BioPharma, Pharma

Major drug partnership aims to develop new cancer drug

Under the terms of the partnership between MEI Pharma and Helsinn, the latter will develop and market the former's cancer drug targeting acute myeloid leukemia.

Name: Rotation Medical Location: Plymouth, Minnesota Amount Raised: $21.7 million Investors: Life Sciences Partners, NEA, Pappas Venturs, Undisclosed firm Product: The company has developed the FDA-cleared Rotation Medical Rotator Cuff System to treat rotator cuff tendon tears. Source: Company Website and MoneyTree Report

A recent cancer partnership worth hundreds of millions of dollars aims to develop a drug to contend with acute myeloid leukemia.

San Diego-based MEI Pharma has inked a deal with Swiss firm Helsinn to develop and market its HDAC (the class of enzyme knows as Histone deacetylase) inhibitor Pracinostat, which is being studied in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Helsinn assumes worldwide development costs and marketing rights for MEI Pharma’s drug and gains a foothold in the cancer therapeutics market. MEI receives $20 million in near-term payments with the potential for $444 million in various milestones. Helsinn is also making a $5 million equity investment in MEI.

Based in Lugano, Switzerland, Helsinn develops and markets supportive care products, such as the anti-nausea drug Aloxi. A successful therapeutic could help the company hedge against more targeted cancer treatments that generate fewer side effects. MEI taps into Helsinn’s significant financial and marketing resources.

“They have relationships with physician who might eventually prescribe Pracinostat through their supportive care arm,” noted MEI president and CEO Daniel Gold. “We’re a small organization, and we knew we wouldn’t be able to build a large sales and marketing force. Helsinn is a good choice for our first lead partner.”

A week before the deal was announced on Aug. 8, Pracinostat was granted Breakthrough Therapy Designation from the FDA for AML, potentially accelerating development. The drug showed positive results in a recent phase II trial, in which Pracinostat was administered with azacitidine in patients 75 and older who likely could not tolerate standard chemotherapy.

Of the 50 patients in the study, 21 had a complete response, 19 of whom were still alive in December 2015. The overall survival was 19.1 months, basically doubling the OS for azacitidine alone. HDAC inhibitors, like Pracinostat, are designed to overcome cancer’s ability to co-opt epigenetic mechanisms.

“Cancer cells take advantage of this epigenetic program to downregulate tumor suppressor genes,” said Gold. “The drug allows these tumor suppressor genes to express, stopping the cancer from growing.”

Pracinostat could fill a small but important niche in AML treatment. The median age for AML patients is 67 and a significant number have trouble tolerating the standard 7+3 chemotherapy regimen. The drug could provide a less toxic alternative for these patients. According to the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) program, there will be around 17,000 new cases of AML in the U.S. this year.

“Because it’s an older population, you’re going to have a large chunk of those patients who can’t tolerate aggressive chemotherapy,” said Stephanie Hawthorne, vice president, Clinical & Scientific Assessment at Kantar Health. “Definitely a niche with a high unmet need.”

In addition to AML, Pracinostat could also be used to treat MDS, which hits around18,000 people in the U.S. However, Hawthorne notes that MDS may be underreported and the numbers might approach 50,000. Helsinn will take over development and commercialization for this indication as well.

While the phase II results are promising, at 50 patients, it was a small study. Pracinostat will enter a phase III trial for AML in early 2017. If all goes well, according to Gold, the drug could hit the market in 2021.

Still, MEI and Helsinn are not alone. Reformulated chemotherapies, such as Jazz Pharmaceuticals’ Vyxeos, might provide gentler alternatives for AML patients. In addition, Vadastuximab Talirine, an antibody drug conjugate from Seattle Genetics, targets a similar population and is currently in phase III trials.

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