Lantheus Holdings Inc., of North Billerica, Mass., has entered a strategic collaboration with Paris-based Carthera SAS for the use of its microbubbles in combination with Carthera’s investigational Sonocloud system. The implantable device is in development for the treatment of recurrent glioblastoma, a fast-growing brain tumor with a post-diagnosis median survival of just 15 months.

The agreement follows a strategic collaboration earlier this year with Cerevast Medical Inc., of Bothell, Wash., for the use of microbubbles with Cerevast’s ocular ultrasound device in the treatment of retinal vein occlusion. Lantheus also is working with Shanghai-based Nanomab Technology Ltd., a privately held company focused on next-generation radiopharmaceuticals for use in developing immuno-oncology therapies.

The new deal furthers two of Lantheus’ strategic goals, finding new applications for its microbubbles and expanding its footprint in oncology.

“We are excited to collaborate with Carthera to extend our microbubble franchise into the oncology field to target glioblastoma, an aggressive type of brain cancer with significant unmet medical need,” said Mary Anne Heino, Lantheus’ president and CEO. “Our collaboration leverages both companies’ strengths to bring novel solutions to the healthcare community.”

With an incidence rate of 3.19 per 100,000 people in the U.S., glioblastoma is rare but devastating. Few patients survive 2.5 years, and less than 5% are alive five years after diagnosis. The median age of diagnosis is 64 years, with men having a 1.6 times higher incidence than women. Treatments for glioblastoma include radiation, chemotherapy and surgery, but there is no cure.

Under the commercial supply agreement, Lantheus’ microbubbles will be incorporated as an element in Carthera’s Sonocloud system, which uses low-intensity pulsed ultrasound (LIPU) to open the blood-brain barrier and allow chemotherapy to reach tumors. Carthera will handle all regulatory submissions, approvals and commercialization of Sonocloud in the U.S., Europe and other parts of the world. Lantheus will provide its microbubble vials, the ultrasound resonator, as well as activation devices at a predetermined transfer price. Lantheus will also receive royalties on future sales of the Sonocloud kit.

“As the use of microbubbles in diagnostic and therapeutic applications gains more interest around the world, our collaboration with Carthera demonstrates our commitment to drive Lantheus’ microbubble into new disease areas with great potential for significant improvement in patient outcomes.”

Sonocloud. Credit: Carthera SAS

Earlier this year, Carthera published promising results from a phase I/IIa study using Sonocloud-1 to open the blood-brain barrier prior to carboplatin chemotherapy in patients with recurrent glioblastoma. Specifically, 11 patients who got optimal pressure levels of ultrasound had a median progression-free survival of 4.11 months and a median overall survival of 12.94 months, compared with 2.73 months and 8.64 months, respectively, in patients who received a suboptimal dose. Carthera’s next-generation Sonocloud-9 system is currently being assessed in a phase IIa study, with a phase IIb/III pivotal trial in the U.S. and Europe to follow.

“With Lantheus’ expertise in the field of microbubbles combined with Carthera’s novel and proprietary ultrasound technology, we see the potential for a long-term highly successful collaboration,” said Carthera CEO Frederic Sottilini. “We are excited to work with Lantheus to advance our promising Sonocloud technology with the goal of improving treatment and prognosis of patients with glioblastoma, a debilitating, and all too often, fatal disease.”

This has been a busy year for Lantheus and one marked by its growing focus on oncology. In October, the company reported it was buying New York-based Progenics Pharmaceuticals Inc. in an all-stock transaction valued at about $400 million. Progenics develops medicines and other technologies to target and treat cancer.

Under the Nanomab collaboration, announced in May, Lantheus is licensing NM-01, a radiopharmaceutical biomarker camelid single-domain antibody, which has shown a high affinity for the PD-L1 protein, whose presence on the surface of tumor cells helps them trick the immune system and avoid being attacked as harmful substances. Lantheus said it would provide Nanomab’s NM-01 as a clinical research tool to drug companies and large academic centers.

NM-01 is currently being assessed in a phase I study of up to 50 patients with non-small cell lung cancer who have undergone biopsy of the primary lesion. Early data, published in February in the Journal of Nuclear Medicine, showed that 99mTc-labeled anti-PD-L1-sdAb SPECT/CT imaging is safe and associated with acceptable dosimetry, with no drug-related adverse events. Tumor uptake was also easily seen against background tissues.

For the third quarter of 2019, Lantheus reported global revenue of $85.8 million, down 3.5% from $88.9 million in the same period the previous year. Net income dropped 47.6% year over year to $4.9 million. The company attributed the difference in part to $7.5 million in sales of its Technelite Technetium-99m generator to an international partner in Q3 2018.

During a third-quarter earnings call, Heino highlighted Lantheus’ microbubble franchise and its flagship product, Definity. “Definity’s continued growth is a result of an increasing appreciation of the benefits of echocardiography as well as our ability to continue to grow the appropriate use of Definity in suboptimal echocardiograms. This strength fuels our confidence in the long-term growth of our existing business as well as our commitment to key pipeline and infrastructure initiatives, which we believe will support the sustained growth and profitability of our microbubble franchise.”

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