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EMA Grants Orphan Drug Designation to NeoImmuneTech’s NT-I7 for the Treatment of Acute Radiation Syndrome

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This regulatory milestone marks an acceleration of the process around NT-I7’s potential first indication, after other recent positive news.NeoImmuneTech’s NT-I7 has shown potential in nonclinical studies to address the immunosuppressive effects of ARS.

ROCKVILLE, Md.  , June 4, 2024 /PRNewswire/ — NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to NT-I7 (efineptakin alfa) for the treatment of Acute Radiation Syndrome (ARS).

This regulatory milestone follows the ODD granted to NT-I7 by the FDA in the US for the same indication in November 2023. It is the second ODD received by NT-I7 from the EMA, following the one granted in Idiopathic CD4+ Lymphocytopenia (ICL) in May 2017.

ARS is a critical condition resulting from a high dose of radiation exposure, causing severe, sometimes fatal damage to the bone marrow and the immune system. Currently, there are no treatments available that effectively promote T cell recovery after such exposure. NT-I7, a novel long-acting human interleukin-7 (IL-7), has shown promise to accelerate T cell reconstitution and enhance the immune response, offering a potential solution for this medical unmet need. Clinical studies have shown that NT-I7 significantly boosts T cell counts, while maintaining a high level of safety and tolerability.

NeoImmuneTech is actively developing NT-I7 in ARS through partnerships with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and Duke University. Recently, Duke University secured a $6 million grant from NIAID for NT-I7 development in ARS.

Luke Oh, Ph.D., President and Chief Executive Officer of NeoImmuneTech, said: “We are thrilled to see the deep interest of the scientific and regulatory community around the potential use of NT-I7 as a medical countermeasure in ARS. The EMA Orphan Drug Designation marks a new milestone for us, following our recent pre-IND discussions we had with the FDA to accelerate our development program. It is an important acknowledgment of the potential that NT-I7 holds in providing a beacon of hope for the treatment of ARS.”

ODD is a status assigned to a medicine intended for use against a rare disease or condition. The designation provides incentives to advance the development of treatments for rare diseases, including reduced fees for multiple steps in the development process, such as protocol assistance, marketing authorization applications, and inspections before authorization.

About Acute Radiation Syndrome (ARS)
Acute Radiation Syndrome (ARS) is an acute illness caused by irradiation of the entire body by a high dose of penetrating radiation in a very short period of time (typically a matter of minutes or less). Examples of people who suffered from ARS are individuals exposed during the Hiroshima and Nagasaki atomic bombings, and the firefighters that responded after the Chernobyl Nuclear Power Plant incident in 1986.[1]

About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech, Inc.
NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and has a strong executive team with rich industry experience. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.

Forward-looking Statements
The statements contained herein may contain certain forward-looking statements relating to NeoImmuneTech, Inc. (the “Company”) that are based on its beliefs and expectations about the future. These forward-looking statements are based on a number of assumptions about the future, some of which are beyond the Company’s control and are not a guarantee of future performance or developments. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that arise after the date of these documents. Accordingly, you should not place reliance on any forward-looking information or statements contained herein.

Some of the data contained in these documents were obtained from various external sources, and the Company has not independently verified such data. Accordingly, the Company makes no representations as to the accuracy or completeness of the data, and such data involves risks and uncertainties and is subject to change based on various factors.

[1] https://www.cdc.gov/radiation-emergencies/hcp/clinical-guidance/ars.html?CDC_AAref_Val=https://www.cdc.gov/nceh/radiation/emergencies/arsphysicianfactsheet.htm

 

View original content:https://www.prnewswire.com/news-releases/ema-grants-orphan-drug-designation-to-neoimmunetechs-nt-i7-for-the-treatment-of-acute-radiation-syndrome-302163015.html

SOURCE The NeoImmuneTech, Inc

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Greenlane Renewables Announces Management and Board of Director Changes

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~Appointment of Stephanie Mason as CFO completes planned succession~

VANCOUVER, BC, Nov. 15, 2024 /CNW/ – Greenlane Renewables Inc. (“Greenlane”) (TSX: GRN) (FSE: 52G) today announces the appointment of Stephanie Mason as Chief Financial Officer (“CFO”), effective January 13, 2025.

Ms. Mason brings over 15 years of experience to her new role as Greenlane’s CFO. Ms. Mason has been with Greenlane for over 4 years, most recently as Director of Finance following a promotion from Corporate Controller. Prior to working at Greenlane, Ms. Mason gained experience at other TSX-listed renewable energy companies managing teams responsible for financial reporting, regulatory compliance and other finance activities. Ms. Mason developed her strong accounting foundation at PricewaterhouseCoopers where she obtained her CPA, CA designation.

“We are excited to welcome Stephanie into the role of CFO,” said Brad Douville, CEO of Greenlane Renewables. “Stephanie brings a depth of expertise in finance, reporting, and operations and provides continuity in leadership at Greenlane. Transitioning overall financial leadership from Monty Balderston to Stephanie starting at the beginning of 2025 completes a planned succession as we continue to advance our strategic goals in the RNG space. During his tenure as CFO over the last couple of years, Monty has provided solid leadership of the finance function at Greenlane and played a pivotal role on the senior management team. I want to thank Monty for all of his contributions.”

“I am honored to become Greenlane’s CFO. This is an organization recognized for its commitment to sustainability and innovation,” stated Ms. Mason. “I look forward to contributing to the company’s financial reporting strength and supporting its growth objectives.”

Mr. Balderston will remain as CFO until voluntarily resigning effective January 13, 2025. Mr. Balderston will support the transition to Ms. Mason upon her appointment, following which he will leave the Company on January 24, 2025.

Further to the management update announced on August 23, 2024, Ian Kane will be completing his transitional role as President and will leave the Company on November 22, 2024 when he will step down from Greenlane’s Board of Directors. The Company wishes to thank Mr. Kane for all of his efforts in helping drive Greenlane’s business plan.

About Greenlane Renewables

Greenlane is driving change: accelerating the energy transition to a net-zero emissions economy. We are cleaning up two of the largest and most difficult to decarbonize sectors of the global energy system: the natural gas grid and commercial transportation. As a pioneer and leading specialist in biogas upgrading, we have been actively contributing to the decarbonization of our planet for over 35 years. The systems we provide transform biogas generated from organic waste into high-value grid-ready renewable natural gas (“RNG”). Our systems produce clean, low-carbon and carbon-negative RNG from organic waste sources including agriculture (such as dairy and hog manure), water resource recovery facilities, food waste, landfills, and sugar mills. Greenlane is the only biogas upgrading company offering and actively deploying the three main upgrading technologies: waterwash, pressure swing adsorption, and membrane separation, plus proprietary biogas desulfurization technology. Greenlane has delivered over 145 biogas upgrading systems into 19 countries, including some of the largest RNG production facilities in the world, and over 160 biogas desulfurization units. For further information, please visit www.greenlanerenewables.com.

SOURCE Greenlane Renewables Inc.

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Eastside Distilling, Inc. Announces Private Placement Offering

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Eastside Distilling, Bridgetown Spirits Corp., a consumer-focused beverage company that builds craft inspired experiential brands and Beeline Financial Holdings, Inc. (“Beeline”), a digital mortgage technology and lending company, announces the completion of a private placement offering (the “Offering”) with accredited investors, resulting in gross proceeds of $1,615,000.

PORTLAND, Ore. and PROVIDENCE, R.I. , Nov. 15, 2024 /PRNewswire-PRWeb/ — Eastside Distilling, Inc. (NASDAQ: EAST) (“Eastside” or the “Company”), a holding company for Bridgetown Spirits Corp., a consumer-focused beverage company that builds craft inspired experiential brands and for Beeline Financial Holdings, Inc. (“Beeline”), a digital mortgage technology and lending company, announces the completion of a private placement offering (the “Offering”) with accredited investors, resulting in gross proceeds of $1,615,000. Under the terms of a Securities Purchase Agreement, the Company sold $1,938,000 in original issue discount Senior Secured Notes (the “Notes”) and Pre-Funded Warrants to purchase 363,602 shares of Common Stock (the “Warrants”).

Joseph Gunnar & Co., LLC acted as the exclusive placement agent in connection with the Offering.

For an overview of the terms of the securities and transactions involved in the Offering, and copies of the forms of transaction documents entered into in connection therewith, please refer to the Company’s Current Report on Form 8-K filed on November 15, 2024 with the Securities and Exchange Commission. The Company plans to utilize the net proceeds for working capital and general corporate expenses, among other uses.

About Eastside Distilling

Eastside Distilling, Inc. (Nasdaq: EAST) is a producer of award-winning craft spirits, including whiskey, vodka, and rum. Founded in Portland, Oregon, Eastside is committed to quality, innovation, and sustainability, delivering exceptional products that reflect the spirit of the Pacific Northwest.

About Beeline Financial Holdings, Inc.

The Company recently closed on a merger with Beeline Financial Holdings, Inc. Beeline is a technology-driven mortgage lender offering a fully digital, AI-enhanced, platform that simplifies and accelerates the home financing process for homeowners and property investors. Based in Providence, RI, Beeline is dedicated to transforming the mortgage industry through innovative technology and customer-centric solutions.

Media Contact

Nick Luzza, BEELINE MORTGAGE , LLC Refinance, 1 4014184461 4014184461, nick@makeabeeline.com, https://www.eastsidedistilling.com/ 

View original content:https://www.prweb.com/releases/eastside-distilling-inc-announces-private-placement-offering-302306634.html

SOURCE BEELINE MORTGAGE , LLC Refinance

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The game-changer: New partnership between real estate tech innovator and luxury brokerage investor just gave agents at select firms valuable advantages and ease

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DALLAS, Nov. 15, 2024 /PRNewswire/ — The parent company of Briggs Freeman Sotheby’s International Realty, the leading luxury brokerage in Dallas, Fort Worth and all of North Texas, announces its groundbreaking partnership with Rechat, real estate’s only AI-powered Experience Management Platform for agents.          

Peerage Realty Partners, the world’s largest strategic investor in Sotheby’s International Realty affiliates, and Dallas-based Rechat have just advanced the real estate industry in a significant leap, through state-of-the-art technology. With the partnership, Rechat is now offering its advanced suite of tools and services to all Peerage Realty Partners brokerages — 206 offices across the U.S. and Canada — equipping its advisors with valuable advancements in real estate technology.          

Rechat was built to solve a universal and persistent problem faced by agents: the need to toggle between disparate platforms to manage the various aspects of their business. Briggs Freeman Sotheby’s International Realty has been working with Rechat almost since its beginning, as a first client, test case and collaborator. Now, years of innovation later, Rechat includes a marketing center, people center and deals center, allowing advisors to work within one integrated ecosystem to streamline tasks, automate listing marketing, create high-quality collateral, track transactions and more.          

Says Rechat CEO Shayan Hamidi: “We are dedicated to equipping agents with all of the tools they need — in one single tab or one single app — to excel in today’s competitive market.”          

Peerage Realty Partners is a leading residential real estate services firm, serving luxury markets across North America. Its brokerage partners include top Sotheby’s International Realty affiliates and other renowned independent firms. It has more than 6,100 advisors across 206 offices in the U.S. and Canada, to whose brokerages it provides strategic input, technology, marketing, operational expertise and much more. Its primary goal is to continually enhance the client, advisor and brokerage experiences through every phase of a transaction and beyond. Peerage Realty is projected to transact about $34.8 billion in sales in 2024 through its partner firms. Peerage Realty Partners, based in Toronto, Canada, has the unique benefit of being a privately owned enterprise, committed to long-term partnerships and investments.  

Says Gavin Swartzman, CEO of Peerage Realty Partners: “We are delighted to partner with Rechat to enhance our technological capabilities and provide our advisors with industry-leading tools. This collaboration aligns seamlessly with our ongoing commitment to leveraging innovation to better serve our clients and propel growth across our network.”    

To learn more, visit briggsfreeman.com, rechat.com and peeragerealty.com.

Peerage Realty Partners — the parent company of Dallas-based Briggs Freeman Sotheby’s International Realty and the world’s largest strategic investor in Sotheby’s International Realty affiliates — and Dallas-based Rechat, the creator of real estate’s only AI-powered Experience Management Platform for agents, have just advanced the real estate industry via state-of-the-art technology. With the partnership, Rechat is now offering its advanced suite of tools and services to all Peerage Realty Partners brokerages — 206 offices across the U.S. and Canada — equipping its advisors with valuable advancements in real estate tech. Rechat has eliminated the need for agents to toggle between disparate platforms to manage the various aspects of their business. After years of collaboration with Briggs Freeman Sotheby’s International Realty, Rechat now includes a marketing center, people center and deals center, allowing advisors to streamline tasks, automate listing marketing, create collateral, track transactions and more.

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SOURCE Briggs Freeman Sotheby’s International Realty

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