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HPV-Related Diseases

The CDC estimates that there are approximately 14M new infections with HPV each year. The annual cost to the US healthcare system of HPV is over $4B in diagnosis and treatment, making it the second costliest sexually-transmitted infection. While many of these are transient infections, the infections that persist are known to drive the formation of malignancies.

Cervical cancer incidence in the US is approximately 12,000, of which 99% is attributable to HPV. HPV-associated cancers are a major global health problem, with 500,000 new cases of cervical cancer annually.

While cervical neoplasias and cancer are the most well-known HPV-related conditions, HPV is also a major cause of anal neoplasias and anal cancer, oropharyngeal neoplasias that cause head and neck cancer, genital warts, and respiratory papillomatosis.

The advent of the prophylactic vaccine for HPV 16/18 in 2006 was a major step forward in the fight against HPV-associated cancers. However, the prophylactic vaccines do not cover all oncogenic HPV subtypes and adoption rates have been disappointing, particularly in the US and EU. Therefore, HPV infections and the disease states driven by such infections remain a major clinically unmet need.

Antiva Biosciences’s lead drug program is aimed at intervening before intraepithelial lesions in the cervix and anus become cancerous.

ABI-1968

ABI-1968 is a double prodrug of an acyclic nucleoside phosphonate with known potent anti-viral activity but poor cellular permeability and use-limiting systemic toxicity. When administered topically or locally, ABI-1968 provides rapid uptake into cells and slow release of the active metabolite, thereby overcoming the challenges of the parent compound. ABI-1968 works by directly blocking HPV replication and inducing apoptosis in HPV-infected lesions, while sparing normal cells.

Pipeline

Target Research Preclinical Development Phase 1 Phase 2

CIN

(Cervical intraepithelial neoplasias)

CIN

(Cervical intraepithelial neoplasias)

AIN

(Anal intraepithelial neoplasias)

AIN

(Anal intraepithelial neoplasias)

VIN

(Vulvar intraepithelial neoplasias)

VIN

(Vulvar intraepithelial neoplasias)

Other HPV-Based Diseases

Other HPV-Based Diseases

CIN

Cervical Intraepithelial Neoplasia (CIN) is a precancerous condition in which abnormal cell growth occurs on the surface of the cervix; over 99% of CIN is caused by HPV. There are approximately 500,000 new cases of CIN 1 (low grade) each year in the US, and an equal number of new cases of CIN 2/3 (high grade). Standard of care for CIN 1 is watchful waiting. However, many women with CIN 1 experience anxiety over harboring a sexually-communicable, cancer-causing virus and are requesting treatment. CIN 2/3 is treated with either surgical excision or ablation of lesions, but these carry increased risk of cervical stenosis, pre-term labor, and other problems. ABI-1968 is designed to address all stages of CIN with just a few, self-administered, intra-vaginal weekly doses.

Phase 1a/1b study: Our Phase 1a will evaluate the safety and tolerability of ABI-1968 volunteers. Our Phase 1b study will be conducted in women with cervical HSIL (CIN 2, 3). In addition to standard safety and tolerability measures, endpoints in our Phase 1b study will include evaluations of lesion appearance, histology, and changes in viral load.

AIN

Anal Intraepithelial Neoplasia (AIN) is a significant and rapidly growing indication, with prevalence estimated at well over 300,000 in the US. AIN is usually diagnosed at a late stage and progresses more rapidly to anal cancer than CIN does to cervical cancer. AIN is currently treated with ablation and off-label use of anti-viral and chemotherapeutic agents, but recurrence, toxicity and organ dysfunction are problematic. ABI-1968 may offer a safe and efficacious drug treatment option as a self-administered, topical therapy.

Phase 1 study: We plan to conduct a Phase 1 study in patients with anal HSIL (AIN 2, 3) in parallel with the Phase 1b CIN study.

VIN

Vulvar Intraepithelial Neoplasia (VIN) is a rare disease with high unmet medical need. VIN can be caused by HPV or by a genetic mutation and occurs most frequently in immune-compromised patients or those with concurrent CIN or AIN. If left untreated, VIN can progress to vulvar cancer. The most common treatments are surgical excision and laser ablation; these can cause disfiguration and pain and recurrence is common. Clinicians and patients would welcome a safe and efficacious topical treatment for this disease.