Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced initial safety, pharmacokinetics (PK) and pharmacodynamics (PD) data from the ongoing dose-escalation portion of its Phase 1 clinical trial of SY-5609 in patients with select solid tumors. SY-5609 is a highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor. These early data demonstrate proof of mechanism in patients with advanced solid tumors and establish a maximum tolerated dose (MTD) for continuous daily dosing. The data are being presented in a poster session at the 32nd EORTC-NCI-AACR Symposium.
These early findings from our Phase 1 trial of SY-5609 reinforce our conviction in CDK7 inhibition as a potentially transformative targeted approach for difficult-to-treat cancers, said David A. Roth, M.D., Chief Medical Officer of Syros. As we move forward in this trial, we are committed to fully exploring the potential of SY-5609. To that end, we opened the trial to pancreatic cancer patients, expanded a cohort to focus on lung cancer patients, and also expanded the combination cohort in treatment-resistant breast cancer patients. Additionally, we opened cohorts evaluating alternate dosing regimens, all with the goal of identifying optimal next steps for pursuing single-agent and combination development opportunities and ultimately delivering the greatest benefit to patients.
Early Data Demonstrate Proof-of-Mechanism at Tolerable Doses
Syros presented initial data from its ongoing Phase 1 multi-center, open-label, dose-escalation study of SY-5609 in patients with advanced breast, colorectal, lung, ovarian or pancreatic cancer, or other solid tumors with Rb pathway alterations. The study also includes a cohort evaluating SY-5609 in combination with fulvestrant in CDK4/6 inhibitor-resistant HR-positive breast cancer patients.
As of August 21, 17 patients had been enrolled in the trial and were eligible for safety, PK and PD analysis. Patients were either treated with continuous daily dosing of single-agent SY-5609 at 1, 3, 4 or 5 mg, or for three weeks on and one week off at 3 mg in combination with fulvestrant. The median age of the patients enrolled in the study was 64. Patients were heavily pretreated with a median of four prior therapies. The MTD for continuous daily dosing was achieved at 3 mg. The data showed that:
- SY-5609 demonstrated dose-dependent increases in POLR2A mRNA expression, a PD marker being used in the trial to measure CDK7 biological activity.
- Notably, increases in POLR2A in patients treated at 3 mg daily reached levels associated with tumor regressions in preclinical models, as well as with levels of CDK7 target engagement at which a clinical response and apoptosis were observed in a trial of patients treated with a first-generation IV CDK7 inhibitor.
- SY-5609 demonstrated approximately dose-proportional PK as both a single agent and in combination, minimal accumulation with repeat dosing, and a steady state half-life compatible with once-daily dosing.
- The majority of adverse events reported with SY-5609 as a single agent were low grade. The most common AEs were nausea, diarrhea, fatigue, platelet count decrease, and vomiting.
- The safety profile of SY-5609 in combination with fulvestrant was consistent with that of single-agent SY-5609.
- Five of the 13 patients treated with single-agent SY-5609 were response evaluable, and of those, three achieved stable disease and two had progressive disease; one of the four patients treated in the combination cohort was response evaluable and had progressive disease.
The Phase 1 trial continues to actively enroll patients with select solid tumors, including the recently expanded single-agent cohort in lung cancer patients and combination cohort in breast cancer patients, to further evaluate the 3 mg daily dose in focused patient populations. The trial has also been opened to patients with advanced pancreatic cancer, another tumor type that has demonstrated sensitivity to SY-5609 in preclinical models. Additional cohorts are evaluating alternate regimens, supported by preclinical data showing that intermittent regimens of SY-5609 induced tumor regressions.
Syros expects to report additional dose-escalation data, including clinical activity data, in mid-2021. Additional details about the Phase 1 trial of SY-5609 can be found using the identifier NCT04247126 at www.clinicaltrials.gov.
About Syros Pharmaceuticals
Syros is redefining the power of small molecules to control the expression of genes. Based on its unique ability to elucidate regulatory regions of the genome, Syros aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches. Syros is advancing a robust pipeline, including SY-1425, a first-in-class oral selective RARÎ± agonist in a Phase 2 trial in a genomically defined subset of acute myeloid leukemia patients, and SY-5609, a highly selective and potent oral CDK7 inhibitor in a Phase 1 trial in patients with select solid tumors. Syros also has multiple preclinical and discovery programs in oncology and monogenic diseases. For more information, visit www.syros.com and follow us on Twitter (@SyrosPharma) and LinkedIn.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the timing for reporting additional dose-escalation data, including clinical activity data, from the Phase 1 clinical trial of SY-5609, the future expansion of such trial to include additional cohorts and dosing regimens, and the ability of SY-5609 to have a benefit for patients. Moreover, there can be no assurance that the initial clinical data generated to date in the ongoing Phase 1 clinical trial of SY-5609 are predictive of the ability of any cohort of such trial to meet any of its endpoints or to continue comparing favorably with other treatments or treatment regimens. The words ˜˜anticipate, ˜˜believe, ˜˜continue, ˜˜could, ˜˜estimate, ˜˜expect, hope, ˜˜intend, ˜˜may, ˜˜plan, ˜˜potential, ˜˜predict, ˜˜project, ˜˜target, ˜˜should, ˜˜would, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including Syros ability to: advance the development of SY-5609 under the timelines it projects in current and future clinical trials; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of SY-5609; sustain the response rates seen to date with SY-5609; replicate scientific and non-clinical data in clinical trials; successfully establish a patient selection strategy and develop a companion diagnostic test to identify patients most likely to benefit from SY-5609; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third parties; manage competition; manage expenses; raise the substantial additional capital needed to achieve its business objectives; attract and retain qualified personnel; and successfully execute on its business strategies; risks described under the caption Risk Factors in Syros Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, each of which is on file with the Securities and Exchange Commission; and risks described in other filings that Syros makes with the Securities and Exchange Commission in the future. In addition, the extent to which the COVID-19 outbreak continues to impact our workforce and our research, supply chain and clinical trial operations activities, and the operations of the third parties on which we rely, will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, additional or modified government actions, and the actions that may be required to contain the virus or treat its impact. Any forward-looking statements contained in this press release speak only as of the date hereof, and Syros expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.
Stern Investor Relations, Inc.
Leading Digital Fitness and Nutrition Platform Openfit Acquires LeBron James’ and Arnold Schwarzenegger’s Sports Nutrition Company Ladder
Openfit, one of todays fastest growing digital fitness and nutrition platforms, continues to expand its offering, today announcing its acquisition of Ladder, the sports nutrition company founded by LeBron James and Arnold Schwarzenegger. Advancing the companies shared commitment to a holistic approach to health and wellness, the Ladder brand and its performance supplements will now be integrated into the Openfit platform alongside its growing library of live and on-demand fitness programs, personalized nutrition plans and virtual access to NASM certified trainers. James and Schwarzenegger will become partners in Openfit while continuing to support and grow Ladder.
With people shifting their focus to health and well-being more than ever, this acquisition is exciting for Openfit as it will allow us to continue our mission of serving even more customers with a unique combination of live trainer-supervised and on-demand fitness, nutrition, meditation and supplement offerings, said Jon Congdon, Chief Executive Officer of Openfit. Ladders innovative approach toward effective supplement-assisted training matches our dedication to deliver healthy, lasting results, and we see tremendous synergistic opportunities for the Ladder brand with Openfit. Were thrilled to have LeBron and Arnold as a part of the team and join us on the journey to helping more people achieve their health and fitness goals.
Ladders roots trace back to 2014, when LeBron James personal experience and need for a better supplement to help avoid cramping during training uncovered a gaping need in the market. James team worked with experts to create a line of clean performance supplements with the highest standards for quality and safety. When James shared the products with longtime friend Arnold Schwarzenegger, who has deep roots in the fitness industry, they agreed they needed to share Ladder with their fans and athletes everywhere. Formulated with a focus on taste, performance, and quality, each Ladder product is NSF Certified for Sport, a third-party certification trusted by all major sports governing bodies and verifies that products do not contain any of approximately 270+ substances banned by major athletic organizations and that the contents of the product match whats printed on the label.
Ive been on a fitness crusade for five decades, and LeBron and I created Ladder to achieve a new level of quality and reliability for people who want the best from performance supplements. But supplements are just one part of any good fitness plan – they wont lift the weights for you or clean up your diet, said Arnold Schwarzenegger, Ladder co-founder and fitness titan. Proven by their track record of creating world-class fitness and nutrition content, Openfit brings the real work of fitness to the table which complements our hybrid retail and direct-to-consumer model, and fits perfectly with my crusade to make health and fitness a part of everyones life.
Ladders integration into the Openfit platform aligns with the brands ongoing strategy of offering a comprehensive and personalized solution to fitness, nutrition and wellness direct to the consumer. Additionally, it will also provide significant opportunities to expand Ladders reach.
After pushing my body to its limits season after season, I needed a different level of supplements that I could trust to complement my workouts and aid in the recovery process. With Ladder, we achieved that. We were able to work with experts to create an incredible line of certified, high caliber supplements for all athletes, but we always recognized that is just one part of the process, said LeBron James, champion athlete and Ladder co-founder. Now with the reach and resources of the Openfit platform, were excited about bringing this all together and creating a new level of training and nutrition that fits everyones individual needs.
The Openfit platform encompasses a wide variety of fitness genres that includes digital and on demand classes led by certified instructors, guided runs, walks, HIIT training, ballet barre, yoga, Pilates and more.
To learn more please visit Openfit.com/Ladder.
About Openfit Openfit is the digital streaming platform that integrates fitness, nutrition, and wellness together in one place. At Openfit, we provide world-class fitness programs with live trainer-led and on-demand workouts designed to reach any goal, personalized nutrition plans and tracking. As convenient as your smart phone in the palm of your hand, Openfit takes whats so powerful about boutique, small-group fitness and makes it available to everyone at a fraction of the price. Join us at Openfit.com, on Facebook at facebook.com/Openfit, and on Instagram @myOpenfit.
About Ladder Founded by LeBron James and Arnold Schwarzenegger, along with Main Street Advisors, Ladder is a sports nutrition company dedicated to creating high-performance, NSF Certified for Sport workout supplements for daily use. Designed for all athletes from every sport to achieve peak performance before, during and after physical activity, we formulate products to complement a strong nutritional foundation and unlock the next level in training and exercise.
Capco Acquires NEOS LLC
Capco, the global management and technology consultancy, today announces the acquisition of NEOS LLC (˜NEOS), a Hartford, CT based consultancy focused on helping leading insurance organizations drive transformational change.
The transaction will complement and extend Capcos growing insurance services. NEOSs leadership team, including Founder and Managing Partner Ernst Renner, and its employees will be joining Capco. Financial terms were not disclosed.
Specializing in working with clients that offer life, annuities, retirement, employee benefits, and property and casualty insurance, NEOS provides consulting and delivery services to solve its clients strategy, operations, data, and technology challenges.
Lance Levy, CEO of Capco, said: The acquisition expands our capabilities and presence in the insurance sector, which is a key component of our growth strategy. This continues our focused approach of using targeted acquisitions to enhance specific capabilities that offer a strong business fit, and an opportunity to accelerate our growth. We have recently established insurance practices which we will grow through the addition of seasoned practitioners and teams. I am excited to welcome Ernst, and the NEOS team, to the Capco family.
Michael Pugliese, Managing Partner of Capcos US business, said: NEOS is an established company with strong growth potential and a highly respected team with extensive experience and expertise in the insurance space. The acquisition will enable Capco to expand our footprint in the insurance sector, and to offer additional services to our current financial services clients that have insurance divisions.
Ernst Renner, CEO and Managing Partner at NEOS, said: Capcos focus on business transformation and building solutions to deliver business value aligns perfectly with our own approach. Our decision to join Capco will expand our delivery capability and depth in areas we have been growing, notably digital transformation and data, and accelerate our ability to support our clients in those areas.
Capco is a global management and technology consultancy dedicated to the financial services and energy industries. Our professionals combine innovative thinking with unrivalled industry knowledge to offer our clients consulting expertise, complex technology and package integration, transformation delivery and managed services to move their organizations forward. Through our collaborative and efficient approach, we help our clients successfully innovate, increase revenue, manage risk and regulatory change, reduce costs, and enhance controls. We specialize in banking, capital markets, wealth and asset management, insurance, and energy. We serve our clients from offices in leading financial centers across the Americas, Europe, and Asia Pacific. To learn more, visit our web site at¯www.capco.com or follow us on Twitter, Facebook, YouTube, LinkedIn and Instagram.
AT&T to Webcast Talk With Scott Mair at Barclay Global Technology, Media and Telecommunications Conference on December 9
AT&T Inc.* (NYSE:T) will webcast a presentation by Scott Mair, AT&T president, technology & operations, at the Barclay Global Technology, Media and Telecommunications Conference on December 9. The presentation will be held virtually and is scheduled to begin at 10 a.m. ET.
The webcast will be available live and for replay at AT&T Investor Relations. Viewers should join the webcast a few minutes before the planned start time in case the conference schedule changes.
AT&T Inc. (NYSE:T) is a diversified, global leader in telecommunications, media and entertainment, and technology. It executes in the market under four operating units. WarnerMedia is a leading media and entertainment company that creates and distributes premium and popular content to global audiences through its consumer brands, including: HBO, HBO Max, Warner Bros., TNT, TBS, truTV, CNN, DC Entertainment, New Line, Cartoon Network, Adult Swim and Turner Classic Movies. AT&T Communications provides more than 100 million U.S. consumers with entertainment and communications experiences across TV, mobile and broadband. Plus, it serves high-speed, highly secure connectivity and smart solutions to nearly 3 million business customers. AT&T Latin America provides pay-TV services across 10 countries and territories in Latin America and the Caribbean and wireless services to consumers and businesses in Mexico, where it is the fastest-growing wireless provider. Xandr provides marketers with innovative and relevant advertising solutions for consumers around premium video content and digital advertising through its platform.
AT&T products and services are provided or offered by subsidiaries and affiliates of AT&T Inc. under the AT&T brand and not by AT&T Inc. Additional information is available at about.att.com. 2020 AT&T Intellectual Property. All rights reserved. AT&T, the Globe logo and other marks are trademarks and service marks of AT&T Intellectual Property and/or AT&T affiliated companies. All other marks contained herein are the property of their respective owners.
Email: [email protected]
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