Selecta narrows focus to gout drug, freezing rest of pipeline

2023-08-17

临床3期基因疗法免疫疗法临床2期

Selecta narrows focus to gout drug, freezing rest of pipeline

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来源: FierceBiotech

Selecta Biosciences "remains committed" to SEL-212, which Selecta still hopes to submit to the FDA for approval as a chronic refractory gout treatment next year.

Three months after laying off a quarter of its workforce, Selecta Biosciences is now halting investment in all but one of its non-partnered programs to eke out enough cash into 2027.

The company “remains committed” to its Swedish Orphan Biovitrum-partnered asset SEL-212, which Selecta still hopes to submit to the FDA for approval as a chronic refractory gout treatment next year.

The drug is a formulation of the immunogenic enzyme pegadricase and biodegradable nanoparticles encapsulating the immunomodulator rapamycin that the biotech calls ImmTOR. It recently hit the primary endpoint in a pair of phase 3 trials that suggest potential to take on Horizon Therapeutics’ gout drug Krystexxa.

The rest of Selecta’s suite of candidates won’t be so lucky, with the biotech announcing today that development will now be paused for a combination ImmTOR-IL program, which had been on track to begin preclinical studies later this year to set up the drug for entering the clinic. Selecta had been hoping to explore the drug’s potential in a variety of autoimmune indications, starting with the liver.

“The company is currently assessing ways to support the development of this program through potential partnerships,” Selecta said in the release.

Analysts had held out hope that Selecta would stick with the ImmTOR-IL program, with Mizuho’s Uy Ear suggesting back in May that prioritizing “ImmTOR-IL for T-cell mediated autoimmune liver diseases would provide multiple shots on goal.”

However, Selecta will continue working on Xork, an IgG protease candidate that Astellas licensed in January to develop with the Japanese pharma’s gene theapy for Pompe disease.

“Our actions today will allow us to preserve capital and maintain our stockholders’ interest in [SEL-212] without the dilution that would have been required to support the development of our pipeline assets over the long term,” CEO Carsten Brunn, Ph.D., said in the release. “While we believe that our pipeline programs represent great potential, we intend to pursue partnership opportunities to advance the balance of our portfolio and maximize their value.”

The company had already sidelined SEL-302 in May, with Selecta reiterating today that it’s hoping to find a partner for the asset. The AAV gene therapy is in a phase 1/2 trial in combination with ImmTOR for the treatment of an inherited disorder called methylmalonic acidemia.

At the time, the biotech also made the decision to lay off 25% of its workforce as part of cost-cutting measure to keep cash flowing into the second half of 2025. Selecta ended June with $115 million in cash and equivalents, which—combined with its latest pipeline refocus and money coming in from Sobi—it now expects to last through to 2027.

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