Celldex Therapeutics (CLDX) recently presented updated data at the EAACI meeting from the randomized, placebo-controlled Phase Ib study testing its KIT targeting mAb, barzolvolimab (CDX-0159) for antihistamine refractory chronic spontaneous urticaria (CSU). In our view, the company is making progress in the clinic and has positioned the company for multiple upcoming stock catalysts, writes John McCamant, editor of The Medical Technology Stock Letter.

The CSU results were very similar to what was presented at the AAAAI meeting in February, with the caveat of more data being available on the durability of effect with barzolvolimab. In our view, ‘0159 is the leader in KIT inhibition and represents a promising and potentially differentiated treatment mechanism for patients with chronic urticaria and other mast cell driven disorders.

We got the updated results from the randomized, placebo-controlled, multiple-ascending dose Phase Ib study with IV barzolvolimab for antihistamine refractory CSU (35 patients treated across barzolvolimab cohorts, and 10 on placebo). As a reminder, both Xolair (omalizumab) naïve and experienced patients are allowed to enroll in the trial, and 37% of patients treated with barzolvolimab were omalizumab experienced.  ‘0159 responses occurred rapidly with good durability.

1Celldex Therapeutics (CLDX)
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This is highlighted by the fact that at week 12, 56% of all patients in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had a complete response (UAS7=0), and 64% had well-controlled disease (UAS7 ≤ 6). Of note, each of these dose groups is expected to saturate the KIT receptor, although for different durations of time.

CLDX has disclosed they now expect that topline data by YE 2023 from the randomized, placebo-controlled Phase II study with barzolvolimab in chronic spontaneous urticaria (CSU), with the Phase II CIndU study continuing to enroll patients (we expect data in 2024).

We like the ‘0159 data on chronic urticaria, and with the caveat of cross-trial comparisons and this being just a Phase Ib study, we believe these data (and the CIndU trial data) are supportive of barzolvolimab having a more profound effect than omalizumab (Xolair) in the chronic urticarial indication.

The SC data for ‘0159 will be very important for CLDX as the much easier delivery in the home setting could help make the drug candidate a blockbuster for chronic usage.

Recommended Action: Buy CLDX

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