DevPro Biopharma is proud to partner with Uniquity Bio to rapidly advance their novel monoclonal antibody targeting TSLP into asthma and COPD studies
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Blackstone Life Sciences Launches Uniquity Bio to Develop Novel Medicines in Immunology & Inflammation

Uniquity Bio Set to Start Phase 2 Clinical Trials in COPD & Asthma with Novel Anti-TSLP Monoclonal Antibody

NEW YORK — May 15, 2024 — Blackstone (NYSE:BX) today announced the launch of the Blackstone Life Sciences (“Blackstone”) portfolio company Uniquity Bio, a clinical-stage drug development company focused on immunology and inflammation. Uniquity Bio is emerging from stealth with an FDA acceptance of its Phase 2 investigational new drug (IND) application for solrikitug, a monoclonal antibody targeting TSLP, and up to $300 million in capital from Blackstone to advance the asset in multiple indications.

The company aims to deliver best-in-class efficacy with solrikitug across several critical respiratory and GI indications with significant unmet needs. In the next month, Uniquity Bio will launch Phase 2 clinical trials in chronic obstructive pulmonary disease (COPD) — the third leading cause of death worldwide, according to the World Health Organization — and asthma, which the WHO estimates affects more than 260 million people across the globe.

“Our investment in Uniquity Bio illustrates Blackstone Life Sciences’ commitment to finding, developing and delivering potentially transformative medicines to patients around the world,” said Nicholas Galakatos, Ph.D., Global Head of Blackstone Life Sciences. “We are proud to partner with Uniquity’s team of veteran industry leaders as they advance solrikitug and expand their immunology and inflammation pipeline with additional programs in the near future.”

Solrikitug is a highly potent anti-TSLP monoclonal antibody, which prevents the binding of TSLP to its receptors. Given TSLP’s position as the “master switch” cytokine sitting at the top of the inflammatory cascade, solrikitug could have potential utility in a wide array of immunology and inflammation programs. Solrikitug was in-licensed from Merck & Co., Inc. (known as MSD outside of the U.S. and Canada).

“We believe solrikitug has the potential to be a life-changing medication for a significant number of patients who currently have very limited treatment options, and we are excited to move into the next phase of development,” said Brian Lortie, CEO of Uniquity Bio. “Our approach to development pairs the scientific rigor and quality standards of a global pharma company with the operational agility of a biotech startup, which allows us to move quickly without cutting corners. As we advance solrikitug and build our immunology and inflammation pipeline, we’re proud to have the ongoing support from Blackstone Life Sciences, which extends beyond capital investment to include their renowned corporate and scientific expertise.”

Kiran Reddy, MD, Senior Managing Director with Blackstone Life Sciences, added, “Uniquity Bio’s launch with a Phase 2-ready therapeutic demonstrates our approach of providing expertise and scale capital to our portfolio companies to help them advance their mission — and medicines — as fast as possible. We’re excited about the work that Uniquity has done so far with solrikitug and look forward to providing long-term financial support to the company.”

Uniquity Bio was founded by industry executives with an extensive track record of developing new therapeutics in immunology and inflammation, and successfully advancing many clinical programs from development through commercialization. With Blackstone Life Sciences supporting the company’s capital requirements, Uniquity Bio has a unique and sustainable business model that supports the parallel development of high-potential medicines along with a range of collaboration structures for maximum value.

The need — and market interest — in the field of immunology and inflammation are extensive and growing, as the global immunology market is projected to skyrocket from $98 billion in 2023 to $257 billion in 2032, according to Fortune Business Insights.

“As a nimble startup with a proven leadership team, we believe Uniquity Bio is well-positioned to develop promising therapeutics in this field and partner with leading global pharmaceutical companies,” said Stephen Tullman, Executive Chairman of Uniquity Bio. “I’m confident that our work will deliver new and highly valuable medicines to people living with immune-mediated diseases.”

ABOUT BLACKSTONE LIFE SCIENCES

Blackstone Life Sciences is an industry-leading private investment platform with capabilities to invest across the life cycle of companies and products within key life science sectors. By combining scale investments and hands-on operational leadership, Blackstone Life Sciences helps bring to market promising new medicines and medical technologies that improve patients’ lives and currently has more than $9 billion in assets under management.

ABOUT UNIQUITY BIO

Uniquity Bio is a clinical-stage drug development company built by biopharmaceutical executives with a proven track record and backed by Blackstone Life Sciences. The company is specifically structured to identify and advance therapeutic programs in immunology and inflammation with the scientific rigor and quality standards of a global pharma company, the operational agility of a biotech startup and a laser focus on improving patients’ lives. With a unique and sustainable business model, Uniquity Bio is actively building an immunology and inflammation pipeline. Its first lead asset is solrikitug, a monoclonal antibody targeting TSLP. The company anticipates delivering best-in-class efficacy in multiple respiratory and gastrointestinal indications with significant unmet needs.

DevPro Biopharma and Bespak Complete Early Feasibility Studies for New Groundbreaking Albuterol Inhaler

Ventolin-equivalent pMDI utilizes near-zero global warming potential propellant

BASKING RIDGE, NJ, & HOLMES CHAPEL, UK, May 7, 2024 – DevPro Biopharma and Bespak have announced the completion of early feasibility studies on DP007, a new formulation of albuterol in a pressurized metered dose inhaler (pMDI) which shows comparable performance to Ventolin® HFA but with a significant reduction in greenhouse gas emissions. This breakthrough pMDI is being developed by DevPro Biopharma, a respiratory-focused clinical development accelerator, and Bespak, a leading contract development and manufacturing organization (CDMO) focused on orally inhaled and nasal drug-device combination products. Clinical studies are planned to be initiated by the end of the year to fast-track its development, as the pharmaceutical industry begins to accelerate its transition to climate-friendly respiratory care.

The preliminary results will be presented on May 18, 2024, at the 2024 Respiratory Innovation Summit, hosted by the American Thoracic Society (ATS) during their 2024 International Conference at the San Diego Convention Center, San Diego, CA.

The new formulation has the potential to revolutionize the treatment of respiratory disease by reducing the global warming potential (GWP) impact of albuterol inhalers such as Ventolin, the most commonly prescribed inhaler type globally. It is expected to be commercialized by mid-2027 to meet the requirements of the US phasedown of fluorinated gases under the American Innovation and Manufacturing Act of 2020.⁽¹⁾

As many as 384 million people globally suffer from chronic obstructive pulmonary disease (COPD), and about 262 million people suffer from asthma.⁽²⁾ Most of these patients are treated using pMDIs that have a high GWP due to the use of greenhouse gases known as hydrofluoroalkanes (HFAs) as propellants. Greenhouse gas emissions challenge efforts to keep the global temperature rise at or below 2°C this century, and regulation is being tightened across the world as a result.

The innovative formulation is being developed by Bespak at its Research Triangle Park, NC research facility under the terms of an exclusive agreement with DevPro Biopharma.  The new formulation contains Honeywell’s Solstice® Air (HFO-1234ze(E) cGMP), a hydrofluoroolefin (HFO) propellant that has 99.9% less global warming potential than current HFAs and is in clinical development for pMDI products. This announcement follows an earlier announcement of the commercial partnership between Bespak and Honeywell to speed the development of near-zero GWP inhalers.

Colin Reisner, CEO of DevPro Biopharma, said, “Albuterol pMDIs account for approximately 45% of all pMDIs used worldwide, contributing substantially to global warming.  In the US, about 60 million prescriptions are written annually for albuterol pMDIs producing emissions equivalent to more than 200,000 passenger vehicles. There is an urgent need to develop a low-GWP albuterol pMDI to reduce the environmental impact of the life-saving inhalers patients need, without sacrificing performance or ease-of-use. Working with Bespak, we are excited about the results we have seen with DP007 showing comparable performance with Ventolin HFA. Based on our own market research, it has the potential to generate peak sales in excess of $500 million USD annually.”^(3-7)

Chris Hirst, CEO of Bespak, commented, “We’re committed to leading the transition to low-GWP propellants in pMDIs to help halt the global warming caused by greenhouse gases. Bespak has a long history in the development, scale-up, and clinical and commercial supply of inhalers and our goal now is to transition as many pMDI products as possible to meet the requirements of evolving global legislation. We believe in not only leveraging our own skills and capabilities, including our expertise in valves, actuators, and dose counters, but also working together across the industry to achieve this goal. Building on our partnership with Honeywell, we are proud to partner with the experienced team at DevPro Biopharma on this exciting development.”

Reisner added, “This is a low risk, high reward development program with opportunity for a major reduction in global warming. We have assembled a world-class team of experts from Bespak and DevPro Biopharma who have developed the plan together for the next phase of the program to quickly de-risk the asset. We are encouraged by interest in the program and look forward to speaking with potential investors at ATS 2024 Respiratory Innovation Summit.”

DevPro Biopharma is inviting expressions of interest from investors and pharmaceutical organizations in the next phase of the development program. Interested parties should contact Lin Ling.

For further information and interview opportunities with Bespak, contact Sarah Guinane at Notch Communications. 

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Bespak
Bespak is a global contract development and manufacturing organization (CDMO) focused on inhaled and nasal drug delivery devices and drug-device combination products. The company’s service offering spans early-stage feasibility, analytical services, and product development, from pilot-scale, through to clinical supply and commercial-scale drug product fill-finish, device, and component manufacturing. The company has made significant investments in commercial-scale and pilot-scale filling equipment for the manufacture of pMDIs using low GWP propellants and is the first CDMO to manufacture a pMDI at commercial scale with HFO-1234ze. Visit Bespak.com for more information.

DevPro Biopharma
DevPro Biopharma LLC is a respiratory-focused, fully integrated clinical development company with the mission to design, develop, and deliver molecules into medicines. The DevPro Biopharma team has collectively contributed to more than 50 approved products or label expansions. DevPro Biopharma is actively conducting studies in cystic fibrosis, idiopathic pulmonary fibrosis, progressive pulmonary fibrosis, asthma, and chronic obstructive pulmonary disease (COPD). Visit DevProBiopharma.com for more information.

References: 

1. The American Innovation and Manufacturing (AIM) Act authorizes the United States Environmental Protection Agency (EPA) to phase down production and consumption of Hydrofluorocarbons (HFCs) in the United States by 85 percent by 2036. More information: https://www.epa.gov/climate-hfcs-reduction.
2. The Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: https ://www.globalasthmanetwork.org/; Adeloye D, et al. Global Health Epidemiology Reference Group (GHERG). Global and regional estimates of COPD prevalence: Systematic review and meta-analysis. J Glob Health. 2015; 5 (2): 020415.
3. Pritchard JN. The Climate is Changing for Metered-Dose Inhalers and Action is Needed. Drug Des Devel Ther. 2020 Jul 29;14:3043-3055. doi: 10.2147/DDDT.S262141. PMID: 32801643; PMCID: PMC74103334.
4. Albuterol prescriptions number U.S. 2004-2021, Statista.
5. Hydrofluorocarbons, Climate, and Health —Moving the Montreal Protocol beyond Ozone-Layer Recovery. Author: Ashley Woodcock, M.D. Published June 24, 2023, N Engl J Med 023;388:2404-2406 DOI: 10.1056/NEJMp2302197. VOL. 388 NO. 26.
6. Greenhouse Gas Emissions from a Typical Passenger Vehicle, US EPA, https://www.epa.gov/climate-hfcs-reduction.
7. DevPro Biopharma data on file.

VENTOLIN® is a trademark of the GlaxoSmithKline group of companies.

Contacts: 

Investor Inquiries:  Lin Ling, DevPro Biohpharma: [email protected]

Media Inquiries: Sarah Guinane, Notch Communications:  [email protected]