BioPharma, Pharma

Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck

Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.

Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies.

Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication.

Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein (TSLP), a cytokine or signaling protein found in the skin, gut, lungs, and thymus. TSLP is involved in immune responses that drive disorders such as asthma and COPD. Blackstone describes it as a “master switch” atop the inflammatory cascade. As such, targeting it could address a wide range of immunology and inflammatory conditions.

“Our investment in Uniquity Bio illustrates Blackstone Life Sciences’ commitment to finding, developing and delivering potentially transformative medicines to patients around the world,” Nicholas Galakatos, global head of Blackstone Life Sciences, said in a prepared statement. “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.”

TSLP is already successfully hit by AstraZeneca antibody drug Tezspire, a once-monthly injectable drug that won FDA approval in 2021 as a treatment for asthma. A clinical trial is underway that could support expanding use of the drug to COPD. But Uniquity contends there’s still room for improvement in this drug class. On its website, Uniquity says its research suggests that the ceiling of efficacy has not yet been reached for TSLP drugs, and the company aims to achieve best-in-class efficacy through appropriate dose optimization. In antibody drug development, one way of standing out from competitors is with less frequent dosing, which eases the burden to patients. Uniquity has not disclosed the dosing interval for solrikitug.

There are other companies trying to get a piece of the TSLP drug market. Early this year, GSK paid $1 billion up front to acquire Aiolos Bio and its TSLP-targeting antibody with the potential for dosing every six months. That drug is ready for Phase 2 testing in asthma. Upstream Bio’s contender is verekitug, a TSLP-blocking antibody currently in Phase 2 testing in asthma and chronic rhinosinusitis with nasal polyps. Upstream is evaluating dosing at three-month and six-month intervals. These clinical programs are supported by a $200 million Series B financing that the Waltham, Massachusetts-based biotech closed nearly a year ago.

Publicly traded Zura Bio is preparing for mid-stage clinical development of ZB-168, an antibody licensed from Pfizer. This drug is designed to block IL-7 receptor alpha, which inhibits both IL7 and TSLP signaling. Phase 1 development of the drug under Pfizer spanned type 1 diabetes and multiple sclerosis. In its annual report, Henderson, Nevada-based Zura said its preparation for Phase 2 development of the antibody will be informed by the clinical progress of other companies’ IL-7 receptor programs in indications that include ulcerative colitis, atopic dermatitis, and alopecia areata.

Sanofi is focused on expanding approval of blockbuster immunology drug Dupixent to include COPD. But the pharma giant’s pipeline also includes lunsekimib (formerly SAR443765), a bispecific antibody that blocks the TSLP and IL-13 pathways. This drug has reached Phase 2 testing in asthma.

Blackstone Life Sciences invests in companies at various stages of development. In March, the firm announced it would provide up to $750 million to fund Moderna’s messenger RNA influenza program. Other deals include its support of RNA-interference research of Alnylam Pharmaceuticals and the launch of the cell therapy startup now known as AvenCell.

Uniquity said it expects its Phase 2 tests in asthma and COPD will start within the next month.