools. Led by a team of highly experienced scientists and engineers, the company’s internal pipeline is focused on synthetic lethal oncology. Learn more about us at www.anagenex.com or connect with us on LinkedIn.

Contacts

Anagenex Media Contact
Karen Sharma
MacDougall Advisors
ksharma@macdougall.bio

Nimbus Media Contact
Cindy Fung, Ph.D.
cindy.fung@nimbustx.com

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– Monotherapy clinical benefit observed in three patients, including one complete response in a patient with renal cell carcinoma –

 – Data support continued clinical development of NDI-101150 as novel, non-checkpoint immunotherapy –

BOSTON, Mass. – October 31, 2023 – Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced initial data from the company’s ongoing Phase 1/2 study of NDI-101150, a small-molecule inhibitor of HPK1, which are being presented in a poster at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.

The data presented at SITC include initial safety and efficacy results from single agent therapy (n=13) in the dose escalation portion of the trial. Monotherapy treatment with NDI-101150 resulted in clinical benefit in 3 patients: One patient with renal cell carcinoma exhibited a complete response (CR) — the absence of all detectable cancer following treatment — while two patients with pancreatic cancer and renal cell carcinoma, respectively, exhibited prolonged (> 6 months) stable disease. Notably, the renal cell carcinoma patient who experienced a CR and clinical benefit with monotherapy NDI-101150 had been previously treated with and progressed on a regimen of nivolumab, an immune checkpoint inhibitor antibody. Furthermore, NDI-101150 demonstrated an acceptable safety profile below 200 mg/day, the identified non-tolerated dose.

“We’re pleased to share these first clinical data from our clinical trial of NDI-101150. We are encouraged by the preliminary efficacy we have seen thus far, which supports the potential of NDI-101150 to provide a meaningful therapeutic option for patients with solid tumors,” said Nathalie Franchimont, M.D., Ph.D., Chief Medical Officer of Nimbus. “HPK1 inhibition is an exciting approach because of its potential to activate not just T cells, as checkpoint inhibitors do, but also B cells and dendritic cells. We look forward to sharing future updates on NDI-101150, including data from ongoing combination cohorts and dose expansion cohorts.”

The Phase 1/2 trial (NCT05128487) is a multicenter, open-label study to 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 or metastatic solid tumors.

In a second poster at SITC, Nimbus is presenting new preclinical data which support the potential for both broad immunotherapeutic potential and best-in-class selectivity of NDI-101150 among publicly disclosed HPK1 inhibitor programs to date. NDI-101150 was found to be over 300 times more selective for HPK1 than related proteins in the MAP4K family — potentially reducing off-target effects.

“Our driving purpose at Nimbus is to leverage our expertise and technology to design breakthrough medicines for patients,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “The data presented at SITC reinforce the potential first-in-class and best-in-class profile of our HPK1 inhibitor, and we will continue to work to realize its possible benefits to patients with cancer.”

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’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contact

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

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– GV joins the company’s distinguished investor base, validating Nimbus’ computational drug discovery engine and early clinical capabilities –

 – Financing will support advancement of Nimbus’ pipeline of development programs in immunology, cancer and metabolic disease –

BOSTON, Mass. – September 6, 2023 – Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the closing of a $210 million private financing to advance its next wave of tech-enabled small molecule medicines. The round was co-led by new investor GV (Google Ventures) and existing investors SR One and Atlas Venture, with participation from another new investor that is a U.S.-based life sciences-focused fund as well as existing investors Bain Capital Life Sciences, BVF Partners L.P., Gates Frontier, Lightstone Ventures, Pfizer Ventures, RA Capital Management, and SV Health Investors.

“We’re proud to have built an R&D organization that is a paradigm of excellence in small molecule drug discovery and development. We embark on this next chapter of our history with the backing of a first-rate investor base, a strong pipeline and an unmatched team, which sets us up for lasting success,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus.

Nimbus will continue the ongoing clinical development of NDI-101150, a hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with solid tumors. The new capital will enable the advancement of multiple preclinical programs into and through early clinical development, including programs targeting Werner syndrome helicase (WRN) and an undisclosed autoimmune disease target. Nimbus is also pursuing the development of novel targeted therapies that activate AMPK to treat a potentially broad range of metabolic disorders via a collaboration with Eli Lilly and Company.

“Nimbus is a leader in integrating cutting-edge computational chemistry, high-tech structural biology tools and other industry-shaping technologies and approaches. We’re thrilled to support Jeb Keiper and the team as they bring difficult-to-drug, high-impact targets within reach across a wide range of therapeutic areas,” said Krishna Yeshwant, M.D., MBA, General Partner at GV.

“Nimbus has demonstrated its ability to advance early science through to successful product development multiple times. We eagerly anticipate what lies ahead, and we look forward to being part of the company’s next chapter,” said Rajeev Dadoo, Ph.D., Managing Partner at SR One.

“Nimbus’ ability to reproducibly design and develop differentiated, clinically proven small molecules is a testament to the strength of its expert team and its unmatched structure-based drug design platform. We’re gratified to see that sentiment reflected in the strong investor interest we received for this financing, the proceeds of which will advance the next breakthrough medicines from Nimbus’ portfolio,” said Bruce Booth, D.Phil., Partner at Atlas Venture, Chairman and co-founder of Nimbus.

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’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, MA. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contact

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

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BOSTON, Mass. – March 20, 2023 – Results from the Phase 2b clinical trial of TAK-279 (formerly NDI-034858), a novel allosteric TYK2 inhibitor developed by Nimbus Therapeutics and owned by Takeda (TSE:4502/NYSE:TAK), in patients with moderate-to-severe plaque psoriasis were presented on Saturday, March 18, 2023 at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans.

The results were presented as part of the Late-Breaking Research session by April Armstrong, M.D., MPH, clinical investigator in the Phase 2b study and Associate Dean and Professor of Dermatology at the University of Southern California.

From Takeda’s press release dated March 18th:

In the Phase 2b study, 259 patients were randomized (1:1:1:1:1 ratio) to receive one of four doses of TAK-279 once-daily, or placebo for 12 weeks. Results showed:

• A significantly greater proportion of TAK-279 patients achieved PASI 75 (44%, 68%, 67%; 5mg, 15mg, 30mg, respectively) versus placebo (6%; p<0.001), meeting the study’s primary endpoint.
• A significantly greater proportion of TAK-279 patients achieved PASI 90 (21%, 45%, 46%; 5mg, 15mg, 30mg, respectively) versus placebo (0%; p<0.001), and PASI 100 (10%, 15%, 33%; 5mg, 15mg, 30mg, respectively) versus placebo (0%; p<0.001 at 30mg).
• A significantly greater proportion of TAK-279 patients achieved Physician Global Assessment (PGA) scores of 0/1 (27%, 49%, 52%; 5mg, 15mg, 30mg, respectively) or 0 (10%, 15%, 33%; 5mg, 15mg, 30mg, respectively) versus placebo (4% [p≤0.001] and 0% [p<0.001 at 30mg], respectively) at 12 weeks. A PGA score of 1 indicates almost clear skin and 0 indicates totally clear skin.
• There were no statistically significant differences in PASI or PGA response rates seen in the TAK-279 2mg arm (18%, 2%, 10%, 2%; PASI 75, PASI 100, PGA 0/1, PGA 0, respectively) compared to placebo.

“We are thrilled to see this data shared with the scientific community, underscoring this medicine’s potential to address the high unmet need among patients with psoriasis and other immune-mediated diseases,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “This marks a turning point to the next ‘chapter’ of Nimbus. We have advanced our leading-edge technologies and grown our expertise in small molecule drug development to deliver breakthrough medicines, by design, for the benefit of patients.”

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’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, inflammatory and autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, MA. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contact

Chris Railey, +1 (617) 834-0936
Ten Bridge Communications

chris@tenbridgecommunications.com

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BOSTON, Mass. – February 8, 2023 – Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the closing of Takeda’s (TSE:4502/NYSE:TAK) acquisition of Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus, and its tyrosine kinase 2 (TYK2) inhibitor program, which includes the oral, selective allosteric TYK2 inhibitor NDI-034858, now known as TAK-279. The completion of this acquisition triggered a $4 billion upfront payment from Takeda to Nimbus, which is also eligible to receive up to $2 billion total in sales-based milestone payments.

“We are thrilled to reach this important milestone for what we believe is a best-in-class molecule in the new therapeutic class of oral, selective allosteric TYK2 inhibitors, which has the potential to address high unmet need for patients across a broad range of immune-mediated diseases,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “We look forward to continuing to design future breakthrough medicines, leveraging Nimbus’ unique approach at the intersection of computational chemistry and pharmaceutical sciences, and building on our track record of success.”

Nimbus plans to present detailed data from its Phase 2b clinical trial of NDI-034858 in patients with moderate-to-severe plaque psoriasis at an upcoming medical meeting. Nimbus previously announced that NDI-034858 achieved the trial’s primary efficacy endpoint, with a statistically significant greater proportion of patients reaching PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) compared to placebo at 12 weeks.

Nimbus retains ownership of and continues to advance a portfolio of potentially transformative therapeutics for cancer, autoimmune diseases and metabolic disorders, including NDI-101150, a selective hematopoietic progenitor kinase 1 (HPK1) inhibitor, currently being evaluated in a Phase 1/2 study in patients with solid tumors.

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’ pipeline includes a clinical-stage program, HPK1 (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, inflammatory and autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, MA. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contact
Chris Railey, +1 (617) 834-0936
Ten Bridge Communications
chris@tenbridgecommunications.com

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– Nimbus to receive $4 billion in upfront cash, and up to $2 billion in commercial milestone payments –

– NDI-034858 has potential best-in-class profile among new therapeutic class of selective allosteric TYK2 inhibitors for immune-mediated diseases –

BOSTON, Mass. – December 13, 2022 – Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it has signed a definitive agreement under which Takeda (TSE:4502/NYSE:TAK) will acquire Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858. NDI-034858 is an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis.

“Nimbus’ allosteric TYK2 inhibitor has the potential to be a best-in-class medicine in multiple disease areas, and we are confident that Takeda’s commitment and capabilities will enable NDI-034858 to reach its full value to patients,” said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. “The proposed acquisition highlights Nimbus’ ability to discover and develop high-value investigational medicines leveraging our computational structure-based drug design and development engine. We will continue to advance other exciting target programs in our R&D pipeline — including our selective HPK1 inhibitor, currently in a Phase 1/2 study in patients with solid tumors — as we have done since our founding in 2009.”

Under the terms of the agreement, Takeda will pay Nimbus Therapeutics $4 billion upfront, and sales-based milestone payments up to $2 billion. The transaction is expected to be finalized in the first half of 2023. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Nimbus Therapeutics will retain ownership of its other research and development subsidiaries. Takeda will be solely responsible for future development and commercialization of NDI-034858 and other TYK2 inhibitors.

J.P. Morgan Securities LLC is acting as exclusive financial advisor to Nimbus Therapeutics and Goodwin Procter LLP is serving as its legal advisor.

About NDI-034858

NDI-034858 is an allosteric TYK2 inhibitor discovered and developed by Nimbus Therapeutics that is being evaluated for the treatment of multiple autoimmune diseases. In preclinical studies, NDI-034858 has demonstrated exceptional functional selectivity and wide therapeutic margins. In Phase 1 studies, NDI-034858 showed a good tolerability profile, a dose-dependent trend in exploratory clinical activity and a pharmacokinetic profile allowing for once-daily solid oral dosing. Results from Nimbus’ Phase 2b clinical trial in patients with moderate-to-severe plaque psoriasis demonstrated a significantly greater proportion of patients in the study achieving the primary endpoint of PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) compared to placebo after twelve weeks of treatment. Data from this trial will be presented at an upcoming medical conference. In addition to psoriasis, NDI-034858 is in an ongoing Phase 2b trial in active psoriatic arthritis (NCT05153148).

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’ pipeline includes clinical-stage programs targeting TYK2 and HPK1 (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, inflammatory and autoimmune conditions and metabolic diseases. Nimbus is headquartered in Boston, MA. To learn more about Nimbus, please visit www.nimbustx.com.

Media Contact

Chris Railey, +1 (617) 834-0936
Ten Bridge Communications

chris@tenbridgecommunications.com

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