Will AnaptysBio’s HARP Results Be Soothing To Ears?

Hidradenitis suppurativa, also called acne inversa, is a chronic inflammatory skin condition that causes small, painful lumps to form under the skin, particularly in armpits or groin. AbbVie’s injectable biologic Humira is the only FDA-approved treatment for hidradenitis suppurativa. Antibiotics and corticosteroids are also used to manage the symptoms of this condition.

AnaptysBio Inc. (ANAB), a clinical-stage biotechnology company developing innovative immunology therapeutics, also has a drug candidate targeting hidradenitis suppurativa in its pipeline.

The drug candidate in focus is Imsidolimab, an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R. Studies have shown that IL-36 expression was increased in tissue samples of Hidradenitis suppurativa patients.

A phase II trial of Imsidolimab in moderate-to-severe hidradenitis suppurativa, dubbed HARP, is underway, with topline data due this quarter.

Imsidolimab is also being explored as a potential treatment for generalized pustular psoriasis, a systemic, life-threatening inflammatory disease characterized by widespread pustules.

A phase III trial of Imsidolimab in generalized pustular psoriasis, dubbed GEMINI-1, and a phase III, long term extension study of Imsidolimab in generalized pustular psoriasis, dubbed GEMINI-2, are underway. Topline data from the GEMINI-1 trial are anticipated in the fourth quarter of next year.

Also in the pipeline are two other clinical programs – Rosnilimab and ANB032.

Rosnilimab is an antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects. PD-1 is a protein found on T cells (a type of immune cell) that helps keep the body’s immune responses in check. (Source: National Cancer Institute).

— A phase II clinical trial of Rosnilimab in moderate-to-severe alopecia areata, dubbed AZURE, is ongoing, with topline data expected in the first quarter of next year.

ANB032 is an anti-BTLA agonist antibody with a broad potential to treat human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation.

— A phase I trial of ANB032, the results of which were reported in April of this year, demonstrated favorable safety and tolerability with no observed dose limiting toxicities and no serious adverse events.

The company will be seeking FDA clearance to initiate a phase II clinical trial of ANB032 in the fourth quarter of this year.

Collaboration with GSK

AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology collaboration with GSK, including Jemperli, Cobolimab, and GSK4074386, entitling it to receive royalties on sales of the drugs.

Q2 Scorecard

In the second-quarter of 2022, net loss was $32.6 million or $1.15 per share on collaboration revenue of $1.2 million. This compares with a net loss of $0.4 million or $0.02 per share and collaboration revenue of $30 million in the year-ago quarter.

As of June 30, 2022, the company had cash, cash equivalents and investments totaling $572.1 million.

AnaptysBio shares began trading on the NASDAQ Global Select Market on January 26, 2017, priced at $15 per share.

ANAB has traded in a range of $18.20 to $37.89 in the last 1 year. The stock closed Friday’s trading at $26.23, up 4.92%.

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