TG Therapeutics prepares to approach regulators with MS drug; Investors bet $93M on a life sciences tools company
Gearing up for a battle with pharma giants, TG Therapeutics says it’s nearly ready to approach regulators with its CD20 drug for multiple sclerosis.
The biotech read out results from two Phase III trials at AAN, which show its candidate ublituximab reduced patients’ annualized relapse rate by 60% and 50% compared to Sanofi’s Aubagio, or teriflunomide — an 8-year-old drug that’s often used as a benchmark.
Investigators followed relapsing MS patients for 96 weeks, with those in the ublituximab group receiving a one-hour intravenous infusion every six months (except a longer but smaller dose infusion on day 1 and another longer one on day 15). The teriflunomide cohort took the 14 mg oral tablets every day.
Back in August, Novartis got the green light for Kesimpta after demonstrating a significant reduction in ARR of 51% and 59% over the active control arm in a pair of trials.
In addition to the primary endpoints, ublituximab also met key secondary endpoints, according to TG. In the trials, dubbed ULTIMATE I and II, patients in the treatment arm saw their total number of T1 Gadolinium (Gd) enhancing lesions reduced by 97% and 96% relative to the control arm, with a p-value of less than 0.0001. New or enlarging T2 lesions were redacted by 92% and 90%, respectively, compared to the control arm, TG says.
CEO Michael Weiss says he’s aiming to file a BLA in Q3 of this year.
Investors bet $93M on a life sciences tools company
Investors have an appetite not only for innovative therapies, but also for the developers of the tools behind them.
Lumicks, a company that produces equipment for dynamic single-molecule and cell avidity analysis, unveiled a $93 million Series D round on Friday. The round was led by Farallon Capital Management and Lauxera Capital Partners, with a hand from Softbank Vision 2, funds and accounts advised by T. Rowe Price Associates, Parian Global Management, Pura Vida Investments, Gilde Healthcare Irving Investors, and select managers of the Lumicks team.
Most of the funds from this round will back the company’s growth initiatives, including the expansion of its recently released z-Movi Cell Avidity Analyzer, which rapidly measures the binding strength between target and immune cells.
Lumicks got its start in 2014, when it spun out from the research group of professors Gijs Wuite, Erwin Peterman, and Iddo Heller at the Vrije Universiteit Amsterdam.
Ideaya reads out preliminary Ph I/II results in melanoma
Ideaya says patients who took its metastatic uveal melanoma candidate darovasertib achieved a 57% 1-year survival rate compared to a historic 37% 1-year survival rate in similar populations, according to preliminary Phase I/II data.
On Friday, the synthetic lethality-focused company offered an early look at studies testing darovasertib alone and with Pfizer’s Mektovi in patients with metastatic uveal melanoma (MUM) and skin melanoma.
According to Ideaya, a group of predominantly second-line, third-line and heavily pretreated MUM patients on the monotherapy achieved a median overall survival of 13.2 months. The biotech compared the figure to historic median OS in similar MUM populations, which is about 7 months.
As for the combination therapy, researchers noted 2 partial responses out of 9 MUM patients with at least 2 post-baseline scans by RECIST 1.1 guidelines (a standard way to measure how well a cancer patient responds to treatment). And 79% of evaluable MUM patients with at least 1 post-baseline scan showed tumor reduction, Ideaya said.
“The darovasertib single-agent one-year survival data in MUM is encouraging and compares favorably to historical survival rates in this indication, where a therapy has yet to be approved,” said Meredith McKean, an associate director of melanoma and skin cancer research at Tennessee Oncology’s Sarah Cannon Research Institute.