Galera claims positive update in pancreatic cancer but doesn't report p-values; Amgen launches Canadian fund in tandem with CCRM
Malvern, PA-based Galera Therapeutics released updated follow-up data Wednesday afternoon for a Phase I/II trial in pancreatic cancer, though it did not reveal any p-values associated with the results.
According to the company, after six months of follow-up from 42 patients with locally advanced pancreatic cancer, the median overall survival was 20.1 months in the drug arm compared to 10.9 in the control group for the GC4419 candidate. Additionally, 29% of GC4419 patients saw a partial response versus just 11% on control, Galera said.
Galera did not say whether these results were statistically significant. The company also highlighted that positive results were also observed in local tumor control, time to metastases and progression-free survival, but did not show any data points or p-values regarding these measures.
Nevertheless, investors jumped for joy at the news, with Galera $GRTX shares trading up nearly 50% in pre-market movement Thursday.
“Final” results from this Phase I/II pilot study after a minimum of one-year follow-up, Galera added, which should come in the second half of 2021.
Wednesday’s news follows interim data from October regarding the same program. That release showed median OS hadn’t been reached in the drug arm compared to 38.7 weeks on control, good for a p-value of p=0.06. Galera also did not see any statistically significant changes in PFS at the time, with that figure’s p-value clocking in at a measly p=0.29.
Amgen launches Canadian fund in tandem with CCRM
Amgen is teaming up with a Canadian cell and gene therapy outfit to fund early-stage tech in the country, the pair said Thursday.
Going 50/50 with CCRM, Amgen is looking to identify, develop and commercialize what they consider promising technologies and therapies from research conducted in institutions that form CCRM’s global network. Contributions will range from financial support to in-kind technical services and expertise.
The pair will form a committee with representatives from both partners to determine which proposals will qualify for the program.
“There are few places in the world that have clustered all the necessary resources and talent to drive regenerative medicine from the bench to the bedside. Canada has consistently led the way for decades,” said Amgen VP of research Alan Russell in a statement.
CCRM is a global, public-private partnership headquartered in Canada that receives funding from the Canadian government, Ontario and other academic and industry partners. CCRM supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy.
Mirum licenses Chinese development of pruritus program to CANbridge
Mirum Pharmaceuticals has entered into a new licensing agreement where CANbridge Pharmaceuticals will commercialize the experimental cholestatic pruritus drug maralixibat in China, Hong Kong, Macau and Taiwan, the companies said Thursday.
Maralixibat is currently before the FDA under priority review, with Mirum shooting for an indication in cholestatic pruritus in patients with Alagille syndrome. The drug candidate targets the apical sodium dependent bile acid transporter (ASBT), ultimately resulting in lower levels of bile acid systemically, which could mediate liver damage.
Under the deal, Mirum will receive $11 million upfront, additional R&D funding and up to $109 million in future milestones. CANbridge has also agreed to oversee Mirum’s clinical study sites in China.
The drug is further being studied to treat cholestatic pruritus in progressive familial intrahepatic cholestasis and biliary atresia, with a global Phase IIb study in the latter having recently been launched.
Repertoire and Yale to study causes of multiple sclerosis in new research agreement
Repertoire Immune Medicines has signed a new research agreement with Yale University to go into the depths of cellular immunity in multiple sclerosis, the duo said Thursday.
The Cambridge, MA-based biotech and Yale will try determining what types of antigens are activating T cells in patients. They will work together to identify the specificity of various subsets of T cells with a goal of understanding the immunologic causes of MS.
To do so, the pair will examine the cerebrospinal fluid of patients living with MS, looking for potential causes of the disease and how the antigens activate pathogenic T cells. Researchers from Yale will provide human T cell receptor sequences to Repertoire, which will use its proprietary platform to determine the antigens that these TCRs identify.
“By understanding the immune codes in T cells from patients with MS, we will understand the basis of cellular immunity and hope to develop transformational medicines that no longer involve immunosuppression,” Repertoire R&D chief Anthony Coyle said in a statement.