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News Partnering Press Release

Nimble Therapeutics Announces Expansion of its Discovery and Development Partnership with Genentech

MADISON, Wis.–(BUSINESS WIRE)–Nimble Therapeutics, a biotechnology company leveraging its next-generation peptide discovery platform to identify medicines for challenging-to-drug targets, today announced that the company has expanded its collaboration and executed a license agreement with Genentech, a member of the Roche Group (SIX:RO, ROG; OTCQX: RHHBY), for the discovery of peptide therapies for the treatment of diseases across multiple therapeutic areas.

“We are excited to significantly expand our partnership and strengthen our collaboration with Genentech,” said Jigar Patel, Founder & CEO of Nimble Therapeutics. “Genentech has been a valuable strategic partner and we are proud that our success thus far has led to the opportunity to significantly broaden our work together with both Genentech and Roche.”

Under the terms of the agreement, Nimble will receive a $20 million upfront payment; near-term, preclinical, clinical, and commercial milestone payments that could exceed $1.1 billion; as well as tiered royalties. Nimble will apply its platform against multiple targets, and Genentech and Roche will be responsible for preclinical and clinical development, and commercialization of any resulting products.

“This expanded partnership with Genentech, and the multiple recently achieved milestones across all our partnered programs, demonstrates Nimble’s capability to deliver peptide therapeutic candidates,” said Pete Gough, CSO of Nimble Therapeutics. “We are excited to further leverage our differentiated platform to accelerate development of optimized candidates against a larger set of novel targets in partnership with Genentech.”

“Given the success of our initial collaboration, we look forward to deepening our partnership with Nimble as we work together against a larger number of important and challenging targets across various disease areas,” said James Sabry, Global Head of Roche Pharma Partnering.

About Nimble Therapeutics

Nimble is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful analytics to discover and develop next generation peptide therapeutics efficiently and intelligently. Nimble has extensively validated its platform to identify highly biologically active compounds for multiple programs, spanning a wide variety of therapeutic target classes. For more information, visit www.staging.nimbletherapeutics.com.

Media Contact

Nimble Therapeutics, Inc.
Brad Garcia, Ph.D.
Vice President, Corporate Development
info@nimbletherapeutics.com

View the full press release here: https://www.businesswire.com/news/home/20230105005173/en/Nimble-Therapeutics-Announces-Expansion-of-its-Discovery-and-Development-Partnership-with-Genentech

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News Partnering Press Release

Nimble Therapeutics Delivers Lead Compounds for Two Programs Under Collaboration with Large Pharma Partner, Triggering Milestone Payments

MADISON, WI, USA, December 13, 2022 — Nimble Therapeutics Inc., a leading peptide therapeutics company, today announced they have achieved discovery milestones for two programs partnered with a large pharma company. For each program, Nimble has delivered lead compounds ready for further pre-clinical testing and subsequent IND studies. As with all its partnered research programs, Nimble remains eligible for additional future pre-clinical, clinical, and commercial milestones, and royalties attached to each program as development progresses.

In the last nine months alone, Nimble has delivered lead compounds for four programs to its partners. This progress, across multiple targets and partners, validates the power of Nimble’s platform to optimize peptide therapeutics at unprecedented speed. In addition to Nimble’s core platform technology, Nimble continues to expand its internal R&D capabilities, with work ongoing to advance its wholly owned pipeline. This effort is being led by pharmaceutical industry veteran Pete Gough, D.Phil., who joined as the company’s Chief Scientific Officer in November.

“Nimble’s demonstrated ability to consistently reach these important milestones is a testament to the strength of the scientific collaborations we have built with our partners and our powerful drug discovery and development engine and team,” said Jigar Patel, CEO. “We remain committed to working diligently with each of our partners to bring important medicines to patients.” Patel added that, “Nimble continues to advance its own internal pipeline while also evaluating strategic partnering opportunities for 2023 and beyond.”

About Nimble Therapeutics

Nimble is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful analytics to discover and develop next generation peptide therapeutics efficiently and intelligently. Nimble has extensively validated its platform to identify highly biologically active compounds for multiple programs, spanning a wide variety of therapeutic target classes. For more information, visit www.staging.nimbletherapeutics.com.

Media Contact

Nimble Therapeutics, Inc.
Brad Garcia, Ph.D.
Vice President, Corporate Development
info@nimbletherapeutics.com

View the full press release here: https://www.businesswire.com/news/home/20221213005335/en/Nimble-Therapeutics-Delivers-Lead-Compounds-for-Two-Programs-Under-Collaboration-with-Large-Pharma-Partner-Triggering-Milestone-Payments

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News Press Release

Nimble Therapeutics names Pete Gough as Chief Scientific Officer

Madison, WI, USA  November 30, 2022 — Nimble Therapeutics, an industry-leading peptide therapeutics company, today announced the appointment of Pete Gough, D. Phil. as Chief Scientific Officer (CSO). In this newly created role, Dr. Gough will spearhead the expansion of Nimble’s internal drug discovery capabilities that will enable further development of its own pipeline of proprietary therapeutics and drive Nimble towards becoming a fully integrated biotechnology company.

Dr. Gough has more than 25 years of experience in discovery research, both in academic settings as well as in the life sciences industry, and a track record of success in drug discovery and development, driving research programs into clinical study by building and leading high-performance teams. Prior to joining Nimble, Pete served as the CSO for Inzen Therapeutics, a Flagship company pioneering the newly discovered science of Thanokine Biology. At Inzen, he helped advance the company from seed stage to a successful Series B through the development of their pipeline of potentially transformational Immuno-Oncology therapeutics. Previously, Pete spent 15 years at GSK in roles of increasing responsibility. He served as Head of the Hepatitis B Virus Discovery Performance Unit (DPU) where he led GSK’s efforts to develop a functional cure for HBV including proof of concept studies for bepirovirsen. He also served as Head of the Host Defense DPU, and prior to that was Head of Biology and DMPK in the Pattern Recognition Receptor DPU. Pete led, and oversaw, the discovery and development of a number of clinical assets across multiple therapeutic areas including RIP1 kinase inhibitor GSK2982772 and STING agonist GSK3745417.

“We’re excited to welcome Pete to our management team at Nimble,” said Jigar Patel, PhD, Founder and CEO of Nimble Therapeutics. “Since our formation in 2019, Nimble has worked diligently to optimize and validate our peptide discovery platform. Pete brings invaluable experience in drug discovery and development across multiple therapeutic areas that will enable Nimble to deliver on the promise of peptide therapeutics through progressing and expanding our own internal pipeline.”

“Nimble has built the industry leading platform for discovering peptide therapeutics that solves for the challenges that everyone else in the field is struggling with,” said Dr. Gough. “I’m very excited to be part of the team and to help realize the truly transformative nature of the Nimble platform by advancing novel medicines into the clinic.”

Earlier in his career, Pete was a Research Assistant Professor in the Department of Pathology at the University of Washington. He received his D. Phil. and M. A. from the University of Oxford. Pete has authored/co-authored over 100 scientific papers in peer-reviewed journals and has been an invited speaker at numerous academic institutions and scientific conferences.

About Nimble Therapeutics

Nimble is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful analytics to efficiently and intelligently discover and develop next generation peptide therapeutics. Nimble has extensively validated its platform to identify highly biologically active compounds for multiple programs, spanning a wide variety of therapeutic target classes.

Connect with us on LinkedIn at www.linkedin.com/company/nimble-therapeutics or visit our website at www.staging.nimbletherapeutics.com to learn more.

Media Contact

Nimble Therapeutics, Inc.
Brad Garcia, PhD
Vice President, Corporate Development
info@nimbletherapeutics.com

View the full press release here:

https://www.businesswire.com/news/home/20221129005339/en/Nimble-Therapeutics-names-Pete-Gough-as-Chief-Scientific-Officer

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News

Nimble Therapeutics included among the 2022 Best Places to Work by Madison Magazine

Nimble Therapeutics was named a 2022 Best Place to Work by Madison Magazine! 

Administered annually, the Best Places to Work survey measures employee engagement and workplace factors like:
✔ trust in leadership
✔ team dynamics
✔ manager effectiveness
The competition honors superior organizations where cultures are thriving and employees are engaged.

Thank you to all of our employees for their honest feedback, and we look forward to continuing to be one of the Best Places to Work!

Read the article here: https://www.channel3000.com/nimble-therapeutics/

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Scientific Publication

Discovery of anti-Formin-like 1 protein (FMNL1) antibodies in membranous nephropathy and other glomerular diseases

Bruschi, M., Cavalli, A., Moll, S. et al. Discovery of anti-Formin-like 1 protein (FMNL1) antibodies in membranous nephropathy and other glomerular diseases. Sci Rep 12, 13659 (2022). https://doi.org/10.1038/s41598-022-17696-w

Abstract

Evidence has shown that podocyte-directed autoantibodies can cause membranous nephropathy (MN). In the present work we investigated sera of MN patients using a high-density peptide array covering the whole coding sequences of the human genome encompassing 7,499,126 tiled peptides. A panel of 21 proteins reactive to MN sera were identified. We focused our attention on Formin-like 1 (FMNL1), a protein expressed by macrophages in MN patients tissues. High levels of anti-FMNL1 IgG4 were demonstrated in sera of MN patients with an orthogonal methodology (ELISA) contemporary demonstrating FMNL1 positive cells in kidney co-staining with CD68 in glomeruli. High levels of circulating anti-FMNL1 IgG4 were associated with lack of remission of proteinuria, potentially indicating that autoantibodies directed against cells other than podocytes, involved in tissue repair, might play a role in MN disease progression. High serum levels of anti-FMNL1 IgGs were also observed in other non-autoimmune glomerolonephrites, i.e. idiopathic and genetic FSGS, IgAGN. These findings are suggestive of a broader role of those autoantibodies in other glomerular disease conditions.

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News Partnering Press Release

Nimble Therapeutics Announces Achievement of Development Milestones from Multiple Partnered Programs Connected to a Strategic Large Pharma Collaboration

MADISON, Wis.–Nimble Therapeutics Inc. today announced the company has achieved the first development milestone for each of several programs attached to a multi-target collaboration with an undisclosed large pharma partner.

Nimble will receive payments for each milestone connected to the collaboration, and the company remains eligible for additional future downstream milestones attached to each program as development continues.

“This is a significant accomplishment for our young company as we work with our partners to create important medicines for the benefit of patients, and we look forward to supporting this partner as they continue the development activities for each program.” said Jigar Patel, Ph.D., CEO of Nimble Therapeutics.

“Delivering lead candidates to one of our first partners validates the power of our platform, approach, and team; and clearly demonstrates the value that Nimble brings to its partners. We are working diligently to deliver state of the art peptides for each and every partnered program and are confident that these efforts will result in additional milestones being earned by Nimble in 2022, and beyond.”

About Nimble Therapeutics

Nimble Therapeutics is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble integrates the unrivaled chemical and structural diversity of its proprietary, light-directed, massively parallel solid-phase synthesis with biological display techniques, sophisticated assays, and powerful analytics to efficiently and intelligently discover and develop next generation peptide therapeutics. For more information please see www.staging.nimbletherapeutics.com.

Media Contact

Nimble Therapeutics, Inc.
Brad Garcia, PhD
Vice President, Corporate Development
info@nimbletherapeutics.com

View the full press release here: https://www.businesswire.com/news/home/20220517005323/en/Nimble-Therapeutics-Announces-Achievement-of-Development-Milestones-From-Multiple-Partnered-Programs-Connected-to-a-Strategic-Large-Pharma-Collaboration

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Scientific Publication

Targeting intracellular WT1 in AML with a novel RMF-peptide-MHC-specific T-cell bispecific antibody

Augsberger C, Hänel G, Xu W, et al. Targeting intracellular WT1 in AML with a novel RMF-peptide-MHC-specific T-cell bispecific antibody. Blood. 2021 Dec 23;138(25):2655-2669. doi: https://doi.org/10.1182/blood.2020010477. Erratum in: Blood. 2022 Mar 31;139(13):2086-2087.

Abstract

Antibody-based immunotherapy is a promising strategy for targeting chemoresistant leukemic cells. However, classical antibody-based approaches are restricted to targeting lineage-specific cell surface antigens. By targeting intracellular antigens, a large number of other leukemia-associated targets would become accessible. In this study, we evaluated a novel T-cell bispecific (TCB) antibody, generated by using CrossMAb and knob-into-holes technology, containing a bivalent T-cell receptor–like binding domain that recognizes the RMFPNAPYL peptide derived from the intracellular tumor antigen Wilms tumor protein (WT1) in the context of HLA-A*02. Binding to CD3ε recruits T cells irrespective of their T-cell receptor specificity. WT1-TCB elicited antibody-mediated T-cell cytotoxicity against AML cell lines in a WT1- and HLA-restricted manner. Specific lysis of primary acute myeloid leukemia (AML) cells was mediated in ex vivo long-term cocultures by using allogeneic (mean ± standard error of the mean [SEM] specific lysis, 67 ± 6% after 13-14 days; n = 18) or autologous, patient-derived T cells (mean ± SEM specific lysis, 54 ± 12% after 11-14 days; n = 8). WT1-TCB–treated T cells exhibited higher cytotoxicity against primary AML cells than an HLA-A*02 RMF-specific T-cell clone. Combining WT1-TCB with the immunomodulatory drug lenalidomide further enhanced antibody-mediated T-cell cytotoxicity against primary AML cells (mean ± SEM specific lysis on days 3-4, 45.4 ± 9.0% vs 70.8 ± 8.3%; P = .015; n = 9-10). In vivo, WT1-TCB–treated humanized mice bearing SKM-1 tumors exhibited a significant and dose-dependent reduction in tumor growth. In summary, we show that WT1-TCB facilitates potent in vitro, ex vivo, and in vivo killing of AML cell lines and primary AML cells; these results led to the initiation of a phase 1 trial in patients with relapsed/refractory AML (#NCT04580121).

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News Partnering Press Release

Nimble Therapeutics and Incyte Expand their Strategic Research Collaboration to Discover Additional Novel Peptide Therapeutics

Madison, WI, USA September 14, 2021 Nimble Therapeutics, a biotechnology company revolutionizing the discovery and development of peptide therapeutics, today announced their strategic research collaboration with Incyte (NASDAQ: INCY) has been expanded to include discovery of additional novel peptide therapies.

“Nimble looks forward to building upon on the already strong collaboration between the Nimble and Incyte scientific teams. The expansion of the collaboration serves as yet another important validation of Nimble’s powerful capabilities and approach towards engineering the next generation of peptide therapeutics”, said Jigar Patel, CEO and Founder of Nimble Therapeutics.

Under the terms of the agreement, Nimble will receive an upfront payment and reimbursement of certain research program costs and may become eligible for downstream milestone payments and royalties. Incyte has exclusive rights to develop and commercialize any peptides discovered under the collaboration and has an option to further expand the collaboration to include additional targets.

About Nimble Therapeutics

Nimble Therapeutics is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful analytics to efficiently and intelligently discover and develop next generation peptide therapeutics.

Connect with us on LinkedIn at www.linkedin.com/company/nimble-therapeutics or visit our website at www.staging.nimbletherapeutics.com to learn more.

Media Contact

Nimble Therapeutics, Inc.
Brad Garcia, PhD
Vice President, Corporate Development
info@nimbletherapeutics.com

View the full press release here: https://www.businesswire.com/news/home/20210914005143/en/Nimble-Therapeutics-and-Incyte-Expand-their-Strategic-Research-Collaboration-to-Discover-Additional-Novel-Peptide-Therapeutics

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News Press Release

Nimble Therapeutics Appoints Cyrus Arman, PhD, MBA as Chief Business Officer

Madison, WI, USA September 08, 2021 — Nimble Therapeutics, an industry-leading peptide therapeutic discovery and optimization company, today announced the appointment of Dr. Cyrus Arman as Chief Business Officer. Cyrus will be responsible for structuring strategic alliances, licensing agreements, and financial investments, and will further provide management and strategic leadership to the organization. The appointment comes at a time of significant growth for Nimble Therapeutics, as the company continues to advance its technology platform and build out its strategic partnerships. His appointment represents the first step in Nimble’s expansion toward becoming a fully integrated biotechnology company.

Cyrus has over 12 years of experience in corporate, clinical, and commercial strategy. Most recently, he served as Vice President of Corporate Development and Strategy at NEUVOGEN, Inc, an immuno-oncology firm developing cancer vaccines. Prior to NEUVOGEN, Dr. Arman contributed to rebuilding and running Amgen’s Global Competitive Intelligence and Strategy unit, and later served as a Director in Amgen’s Corporate Strategy group.

“We’re excited to welcome Cyrus to our management team at Nimble,” said Jigar Patel, PhD, Founder and CEO of Nimble Therapeutics. “Cyrus brings valuable experience devising strategy, executing transactions, and leveraging innovation that will enable Nimble to deliver on the promise of peptide therapeutics.”

Cyrus has an MBA from the University of California Los Angeles, a PhD in Neuroscience and an MS in Biomedical Engineering from the University of Southern California, and a BS in Biopsychology from the University of California San Diego.

About Nimble Therapeutics

Nimble Therapeutics is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful analytics to efficiently and intelligently discover and develop next generation peptide therapeutics.

Connect with us on LinkedIn at www.linkedin.com/company/nimble-therapeutics or visit our website at www.staging.nimbletherapeutics.com to learn more.

Media Contact

Nimble Therapeutics, Inc.
Brad Garcia, PhD
Vice President, Corporate Development
info@nimbletherapeutics.com

View the full press release here: https://www.businesswire.com/news/home/20210908005289/en/Nimble-Therapeutics-Appoints-Cyrus-Arman-PhD-MBA-as-Chief-Business-Officer

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News Partnering Press Release

Nimble Therapeutics and RayzeBio Announce Strategic Research Collaboration to Discover & Develop Novel Peptide-Based Radiopharmaceuticals

Madison, WI, USA, & San Diego, CA, USA June 28, 2021 — Nimble Therapeutics and RayzeBio today announced the companies have entered a strategic collaboration to discover and develop novel peptide-based radiopharmaceuticals for treatment of cancer.

“We are excited to welcome RayzeBio to our growing family of partners” said Jigar Patel, Ph.D., CEO of Nimble Therapeutics. “Through our pioneering work, we have built a platform to rapidly identify drug-like hits and optimize them into leads, and conduct elaborate medicinal chemistry campaigns to engineer candidates with optimal potency, selectivity, stability, and other important attributes. This agreement with RayzeBio underscores the value inherent in Nimble’s platform to advancing the radiopharmaceutical field.”

“Nimble’s platform technology is promising,” said Ken Song, M.D., CEO of RayzeBio. “Nimble’s rational approach to using its platform to identify novel peptide-like molecules allows us to further expand our radiopharmaceutical pipeline and pursue multiple therapeutic programs in parallel.”

Under the terms of the agreement, Nimble will receive an undisclosed upfront payment, research reimbursements and may also receive further milestone payments and royalties on sales of resulting products. RayzeBio has exclusive rights to develop and commercialize peptides discovered under the collaboration, and an option to further expand the collaboration to include additional targets.

About Nimble Therapeutics
Nimble Therapeutics is a biotechnology company revolutionizing the discovery & development of peptide therapeutics. The company’s discovery platform integrates leading-edge peptide synthesis, bioinformatic and chemoinformatic tools, a variety of naïve and scaffolded chemical libraries, custom screening and validation assays, and accelerated medicinal chemistry. The company has established partnerships with leading pharmaceutical and biotech companies, and seeks to leverage its technology across many therapeutic areas. For more information, please visit www.staging.nimbletherapeutics.com.

About RayzeBio
RayzeBio is a biotechnology company focused on improving outcomes for people with cancer by harnessing the power of targeted radioisotopes. With a focus on clinically validated solid tumor targets, RayzeBio is developing novel peptide mimetic binders to deliver potent therapeutic radioisotopes such as Actinium-225, an alpha-emitter. The company is backed by a syndicate of sophisticated healthcare investors and was established in 2020. For additional information, please visit www.rayzebio.com.

Media Contact

Nimble Therapeutics, Inc.
Brad Garcia, Ph.D.
Vice President, Corporate Development
info@nimbletherapeutics.com

RayzeBio, Inc.
Ken Song, M.D.
President and CEO
info@rayzebio.com

View the full press release here: https://www.businesswire.com/news/home/20210628005106/en/Nimble-Therapeutics-and-RayzeBio-Announce-Strategic-Research-Collaboration-to-Discover-Develop-Novel-Peptide-Based-Radiopharmaceuticals