Absci expects 2025 to shape up into a busy year with a planned release of interim data for the lead AI-designed candidate it anticipates advancing into the clinic early next year, as well as additional preclinical development for its two other disclosed pipeline programs.

The company is on track for an early 2025 launch of a first-in-human Phase I trial of lead candidate ABS-101, CEO Sean McClain told GEN Edge, with an interim data readout expected in the second half of next year.

Absci is in IND-enabling studies for ABS-101, which is designed to treat inflammatory bowel disease (IBD) by targeting tumor necrosis factor-like cytokine 1A (TL1A). The company began those studies earlier this year after selecting a primary and a backup development candidate from three versions of ABS-101.

The primary candidate was selected based on its profile seen in mouse PK studies, the potency it showed in in vitro assays, and its binding affinity, as well as its manufacturability and developability.

“The candidate that had the best attributes across the board is the one we advanced as the actual candidate,” McClain said. “The backup had the same potency, similar affinity, and similar half-life. There were just some attributes on the developability side that weren’t as good as the actual candidate itself. But it still was a strong candidate.”

In releasing first-quarter results last month, Absci also presented preclinical data showing that all three versions of ABS-101 could bind both the TL1A monomer and trimer—activity that the company said could potentially lead to differentiated clinical efficacy.

“This is really exciting because it allows us to potentially—and we’ll find it out in the clinic—be able to go after patient populations that competitor molecules are unable to,” McClain said.

All three versions of ABS-101 demonstrated high affinity, high potency, favorable developability, and extended half-life. In addition, using its de novo AI model, Absci has designed ABS-101 toward a specific epitope with the aim of achieving superior potency and lower immunogenicity.

At the 42nd Annual J.P. Morgan Healthcare Conference in January, Absci presented preclinical data on ABS-101 from multiple biophysical and cellular assays showing it to demonstrate equal or superior potency to two other TL1A-targeting drug candidates—RVT-3101, Roche’s TL1A-directed antibody candidate being developed for IBD, including ulcerative colitis (UC) and Crohn’s disease (CD); and Tulisokibart (MK-7240), which Merck & Co. is developing to treat immune-mediated diseases, including UC, CD, and other autoimmune conditions.

Later this year, Absci plans to share additional preclinical data, including results from nonhuman primate studies of ABS-101, likely via press release and data package.

Two additional candidates

Also in Absci’s pipeline are two additional preclinical candidates. One is ABS-201, a lead optimization phase drug to be developed for an undisclosed dermatological indication that according to the company has significant unmet need.

“I will say that we view this as an underappreciated target similar to TL1A,” McClain said.

TL1A was underappreciated, he said, until 2022 when Tulisokibart, then known as PRA023, generated positive clinical data as the lead candidate of Prometheus Biosciences—which Merck acquired last year for $10.8 billion.

“We think this derm target [ABS-] 201 is a very similar type of profile,” McClain asserted.

Absci expects to have a primary candidate for ABS-201 by the end of the year, at which point the company plans to release preclinical data. The company says ABS-201 has potential to be a best-in-class antibody showing high efficacy following once monthly or less frequent, low-volume, subcutaneous injection.

The other preclinical candidate in Absci’s pipeline is ABS-301, a lead optimization phase, fully human antibody that is designed to bind to a novel target discovered through Absci’s Reverse Immunology platform.

“We took a patient sample that had an extraordinary immune response, took the antibodies from the tertiary lymphoid structure, and then did a protein panel screen to find out what antigens or targets it was binding to. And that ended up allowing us to discover ABS-301, a novel I/O target,” McClain said.

He said the mode of action for ABS-301 will be validated in in vivo studies that are expected to be completed in the second half of this year: “This will be like essentially preclinical proof-of-concept similar to a Phase II POC [proof-of-concept].

Absci considers ABS-301 a potentially first-in-class immuno-oncology candidate. ABS-301’s target, which has not been disclosed, is an immune evasion strategy to limit immune infiltration and turn tumors immunologically “cold.” Absci reasons that ABS-301 treatment in cancer may release immune suppression and permit immune cells to infiltrate the tumor, allowing for a robust anti-tumor response.

Oncology and immunology and inflammation

Oncology and immunology and inflammation (I&I) have emerged as Absci’s key therapeutic areas of interest. In addition to -101, -201, and -301, Absci said, it expects to advance at least one additional internal asset program to a lead-identification stage this year.

The company’s pipeline could also grow if it succeeds in growing current collaborations with biopharma partners and establishing new ones. Absci has said it expects to sign drug creation partnerships with at least four additional partners this year, of which at least one could be a multi-program partnership.

Absci continues to make further progress on its existing drug creation partnerships and anticipates signing additional drug creation partnerships with at least four partners in 2024, including one or more multi-program partnerships.

“We are on track to achieve that goal,” McClain said. “We look to partner anywhere from a drug candidate phase, where we have preclinical proof of concept, all the way to a Phase II. There are a lot of factors that end up going into that, like what are the costs of the clinical trials? What is our own internal domain expertise? I think something like ABS-301, where we don’t have as strong of I/O expertise, that may get partnered sooner rather than later, but there’s a lot of factors that go into when we go about partnering.”

Absci finished the first quarter with $58.831 million in cash, cash equivalents, and another $102.712 million in short-term investments—enough of a “runway,” the company says, to fund its operations into the first half of 2027.

For the full fiscal year, Absci said, it expects to use approximately $80 million in cash, cash equivalents, and short-term investments—including expected costs associated with completing the IND-enabling studies for ABS-101 with an undisclosed contract research organization.

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