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Absci Highlights Progress and Updates Across Proprietary Pipeline and Leading AI Platform at 2024 R&D Day

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Absci (NASDAQ: ABSI) announced significant updates across its pipeline and AI platform at its 2024 R&D Day. The company highlighted progress on several drug candidates:

ABS-201, a novel anti-PRLR antibody for androgenic alopecia, demonstrated improved hair regrowth compared to minoxidil in preclinical trials, targeting a market of approximately 80 million individuals in the U.S. Phase 1 trials are expected to begin in 1H 2026.

ABS-101, an anti-TL1A antibody, showed promising safety profile in 13-week toxicology studies, with Phase 1 trials anticipated in 1H 2025. The company also reported progress on ABS-301 for immuno-oncology and ABS-501, a novel anti-HER2 antibody. Additionally, Absci achieved a breakthrough in designing antibodies targeting the HIV 'caldera' region, potentially advancing universal HIV vaccine development.

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Positive

  • Drug candidate selected for ABS-201 with demonstrated superior hair regrowth compared to existing treatment
  • Large market opportunity with 80 million potential patients in U.S. for ABS-201
  • ABS-101 showed favorable safety profile in 13-week toxicology studies
  • Breakthrough in targeting previously difficult-to-drug HIV epitope

Negative

  • ABS-201 Phase 1 trials not starting until 1H 2026
  • Multiple drug candidates still in early development stages

Insights

The R&D Day updates reveal significant progress in Absci's AI-driven drug development platform. The highlight is ABS-201, targeting a massive market of 80 million U.S. patients with androgenic alopecia. The preclinical data showing superior efficacy to minoxidil, combined with convenient dosing and favorable safety profile, positions it as a potential breakthrough treatment. The anticipated Phase 1 trial in 1H 2026 marks a clear development timeline.

The pipeline expansion with ABS-501, a novel HER2 antibody showing efficacy against trastuzumab-resistant tumors, demonstrates the platform's ability to address existing treatment limitations. The HIV caldera targeting breakthrough validates their AI platform's capability to tackle previously "undruggable" targets.

This comprehensive pipeline update strengthens Absci's market position in the AI-driven drug discovery space. The company is strategically targeting high-value markets - particularly with ABS-201 addressing the lucrative hair loss segment, which has significant commercial potential given the large addressable market and consumer-driven nature. The advancement of multiple candidates toward clinical trials in 2025-2026 provides clear value-creation milestones.

The platform validation through the HIV antibody breakthrough could attract more pharmaceutical partnerships, potentially leading to increased collaboration revenue. With a market cap of $470.9M, successful execution of these programs could significantly impact valuation.

Drug candidate selected for ABS-201, a novel, potentially category-defining anti-PRLR antibody in development for androgenic alopecia

Leading AI platform demonstrated breakthrough in successful de novo design of antibody targeting previously difficult-to-drug epitope in the HIV “caldera” region

VANCOUVER, Wash. and NEW YORK, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a data-first generative AI drug creation company, today announced updates and progress across its internal pipeline of proprietary Drug Creation programs, as well as new breakthroughs demonstrated by Absci’s AI Integrated Drug Creation™ platform. Absci leadership and a series of distinguished guest speakers will be presenting on these updates today at Absci’s 2024 R&D Day.

“Today’s updates represent another major step forward for Absci, as we continue to demonstrate our leadership in de novo AI antibody design, which is driving significant advancements in our internal and partnered programs,” said Sean McClain, Founder and CEO. “We are excited to showcase the target and significant opportunities we see for ABS-201, present new data for ABS-101 and ABS-301, and introduce ABS-501 to our pipeline. ABS-201, a potential treatment for male and female pattern hair loss, represents an opportunity to unlock an entirely new category of therapy for a substantial consumer-driven market with significant clinical unmet need. And as we near the end of 2024, we see next year as an opportunity to reach multiple milestones across our internal portfolio, and maintain a robust pipeline of potential partners across the Pharma and broader healthcare industry landscape.”

Speakers and topics to be covered during today’s presentation include:

Absci Leadership

  • Sean McClain, Founder & CEO, Absci
  • Andreas Busch, PhD, Chief Innovation Officer, Absci
  • Zach Jonasson, PhD, Chief Financial Officer & Chief Business Officer, Absci
  • Amaro Taylor-Weiner, PhD, Chief AI Officer, Absci
  • Christian Stegmann, PhD, SVP Drug Creation, Absci

Guest Presenters

  • Sir Mene Pangalos, PhD, Biopharmaceutical Executive; Board Director, Absci; Co-Chair, Absci Scientific Advisory Board
  • Dr. Luis Diaz, MD, Head of the Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center; Advisor, Absci
  • Dr. Dennis Slamon, MD, PhD, Chief of Division of Hematology and Oncology, UCLA Medicine
  • Karl ​​Ziegelbauer, PhD, Chief Scientific Officer, Almirall
  • Dr. Anthony Rossi, MD, Attending Dermatologist, Memorial Sloan Kettering Cancer Center; Professor of Dermatology, Weill Cornell Medical College; Advisor, Absci
  • Mike Jafar, Medical Aesthetics Executive; Advisor, Absci

ABS-201
ABS-201 is a potential best-in-class anti-PRLR antibody in development for androgenic alopecia, an indication with significant clinical unmet need and a large potential patient population of approximately 80 million individuals in the U.S. alone.

  • Absci has nominated a drug candidate with preclinical profile suggesting:
    • High affinity and potency
    • Favorable safety and immunogenicity
    • Extended half-life for convenient infrequent dosing
    • Excellent developability and manufacturability
  • Preclinical model demonstrates improved hair regrowth compared to minoxidil
  • ABS-201 has potential to offer a safe option as compared to current standard of care
  • Anticipate initiation of Phase 1 clinical trial in 1H 2026

ABS-101
ABS-101 is a potential best-in-class anti-TL1A antibody that demonstrates high affinity and potency, ability to bind the monomer and trimer of TL1A, anticipated low immunogenicity, high bioavailability in non-human primates, and potential to be administered subcutaneously with an anticipated dosing interval of 8-12 weeks, or even less frequently.

  • ABS-101 shows reduced internalization of TL1A complexes in in vitro THP-1 immunogenicity tests compared to a competitor molecule with a high clinical anti-drug antibody (ADA) rate.
    • This suggests a lower chance of developing ADAs in clinical settings, as internalization of mAb:TL1A complexes could contribute to immune activation and ADA formation.
  • 13-week GLP toxicology studies: No treatment-related adverse findings during in-life phase and necropsy were observed; histopathology is pending.
  • Anticipate initiation of Phase 1 clinical trial in 1H 2025

ABS-301
ABS-301 is a potential first-in-class antibody for an undisclosed immuno-oncology target, discovered through Absci’s AI Reverse Immunology target discovery platform.

  • Expression of ABS-301’s target suggests broad potential in squamous cell carcinomas and beyond.
  • For this program, Absci has optimized an antibody lead with high affinity and potency, and anticipates selecting a drug candidate in 1H 2025.

ABS-501
ABS-501 is a potential best-in-class novel AI-designed anti-HER2 antibody.

  • Absci has identified lead molecules using its zero-shot de novo AI technology with the following characteristics:
    • Novel epitope interactions
    • Increased or equivalent affinity to trastuzumab in preclinical settings
    • Efficacious against a trastuzumab-resistant xenograft tumor expressing wild-type HER2
    • Good developability
  • Anticipate selection of a drug candidate in 2025, and multiple paths for therapeutic development of this program are under consideration.

AI Platform Breakthrough Demonstrated through Collaboration with California Institute of Technology

  • Absci has achieved a breakthrough by de novo designing an antibody that targets a previously difficult-to-drug epitope in the HIV “caldera” region. This breakthrough potentially aids the development of a universal HIV vaccine.
  • Leveraging its proprietary de novo antibody design model AbsciDesign, Absci created antibodies targeting a highly conserved and structurally challenging region of the HIV gp120 protein. The “caldera” region, uniquely accessible only in the open conformation of gp120, has remained untargeted by previous broadly neutralizing antibodies.
  • Preliminary screening data indicates that designs bind clades A, B, and C with selective binding to open conformation. Antibodies from this study will be further experimentally evaluated to confirm fidelity of the de novo designed structure and epitope specificity.
  • Successful creation of these antibodies marks a potential pivotal milestone in HIV vaccine research and underscores the capability of AbsciDesign to target conserved epitopes that were previously considered out of reach.

A live and archived webcast of Absci’s 2024 R&D Day may be accessed via the company’s investor relations website at: investors.absci.com.

About Absci
Absci is a data-first generative AI drug creation company that combines AI with scalable wet lab technologies to create better biologics for patients, faster. Our Integrated Drug Creation™ platform unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimizing multiple drug characteristics important to both development and therapeutic benefit. With the data to train, the AI to create, and the wet lab to validate, we can screen billions of cells per week, allowing us to go from AI-designed candidates to wet lab-validated candidates in as little as six weeks. Absci’s headquarters is in Vancouver, WA, with our AI Research Lab in New York City and an Innovation Center in Zug, Switzerland. Visit www.absci.com and follow us on LinkedIn (@absci), X (Twitter) (@Abscibio), and YouTube.

Investor Contact
Alex Khan
VP, Finance & Investor Relations
investors@absci.com

Media Contact
press@absci.com


FAQ

When will Absci (ABSI) begin Phase 1 trials for ABS-201?

Absci plans to initiate Phase 1 clinical trials for ABS-201 in the first half of 2026.

What is the market size for Absci's (ABSI) ABS-201 drug candidate?

The potential patient population for ABS-201 is approximately 80 million individuals in the U.S. alone.

What breakthrough did Absci (ABSI) achieve in HIV research?

Absci successfully designed antibodies targeting a previously difficult-to-drug epitope in the HIV 'caldera' region, potentially advancing universal HIV vaccine development.

When will Absci (ABSI) begin Phase 1 trials for ABS-101?

Absci anticipates initiating Phase 1 clinical trials for ABS-101 in the first half of 2025.

How did ABS-201 perform compared to existing treatments in preclinical trials?

ABS-201 demonstrated improved hair regrowth compared to minoxidil in preclinical models.
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