RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Privately-held Galera Therapeutics secured $150 million in a Series C funding round that will be used to drive its experimental head and neck cancer treatment GC4419 into Phase III trials, as well as support pre-commercialization activities.
In a Phase IIb clinical trial, GC4419 demonstrated significant reductions in the incidence and duration of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer. Data showed that GC4419 was able to reduce the duration of SOM from 19 days to 1.5 days, a reduction of 92 percent. SOM is one of the most debilitating side effects of radiotherapy, and there are currently no effective therapies to prevent or mitigate it, the company said this morning.
GC4419 is a “highly selective and potent small molecule dismutase mimetic” that closely imitates the activity of human superoxide dismutase enzymes, according to company data. The experimental drug works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Phase III is expected to be initiated in the fourth quarter of this year, the company noted.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. It was also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced oral mucositis.
Mel Sorensen, president and chief executive officer of Galera, said the $150 million Series C validates the “dramatic and meaningful results” of the Phase IIb trial.
“The funds provide Galera with ample financial resources to complete the Phase III clinical trial, begin commercial planning activities and further explore the potential of GC4419 beyond SOM. We look forward to initiating a supportive care trial of GC4419 in radiation-induced esophagitis and a therapeutic trial in a second cancer indication, as well as continuing to evaluate the safety and anti-tumor effect of GC4419 in our ongoing Phase I/II pancreatic cancer clinical trial,” Sorensen said in a statement.
Galera dosed the first patient in the pancreatic cancer trial in February.
The Series C funding round included a $70 million equity raise and an $80 million royalty financing payable from future sales. The round was supported by new investor Clarus, with participation from additional new investors Adage Capital Management, HBM Healthcare Investments, Nan Fung Life Sciences, RA Capital, Rock Springs Capital and Tekla Capital Management LLC. Existing investors Correlation Ventures, Galera Angels, New Enterprise Associates, Novartis Venture Fund, Novo Ventures and Sofinnova Ventures.
Under terms of the financing agreement, Emmett T. Cunningham, managing director of Clarus, will assume a seat on the Galera board of directors. Additionally, Clarus will receive single-digit future commercial royalties from the sales of GC4419 and a related pipeline asset until the total royalty amount achieves an undisclosed multiple of the initial $80 million, upon which the royalty terminates.
“With its highly differentiated scientific approach and its potential in a number of indications, GC4419 is well-positioned to address serious unmet medical needs. We’re pleased to support Galera as the company moves closer to potentially bringing GC4419 to head and neck cancer patients with SOM who need a new treatment option,” Cunningham said in a statement.
Source: Biospace
