Celldex Therapeutics (CLDX) Gains on CDX-0159 Update, Which Has Drug 'In the Driver's Seat'
Celldex Therapeutics (NASDAQ: CLDX) shares are ramping 30% in early trading Monday following updated data from the company’s ongoing Phase 1b trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria.
The update highlights several key metrics:
- All 19/19 (100%) patients experienced a clinical response as assessed by provocation threshold testing; 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a partial response.
- Rapid onset of responses after dosing and sustained durability were observed.
- The median duration of response for patients was 77+ days for cold urticaria and 57+ days for symptomatic dermographism.
- A single 3 mg/kg dose of CDX-0159 resulted in rapid, marked and durable suppression of serum tryptase and depletion of skin mast cells (87% depletion) as measured through biopsy.
Celldex remains on track to initiate the Phase 2 studies in both spontaneous and inducible urticaria in the first half of 2022.
H.C. Wainwright analyst Joseph Pantginis finds the data encouraging and believes that “the future appears to have CDX-0159 in the driver's seat.”
While acknowledging that a “randomized Phase 2 data are going to be required to provide a significant portion of convincing to investors” the analyst points to the consistency in the clinical efficiency demonstrated by studies thus far, continuous positive safety profile, and the fact that currently no approved therapies exist for the condition, as he increases “our projected chance of success for CDX-0159 to 40% from 30% based on clinical and mechanistic data.”
Following the data, Pantginis raised the price target on CLDX to $50 from $36 while maintaining a Buy rating.
Cantor Fitzerald analyst Kristen Kluska said the 95% complete response rate (n=19) exceeded their expectations, and appear to show significant benefits in terms of time to onset and durability.
"As many investors remain focused on evaluating CDX-0159 as a therapy that could target many indicatons where mast cells are involved, the data today also demonstrate the mirrored effects of depleting mast cells with powerful effects on clinical efficacy, which we think can bode well for future applications," Kluska commented.
Written by Vlad Schepkov | [email protected]