The US Economic Development Administration has awarded a $47 million grant to a coalition led by Moffitt to build a radiopharmaceutical hub. The grant will fund five projects covering isotope production, drug manufacturing, and startup support, among other areas.

Private investors commit $200M to Moffitt's Pasco County cancer drug hub. Moffitt Cancer Center's plans to build a cancer drug manufacturing industry in Pasco County have attracted $200 million in private-sector commitments, according to an announcement Thursday by the U.S. Department of Commerce. The announcement also included a proposed $47.3 million federal award for the Florida Oncology and Radiopharmaceutical Growth Engine, or FORGE, a coalition built around Moffitt's 775-acre Speros campus in Pasco County. The federal money would help build manufacturing facilities, support biotechnology startups and train workers, bringing the combined public and private funding identified Thursday to more than $247 million if the federal award is finalized. Five months earlier, Moffitt and its partners had launched FORGE with plans to bring cancer drug development and manufacturing into the same regional network, working with the University of South Florida, Pasco-Hernando State College and Tampa-based startup accelerator Embarc Collective. Their particular interest is radiopharmaceuticals, a class of treatments that combine radioactive isotopes with compounds designed to find specific cancer cells, delivering radiation directly to tumors while limiting exposure to surrounding tissue. Producing those treatments presents a manufacturing challenge because radioactive isotopes lose radioactivity over time, and some decay quickly enough to make long-distance transportation difficult. Manufacturers need facilities capable of preparing the materials, hospitals need reliable access to them and researchers need laboratories to develop additional treatments - giving Moffitt a reason to concentrate those operations around Speros. The cancer center opened its 250,000-square-foot Discovery and Innovation Center on Oct. 22, adding research and laboratory space to its expanding Pasco County campus, where more than $600 million in broader infrastructure investments are supporting its growth. When FORGE launched earlier this year, its economic projections called for 4,000 high-wage jobs and $2.6 billion in statewide economic impact over 10 years, although the coalition had not identified how much capital had been committed specifically to the initiative. Thursday's disclosure provided a new financing figure, but the Commerce Department did not identify the private investors or explain how the $200 million would be divided among the proposed facilities. Manufacturing radioactive cancer treatments will also require specialized workers, bringing the coalition's education partners into plans for the new manufacturing and research facilities. Pasco-Hernando State College is expected to contribute imaging technologist training, USF will support nuclear pharmacy education and Embarc Collective will work with biotechnology startups developing products that could eventually move from laboratory research into commercial production. The proposed $47.3 million federal contribution comes from a $1.45 billion disaster recovery program administered by the Economic Development Administration, which is directing money toward communities damaged by natural disasters in 2023 and 2024. FORGE was selected under a funding pathway tied to hurricanes Helene and Milton that aims to help affected communities develop new industries as part of their economic recovery. The Commerce Department has not disclosed whether the $200 million in private commitments overlaps with previously announced investments or how much will go toward individual manufacturing and research facilities. The agency also has not released a construction schedule, a project-by-project budget or a date when the proposed $47.3 million federal award will become final. Read the latest coverage of business, commercial real estate, development, technology, finance and leadership from across the Tampa Bay region.

Novel HDAC inhibitor hits main goal in unresectable melanoma trial. - Four-month gain in PFS with HBI-8000, 13 months in LDH-normal subgroup, but toxicity a concern Progression-free survival (PFS) in unresectable melanoma improved significantly with the addition of an investigational histone deacetylase (HDAC) inhibitor to immunotherapy, a randomized trial showed. Median PFS increased from 7.36 months with nivolumab (Opdivo) and placebo to 11.66 months with nivolumab and HBI-8000. At 24 months, 41.3% of the combination arm remained alive and progression free compared with 28.7% of the control group. Patients with normal lactate dehydrogenase (LDH) levels at baseline, a majority of the study population, derived even more benefit from nivolumab-HBI-8000, with a median PFS of 20.04 months. Grade 3/4 treatment-related adverse events (TRAEs) occurred three times as often with nivolumab and HBI-8000 but were manageable in most cases, reported Nikhil Khushalani, MD, of Moffitt Cancer Center in Tampa, Florida, at the European Society for Medical Oncology congress in Madrid. "While GI [gastrointestinal] toxicities are certainly more common with this combination, these adverse events tend to be manageable with low rates of grade 3 and 4 nonhematologic adverse events," said Khushalani. "'The rate of endocrine toxicity appears similar to nivolumab alone. Combination HBI-8000 plus nivolumab can certainly be considered a standard-of-care option for advanced, unresectable melanoma, offering an advantage of oral dosing and potentially drug-specific dose attenuation for unique toxicities." The trial is clearly positive for the HDAC inhibitor-nivolumab arm, said ESMO invited discussant Olivier Michielin, MD, PhD, of Geneva University Hospital in Switzerland. The 2-year results compare favorably with 2-year results from two previous trials that established benchmarks for unresectable melanoma, CheckMate 067 (nivolumab with or without ipilimumab [Yervoy]) and RELATIVITY-047 (nivolumab alone or with relatlimab [Opdualag]). Two-year overall survival (OS) data for the earlier studies showed a nonsignificant trend favoring combination therapy, whereas 2-year OS data for the current study remain immature. "HDAC inhibitors clearly have an impact on cancer cells, promoting antigen presentation, but also making the cells more susceptible to immune killing," said Michielin. "There is also a wealth of impact on the tumor microenvironment, touching on all the cells, either directly or indirectly, and promoting generally a more immunostimulatory microenvironment, hence, a good rationale to combine these compounds with PD-1 blockade." "My personal take out of this abstract is that data could support HBI-8000 plus nivolumab as a first-line option, but the evolving dataset should be looked at carefully for OS but also toxicity in the coming months to really base our decision on the full package," he added. The phase III HBI-8000-303 trial followed a small phase Ib/II trial of the combination therapy in patients with anti-PD(L)1-naive advanced melanoma. The treatment led to an objective response rate of 65.8% with no unexpected toxicity. Conducted at 123 sites in 15 countries, the phase III trial enrolled 404 patients with unresectable stage III/IV melanoma and no prior exposure to a PD(L)1 inhibitor or any other immune checkpoint inhibitor. They were randomized to nivolumab with HBI-8000 or placebo and followed until disease progression or unacceptable toxicity. PFS was the primary endpoint. The patients had a median age of 67, and men accounted for 60-65% of the study population. Two-thirds of the patients had normal LDH levels at baseline, and about half had PD-L1-positive tumors. About 60% of the patients had clinical M0/M1a/M1b disease stage. After a median follow-up of 37 months, the primary analysis showed a 4.3-month difference in PFS in favor of the HBI-8000 arm, representing a 27% reduction in the PFS hazard (95% CI 0.56-0.95, P=0.0141). The subgroup analysis favored HBI-8000 for almost all patient categories. The PFS benefit with HBI-8000 in patients with normal LDH increased to 35% (CI 0.47-0.90, P=0.0082). PFS at 24 months showed a clear advantage for the HBI-8000 arm (41.3% vs 28.7% in all patients and 47.2% vs 32.6% in patients with normal LDH). Objective response rates were 41.4% versus 32.3%, a difference driven by a higher number of complete responses (14.3% vs 7.0%). Grade 3/4 TRAEs occurred in 54.8% of the HBI-8000 group and 17.9% of the placebo group. TRAE-related discontinuation rates were 14.1% with HBI-8000 and 5.0% in the control group. Notable differences in grade 3/4 hematologic TRAEs included thrombocytopenia (7.5% vs 0%) and neutropenia (16.6% vs 0.5%). Rates of pneumonitis, hyperthyroidism, and adrenal insufficiency were similar, including all-grade and grade 3/4.