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

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

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

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

The details of the poster presentation are as follows: 

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

About Nimbus Therapeutics 

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

Media Contact: 

Chris Railey
Ten Bridge Communications
chris@tenbridgecommunications.com   

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

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

Details of the AACR presentation are as follows:

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

About Nimbus Therapeutics

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

Media Contacts:

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

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

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

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

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

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

About Nimbus Therapeutics

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

About the Nimbus TYK2 Program

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

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

Media Contacts:

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

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

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

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

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

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

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

Media Contacts:

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

About Nimbus Therapeutics

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

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

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

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

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

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

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

Media Contact:

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

About Nimbus Therapeutics

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

About the Nimbus TYK2 Program

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

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

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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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