LOS ANGELES, Aug. 6, 2024 — Nammi Therapeutics, Inc. (Nammi) announces a $1M investment commitment by the Myeloma Investment Fund (MIF) in a $30M Series B financing round prior to the planned start of a first-in-human Phase 1 study of our lead program, QXL138AM, in patients with locally advanced unresectable and/or metastatic solid tumors and multiple myeloma.

QXL138AM is a Masked Immunocytokine (MIC) comprised of a masked interferon alpha (IFNa) fused to an antibody that targets the CD138 protein on the surface of the tumor cells. Once QXL138AM binds to the tumor cell, proteases on the cell surface cleave the mask off of the IFNa allowing it to bind its receptor. Activation of the IFNa receptor complex induces direct killing of tumor cells in addition to activating innate and adaptive anti-tumor immunity. Preclinical data has demonstrated significant anti-tumor efficacy across more than 10 tumor types including multiple myeloma where complete regression at doses as low as 0.1 mg/kg have been observed. Nammi has secured Orphan Drug Designation in multiple myeloma from the FDA on the strength of this data.

“While the multiple myeloma field has greatly benefitted from development of bispecific and cell therapies, there unfortunately remains a significant need for novel therapeutics such as QXL138AM.”, said David Stover, Ph.D., President and CEO of Nammi. “We are very excited to partner with MIF and the Multiple Myeloma Research Foundation (MMRF) and leverage their expertise to accelerate the development of QXL138AM. Together, we will work to realize the potential of this therapy to improve the lives of patients with multiple myeloma.”

With this investment by MIF, Nammi anticipates the $30M Series B financing round will be fully subscribed upon its closing when the first patient has been treated with QXL138AM.

“Nammi’s innovative technology and its application in multiple myeloma is an important step for the myeloma patient community,” said Michael Andreini, President and CEO of the Multiple Myeloma Research Foundation. “Advancing new therapeutic options for patients is the most critical task-at-hand, so we are thrilled to support Nammi’s Phase-1 trial to learn the potential of this exciting new immunotherapy approach.”

About Nammi Therapeutics, Inc.

Nammi Therapeutics, Inc. is an immuno-oncology company based in Los Angeles that is developing platforms and products that selectively activate anti-tumor immunity within the tumor microenvironment while minimizing systemic activation.  By reducing systemic activation of the immune system, Nammi expects to improve safety and enhance the ability to combine multiple immune modulators.  In addition to the MIC platform, Nammi has also developed a nanoparticle platform to deliver Immune Modulating Prodrugs (IMPs) using their Nammisome technology. Multiple Nammisome clinical candidates have also been selected for development. For more information visit www.nammirx.com or email [email protected]  

About the Myeloma Investment Fund (MIF)

The Myeloma Investment Fund is a venture philanthropy fund that invests in promising companies, clinical assets, and technologies in oncology to drive the development of new therapies for multiple myeloma. The MIF collaborates closely with portfolio companies to help them advance multiple myeloma research. This evergreen fund is supported entirely by philanthropy; all profits will be reinvested back into research for more effective treatments until there is a cure for every patient. For more information, visit www.myelomainvestmentfund.org 

About the Multiple Myeloma Research Foundation (MMRF)

The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit in the world solely focused on accelerating a cure for each and every multiple myeloma patient. We drive the development and delivery of next-generation therapies, leverage data to identify optimal and more personalized treatment approaches and empower myeloma patients and the broader community with information and resources to extend their lives. Central to our mission is our commitment to advancing health equity so that all myeloma patients can benefit from the scientific and clinical advances we pursue. Since our inception, the MMRF has committed over $600 million for research, opened nearly 100 clinical trials, and helped bring 15+ FDA-approved therapies to market, which have tripled the life expectancy of myeloma patients. To learn more, visit www.themmrf.org 

For MMRF or MIF media inquiries, please contact: Anna Otis, Manager, Brand Marketing, [email protected]

SOURCE Nammi Therapeutics, Inc.

New Equity Financing to Fuel Continued Growth, Product Innovation, and Expansion into New Markets

NEW YORK, Aug. 6, 2024 — Octane^® (Octane Lending, Inc.^®), the fintech revolutionizing the buying experience for major recreational purchases, announced that it has closed its Series E funding round with $50 million in new equity capital. Octane has raised $242 million in total equity funding to date.

The capital will fuel Octane’s expansion into new markets, supercharge its growth in existing markets, and position the company even more favorably for long-term success. This funding round is unique in that it was composed entirely of existing investors looking to increase their investment in the company. Valar Ventures led the round with participation from Upper90.

“We’re honored to strengthen our relationship with Valar and Upper90 as we bring speed and ease to the financing experience,” said Jason Guss, CEO and Co-Founder of Octane. “Octane’s digital tools and broad credit coverage have propelled us to become a leader in our initial market of powersports and gain significant traction in adjacent markets, like RVs. This new funding will help us build on this momentum and expand into new markets as we connect even more people with their passions.”

Since its founding in 2014, Octane has redefined the financing experience in the nearly $30 billion powersports market, which includes motorcycles, ATVs, UTVs, and personal watercraft. The company’s innovative digital tools, including the industry-leading dealer platform and award-winning suite of soft-pull prequalification tools, help its over 4,000 dealer partners deliver a seamless experience to their customers. Through its in-house lender, Roadrunner Financial^®, Inc., Octane has originated over $4 billion in loans and expanded into recreational vehicles (RVs), tractors, trailers, and electric vehicles. The company works with over 30 original equipment manufacturer (OEM) partners.

About Octane: 
Octane^® is revolutionizing recreational purchases by delivering a seamless, end-to-end digital buying experience. We connect people with their passions by combining cutting-edge technology and innovative risk strategies to make lifestyle purchases–like powersports vehicles, RVs, and outdoor power equipment–fast, easy, and accessible.

Octane adds value throughout the customer journey: inspiring enthusiasts with the Octane Media™ editorial brands, including Cycle World^® and UTV Driver^®, instantly prequalifying consumers for financing online, routing customers to dealerships for an easy closing, and supporting customers throughout their loan with superior loan servicing.

Founded in 2014, we have more than 30 OEM and 4,000 dealer partners, and a team of over 500 in remote and hybrid roles. Visit www.octane.co.

Octane^® and Roadrunner Financial^® are registered service marks of Octane Lending, Inc.

Media Relations: Shannon O’Hara
[email protected]                                                                  

Investor Relations: 
[email protected]

SOURCE Octane

COLUMBUS, Ohio, Aug. 6, 2024 — HubiFi, an advanced financial intelligence and revenue recognition solution, announced today it has secured $2.5M in a seed funding round co-led by Motivate Ventures, Anthemis (supported by Foxe Capital), and Rev1. Today also marks the launch of HubiFi’s Stripe Connector, enabling enterprise accounting and finance teams to measure revenue to cash with the click of a button.

Founded in 2023, HubiFi supports high-transaction companies’ accounting and finance teams to streamline complex financial data management processes. In today’s competitive business landscape, current financial teams and operators utilize heroics and heuristics to create a comprehensive analysis of revenue and margin performance because the underlying financial data on “profit and loss” (P&L) is never at the level of detail or segmentation needed; obstacles within this process lead to revenue leakage, and margin erosion. HubiFi’s fully automated system allows teams to aggregate and disaggregate by any segment, swiftly identifying operational drivers in their financials and capitalizing on often overlooked opportunities.

With the capital infusion, HubiFi plans to build a foundational team with a focus on product and engineering and add to the team with CPA and accounting expertise. By bolstering its talent base, HubiFi will gain deeper insights into customer needs and optimize the product development roadmap.

Since its inception, HubiFi has bootstrapped and validated its thesis, attracting a customer cohort within the high-transaction enterprise landscape, particularly in digital D2C and insurance.

By 2024, the startup had enough traction and data to clearly demonstrate a significant market gap to its team and investors. With HubiFi’s latest integration with Stripe, the technology manages complex revenue recognition use cases for customers utilizing subscription management, billing, payment, or any of Stripe’s products. In addition, the solution’s partnership with Paystand highlights their complementary strengths, with HubiFi focusing on revenue recognition and analytics while Paystand provides payment solutions without the variable fee model of Stripe.

“Unlike current ‘Revenue Management’ tools on the market, HubiFi is built to handle not just the ‘happy path’ use cases. We actually support mid-stream changes, multiple product lines, backdating, and disputes. said Jason Berwanger, co-founder and CEO of HubiFi. “Accounting and finance teams can rely on our automation, move beyond data management, and focus on improving their businesses.”

“Motivate is proud to be backing Jason and Bill, exceptional people who identified and began solving a simple yet difficult problem pervasive to tens of thousands of businesses,” said David Wieland, Founder and Managing Partner at Motivate VC. “We believe HubiFi is soon to become the next must-have tool for CFOs.”

“HubiFi has consistently demonstrated that existing ERP and General Ledger solutions do not adequately adapt to the needs of high-transaction businesses,” said Amy Nauiokas, Founder and CEO at Anthemis. “We are highly impressed by HubiFi’s proprietary data-mapping capabilities, which allow customers to adopt the technology in just days, swiftly enhancing their business processes.”

For more information, visit HubiFi.

About HubiFi

HubiFi is a finance intelligence and data management platform for built for high-transaction finance and accounting teams. Founded in 2023 by Jason Berwanger and Bill Kaper, HubiFi fully automates accounting and continuous reconciliations, enabling businesses to close an accounting period in hours instead of weeks.

For more information please contact: [email protected]

SOURCE HubiFi

SEATTLE, Aug. 6, 2024 — Seeq, a leader in industrial analytics, AI, and monitoring, announced today it has closed a $50 million Series D funding round led by leading global investment firm Sixth Street Growth, with participation from existing investors including Insight Partners, Altira Group, Second Avenue Partners, and Saudi Aramco Energy Ventures. This round brings Seeq’s total funding to approximately $165 million. Nari Ansari, Managing Director at Sixth Street Growth, will join Seeq’s Board of Directors.

Founded in 2013, Seeq serves hundreds of customers in energy, chemicals, pharmaceuticals, utilities, mining and materials, and other industrial sectors in 36 countries.

“Seeq has become the industry leader in industrial analytics through continuous, customer-inspired innovation, including its newest product, Seeq Vantage for Industrial Enterprise Monitoring,” said Dr. Lisa Graham, CEO at Seeq. “This investment bolsters Seeq’s ability to support our customers’ critical industry needs. We are excited to continue our growth with a stronger balance sheet and partnership with Sixth Street.”

“Seeq is uniquely positioned to build the next generation of technologies, especially AI, to optimize manufacturing and operational processes across multiple industries,” said Ansari. “Seeq brings together a company’s disparate time-series operational data sources with other structured and unstructured data to enable unique insights into understanding both the best and most challenging aspects of their operations.”

“Every company wants to identify key improvements through use cases like golden batch, emission reduction, energy utilization, asset optimization, and predictive maintenance,” added Claire Zhang and Chris Perron, Vice Presidents at Sixth Street Growth. “We are confident Seeq will continue to transform the way organizations unlock the power of their people and data to drive consistent, sustainable business results.”

“Seeq enables us to make data-driven decisions across many use cases that have delivered fast, quantifiable, real value,” said Dr. Sami Bahroun, Head of Industrial Data Science and Advanced Automation at Syensqo, formerly Solvay. “The new GenAI, advanced machine learning, and industrial monitoring capabilities fulfill unmet needs in addressing today’s workforce upskilling and operational challenges. We look forward to continuing to accelerate our digital transformation efforts and gain more value across the enterprise with Seeq.”

Lazard served as financial advisor to Sixth Street Growth in connection with the investment.

To learn more about Seeq, visit www.seeq.com.

About Seeq Corporation
Seeq, a global leader in advanced analytics, AI, and enterprise monitoring for industrial companies, delivers a self-service, enterprise SaaS platform and solutions to accelerate critical insights and action from historically unused data. Energy, pharmaceutical, specialty chemical, materials, mining, utility, and numerous other vertical industries rely on Seeq to optimize business and production outcomes, including yield, margins, quality, and sustainability. Seeq is a privately held virtual company with employees across the United States, Asia, Canada, Europe, and South America. To learn more about Seeq, visit www.seeq.com.

About Sixth Street Growth
Sixth Street Growth makes investments in mid- and late-stage technology companies. The Sixth Street Growth team partners with founders and management teams to provide differentiated capital solutions to accelerate organic and inorganic growth. Sixth Street Growth is the dedicated growth investing platform of Sixth Street, a leading global investment firm with over $75 billion in assets under management and committed capital. Sixth Street has invested over $9 billion in more than 70 companies through its Growth franchise since inception. Select Sixth Street Growth investments include Airbnb, AvidXchange, Bloomreach, Clio, Contentsquare, Datavant, Gainsight, Kaseya, MasterControl, MDLIVE, Spotify, and Sprinklr. For more information, visit www.sixthstreetgrowth.com, and follow Sixth Street on LinkedIn.

Media Contact:
Sydney DeLosh
206-801-9339
[email protected] 

SOURCE Seeq Corporation

Strong support from existing shareholders which includes Lilly, Advent Life Sciences, Columbus Ventures, Sound Bioventures and Belinda Termeer

CAMBRIDGE, Mass., Aug. 6, 2024 — Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, today announces the closure of an $8 million convertible debt financing, supported by Eli Lilly and Company, Advent Life Sciences, Columbus Ventures, Sound Bioventures and Belinda Termeer.

Artax’s lead asset, AX-158, is the first in a new class of Nck blockers, which have the potential to establish a new standard of care in autoimmune disease treatment. The molecule acts by selectively targeting Nck function, which plays a critical role in immune system function, and recalibrates the body’s T-cell receptor (TCR) responses. This recalibration to responses allows the immune system to continue functioning properly and activate only when it recognizes true disease threats – preventing self-activation without causing immune suppression that makes the body susceptible to numerous infections. Results from the Phase 2a clinical trial in psoriasis is expected before year end. 

“We have been strong believers in the broad potential of Nck modulation and very much look forward to see the highly anticipated topline data of first-in-class Nck modulator AX-158 in psoriasis later this year,” said Damià Tormo, a partner at Columbus Venture Partners. “Artax has a highly experienced team who have executed well, getting us into position to discover what Nck modulation can mean for autoimmune patients.”

“We are very grateful to participating shareholders, who see great promise in Nck modulation to address unmet need in autoimmune disease, for their continued support as we execute on our strategy to make Nck a universal oral therapy for autoimmune diseases. We are now well on our way to announcing first patient data with lead program AX-158 in psoriasis patients later this year,” commented Artax Chief Executive Officer, Rob Armstrong, Ph.D.

About Artax Biopharma
Artax Biopharma is a clinical-stage biotechnology company transforming the treatment of T Cell-driven autoimmune diseases. Artax’s first-in-class oral small molecules aim to deliver immune system modulation without immunosuppression, potentially unlocking new treatment options as both monotherapy and in combination with other treatments. The lead program AX-158 will deliver Phase 2a Proof of Concept data in psoriasis later in 2024.

We believe there is significant potential for its approach to revolutionize treatment of T Cell-driven diseases. Immunomodulation maintains healthy control of the immune system and addresses the underlying source of T Cell-driven diseases. Central to a well-functioning immune system is the T Cell Receptor (TCR). When TCR signaling becomes dysregulated, it causes T Cell-driven conditions, including autoimmune diseases, and induced T Cell pathologies where medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-host-disease or immuno-oncology treatments resulting in immune related-adverse events). We believe the immunomodulation mechanism offered by our investigational agents holds broad potential to revolutionize how these T Cell-driven autoimmune diseases are addressed, while not impairing the ability of a patient’s immune system to function properly.

Artax Biopharma is based in the Boston area and raised Series A & B and a convertible debt financing from Eli Lilly & Co., Advent Life Sciences, Sound Bioventures, Columbus Venture Partners, and others. For more info, see www.artaxbiopharma.com or follow us on LinkedIn. 

SOURCE Artax Biopharma

H3X builds innovative high power density electric motors for the aerospace, defense, marine, and heavy industry sectors. The company will utilize the funding to expand production and bring its megawatt-class electric motors to market

Infinite Capital leads the round, joined by Hanwha Asset Management, Cubit Capital, Industrious Ventures, Origin Ventures, Venn10 Capital, and Lockheed Martin Ventures, among others

DENVER, Aug. 6, 2024 — H3X, the leading manufacturer of high power density electric motors, announced today a $20 million oversubscribed Series A raise. The funding round was led by Infinite Capital, with participation from Hanwha Asset Management, Cubit Capital, Origin Ventures, Industrious Ventures, Venn10 Capital, and follow-on investors that include Lockheed Martin Ventures, Metaplanet, Liquid 2 Ventures, and TechNexus.

“We’re on an ambitious journey to become the world’s leading supplier of advanced electric motors,” said Jason Sylvestre, Co-Founder and CEO of H3X. “With remarkable speed, we’ve proven that this technology works and has a key role to play in enabling sustainable aviation, decarbonizing the marine and industrial sectors, and unlocking next-generation electrified defense technology. This funding round will enable us to scale up production and operations and deliver on some very large contracts in our pipeline.”

“Through the past three years working with H3X, I have seen a phenomenal display of rapid innovation from the team. Bringing technical advancements to market this fast is rare, as they have already commercialized a series of market-leading electric motors,” said Nathan Doctor, Founder and Managing Partner at Infinite Capital. “I strongly believe we’re on the verge of electrifying aviation and maritime transport, with H3X’s electric propulsion systems as the foundational technology.”

In the past 24 months, H3X has successfully validated its high-performance core technology, launched the HPDM-30, HPDM-250, and HPDM-140 integrated motor drives, and delivered these units to leading aerospace and defense customers. They also successfully completed multiple contracts with both NASA and the Air Force. With the Series A funding, H3X plans to expand production and bring its next-generation, multi-sector class of integrated motor drives to the market (HPDM-350, HPDM-1500, and HPDM-2300). The HPDM-1500 and HPDM-2300 are megawatt-class machines that will significantly enhance the performance of electric aircraft through their high power density and fault tolerance. In some cases, aircraft range can be doubled by using H3X motors versus conventional solutions by freeing up weight for additional energy storage onboard. These megawatt-class machines will also unlock new market segments for H3X in both marine and heavy industry.

“H3X is focused on scaling innovative technologies that we believe could offer our customers effective solutions for electrifying legacy, multi-domain systems,” said Chris Moran, vice president and general manager of Lockheed Martin Ventures. “Lockheed Martin’s continued investment in H3X underscores our dedication to advancing innovative solutions and expanding the defense industrial base to ensure the U.S and its allies remain ahead of emerging threats.”

“As an investor in frontier technologies, we were immediately impressed that H3X has solved the biggest engineering challenges to unlock major benefits for weight and volume sensitive applications,” said Philip Carson of Cubit Capital. “Notably, every customer spoke about how they want to work with this team above others. With strong traction today at the Department of Defense, we’re excited about how they can leverage that success to scale across industries.” 

Engineered, built, and tested at H3X headquarters in Denver, Colorado, these advanced integrated motor drives can scale in power from 30kW to 30MW and fill a large gap in the market for US-made, high power density motors and generators. H3X sees hybrid systems playing an increasingly larger role in the electrification transition of these industries because of the fuel burn reduction that can be realized without sacrificing mission range/endurance. This translates to lower operating costs as well as reduced emissions. In hybrid applications, H3X’s products can be used as either motors or generators without any hardware modifications required.

About H3X
Founded in 2020 by a team of engineers, H3X is an advanced technology and electric motor manufacturing company based in Denver, Colorado. Their team brings together driven minds from aerospace, automotive, and motorsports with deep knowledge in electric machines, power electronics, material science, and advanced manufacturing. They are heavily vertically integrated: designing, manufacturing, and testing their integrated motor drives under one roof at their 17,000 sq-ft headquarters facility. The mission of the company is to become the world’s leading supplier of advanced electric motors by 2030 to drive deep decarbonization in aviation, marine, and heavy industrial applications and unlock next-generation electrified defense technology to strengthen national security. For more information, visit http://www.h3x.tech/ and follow the company on LinkedIn.

Media Contact
[email protected]

SOURCE H3X

PITTSBURGH, Aug. 6, 2024 — Incline Equity Partners (“Incline”), a leading private equity firm dedicated to investing across the middle market, is pleased to announce the sale of ASP Global (“ASP” or the “Company”). ASP develops, sources and distributes consumable medical products for healthcare providers and distributors.

Based in Atlanta, GA, ASP leverages its global sourcing network to provide high quality products that are customized to meet the specific needs of health systems, labs, GPOs and distributors. The Company’s capabilities give customers control over the design and functionality of their products, helping them meet patient experience goals in a cost-effective manner.

“We are proud that ASP has more than doubled revenue since our investment in January 2020,” said Tom Ritchie, Partner at Incline. “Together, we strengthened the commercial team, driving organic growth through new hospital system wins and increasing wallet share with existing customers.”

“Our partnership with Incline has allowed us to complete four acquisitions, adding new product categories and expanding the breadth of the existing portfolio,” said Doug Shaver, CEO and President of ASP Global. “Our team has enjoyed the dynamic partnership with Incline, which has positioned us for continued growth.”

About Incline Equity Partners:

Incline Equity Partners is a leading private equity firm dedicated to investing across the middle market in services, value-added distribution and specialized light manufacturing companies. Incline is generally seeking growing companies with enterprise values of $25 – $750 million. Incline’s typical investment types are ownership transitions for privately held businesses, buyouts and corporate divestitures within the U.S. and Canada.

Disclaimer:

Incline Management, L.P. (“IMLP”) is registered with the U.S. Securities and Exchange Commission as an investment adviser under the U.S. Investment Advisers Act of 1940, as amended. Registration as an investment adviser does not imply a certain level of skill or training.  IMLP provides investment advisory services only to privately offered funds. IMLP does not solicit or make its services available to the public or other advisory clients. This press release is intended solely to provide information regarding Incline’s potential capabilities for prospective portfolio companies, and is not an offer to sell to any person, or a solicitation from any person of an offer to buy, any securities. The statements contained herein are not statements of any IMLP client fund or investor and do not describe any experience with or endorsement of IMLP as an investment adviser by any such client or investor.

SOURCE Incline Equity Partners

Investment will allow NeuroTherapia to continue the development of an orally available treatment for Alzheimer’s disease.

CLEVELAND, Aug. 6, 2024 — NeuroTherapia, Inc., a clinical-stage company and Cleveland Clinic Innovations portfolio company focused on developing therapies for neurodegenerative diseases, announced today the first closing of its Series B financing with $12.3M in funding. The Series B round, led by Cleveland Clinic, includes all previous investors, Brain Trust Accelerator Fund II, Dolby Family Ventures and the Alzheimer’s Drug Discovery Foundation (ADDF) as well as new investors, Foundation for a Better World and CRUINT. NeuroTherapia is using this funding primarily for the continued clinical development of NTRX-07, an orally available cannabinoid receptor agonist, for the treatment of Alzheimer’s disease (AD). The company will continue to raise additional funds for its second close in six months, which will enable development of a recently discovered second generation molecule for a separate indication in which neuroinflammation plays a major role.

 “We were pleased with the Phase 1b trial results that demonstrated a trend toward cognitive benefits in Alzheimer’s disease and wanted to continue its development as rapidly as possible,” commented Joseph Rich, JD, MBA, Senior Director, Cleveland Clinic Innovations, and lead investor representative in this financing. “We believe that the Company’s planned Phase 2a trial has the potential to not only demonstrate the ability of NTRX-07 to inhibit neuroinflammation, but it could also lead to an improvement in biomarkers of cognitive function in patients with Alzheimer’s disease.”

Coincident with the financing, the company welcomes Adam Hoffman to its Board of Directors as an Observer. Mr. Hoffman is an experienced investor and entrepreneur, currently serving as President of Foundation for a Better World. Mr. Hoffman joins Mr. Reher, who will continue to serve as Chairman of the Board, Tony Giordano, Ph.D., NeuroTherapia’s President and CEO, and Joseph Rich and Jim Ellis from Cleveland Clinic and Akhil Saklecha, M.D., the CSO at Danaher, on the Board. In addition, Meriel Owen, Ph.D., Director of Search and Evaluation at the ADDF, serves as an Observer.

“We are extremely fortunate to have the continued support of our previous investors and to add new investors with significant AD experience,” said Dr. Giordano. “The Board has provided invaluable insights over the past 4+ years and I am excited to continue to work with them to advance NTRX-07 for treating AD.”

In addition to the Phase 2a trial, NeuroTherapia will use funding from this financing to study NTRX-07 in a preclinical model of ARIA (a significant side effect observed with administration of therapeutic monoclonal antibodies) in combination with therapeutic monoclonal antibodies. Based on its mechanism of action, NTRX-07 may reduce or prevent the ARIA side effect associated with monoclonal antibody treatment and/or improve the benefits of these therapies. A demonstration of activity in the preclinical ARIA study could lead to subsequent trials where NTRX-07 is used in combination with the therapeutic monoclonal antibodies to provide additional patient benefits. The company has also identified second-generation molecules that will be advanced for other indications associated with increased neuroinflammation, such as pain, Parkinson’s disease or ALS.

About NeuroTherapia

NeuroTherapia is a clinical-stage, privately held biotechnology company developing oral, small-molecule drugs to address neuro-inflammatory conditions of the central nervous system (CNS), including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, and other CNS conditions. There is an emerging consensus that neuroinflammation plays a significant role in CNS disease. NeuroTherapia is developing therapeutics that inhibit microglia cells, which are known to express proteins that drive inflammation in the CNS, without affecting the clearance of toxic beta amyloid. We believe this approach will result in improved neuronal function and survival. At NeuroTherapia, our mission is to change the course of the most debilitating and deadly CNS diseases that patients and their families face today. Additional information about NeuroTherapia can be found at www.neurotherapia.com.

About The Alzheimer’s Drug Discovery Foundation (ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer’s Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer’s disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer’s, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF’s leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer’s PET scan (Amyvid^®) and blood test (PrecivityAD^®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer’s drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: http://www.alzdiscovery.org/.

SOURCE NeuroTherapia, Inc.

CHICAGO, Aug. 6, 2024 — Professor Sarfaraz K. Niazi of the University of Illinois has published a research paper in the journal Pharmaceuticsⁱ and filed a Citizen Petition to advise the US FDA to remove its 2017 ban on the US Pharmacopeia (USP) from developing analytical specifications of biological drugs that can enable removal of side-by-side analytical assessment of biosimilars that will reduce the cost of biosimilar development and establish a global standard of quality.

Professor Niazi, a biosimilars pioneer with dozens of textbooks, hundreds of research papers, and a history of FDA-approved biosimilars, created a new class of “monograph” that will not be labeled as a monograph. Instead, it will be called Biological Product Specification (BPS), which the USP will develop using commercial lots of reference products, just as the developers do. It will also provide validated test methods, removing the need for side-by-side testing of biosimilar candidates with their reference product.

“Biosimilars have failed to fulfill their role as over the past 15 years, only 15 molecules have come up as biosimilars, while hundreds are available, and even then, the cost has not dropped as anticipated due to the high cost of hundreds of millions of dollars and years to develop biosimilars. The backbone of biosimilarity is the analytical comparison that requires creating testing methods, obtaining ten lots of reference products, and conducting extensive testing. This can be removed if the US Pharmacopeia accepts this task and provides release specifications and test methods. In this case, all a biosimilar development does is test a small number of lots for meeting this specification; I anticipate that the FDA will be responsive as it has always been to favor scientific arguments and enable the USP to provide this service,” said Professor Niazi in an interview with Forbes Magazine.

In supporting Professor Niazi’s proposition, the SVP of Global Biologicals at the USP, Dr. Fouad Atouf, said, “It is crucial to remove barriers to testing biosimilars through reference standards, analytical methods, or quality guidelines. USPⁱⁱ is prioritizing the development of state-of-the-art analytical tools to accelerate the advancement of biologics and biosimilars. This supports continuous innovation, reduces barriers to market access for quality medicines, and provides solutions available to stakeholders across the global supply chain. Because of our longstanding work with manufacturers and regulators to ensure the quality of medicines, USP is uniquely positioned and eager to partner with government agencies, including the FDA, to remove obstacles and build solutions to bring biosimilars to patients faster.”

Professor Niazi is now expecting the US FDA to take the lead and implement this pivotal change, dramatically changing the accessibility of biological drugs globally.

Contact: [email protected] +1-312-297-0000

ⁱ Niazi, S.K. Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS) to Remove Side-by-Side Analytical Comparisons of Biosimilars with Reference Products. Pharmaceutics 2024, 16, 1013. https://doi.org/10.3390/pharmaceutics16081013
ⁱⁱ (https://www.usp.org/biologics/biosimilars)

SOURCE Professor Sarfaraz K. Niazi