Pharma Focus Asia

Sobi and Selecta Announce Strategic Licensing Agreement for SEL-212, a Phase 3-ready Novel Treatment for Chronic Refractory Gout

Friday, June 12, 2020

Swedish Orphan Biovitrum AB  and Selecta Biosciences, Inc. (Nasdaq: SELB) announced that the companies have entered into a strategic licensing agreement for the product candidate SEL-212. SEL-212 is a combination of Selecta's tolerogenic ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase) that is designed to durably control serum uric acid, reduce immunogenicity, and allow for repeated monthly dosing for the treatment of chronic refractory gout.

Gout is an autoinflammatory disease that causes intensely painful flares and debilitating inflammatory arthritis due to deposition of pro-inflammatory monosodium urate (MSU) crystals in synovial fluid and other tissues. Gout is the most common form of inflammatory arthritis in the US and prevalence in both US and Europe is rising. Chronic refractory gout occurs in patients who do not respond to conventional therapies and therefore suffer from high tissue MSU-burden that can cause frequent gout flares and chronic arthritis. The chronic refractory gout market is estimated to be worth at least USD 1 billion in sales in the US alone.

SEL-212 has the potential to reduce serum uric acid and MSU deposits in patients with chronic refractory gout. SEL-212 is a combination therapy comprised of pegadricase, a recombinant enzyme that metabolizes uric acid, and ImmTOR, a platform technology. Recombinant uricases are highly immunogenic in humans, and SEL-212, through Selecta's proprietary ImmTOR platform, has the potential to mitigate the formation of anti-drug antibodies, thereby enabling convenient once-monthly dosing and improving the efficacy and tolerability of the uricase. The phase 3 programme is expected to commence in 2H 2020."SEL-212 is a unique, late-stage product candidate containing a novel enzyme and a potentially ground-breaking immune tolerance platform, which could significantly improve the treatment for patients with chronic refractory gout, a debilitating disease with significant unmet need," said Guido Oelkers, Chief Executive Officer of Sobi. "This product candidate is highly differentiated based on the ImmTOR technology and has the potential to become a significant product in our growing Immunology business, and we are excited to become a shareholder and partner of Selecta."

"This agreement represents an important milestone for Selecta, and for patients with chronic refractory gout, as Sobi is the ideal partner with the commitment, resources, and complementary product portfolio to advance SEL-212 through development and commercialisation," said Carsten Brunn, Ph.D., President and CEO of Selecta. "This transaction further demonstrates our ability to execute on strategic business development, and provides Selecta with significant non-dilutive capital and cost savings, allowing the company to focus on utilising its pioneering ImmTOR, immune tolerance, platform to potentially improve the efficacy of biologics, enable re-dosing of life-saving gene therapy, and create novel immunotherapies for autoimmune diseases".

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