Dynavax Technologies Corp Reports Positive Results for Novel Shingles Vaccine

By Bobby Samwell • Thursday, August 21 15:36 • Permanent Link

Dynavax Technologies Corporation (NASDAQ: DVAX) has announced positive topline results from part 1 of its phase 1/2 clinical trial of Z-1018, its novel shingles vaccine candidate. The trial compared Z-1018 to Shingrix, the currently licensed shingles vaccine, in participants aged 50 to 69 years. The company reported robust immune responses in all dose arms, including a 100% humoral vaccine response rate at the selected dose for advancement, with comparable immunogenicity to Shingrix. Z-1018 also demonstrated a favorable tolerability profile, with lower rates of solicited local and systemic post-injection reactions compared to Shingrix.

The selected 100 mcg dose of Z-1018, adjuvanted with CPG 1018 and alum, with an 8-week dosing interval, showed promising results. At one month after the second vaccine dose, Z-1018 achieved a 100.0% humoral vaccine response rate compared to Shingrix at 96.9%, and an 89.7% cellular immune vaccine response rate compared to Shingrix at 93.5%. The geometric mean concentration of anti-GE antibodies for Z-1018 was 63.5 IU/ml, with a 49.6-fold increase, while Shingrix showed a geometric mean concentration of 71.7 IU/ml with a 56.0-fold increase.

In terms of tolerability, the Z-1018 arms with the 100 mcg dose and 8-week dosing interval showed lower rates of grade 2 or 3 local and systemic post-injection reactions compared to Shingrix.

Dynavax intends to advance Z-1018 into part 2 of the phase 1/2 program in adults 70 years of age and older, with plans to initiate the trial in the second half of 2025.

Z-1018 is an investigational non-live, recombinant subunit vaccine aimed at preventing shingles in adults 50 and over. It combines an antigen, glycoprotein E, with Dynavax’s proprietary adjuvant system, CPG 1018, and alum.

The positive results from this trial mark an important milestone for Dynavax's shingles vaccine program, positioning Z-1018 as a potential disruptor in the multi-billion-dollar shingles vaccine market, which is currently dominated by one product.

As of the time of the press release, no safety concerns have been identified in the ongoing blinded study, and the company is optimistic about the potential of Z-1018 to provide a strong immune response alongside favorable tolerability, compared to the current standard of care for shingles. Today the company's shares have moved 5.66% to a price of $11.01. For more information, read the company's full 8-K submission here.

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