Newcomer Partner Therapeutics Nabs $60M, Acquires Leukine From Sanofi

Only a week after launch, Partner Therapeutics, or PTx, acquired the global rights to Leukine (sargramaostin) from Paris-based Sanofi.

Partner Therapeutics was formed by former executives of Sanofi and Merrimack Pharmaceuticals. The company’s launch didn’t provide much detail, other than it "is focused on the development and commercialization of approved and late-stage therapies. The Boston-area company is committed to supporting patient care with medicines that improve cancer treatment outcomes and reduce the total cost of care."

Today’s announcement provides significant more direction. Leukine is an immuno-stimulator. Its stimulant effects target a wide range of immune cells. The drug is already approved by the U.S. Food and Drug Administration (FDA) for acute myelogenous leukemia (AML) in older patients, and is used in both allogeneic and autologous bone marrow transplants.

In addition to gaining the global rights to develop, manufacture, and commercialize Leukine, PTx is buying a dedicated manufacturing facility in Lynnwood, Washington. It is a biologics manufacturing facility certified for commercial production in 2012. PTx will use it for core manufacturing and as a supply chain center.

Leukine is a recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF), the only one approved by the FDA. It stimulates growth and activation of monocytes, macrophages, neutrophils and dendritic cells.

The company plans to develop Leukine for new indications, and is already being evaluated in clinical trials in combination with various immuno-oncology therapies. One Phase II trial showed an improvement in survival with Leukine in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab) in refractory melanoma over Yervoy alone.

Leukine is presently in a Phase III trial in front-line melanoma in combination with Yervoy and Bristol-Myers Squibb’s Opdivo. It is also in development for Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS). Data was presented on that study at the 2016 American Society of Hematology meeting. A supplemental biologics licensing application (sBLA) was submitted in September 2017 with the FDA to approve Leukine for the treatment of H-ARS. The FDA granted it Priority Review status in December 2017, with a PDUFA date of March 29, 2018.

"We are delighted to have the opportunity to build a new future for Leukine and welcome the talented and dedicated team in Lynnwood to the PTx family," said Robert Mulroy, PTx’s chief executive officer, in a statement. "The acquisition of Leukine provides us with an established commercial business, a product that has demonstrated a clear and substantial impact on outcomes, and a program with the potential to become a core component of immuno-oncology, the treatment of acute radiation syndrome and the treatment of infections."

No financial details were released about the licensing arrangement. However, the company also announced today that it had closed on a Series A financing worth $60 million. It was led by Perceptive Advisors, Adams St. Partners and MidCap Financial.

"Given the significant expansion of programs and the growing complexity of early stage cancer therapies, we share PTx’s vision for a later stage oncology company that can serve as a translational bridge for new and existing programs to expand commercial access," said Terry Gould, Adams Street’s managing partner, in a statement. "Our investment continues our firm’s commitment to improving healthcare and is in complete sync with the mission-driven passion of the PTx leadership."

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