Acuity Brands To Announce Fiscal 2021 First Quarter Results on January 7, 2021

Atlanta, Dec. 10, 2020 (GLOBE NEWSWIRE) — Acuity Brands, Inc. (NYSE: AYI) will host a conference call on Thursday, January 7, 2021, at 10:00 a.m. (EST) to discuss the Company’s performance for the first quarter of fiscal 2021, following the announcement of those results earlier that day.  Neil M. Ashe, President and Chief Executive Officer of Acuity Brands, will lead the call.  A live Webcast of the discussion will be accessible at the Company’s Website:  www.acuitybrands.com.  A replay of the call will also be posted to that site within two hours of the completion of the conference call and will be archived on the site. 

Ab
out Acuity Brands  

Acuity Brands, Inc. (NYSE: AYI) is a market-leading industrial technology company. We design, manufacture, and bring to market innovative products and services that make the world more brilliant, productive, and connected including building management systems, lighting, lighting controls, and location-aware applications.  Based in Atlanta, Georgia, with operations across North America, Europe, and Asia, we are powered by approximately 11,000 dedicated and talented associates. Visit us at www.acuitybrands.com.

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Company Contact:                                      

Pete Shannin             
Acuity Brands, Inc.    
(770) 860-2873                      
[email protected]



II-VI Incorporated to Present at MKM Partners Virtual Conference

PITTSBURGH, Dec. 10, 2020 (GLOBE NEWSWIRE) — II-VI Incorporated (Nasdaq: IIVI), a global leader in engineered materials and optoelectronic components, today announced that the Company will present at the following upcoming investor conference:

MKM
Partners Virtual Conference

  • Date:  Wednesday, December 16, 2020
  • Time:  11:50 a.m. ET
  • Place:  Virtual

Participants

  • Dr. Chuck Mattera, Chief Executive Officer, II-VI
  • Mary Jane Raymond, Chief Financial Officer, II-VI

A real-time audio webcast of the presentation can be accessed via the Investors section of the II-VI website at https://www.ii-vi.com/investors-events/. A replay of the webcast will be available on the Company’s website following the conclusion of the event.


About II-VI Incorporated

II-VI Incorporated, a global leader in engineered materials and optoelectronic components, is a vertically integrated manufacturing company that develops innovative products for diversified applications in communications, materials processing, aerospace & defense, semiconductor capital equipment, life sciences, consumer electronics, and automotive markets. Headquartered in Saxonburg, Pennsylvania, the Company has research and development, manufacturing, sales, service, and distribution facilities worldwide. The Company produces a wide variety of application-specific photonic and electronic materials and components, and deploys them in various forms, including integrated with advanced software to support our customers. For more information, please visit us at www.ii-vi.com.

CONTACT: Mark Lourie
  Vice President, Corporate Communications
  [email protected]
 
www.ii-vi.com/contact-us



Sodexo joins CDP’s A List of global climate change leaders with key progress on its carbon strategy

Sodexo joins CDP’s A List of global climate change leaders with key progress on its carbon strategy

Paris, December 10, 2020 – On the occasion of the 5th anniversary of the Paris Agreement, Sodexo, world leader in Quality of Life Services, has secured a place on the global environmental non-profit Carbon Disclosure Project’s ‘A list’ of climate change leaders’.

For the first time, Sodexo scored an “A” grade, joining 270 high-performing companies out of more than 9,500. This recognition demonstrates key progress on its carbon strategy which includes a target aligned with the most ambitious goal of the Paris Agreement to limit global warming to 1.5°C above pre-industrial levels, as well as concrete actions to cut emissions and transparency in reporting.

“Sodexo is the only company from the foodservices and facility management sectors to be part of this exclusive list of corporate sustainability leaders. This clear testimony to the efforts our teams are deploying alongside our suppliers and clients encourages us on our path towards fundamentally sustainable services,” said Maria Outters, Senior Vice President, Corporate Responsibility at Sodexo. “We are progressing in several areas of our carbon strategy, in line with our science-based and industry-leading target to reducing our total carbon emissions by 34% by 2025.”

Since 2017, Sodexo reduced its Scopes 1 and 2 carbon emissions by 15.9% and its Scope 3 Supply Chain carbon emissions by 10.5%*.

“The partnership between WWF and Sodexo on its carbon strategy over the last 10 years is showing results, and WWF is heavily invested in supporting Sodexo’s transformation and driving sustainable change within the foodservices sector”, said Marie-Christine Korniloff, Deputy Director for Economic affairs, WWF FRANCE. “The entrance of Sodexo in the CDP ‘A-list’ for Climate highlights the commitment of the Group in delivering progress on the reduction of its environmental impact, despite a challenging economic situation.”

Sodexo carbon strategy is built on four key actions:


  1. Fighting food waste with WasteWatch

    WasteWatch, Sodexo’s game-changing food waste prevention program has an ambitious objective of reducing food waste on our sites by 50% by 2025, through measurement and prevention. As the most comprehensive program in the foodservices sectors, Sodexo helped its clients and the consumers served avoid 2,468 tons of food being waste – more than 17,000 tons of carbon since the program started.


  2. Promoting plant-based meal options

    Sodexo has increased its menu mix target for plant-based meals to more than 30% globally to address the growing consumer demand for sustainable food and more natural, local and healthy ingredients. In 6,500 sites in 13 countries, Sodexo also offers menus based on “Future 50 Foods”, which are nutritious and have a lower environmental impact.


  3. Building a low-carbon supply chain

    With 49% of its emissions being linked to its supply-chain, Sodexo is working with suppliers and partners such as the WWF to build a more local and low-carbon supply chain. Sodexo has committed to a deforestation-free and conversion-free supply chain globally by 2030 for the following priority commodities: palm oil, soy, beef and paper products.


  4. Focusing on energy management and renewable energies

    Sodexo has committed to switching to 100% renewable electricity by 2025 at its directly operated sites. Sodexo is also supporting clients in this respect, through Sodexo’s energy management service that generates significant savings and significant returns on investment.

Partnering to act on climate change is part of the positive impact of doing business with Sodexo.

*More information on Sodexo’s reduction in carbon emissions are available on page 78 of the company’s Fiscal 2020 Universal Registration Document.


About the CDP A List

CDP’s annual environmental disclosure and scoring process is widely recognized as the gold standard of corporate environmental transparency. A detailed and independent methodology is used by CDP to assess responding companies, allocating a score of A to D- based on the comprehensiveness of disclosure, awareness and management of environmental risks and demonstration of best practices associated with environmental leadership, such as setting ambitious and meaningful targets.
The full list of companies that made this year’s CDP A List is available here, along with other publicly available company scores: https://www.cdp.net/en/companies/companies-scores


About Sodexo

Founded in Marseille in 1966 by Pierre Bellon, Sodexo is the global leader in services that improve Quality of Life, an essential factor in individual and organizational performance. Operating in 64 countries, Sodexo serves 100 million consumers each day through its unique combination of On-site Services, Benefits & Rewards Services and Personal & Home Services. Sodexo provides clients an integrated offering developed over more than 50 years of experience: from foodservices, reception, maintenance and cleaning, to facilities and equipment management; from services and programs fostering employees’ engagement to solutions that simplify and optimize their mobility and expenses management, to in-home assistance, child care centers and concierge services. Sodexo’s success and performance are founded on its independence, its sustainable business model and its ability to continuously develop and engage its 420,000 employees throughout the world.
Sodexo is included in the CAC Next 20, ESG 80, FTSE 4 Good and DJSI indices.

Key figures

19.3 billion euro in Fiscal 2020 consolidated revenues
420,000 employees as at August 31, 2020
N°1 France-based private employer worldwide
64 countries
100million consumers served daily
8.1 billion euro in market capitalization (as at October 28, 2020)

Contact

Media
Tugdual HOUEX

Tel: +33 1 57 75 85 46
[email protected]

 

Attachment



IIROC Trading Halt – CKG

Canada NewsWire

VANCOUVER, BC, Dec. 10, 2020 /CNW/ – The following issues have been halted by IIROC:

Company: Chesapeake Gold Corp.

TSX-Venture Symbol: CKG

All Issues: Yes

Reason: At the Request of the Company Pending News

Halt Time (ET): 8:02 AM

IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada.

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) – Halts/Resumptions

ENGIE announces 650 MW of renewable energy offtake contracts with Amazon

PR Newswire

HOUSTON, Dec. 10, 2020 /PRNewswire/ — Today, ENGIE announces several energy offtake contracts with Amazon for a global renewable energy portfolio of wind and solar projects across the United States, Italy and France totaling 650 MW. These Corporate Power Purchase Agreements (PPAs) will exclusively rely upon renewable energy production facilities developed by ENGIE. For ENGIE, this operation is the largest portfolio of agreements signed at once with a single counterparty.

These projects align with Amazon’s goal to power its operations with 100% renewable energy by 2030 and reach net zero carbon by 2040. They also demonstrate ENGIE’s expertise across the green energy value chain, from the construction and operation of renewable energy plants, to the sale of energy to industrial customers. In 2019, ENGIE was the #1 global seller of clean energy Corporate PPAs and signed over 2,000 MW mostly in the US but also in Europe, notably in Spain.

In the United States, Amazon’s new renewable energy solar and wind projects with ENGIE represent 569 MW in Delaware, Kansas, North Carolina, Ohio and Virginia. They will supply Amazon with approximately 1,850 GWh of power and with the associated project renewable energy credits (REC’s) annually. During construction, ENGIE will create approximately 300 jobs at each wind facility and 210 jobs at each solar facility. Projects are expected to reach commercial operation in 2021 through 2022.

In Europe, Amazon’s total contracts with ENGIE add up to 66 MW in Italy and 15 MW in France, and are the company’s first utility-scale renewable energy projects in each country. Amazon will purchase renewable energy from two solar facilities located in Southern Italy and another in Southern France to power its European operations.  

“These new projects with ENGIE represent our first utility-scale renewable energy projects in Italy and France in Europe and our first projects in Delaware and Kansas in the United States. They substantially help us on our path to powering our operations with 100 percent renewable energy by 2030,” said Nat Sahlstrom, Director, Amazon Energy. “Working with ENGIE, we are able to add 650 MW of new power to grids in the US and Europe. Our push for more renewable energy is one step toward our goal of reaching net-zero carbon by 2040 as part of Amazon’s commitment to The Climate Pledge.”

“These contracts demonstrate ENGIE’s capabilities to commercialize green energy internationally for our customers. And in North America – as elsewhere – we recognize that bold commitments are needed from global companies and local communities alike to lead the way to clean energy use,” said Gwenaëlle Avice-Huet, ENGIE’s Executive Vice President in charge of the Renewables Business Line and CEO of ENGIE North America. “We are excited to work with Amazon to create a clean, prosperous, low carbon future – and create economic benefits for the communities involved.”

About ENGIE 
Our group is a global leader in low-carbon energy and services. Our goal is to accelerate the transition towards a carbon-neutral world by reducing power consumption and providing the most environmentally aware solutions, combining financial profitability with a positive impact on people and the planet. We apply our key businesses (gas, renewable energy, services) to provide competitive solutions for our clients. Our 170,000 employees, clients, partners and stakeholders represent a community of Imaginative Builders, committed to a more balanced daily progress.

Business volume in 2019: €60.1 billion. The group is listed in the Paris and Brussels (ENGI) exchanges and is also included in the top financial indices (CAC 40, DJ Euro Stoxx 50, Euronext 100, FTSE Eurotop 100, MSCI Europe), as well as non-financial indices (DJSI World, DJSI Europe and Euronext Vigeo Eiris – World 120, Eurozone 120, Europe 120, France 20, CAC 40 Governance).

About ENGIE North America
ENGIE North America Inc. offers a range of capabilities in the United States and Canada to help customers decarbonize, decentralize and digitalize their operations. These include comprehensive services to help customers run their facilities more efficiently and optimize energy and other resource use and expense; clean power generation; energy storage; and retail energy supply that includes renewable, demand response, and on-bill financing options. Nearly 100% of the company’s power generation portfolio is low carbon or renewable. Globally, ENGIE S.A. relies on their key businesses (gas, renewable energy, services) to offer competitive solutions to customers. With 170,000 employees, customers, partners and stakeholders, we are a community of Imaginative Builders, committed every day to more harmonious progress. For more information on ENGIE North America, please visit our LinkedIn page or Twitter feed, www.engie-na.com and www.engie.com.

Amazon Media Contact:

[email protected] 

ENGIE North America Media Contact:

Sandrine Deparis, [email protected], (202) 855 3705

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/engie-announces-650-mw-of-renewable-energy-offtake-contracts-with-amazon-301190399.html

SOURCE ENGIE North America

Fusion Pharmaceuticals Initiates Multi-Dose Portion of Phase 1 Trial of FPI-1434 in Patients with Advanced Solid Tumors

PR Newswire

Phase 1 Single-Dose Data Show Uptake Across Multiple Tumor Types; No Dose Limiting Toxicities or Treatment-Related Serious Adverse Events

HAMILTON, ON and BOSTON, Dec. 10, 2020 /PRNewswire/ — Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dosed in the multi-dose portion of the Phase 1 study evaluating [225Ac]-FPI-1434 (FPI-1434) in patients with advanced solid tumors. FPI-1434 is a radioimmunoconjugate that utilizes Fusion’s proprietary Fast-Clear™ linker to connect a humanized monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), with the alpha-emitting isotope actinium-225, creating a targeted alpha therapy (TAT).

The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R.  The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. As part of the precision medicine approach, prior to receiving the therapeutic injection of FPI-1434, patients are administered an indium-111 imaging analogue, [111In]-FPI-1547 (FPI-1547). The images collected are used to confirm the presence of tumor uptake and to ensure that estimated radiation doses to organs and tissues are below protocol-specified safety limits.

The multi-dose study follows completion of the single-dose portion of the Phase 1 study, which showed that FPI-1434 was generally well tolerated with no dose limiting toxicities or treatment-related serious adverse events reported to date. The multi-dose portion of the study is expected to enroll patients at sites in Canada, the United States and Australia. The initial patient cohort is being dosed with FPI-1434 at 75kBq/kg with repeat cycles every six weeks up to allowable limits.

“We are pleased with the results of the single-dose portion of our Phase 1 study of FPI-1434 which, following the evaluation of the Safety Review Committee, support initiating the multi-dosing portion of the study,” said Chief Executive Officer John Valliant, Ph.D. “This is a critical next step in the FPI-1434 development program as data from the multi-dose portion of the study may provide important insights on potential anti-tumor activity. The multi-dosing trial will also inform the design of the Phase 2 program and assist in the selection of tumor indications to be pursued in planned expansion cohorts. This is especially important given the broad expression of IGF-1R across multiple tumor types.”  

For additional detail about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03746431.

About FPI-1434

FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

Acknowledgement of US DOE and Actiunium-225 Supply

The actinium-225 used in this research was supplied by the United States Department of Energy Office of Science by the Isotope Program in the Office of Nuclear Physics.

About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion’s lead program, FPI-1434, is currently in a Phase 1 clinical trial.

Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions’ programs’ early stage of development, the process of designing and conducting and clinical trials, , risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion’s quarterly report on Form 10-Q for the quarter ended September 30, 2020 which is available on the Security and Exchange Commission’s website at www.sec.gov and Fusion’s website at www.fusionpharma.com

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/fusion-pharmaceuticals-initiates-multi-dose-portion-of-phase-1-trial-of-fpi-1434-in-patients-with-advanced-solid-tumors-301190376.html

SOURCE Fusion Pharmaceuticals Inc.

IIROC Trade Resumption – ET

Canada NewsWire

TORONTO, Dec. 10, 2020 /CNW/ – Trading resumes in:

Company: Evertz Technologies Limited

TSX Symbol: ET

All Issues: Yes

Resumption (ET): 8:00 AM

IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada.

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) – Halts/Resumptions

Payference is Sage Intacct certified and available on Sage Intacct marketplace

SUNNYVALE, Calif., Dec. 10, 2020 (GLOBE NEWSWIRE) — Payference, provider of AI-driven cash flow management solutions for finance and accounting teams, announced today that its cash flow application is immediately available in the Sage Intacct marketplace. Payference helps CFOs and finance teams manage and forecast cash flow with the highest level of accuracy automatically. Payference eliminates the need to manually update spreadsheets and is natively integrated with Sage Intacct and other leading ERP systems.

“We’re excited to offer Sage Intacct customers with autonomous cash flow management and forecasting capabilities,” said Prashant Kumar, Founder and CEO of Payference. “With Payference, customers can extend the investment in Sage Intacct and benefit from intelligent automation of cash flow management, actionable analytics, and an intuitive dashboard. We’re delighted to partner with Sage Intacct to serve mid-market companies.”

“We are pleased to have Payference available on the Sage Intacct marketplace,” said Eileen Wiens, VP of Business Development at Sage Intacct. “With Payference, our customers can confidently enter the future of cash flow management automation, driven by machine learning.”

Payference’s differentiated approach leads to real-time cash visibility and forecasting, resulting in improved and timely business decision making. Through seamless integrations with ERPs such as Sage Intacct and all major banks, Payference combines accounts receivables, accounts payables, purchase orders and bank transactions and uses AI and machine learning algorithms to view and optimize cash flows in real-time.

Payference’s unique proprietary technology, enables a more accurate prediction of cash inflow from the receivables as well as suggests ways to increase cash from payables. Payference helps you manage your receivables including assistance with the collections process.

“Payference has helped increase our productivity through more efficient cash management replacing the manual processes and Excel spreadsheets to manage burn rate and forecast cash,” said Wei Wang, Head of Finance at Ordr Inc. “Payference’s unique approach enables us to focus on higher value items.”

To learn more, visit the Sage Intacct Marketplace: Payference


About


Payference

Based in Silicon Valley, California, Payference’s AI-driven software enables companies to forecast cash flow and optimize working capital, freeing trapped cash flow to the bottom line. Payference’s mission is to provide financial visibility and enable data driven decision-making, while also making financial data easily accessible and understandable for anyone in the organization.

Learn more about Payference by visiting Payference.com. Follow Payference on LinkedIn.

Contact:

[email protected]



Vantiq Announces Partnership with Infosys for Digital Supply Chain Innovation

Companies to Build Real-time Applications in Logistics, Distribution, Connected Maintenance and Workplace Safety

SAN FRANCISCO, Dec. 10, 2020 (GLOBE NEWSWIRE) — Vantiq today announced that it has created an innovation accelerator with Infosys, a global leader in next-generation digital services and consulting, to help customers quickly build real-time applications for managing digital supply chains. Using pre-built digital domain and development frameworks, the accelerator will enable existing and new customers to rapidly develop innovative real-time applications in logistics and distribution optimization, connected maintenance, modern workplace transformation, real-time compliance and safety management.

The accelerator’s first pre-built framework is for connected maintenance, enabling rapid development of end-to-end systems for real-time railroad condition monitoring, in line with the U.S. Federal Railroad Administration’s safety guidelines. The framework integrates live data streams from multiple wheel sensors and compares that data against safety guidelines. The framework also automates preventive, corrective or prescriptive actions in real time.

Infosys will extend its deep domain expertise and digital-first approach to support the innovation accelerator, in collaboration with Vantiq’s event-driven, edge-native development platform. Working together, the companies will help customers ideate, build and deploy real-time industrial applications in days or weeks, versus months or longer timelines.

“Now, more than ever, industrial businesses need connected real-time applications that can enable innovative strategies, drive new revenue streams, and ensure the safety of people and environments,” said Marty Sprinzen, co-founder and CEO of VANTIQ. “Vantiq and Infosys are excited to open the doors to our new Digital Supply Chain accelerator, where we can bring these powerful real-time applications to market that much faster.”

Ravi Kumar S, President at Infosys, said: “Today, we are seeing an increased need across the software industry for real-time application building to ensure success of many key digital projects. To further accelerate enterprises’ digital transformation agenda, together with Vantiq, we will help digitize the supply chain innovation for clients that will result in enabling smarter real-time economies. Through this collaboration, we will work towards delivering faster digital outcomes for businesses to improve their customer reach, achieving operational efficiency with real-time sensors, and creating immediate and data-driven business impact.”

“E-commerce and expedited demand for goods and services in the digital economy require agile and resilient supply chains,” said Shawn Fitzgerald, Research Director, IDC’s Worldwide Digital Transformation (DX) Strategies. “By enabling low-code development, traditional supply chain processes are transformed through high-productivity applications. In the digital economy, traditional approaches to supply chain software development management are not sufficient nor viable to enable today’s value chains. A great example of dynamic and digitally enabled low-code value chain enablement is this Vantiq and Infosys partnership, providing a jump start to companies looking to transform their supply chains and gain a competitive advantage through scalable low-code development.”

About
Vantiq

Vantiq enables customers to build next-generation applications that combine real-world data and real-time events. Their agile development environment allows complex applications to be created in weeks with minimal coding, taking full advantage of artificial intelligence (AI), Internet of Things (IoT) and edge computing. Vantiq powers a broad array of applications for smart cities, smart buildings, oil and gas, telecom, healthcare and other industries. Vantiq was founded in 2015 by technology veterans Marty Sprinzen and Paul Butterworth, co-founders of Forte Software. Learn more at http://www.vantiq.com.

Media Contacts:

Dave Reddy, Big Valley Marketing for Vantiq, +1 (650) 868-4659, [email protected]



TRACON Pharmaceuticals Announces Dosing of First Patient in ENVASARC Pivotal Trial

Company Expects Interim Data in Mid-2021

SAN DIEGO, Dec. 10, 2020 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced dosing of the first patient in the ENVASARC registration trial.

“We are pleased to initiate dosing in the ENVASARC registration trial of envafolimab in sarcoma,” said Sant Chawla, M.D., Director of the Sarcoma Oncology Center, Santa Monica. “Immunotherapy has radically changed the treatment paradigm for a number of cancers, and we believe envafolimab has the potential to do the same for sarcoma patients who have few treatment options.”

“Dosing the first patient in the ENVASARC registration trial within one year of executing the license to envafolimab fulfills our 2020 expectations for what has been a productive year of clinical development and regulatory interactions for our lead product candidate,” said Charles Theuer, M.D., Ph.D., President and Chief Executive Officer of TRACON. “We look forward to the availability of interim top-line data from this important study, which we expect in mid-2021.”

About
ENVASARC
(
NCT
04480502
)

Key elements of the ENVASARC registration trial include:

  • Multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States.
  • Eligible patients will have undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) and received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
  • Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy®.
  • Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
  • Open-label format with blinded independent central review of efficacy endpoint data.

About
Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently being studied in the ENVASARC Phase 2 registration trial in the U.S. sponsored by TRACON, as well as in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer in November 2020. In the Phase 2 registration trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About TRACON

TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed in a registration trial for the treatment of certain sarcomas; TRC253, a small molecule drug candidate for the treatment of prostate cancer; TRC102, a Phase 2 small molecule drug candidate being developed for the treatment of lung cancer and glioblastoma; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization.  In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S.  To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com.

Forward-Looking Statements

Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON’s plans to further develop product candidates, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development and regulatory milestones and timing thereof, the potential benefits of product candidates, and TRACON’s business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with the COVID-19 pandemic or other pandemics; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials, initiate additional trials or seek regulatory approval of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Company Contact: Investor Contact:
Mark Wiggins Brian Ritchie
Chief Business Officer LifeSci Advisors LLC
(858) 251-3492 212-915-2578
[email protected] [email protected]