Partner Therapeutics (PTx), a Boston startup formed last week by a pair of Merrimack and Seragon executives, has made its first move: it’s acquired an ex-Sanofi cancer drug with hopes that the FDA will OK it for radiation poisoning. Like… the kind from an atomic bomb or a nuclear plant disaster.
Seems like a rare and uncommon event to target, but founder and CEO Bob Mulroy says it’s best to be prepared.
“You would hope you’d never need a drug like this for this kind of incident,” Mulroy told The Boston Globe. “But I think that, should an incident like that occur, being prepared for it is a very important thing.”
The Globe and others are positing that insults slung between President Trump and North Korean leader Kim Jong Un are fueling fears of nuclear war, leading to demand from people and governments to stockpile radiation sickness drugs.
The medicine is called Leukine, and it’s currently approved to treat acute myeloid leukemia patients fighting infections after undergoing bone marrow transplants. But data presented at the 2016 American Society of Hematology meeting showed Leukine’s ability to boost survival in monkeys exposed to radiation if injected 48 hours after exposure. That’s interesting, considering Amgen’s radiation sickness drugs Neupogen and Neulasta must be injected almost immediately after exposure to radiation for it to work.
As part of the asset acquisition deal, PTx also got a dedicated biologics manufacturing facility in Lynnwood, Washington. The location will serve as the core manufacturing and supply chain center for PTx’s operations, the company said in a statement.
An sBLA for the drug was filed in September 2017. The application WAS granted priority review and has a PDUFA data of March 29, 2018.
While radiation poisoning in the context of nuclear war is certainly the most eye-popping application, PTx has plenty of other plans for Leukine’s development.
Leukine has shown promise in combo studies with Yervoy (ipilimumab) against melanoma. A 250-patient, randomized Phase II study in refractory melanoma in combination with Yervoy demonstrated an improvement in survival over Yervoy alone, Partner says. Leukine is currently in a Phase III trial in front-line melanoma in combination with Yervoy and Opdivo (nivolumab).
Leukine is even a hopeful for Alzheimer’s disease.
“In contrast to other approved growth factors that stimulate one cell type, Leukine’s ability to stimulate a broader variety of cells, endows it with unique clinical potential to address serious medical needs across hematologic diseases and cancer as well as infectious, neurological and pulmonary disorders,” said Debasish Roychowdhury, CMO at PTx and former Seragon CMO, in a statement.
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