Absci will partner with Almirall to develop and commercialize AI-designed therapeutics for chronic and debilitating skin diseases, through a collaboration that could generate more than $650 million for the Vancouver, WA-based generative AI drug developer.

Through the partnership, Absci will apply its Integrated Drug Creation™ platform to create and commercialize candidates for two dermatological targets to be identified, with the dermatological expertise of Almirall, a drug developer based in Barcelona, Spain.

Absci CEO Sean McClain told GEN Edge the partnership builds on a professional relationship maintained between two former colleagues—Andreas Busch, PhD, Absci’s chief innovation officer, and Karl Ziegelbauer, PhD, Almirall’s executive VP of R&D and chief scientific officer.

The two first met working at Bayer Pharmaceuticals, where both held several positions, with Busch reaching executive VP and head of global drug discovery and Ziegelbauer advanced to senior VP and head of open innovation and digital technologies.

“That was our entry into Almirall,” McClain said.

Almirall reached out to Absci after a team led by Joshua Meier, Absci’s senior VP and chief AI officer, first posted a preprint on bioRxiv detailed their ability to design new therapeutic antibodies by using the company’s zero-shot generative AI platform.

The first version of the preprint—“Unlocking de novo antibody design with generative artificial intelligence,” posted in January—showed how Absci researchers succeeded in creating and validating de novo antibodies in silico. In an posted in March, the researchers showed how they designed de novo versions of all three heavy chain complementarity determining regions (HCDR123), the antibody regions most critical to target binding.

“Almirall has a deep expertise in dermatology and the disease biology around that. Our domain expertise is on the technology side, the AI side,” McClain said. “Being able to apply that to novel and unique targets that our partners may have in order to solve hard, challenging problems, those are the exact types of partnerships we want to see.”

Adding to skin pipeline

The Almirall dermatology collaboration will add to Absci’s dermatology assets as it does not involve the skin disorder candidates now under development by both companies. Absci’s pipeline includes two preclinical dermatology drugs, both with undisclosed targets: ABS-201, in the lead optimization phase, and ABS-401, in target evaluation phase.

Absci says ABS-201 will be developed for an indication with significant unmet need, where it can stand out as a potentially best-in-class drug showing high efficacy following once monthly or less frequent, low-volume, subcutaneous injection. ABS-401, according to the company, has potential in immune-mediated conditions such as psoriasis, where it can differentiate itself from other drugs by offering a treatment option in poorly served patient populations.

ABS-201 and ABS-401 are two of four pipeline candidates that Absci disclosed at its recent inaugural R&D Day. The others are ABS-101, designed to treat inflammatory bowel disease by targeting TL1A and is in candidate selection phase; and ABS-301, a potentially first-in-class immuno-oncology candidate in lead optimization phase.

According to Absci, ABS-101 has shown potential in treating IBD as well as other inflammatory and fibrotic diseases—a market projected at ~$24 billion and set to grow to $29 billion by 2029, according to third-party figures shared by Absci.

ABS-301 has shown first-in-class potential based on a novel mechanism of tumor immune evasion, which applies reverse immunology​. Absci reasons that while tumors upregulate ABS-301’s target as an immune evasion strategy to limit immune infiltration and turn tumors immunologically “cold,” ABS-301 treatment in cancer may release immune suppression and permit immune cells to infiltrate the tumor, allowing for a robust anti-tumor response.

Each of the four programs could reach the IND filing stage in 2025. Each is a wholly owned asset focused on cytokine biology, and open to potential partnering agreements, McClain said.

“We’re planning on taking all of them to a candidate stage and then, depending on what the interest is from partners, we could sell or license it at a candidate stage. We may take it to an IND, or we could take it all the way to a Phase II,” McClain said. “We’re going to evaluate those options, and what the partner interest is, and what makes the most sense as we continue to progress.”

“IND machine”

Absci’s pipeline also includes several other programs. The company aims to generate 10 new active programs this year in addition to the four disclosed so far. “You’re going to continue to see Absci turn out new, exciting assets, and I think really turn into an IND machine,” McClain declared.

Almirall markets a dozen dermatological drugs in the U.S. and maintains a pipeline that includes two autoimmune dermatology candidates whose expected launch timeframes have yet to be set.

One is ALM27134, a fully human, high-affinity monoclonal antibody that targets IL-1RAP (interleukin-1 receptor accessory protein) in a Phase I trial launched last year. Almirall is developing ALM27134 through exclusive global licensing rights granted by Ichnos Science in 2021. Almirall agreed to pay Ichnos €20.8 million ($22.7 million) upfront, plus an undisclosed amount of milestone payments and royalties based upon future global sales.

The other Almirall pipeline candidate is ALM223 (formerly SIM0278), a preclinical interleukin 2 mutant fusion protein (IL-2 mu-Fc) candidate. Almirall said last week it plans to launch a Phase I trial “around the end of 2023” for ALM223, which is designed to activate regulatory T-cells—and which has shown in preclinical studies the potential to restore immune balance as well an improved PK profile.

Almirall is developing ALM223 under an exclusive, up-to-$507 million-plus licensing agreement inked last year with China’s Simcere Pharmaceutical Group, which developed the drug through its protein engineering platform. The agreement granted Almirall exclusive rights to develop and commercialize ALM223 for all indications worldwide except China, Hong Kong, Macau, and Taiwan. Almirall agreed to pay Simcere $15 million upfront, up to $492 million tied to achieving milestones, plus low double-digit tiered royalties based on future global sales.

Disease Agnostic

While Absci’s collaboration with Almirall focuses on skin disorders, McClain says Absci’s platform is disease-agnostic: “We do see it working across multiple indications, not just dermatology.” Almirall has agreed to pay Absci a combined up to $650 million in upfront fee, R&D work, post-approval payments tied to achieving milestones, and royalties on any product sales.

McClain said the companies are not disclosing how much of the $650 million is being paid upfront—but noted that Absci has not changed its investor guidance last updated projecting its “runway” of cash and cash equivalents and short-term investments will stretch into late 2025.

Absci finished the third quarter with cash and cash equivalents of $113.48 million (as of September 30), down 9% from $124.58 million (June 30), and down 37% from $181.31 million as of September 30, 2022. During Q3, Absci narrowed its net loss year-over-year from $27.26 million to $21.99 million, despite a drop in revenue from $2.37 million to $744,000 attributed to a combination of overall program progress, the timing of project-based milestones achieved, and the mix of ongoing programs activity.

Over the first nine months of the year, however, Absci revenue soared 28%, from $4.19 million to $5.38 million, but its net loss inched up 2% from $85.43 million to $87.02 million. Almirall finished Q3 with net income of €13.6 million ($14.8 million), a 25% jump from €10.9 million ($11.9 million) a year ago, on net sales that rose 6% year-over-year, from €633.8 million ($691.3 million) to €674.6 million ($735.8 million).

Almirall’s earnings before interest, taxes, depreciation, and amortization (EBITDA) fell nearly 6% from €146.4 million ($159.7 million) to €138.2 million ($150.7 million). But core EBIDTA rose 2% year-over-year, from an even €134 million (about $146.2 million) to €137.1 million ($149.5 million). Almirall earlier this month raised its net sales guidance low- to mid-single digit, to mid-single digit, though its EBIDTA forecast range remained at €165 million to €180 million ($180 million to $196 million).

Alex Philippidis is Senior Business Editor of GEN.

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